Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 18 de 18
Filter
1.
Vaccine ; 37(28): 3715-3721, 2019 06 19.
Article in English | MEDLINE | ID: mdl-31122856

ABSTRACT

BACKGROUND: Several studies have shown differences in susceptibility to infections and immune response to vaccines by sex. Prematurely born infants are at higher risk for pneumococcal diseases, with lower effectiveness for some vaccines compared to term infants. We have reported the effectiveness of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) on several endpoints in the Finnish Invasive Pneumococcal disease (FinIP) vaccine trial. Now, we present the results of a post-hoc analysis evaluating PHiD-CV10 effectiveness in subgroups by sex, gestational age, and birth weight. METHODS: The FinIP trial was a phase III/IV cluster-randomized, double-blind trial. Infants enrolled < 7 months of age received PHiD-CV10 in two thirds of clusters (3 + 1 or 2 + 1 schedule) and hepatitis B vaccine as control in remaining third. Outcome data included invasive pneumococcal disease, pneumonia, tympanostomy tube placements, and antimicrobial purchases collected through national, routinely used health registers. Negative binomial model was used in the incidence and vaccine effectiveness estimation, and differences in incidences between subgroups were tested among control children. RESULTS: Of the 30,527 infants enrolled 51% were boys. The incidences of hospital-diagnosed pneumonia and otitis-related outcomes were higher among boys in control groups. There were no significant sex differences in the vaccine effectiveness estimates. Altogether, 1519 (5%) infants were born before 37th gestational week. The incidences of pneumonia outcomes were higher among premature infants when compared to term infants. The vaccine effectiveness estimates among preterm infants were not statistically significant except for antimicrobial purchases, but all point estimates were at the same level among preterm infants as among term infants. There was no significant difference between 2 + 1 and 3 + 1 schedules in any of the subgroups analysed. CONCLUSION: PHiD-CV10 had a similar effectiveness in both sexes, and seemed to be protective in preterm infants. TRIAL REGISTRATION: ClinicalTrials.gov NCT00861380 and NCT00839254.


Subject(s)
Infant, Low Birth Weight/immunology , Infant, Premature/immunology , Pneumococcal Vaccines/immunology , Vaccines, Conjugate/immunology , Anti-Bacterial Agents/therapeutic use , Double-Blind Method , Female , Finland , Humans , Immunization Schedule , Infant , Infant, Newborn , Male , Pneumococcal Infections/immunology , Pneumococcal Infections/prevention & control , Pneumonia/immunology
2.
Vaccine ; 36(39): 5891-5901, 2018 09 18.
Article in English | MEDLINE | ID: mdl-30145098

ABSTRACT

BACKGROUND: Pneumococcal conjugate vaccines have potential to prevent significant proportion of childhood pneumonia. Finnish Invasive Pneumococcal disease vaccine trial was designed to assess the vaccine effectiveness (VE) of the 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine (PHiD-CV10) against several outcomes. We now report results for pneumonia. METHODS: In this nationwide, cluster-randomised, double-blind trial, children younger than 19 months received PHiD-CV10 in 52 clusters or hepatitis vaccines as control in 26 clusters. Infants younger than 7 months at the first vaccination received either 3+1 or 2+1 vaccination schedule, children aged 7-11 months received 2+1, and those 12-18 months of age two-dose schedule. All hospitalizations and outpatient visits to hospital associated with ICD-10 codes compatible with pneumonia were identified through the National Care Register and 1-3 frontal chest X-ray images per event were collected. External readers who were unaware of the patients' vaccination status retrospectively interpreted the images. The evaluated outcomes were hospital-diagnosed, hospital-treated pneumonia as primary diagnosis, and radiologically confirmed pneumonia during the blinded, intention-to-treat follow-up period from the first vaccination to the end of 2011. Total VE was calculated as 1 minus rate ratio of all pneumonia episodes. RESULTS: 47 366 children were enrolled from February 2009, to October 2010. VE against all episodes of hospital-diagnosed pneumonia was 27% (95% confidence interval [CI]: 14%, 38%), 32% (95% CI: 3%, 52%), and 23% (95% CI: -5%, 44%) in subjects enrolled at age <7, 7-11, and 12-18 months, respectively. Corresponding rate reductions were 3.4, 4.7, and 2.5 per 1000 person-years. VE estimates against pneumonia with alveolar consolidation or pleural effusion (WHO criteria) in the three cohorts were 45% (95% CI: 26%, 60%), 56% (95% CI: 14%, 77%), and 48% (95% CI: 2%, 73%), respectively. CONCLUSION: PHiD-CV10 vaccination remarkably reduced disease burden due to pneumonia in infants and young children. CLINICAL TRIAL REGISTRATION: Main trial NCT00861380, nested carriage and otitis media trial NCT00839254 (ClinicalTrials.gov).


Subject(s)
Bacterial Proteins/immunology , Carrier Proteins/immunology , Immunoglobulin D/immunology , Lipoproteins/immunology , Otitis Media/prevention & control , Pneumococcal Infections/prevention & control , Pneumococcal Vaccines/therapeutic use , Pneumonia/prevention & control , Bacterial Proteins/genetics , Carrier Proteins/genetics , Double-Blind Method , Female , Finland/epidemiology , Haemophilus influenzae , Humans , Immunization Schedule , Immunoglobulin D/genetics , Infant , Lipoproteins/genetics , Male , Otitis Media/microbiology
3.
Lancet Respir Med ; 2(9): 717-27, 2014 Sep.
Article in English | MEDLINE | ID: mdl-25127244

ABSTRACT

BACKGROUND: Vaccine effectiveness of pneumococcal conjugate vaccines against culture-confirmed invasive pneumococcal disease has been well documented. In the Finnish Invasive Pneumococcal disease (FinIP) trial, we reported vaccine effectiveness and absolute rate reduction against laboratory-confirmed invasive pneumococcal disease (confirmation by culture or antigen or DNA detection irrespective of serotype). Here, we assessed vaccine effectiveness of PHiD-CV10 against clinically suspected invasive pneumococcal disease in children by use of diagnoses coded in hospital discharge registers. METHODS: For this phase 3/4 cluster-randomised, double-blind trial, undertaken between Feb 18, 2009, and Dec 31, 2011, in municipal health-care centres and the Tampere University Vaccine Research Centre (Finland), we randomly assigned (2:2:1:1) 78 clusters into PHiD-CV10 three plus one, PHiD-CV10 two plus one, control three plus one, control two plus one groups (26:26:13:13 clusters) to give PHiD-CV10 in either three plus one or two plus one schedule (if enrolled before 7 months of age; infant schedules), two plus one (if enrolled between 7 and 11 months; catch-up schedules), and two doses at least 6 months apart (if enrolled between 12 and 18 months; catch-up schedules). Children were eligible if they had not received and were not anticipated to receive any of the study vaccines and had no general contraindications to vaccinations. We collected all inpatient and outpatient discharge notifications from the national hospital discharge register with International Classification of Diseases (ICD) 10 diagnoses compatible with invasive pneumococcal disease or unspecified sepsis, and verified data with patient files. We excluded invasive pneumococcal disease cases confirmed by positive culture or DNA/RNA detection from normally sterile body fluid. The primary objective was to estimate vaccine effectiveness against all register-based non-laboratory-confirmed invasive pneumococcal disease or unspecified sepsis and patient-file verified non-laboratory-confirmed invasive pneumococcal disease in infants younger than 7 months at enrolment. Masked follow-up lasted from the date of the first vaccination to Dec 31, 2011. Vaccine effectiveness was calculated against all episodes. This trial is registered with ClinicalTrials.gov, numbers NCT00861380 and NCT00839254. FINDINGS: We enrolled 47,366 children. On the basis of ICD-10 diagnoses, we recorded 264 episodes of register-based non-laboratory-confirmed invasive pneumococcal disease or unspecified sepsis, of which 102 were patient-file verified non-laboratory-confirmed invasive pneumococcal disease. The vaccine effectiveness was 50% (95% CI 32-63) in the 30,527 infants with three plus one and two plus one schedules combined and the absolute incidence rate reduction was 207 episodes per 100,000 person-years (95% CI 127-286). The vaccine effectiveness against the patient-file verified non-laboratory-confirmed invasive pneumococcal disease was 71% (95% CI 52-83) in infant three plus one and two plus one schedules combined. The absolute rate reduction was 142 episodes per 100,000 person-years (95% CI 91-191) in infant cohorts. INTERPRETATION: This vaccine-probe analysis is the first report showing the effect of pneumococcal conjugate vaccines on clinically suspected invasive pneumococcal disease. The absolute rate reduction was markedly higher compared with laboratory-confirmed invasive pneumococcal disease, which implies low sensitivity of the laboratory-based case definitions and subsequently higher public health effect of pneumococcal conjugate vaccines against invasive pneumococcal disease than previously estimated. FUNDING: GlaxoSmithKline Biologicals SA and National Institute for Health and Welfare (THL), Finland.


Subject(s)
Pneumococcal Infections/prevention & control , Pneumococcal Vaccines/administration & dosage , Bacterial Proteins , Carrier Proteins , Cluster Analysis , Double-Blind Method , Female , Finland , Humans , Immunization Schedule , Immunoglobulin D , Infant , Lipoproteins , Male , Outcome Assessment, Health Care , Pneumococcal Infections/diagnosis , Pneumococcal Vaccines/immunology , Registries , Vaccines, Conjugate/administration & dosage , Vaccines, Conjugate/immunology
4.
Niger Postgrad Med J ; 20(4): 272-81, 2013 Dec.
Article in English | MEDLINE | ID: mdl-24633268

ABSTRACT

AIMS AND OBJECTIVES: The immunogenicity, reactogenicity and safety of the 10- valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) were evaluated in a cohort of Nigerian infants included in a study conducted in Mali and Nigeria (ClinicalTrials.gov identifier: NCT00678301). SUBJECTS AND METHODS: In this open, randomised, controlled study, 119 healthy infants received combined diphtheria-tetanus-whole-cell pertussis-hepatitis B/ Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) and oral poliovirus vaccine (OPV) co-administered with PHiD-CV (PHiD-CV group) or without PHiD-CV (control group) at 6-10-14 weeks of age. Pneumococcal antibody responses and opsonophagocytic activity were measured and adverse events were recorded. RESULTS: One month post-dose 3, for each of the vaccine pneumococcal serotypes, e"90.1% of PHiD-CV recipients had an antibody concentration e"0.2 ug/mL compared to < 9 % (except for serotypes 14 [32.4%] and 19F [27.8%]) in the control group. For each of the vaccine pneumococcal serotypes, e"90.6% of infants in the PHiD-CV group had an OPA titre e"8, compared to % 18% (except for serotype 7F [60.0%]) in the control group. Anti-protein D antibody geometric mean antibody concentrations were 2949.7 EL.U/mL in the PHiD-CV group and 68.9 EL.U/mL in the control group. For each DTPw-HBV/Hib antigen antibody seroprotection/seropositivity rates were e"94.4%. Tolerability was generally comparable between the PHiD-CV and control vaccination groups. CONCLUSIONS: PHiD-CV co-administered with routine vaccines was immunogenic for all vaccine pneumococcal serotypes and protein D in Nigerian infants. Vaccine tolerability was generally comparable between the PHiD-CV and control groups. These results suggest PHiD-CV can be co-administered with other vaccines included in the National Programme on Immunisation.


Subject(s)
Antibodies, Bacterial/blood , Bacterial Proteins/immunology , Carrier Proteins/immunology , Immunoglobulin D/immunology , Lipoproteins/immunology , Pneumococcal Vaccines/adverse effects , Pneumococcal Vaccines/immunology , Streptococcus pneumoniae/immunology , Bordetella pertussis/immunology , Cohort Studies , Diphtheria Toxin/immunology , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Female , Haemophilus Vaccines/administration & dosage , Hepatitis B Surface Antigens/immunology , Hepatitis B Vaccines/administration & dosage , Humans , Immunoglobulin G/blood , Infant , Male , Nigeria , Pneumococcal Vaccines/administration & dosage , Poliovirus Vaccine, Oral/administration & dosage , Polysaccharides/immunology , Tetanus Toxin/immunology
5.
Clin Vaccine Immunol ; 18(12): 2161-7, 2011 Dec.
Article in English | MEDLINE | ID: mdl-21994351

ABSTRACT

We compared the abilities of two serological readouts, antipolysaccharide IgG antibody concentrations and opsonophagocytic activity (OPA) titers, to predict the clinical effectiveness of the 7-valent pneumococcal conjugate vaccine (7vCRM) against invasive pneumococcal disease (IPD). We also assessed the accuracy of the previously established thresholds for GlaxoSmithKline's enzyme-linked immunosorbent assay with 22F adsorption (22F-ELISA) (≥0.2 µg/ml) and OPA assay (titer, ≥8) in predicting effectiveness. We showed that following a 3-dose 7vCRM primary vaccination, the serological response rates as determined using thresholds of ≥0.2 µg/ml IgG and an OPA titer of ≥8 corresponded well with overall effectiveness against IPD. In addition, the OPA assay seemed to better predict serotype-specific effectiveness than enzyme-linked immunoassay. Finally, when applied to post-dose-2 immune responses, both thresholds also corresponded well with the overall IPD effectiveness following a 2-dose 7vCRM primary vaccination. These results support the importance of the OPA assay in evaluating immune responses to pneumococcal conjugate vaccines.


Subject(s)
Antibodies, Bacterial/blood , Opsonin Proteins/blood , Phagocytosis , Pneumococcal Vaccines/immunology , Enzyme-Linked Immunosorbent Assay , Heptavalent Pneumococcal Conjugate Vaccine , Humans , Immunoglobulin G/blood , Pneumococcal Vaccines/administration & dosage
6.
Vaccine ; 27(52): 7257-69, 2009 Dec 09.
Article in English | MEDLINE | ID: mdl-19833248

ABSTRACT

New pneumococcal conjugate vaccines (PCVs) are now becoming available. These formulations differ from the heptavalent diphtheria toxin variant conjugate vaccine (7vCRM, Prevenar/Prevnar) both in the number of serotypes and in serotype-specific immunogenicity. This review proposes an algorithm that attempts to predict the overall impact of these differences in vaccine formulation and immunogenicity on invasive pneumococcal disease (IPD) effectiveness. It builds on the principles underlying WHO licensure criteria for new PCVs, that serotype-specific anti-polysaccharide immunogenicity is potentially predictive of effectiveness. The algorithm used three sources of information: serotype-specific effectiveness data for 7vCRM, serotype-specific head-to-head immunogenicity data with 7vCRM and a recently licensed 10-valent pneumococcal non-typeable H. influenzae protein D-conjugate vaccine (PHiD-CV, Synflorix), and epidemiological information regarding the serotypes causing IPD in young children. Based on this algorithm, PHiD-CV and 7vCRM are predicted to prevent approximately 60-80% and 45-80%, respectively of IPD in young children worldwide, with significant variability by country and region.


Subject(s)
Algorithms , Pneumococcal Infections/prevention & control , Pneumococcal Vaccines/immunology , Heptavalent Pneumococcal Conjugate Vaccine , Humans , Pneumococcal Infections/immunology , Vaccines, Conjugate/immunology
7.
Int J Infect Dis ; 12(3): 278-88, 2008 May.
Article in English | MEDLINE | ID: mdl-17981067

ABSTRACT

OBJECTIVE: To assess immunogenicity, antibody persistence, immune memory, and reactogenicity of a novel heptavalent DTPw-HBV/Hib-MenAC (diphtheria, tetanus, whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b-Neisseria meningitidis serogroups A and C) vaccine. DESIGN: This was an open, randomized study in the Philippines, with DTPw-HBV/Hib-MenAC administered at 6, 10, and 14 weeks of age. Three different polysaccharide contents of the conjugate vaccine components were assessed with conjugated PRP (polyribosylribitol phosphate), MenA, and MenC polysaccharides at the following doses: 2.5 microg of each, 5 microg of each, or 2.5 microg of PRP and 5 microg each of MenA and MenC. Controls received licensed DTPw-HBV and Hib or DTPw-HBV/Hib and MenC conjugate vaccines separately. Immune memory was evaluated via plain polysaccharide challenge administered to half of the subjects at 10 months of age. RESULTS: After primary vaccination, at least 97.7% of DTPw-HBV/Hib-MenAC recipients had serum bactericidal antibody (SBA)-MenA and SBA-MenC titers > or =1:8, and at least 99% had anti-PRP antibody concentrations > or =0.15 microg/ml. Immune responses to DTPw-HBV components were not impaired by the lowest dose of Hib-MenAC vaccine. Plain polysaccharide challenge induced marked increases in Hib, MenA, and MenC antibodies in primed subjects, indicative of immune memory. All of the experimental vaccines were well tolerated. CONCLUSION: The lowest dose of DTPw-HBV/Hib-MenAC polysaccharide conjugate vaccine was well tolerated, immunogenic, had good persistence of antibodies, and demonstrated immune memory, and consequently was selected for further development.


Subject(s)
Diphtheria-Tetanus-Pertussis Vaccine , Haemophilus Vaccines , Hepatitis B Vaccines , Meningococcal Vaccines , Vaccines, Combined , Vaccines, Conjugate , Antibodies, Bacterial/blood , Diphtheria/prevention & control , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Diphtheria-Tetanus-Pertussis Vaccine/immunology , Dose-Response Relationship, Immunologic , Haemophilus Infections/prevention & control , Haemophilus Vaccines/administration & dosage , Haemophilus Vaccines/adverse effects , Haemophilus Vaccines/immunology , Haemophilus influenzae type b/immunology , Hepatitis B/prevention & control , Hepatitis B Antibodies/blood , Hepatitis B Vaccines/administration & dosage , Hepatitis B Vaccines/adverse effects , Hepatitis B Vaccines/immunology , Humans , Immunologic Memory , Infant , Meningococcal Infections/prevention & control , Meningococcal Vaccines/administration & dosage , Meningococcal Vaccines/adverse effects , Meningococcal Vaccines/immunology , Neisseria meningitidis, Serogroup A/immunology , Neisseria meningitidis, Serogroup C/immunology , Tetanus/prevention & control , Treatment Outcome , Vaccines, Combined/administration & dosage , Vaccines, Combined/adverse effects , Vaccines, Combined/immunology , Vaccines, Conjugate/administration & dosage , Vaccines, Conjugate/adverse effects , Vaccines, Conjugate/immunology , Whooping Cough/prevention & control
8.
Vaccine ; 25(6): 1055-63, 2007 Jan 22.
Article in English | MEDLINE | ID: mdl-17049692

ABSTRACT

The immunogenicity and reactogenicity of booster vaccination with GSK Biologicals' hexavalent DTPa-HBV-IPV/Hib vaccine was assessed in toddlers aged 12-18 months previously primed with the same combination (N=341), or with DTPa-IPV/Hib and HBV administered separately (N=102; Trials 217744/059 and 217744/096). Antibody persistence at age 4-6 years was also assessed in children who had received a 4th consecutive dose of DTPa-HBV-IPV/Hib vaccine or separate DTPa-IPV/Hib and HBV vaccines in this study and in another study conducted under similar conditions in Germany. Prior to booster vaccination in the second year of life, antibody concentrations and seroprotection rates were similar irrespective of the primary vaccine used. One month after boosting with DTPa-HBV-IPV/Hib, substantial antibody increases were observed against all vaccine antigens indicative of previous immune priming. Seropositivity and booster response rates against all antigens were 97.4-100%. Reactogenicity following booster vaccination with DTPa-HBV-IPV/Hib was similar regardless of the primary regimen used. Three to four years after administration of the 4th DTPa-HBV-IPV/Hib dose, >90% vaccinees had persistent protective antibody concentrations against diphtheria, hepatitis B, Hib and the three poliovirus types. Anti-tetanus antibody concentrations were > or = 0.1 IU/ml in 76.4% subjects and seropositivity for pertussis antibodies ranged from 34.5% for PT to 98.9% for FHA. In conclusion, the combined hexavalent DTPa-HBV-IPV/Hib vaccine is immunogenic and safe when used for boosting in the second year of life, regardless of the primary vaccine used, and offers sustained protection during early childhood and beyond.


Subject(s)
Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Haemophilus Vaccines/administration & dosage , Hepatitis B Vaccines/administration & dosage , Immunization, Secondary/trends , Poliovirus Vaccine, Inactivated/administration & dosage , Child , Child, Preschool , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Diphtheria-Tetanus-Pertussis Vaccine/immunology , Female , Haemophilus Vaccines/adverse effects , Haemophilus Vaccines/immunology , Hepatitis B Vaccines/adverse effects , Hepatitis B Vaccines/immunology , Humans , Immunologic Memory/immunology , Infant , Male , Poliovirus Vaccine, Inactivated/adverse effects , Poliovirus Vaccine, Inactivated/immunology
9.
Vaccine ; 24(35-36): 6120-8, 2006 Aug 28.
Article in English | MEDLINE | ID: mdl-16822597

ABSTRACT

This study evaluated GSK's combined DTPa-IPV vaccine (Infanrix-IPV) given as a fifth consecutive acellular pertussis booster dose in conjunction with the second dose of MMR vaccine (Priorix) in children aged 4-6 years. The immunogenicity and reactogenicity of this vaccine regimen was compared with separate injections of DTPa and IPV when given concomitantly with MMR. A cohort of 362 children previously primed with four doses of DTPa and OPV, and a single dose of MMR were randomized to receive either DTPa-IPV+MMR (N=181) or DTPa+IPV+MMR (N=181). Antibody concentrations were measured prior to and 1 month after the booster dose. After immunisation all subjects from both groups had seroprotective antibody levels against diphtheria, tetanus and the three poliovirus serotypes, > or = 96% showed vaccine response to PT, FHA and PRN, all were seropositive to mumps and rubella, and all but one subject were seropositive to measles. Immunogenicity results for each component antigen were similar for DTPa-IPV and separately co-administered DTPa and IPV. Local reactions were common with 24.0% and 31.1% of children experiencing swelling >50mm at the DTPa-IPV and DTPa injection sites, respectively. The DTPa-IPV combination did not increase the incidence or intensity of adverse events compared with separately administered DTPa+IPV. The response to the concomitantly administered MMR vaccine was similar in the two groups and similar to previously reported responses for a second dose of MMR. This combined DTPa-IPV vaccine has a similar reactogenicity profile to DTPa, is immunogenic when given as a booster dose at 4-6 years of age, and has no impact on the immunogenicity of a co-administered second dose of MMR vaccine.


Subject(s)
Antibodies/blood , Diphtheria-Tetanus-acellular Pertussis Vaccines/administration & dosage , Immunization, Secondary/methods , Measles-Mumps-Rubella Vaccine/administration & dosage , Poliovirus Vaccine, Inactivated/administration & dosage , Child , Child, Preschool , Diphtheria-Tetanus-acellular Pertussis Vaccines/adverse effects , Diphtheria-Tetanus-acellular Pertussis Vaccines/immunology , Female , Humans , Injections, Subcutaneous , Male , Measles-Mumps-Rubella Vaccine/adverse effects , Measles-Mumps-Rubella Vaccine/immunology , Poliovirus Vaccine, Inactivated/adverse effects , Poliovirus Vaccine, Inactivated/immunology
10.
Vaccine ; 24(13): 2440-8, 2006 Mar 20.
Article in English | MEDLINE | ID: mdl-16406224

ABSTRACT

A combined DTPa-IPV booster vaccine was administered as a 4th or 5th dose after DTPa or DTPw priming. Over 99% vaccines developed antibody levels considered to be protective to diphtheria, tetanus and poliovirus, and >95% mounted a response to acellular pertussis antigens. Rectal temperature >39.5 degrees C was observed in at most 3.2% of vaccinees. Swelling >50 mm occurred in 24% of DTPa-primed compared to 5.5% of DTPw-primed children. Large swelling involving the entire upper arm (extending to involve the elbow joint) was reported for up to 1.2% of DTPa-primed subjects, which is consistent with literature reports for other DTPa vaccines.


Subject(s)
Diphtheria-Tetanus-acellular Pertussis Vaccines/administration & dosage , Poliovirus Vaccine, Inactivated/administration & dosage , Vaccines, Combined/administration & dosage , Antibodies, Bacterial/blood , Antibodies, Viral/blood , Child , Child, Preschool , Diphtheria-Tetanus-acellular Pertussis Vaccines/adverse effects , Humans , Immunization, Secondary , Poliovirus Vaccine, Inactivated/adverse effects , Vaccines, Combined/adverse effects
11.
Vaccine ; 23(12): 1515-21, 2005 Feb 10.
Article in English | MEDLINE | ID: mdl-15670888

ABSTRACT

As aluminium in vaccines has been associated with the incidence of local side effects occurring after vaccination, this observer-blind randomised clinical trial was designed to evaluate the effect of lowering the aluminium content of a combined reduced-antigen-content dTpa vaccine on immunogenicity and safety when administered to healthy adolescents aged 10-18 years. A total of 647 subjects were enrolled, 224 (35%) received a dTpa formulation with 0.5 mg aluminium, 209 (32%) a formulation with 0.3 mg aluminium and 214 (33%) a formulation with 0.133 mg aluminium. One month after boostering, all subjects were seroprotected against diphtheria and tetanus toxoids. All subjects were seropositive for anti-FHA and anti-PRN but 4% of the initially seronegatives in both reduced aluminium groups did not seroconvert for anti-PT. Booster responses did not differ significantly between groups for any antibody, but post booster vaccination anti-PT GMC's differed significantly between groups and decreased when vaccine aluminium content decreased. No clear difference between study groups in local or general side effects was demonstrated. The most frequently reported symptoms after vaccination were injection site pain (89.5-90.7%), fatigue (42.1-47.4%) and headache (41.1-45.1%). This study showed that the aluminium content has a specific influence on the immunogenicity of this dTpa vaccine.


Subject(s)
Adjuvants, Immunologic/pharmacology , Aluminum/pharmacology , Diphtheria-Tetanus-acellular Pertussis Vaccines/chemistry , Diphtheria-Tetanus-acellular Pertussis Vaccines/immunology , Immunization, Secondary , Adjuvants, Immunologic/chemistry , Adolescent , Aluminum/chemistry , Antibodies, Bacterial/blood , Belgium , Child , Diphtheria-Tetanus-acellular Pertussis Vaccines/adverse effects , Enzyme-Linked Immunosorbent Assay , Female , Humans , Male
12.
Vaccine ; 23(9): 1135-43, 2005 Jan 19.
Article in English | MEDLINE | ID: mdl-15629356

ABSTRACT

The safety and reactogenicity of a booster dose of GSK Biologicals' hexavalent DTPa-HBV-IPV/Hib vaccine (N=4725) was compared with the separate administration of GSK Biologicals' DTPa-IPV/Hib and HBV vaccines (N=4474) in two open, randomized multicenter studies (A and B). Solicited symptoms occurring within 4 days of vaccination were recorded on diary cards and serious adverse events (SAEs) were collected throughout the study period. In Study A (N=1149), incidences of solicited symptoms were similar in both groups; there were no SAEs either reported within 4 days of vaccination or considered to be causally related to vaccination. In study B (N=8050), where fever was the only solicited symptom, rectal temperature > or =39.5 degrees C was observed in 2.5% and 2.8% of the subjects, respectively. Fever > or =40.0 degrees C was rare (0.6%), and only two cases of febrile convulsions were recorded during the 4 days following vaccination both in the control group. Large swelling reactions (defined as local injection site swelling with diameter >50 mm, noticeable diffuse injection site swelling or noticeable increased circumference of the injected limb) were reported following 2.3% of the booster vaccine doses, regardless of the vaccine used. Extensive swelling reactions involving an adjacent joint were reported in 0.1% of the subjects. Two SAEs, both reported after booster doses of DTPa-IPV/Hib and HBV vaccines administered separately, were considered by the investigators to be related to vaccination. Both resolved completely without sequelae. The hexavalent DTPa-HBV-IPV/Hib vaccine and the DTPa-IPV/Hib and HBV vaccines administered separately have similar good reactogenicity and safety profiles when given as booster doses in the second year of life.


Subject(s)
Immunization Schedule , Immunization, Secondary/methods , Multicenter Studies as Topic/methods , Randomized Controlled Trials as Topic/methods , Vaccines, Combined/administration & dosage , Confidence Intervals , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Female , Fever/chemically induced , Haemophilus Vaccines , Hepatitis B Vaccines/administration & dosage , Hepatitis B Vaccines/adverse effects , Humans , Immunization, Secondary/adverse effects , Infant , Male , Multicenter Studies as Topic/statistics & numerical data , Poliovirus Vaccine, Inactivated , Randomized Controlled Trials as Topic/statistics & numerical data , Vaccines, Combined/adverse effects
13.
Vaccine ; 23(1): 14-20, 2004 Nov 15.
Article in English | MEDLINE | ID: mdl-15519702

ABSTRACT

A new single-injection combination vaccine against six diseases has been developed to accommodate the growing number of recommended paediatric vaccines. A pentavalent liquid diphtheria, tetanus, acellular pertussis (3-component), hepatitis B, and inactivated polio (types 1-3) combined vaccine (DTPa-HBV-IPV) is extemporaneously mixed with a lyophilized Haemophilus influenza type B (Hib) conjugate vaccine (polyribosyl-ribitol phosphate (PRP)-T) and given as a single-injection. A cohort of 368 healthy infants was initially studied to evaluate the immunogenicity and reactogenicity of this hexavalent combination given as a primary course at 2, 4, and 6 months of age. At 15 months of age, from this cohort, 219 children received a booster dose of a licensed DTPa/Hib (PRP-T) vaccine to assess the booster response, while 70 received a challenge dose of unconjugated PRP (PRP) vaccine (to evaluate Hib-specific memory) plus a separate DTPa vaccine. Seven to 10 days following plain PRP challenge, anti-PRP geometric mean antibody concentrations (GMCs) had increased 13-fold to 5.67 microg/ml, and thirty days after conjugated PRP booster vaccination, anti-PRP antibody GMCs increased 102-fold. Both responses are indicative of immune memory. Vaccination was well tolerated following all primary and booster doses, although 10.5% of booster recipients experienced >50-mm local swelling at the site of DTPa vaccination. We conclude that DTPa-HBV-IPV/Hib is safe and immunogenic for primary vaccination, and that Hib-specific memory is induced by primary vaccination.


Subject(s)
Diphtheria-Tetanus-Pertussis Vaccine/immunology , Haemophilus Vaccines/immunology , Hepatitis B Vaccines/immunology , Immunologic Memory , Antibodies, Bacterial/analysis , Antibodies, Bacterial/biosynthesis , Antibodies, Viral/analysis , Antibodies, Viral/biosynthesis , Cohort Studies , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Haemophilus Vaccines/administration & dosage , Haemophilus Vaccines/adverse effects , Hepatitis B Vaccines/administration & dosage , Hepatitis B Vaccines/adverse effects , Humans , Immunization Schedule , Immunization, Secondary , Infant , Infant, Newborn , Single-Blind Method , Tetanus Toxoid/immunology , Vaccines, Combined/immunology , Vaccines, Conjugate
14.
Vaccine ; 22(17-18): 2226-33, 2004 Jun 02.
Article in English | MEDLINE | ID: mdl-15149781

ABSTRACT

Safety, reactogenicity and immunogenicity of GSK Biologicals' hexavalent DTPa-HBV-IPV/Hib vaccine (Infanrix)hexa) was assessed when used for primary vaccination at 3, 4 and 5 months of age (N = 2163), compared to the separate administration of DTPa-IPV/Hib and HBV vaccines (N = 720). A similar safety and reactogenicity profile was demonstrated for both vaccine regimens, as well as a good immune response for all antigen components. By offering protection against six diseases in a series of single injections, the hexavalent DTPa-HBV-IPV/Hib vaccine was shown to be a safe, well tolerated and immunogenic alternative to primary immunization with licensed separately administered vaccines.


Subject(s)
Vaccines, Combined/adverse effects , Vaccines, Combined/immunology , Bacterial Capsules , Diphtheria/prevention & control , Diphtheria Toxoid/administration & dosage , Diphtheria Toxoid/adverse effects , Diphtheria Toxoid/immunology , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Diphtheria-Tetanus-Pertussis Vaccine/immunology , Female , Haemophilus Infections/prevention & control , Haemophilus Vaccines/administration & dosage , Haemophilus Vaccines/adverse effects , Haemophilus Vaccines/immunology , Hepatitis B/prevention & control , Hepatitis B Vaccines/administration & dosage , Hepatitis B Vaccines/adverse effects , Hepatitis B Vaccines/immunology , Humans , Infant , Male , Pertussis Vaccine/administration & dosage , Pertussis Vaccine/adverse effects , Pertussis Vaccine/immunology , Poliomyelitis/prevention & control , Poliovirus Vaccine, Inactivated/administration & dosage , Poliovirus Vaccine, Inactivated/adverse effects , Poliovirus Vaccine, Inactivated/immunology , Polysaccharides, Bacterial/administration & dosage , Polysaccharides, Bacterial/adverse effects , Polysaccharides, Bacterial/immunology , Tetanus/prevention & control , Tetanus Toxoid/administration & dosage , Tetanus Toxoid/adverse effects , Tetanus Toxoid/immunology , Vaccination , Vaccines, Combined/administration & dosage , Whooping Cough/prevention & control
15.
Int Migr ; 29(4): 573-99, 1991 Dec.
Article in English | MEDLINE | ID: mdl-12159612

ABSTRACT

The authors describe the socioeconomic characteristics and fertility patterns of female immigrants from Latin America to the United States, with a focus on reasons for fertility differentials. "Using the one per cent public use sample from the 1970 and 1980 United States census, we first compare changes in socio economic characteristics from 1970 to 1980, and then examine the determinants of fertility of female immigrants to the United States, aged 16-49, from four Latin American areas or countries of birth.... The findings...suggest that there are direct effects of demographic, assimilation, and socioeconomic variables beyond those mediated by the variables in each of these sets. Further, regardless of the model, the effect of the clusters of demographic characteristics is most apparent. Age categories and marital status are the strongest indexed determinants of immigrant fertility.... The effect of education and employment is strong. Among assimilation variables, duration of residence and language ability are significant determinants of Hispanic immigrant fertility." (SUMMARY IN FRE AND SPA)


Subject(s)
Acculturation , Age Factors , Demography , Educational Status , Emigration and Immigration , Employment , Fertility , Hispanic or Latino , Language , Marital Status , Residence Characteristics , Socioeconomic Factors , Transients and Migrants , Americas , Communication , Culture , Developed Countries , Developing Countries , Economics , Ethnicity , Geography , Latin America , Marriage , North America , Population , Population Characteristics , Population Dynamics , Research , Social Change , Social Class , United States , Humans
16.
Int Migr ; 28(4): 451-75, 1990 Dec.
Article in English | MEDLINE | ID: mdl-12159560

ABSTRACT

"This paper examines the assimilation of immigrants in familial and economic fields.... Specific objectives are as follows: (1) to describe fertility and earning patterns among immigrants to the United States in 1970-1980, from several countries of origin, and (2) to describe some effects of assimilation, human capital, and the dual labor market perspectives on immigrant earnings." Findings vary in both fertility and economic categories for migrants depending on whether they are from developed or developing countries. (SUMMARY IN FRE AND SPA)


Subject(s)
Acculturation , Developed Countries , Developing Countries , Economics , Emigration and Immigration , Fertility , Income , Socioeconomic Factors , Americas , Demography , Health Workforce , North America , Population , Population Dynamics , Research , Social Change , United States
SELECTION OF CITATIONS
SEARCH DETAIL
...