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1.
Hum Vaccin Immunother ; 14(1): 95-105, 2018 01 02.
Article in English | MEDLINE | ID: mdl-29125809

ABSTRACT

BACKGROUND: Few studies describe the community-acquired pneumonia (CAP) burden in children in Asia. We estimated the proportion of all CAP hospitalizations in children from nine hospitals across the Republic of Korea (high-income), Indonesia, Malaysia (middle-income), and Vietnam (low/middle-income). METHODS: Over a one or two-year period, children <5 years hospitalized with CAP were identified using ICD-10 discharge codes. Cases were matched to standardized definitions of suspected (S-CAP), confirmed (C-CAP), or bacterial CAP (B-CAP) used in a pneumococcal conjugate vaccine efficacy study (COMPAS). Median total direct medical costs of CAP-related hospitalizations were calculated. RESULTS: Vietnam (three centers): 7591 CAP episodes were identified with 4.3% (95% confidence interval 4.2;4.4) S-CAP, 3.3% (3.2;3.4) C-CAP and 1.4% (1.3;1.4) B-CAP episodes of all-cause hospitalization in children aged <5 years. The B-CAP case fatality rate (CFR) was 1.3%. Malaysia (two centers): 1027 CAP episodes were identified with 2.7% (2.6;2.9); 2.6% (2.4;2.8); 0.04% (0.04;0.1) due to S-CAP, C-CAP, and B-CAP, respectively. One child with B-CAP died. Indonesia (one center): 960 CAP episodes identified with 18.0% (17.0;19.1); 16.8% (15.8;17.9); 0.3% (0.2;0.4) due to S-CAP, C-CAP, and B-CAP, respectively. The B-CAP CFR was 20%. Korea (three centers): 3151 CAP episodes were identified with 21.1% (20.4;21.7); 11.8% (11.2;12.3); 2.4% (2.1;2.7) due to S-CAP, C-CAP, and B-CAP, respectively. There were no deaths. COSTS: CAP-related hospitalization costs were highest for B-CAP episodes: 145.00 (Vietnam) to 1013.3 USD (Korea) per episode. CONCLUSION: CAP hospitalization causes an important health and cost burden in all four countries studied (NMRR-12-50-10793).


Subject(s)
Community-Acquired Infections/economics , Cost of Illness , Health Care Costs , Pneumococcal Vaccines/therapeutic use , Pneumonia/economics , Child, Preschool , Community-Acquired Infections/epidemiology , Community-Acquired Infections/microbiology , Community-Acquired Infections/prevention & control , Cross-Sectional Studies , Female , Hospitalization/economics , Hospitalization/statistics & numerical data , Humans , Incidence , Indonesia/epidemiology , Infant , Malaysia/epidemiology , Male , Pneumococcal Vaccines/economics , Pneumonia/epidemiology , Pneumonia/microbiology , Pneumonia/prevention & control , Republic of Korea/epidemiology , Retrospective Studies , Streptococcus pneumoniae/isolation & purification , Survival Rate , Treatment Outcome , Vaccines, Conjugate/economics , Vaccines, Conjugate/therapeutic use , Vietnam/epidemiology
2.
BMC Public Health ; 16: 923, 2016 09 02.
Article in English | MEDLINE | ID: mdl-27590503

ABSTRACT

BACKGROUND: Under the National Childhood Immunisation Schedule (NCIS) in Singapore most vaccines are provided free while some, including pneumococcal conjugate vaccines (PCV), added to the NCIS in October 2009, are not free. In contrast to ≥95 % coverage achieved for recommended childhood vaccines that are free, 2013 coverage of the PCV booster dose was 58.9 % (for unclear reasons). To date, no population impact on pneumococcal disease (PD) has been observed. We conducted a questionnaire-based study of parents of young children to assess the value of PCV to parents, and to quantify the extent to which vaccine cost is a barrier to PCV uptake in Singapore. METHODS: A single, trained interviewer administered a questionnaire to 200 parents ≥21 years of age with young children attending the Singapore Sengkang Polyclinic. The questionnaire asked closed-ended questions on parents' knowledge about PD and PCV. A 5-point Likert scale measured perceived benefits and barriers to PCV vaccination. RESULTS: There were 162 parents whose children were either PCV-vaccinated or who intended to vaccinate their child with PCV (Vaccinated group), and 38 whose children were non-PCV vaccinated or who did not intend to vaccinate (Unvaccinated group). The odds ratio for PCV vaccination among parents who perceived cost as a barrier was 0.16 (95%CI 0.02-1.23). Compared to the Vaccinated group, parents in the Unvaccinated group were less willing to pay for PCV (50.0 %/94.4 %). Compared to the Vaccinated group, fewer parents in the Unvaccinated group had heard about PD (34.2 %/82.1 %) or PCV (36.8 %/69.1 %), or perceived that PD was a threat to their child. Fewer parents in the Unvaccinated group knew that vaccination could prevent PD (28.9 %/77.8 %), or reported that PCV vaccination was recommended to them by any source (63.2 % had no PCV recommendation, versus 20.4 %). When informed that PCV is included in the NCIS only 65.8 % of parents in the Unvaccinated group, versus 98.8 % in the Vaccinated group, indicated that they would be willing to vaccinate their child. CONCLUSIONS: Cost considerations, not having vaccination recommended to parents and a lack of knowledge among parents of the benefits of PCV to the child may adversely impact PCV uptake in Singapore.


Subject(s)
Health Knowledge, Attitudes, Practice , Parents/psychology , Pneumococcal Infections/prevention & control , Pneumococcal Vaccines/administration & dosage , Vaccines, Conjugate/administration & dosage , Adult , Child, Preschool , Cross-Sectional Studies , Female , Humans , Immunization Schedule , Infant , Infant, Newborn , Interviews as Topic , Male , Singapore , Surveys and Questionnaires , Vaccination/statistics & numerical data , Young Adult
3.
Hum Vaccin Immunother ; 11(9): 2207-14, 2015.
Article in English | MEDLINE | ID: mdl-26020101

ABSTRACT

Pneumonia is still the leading cause of death among African children with pneumococcal serotypes 1 and 5 being dominant in the below 5 y of age group. The present study assessed the safety, reactogenicity and immunogenicity of a 2-dose catch-up vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae Protein D conjugate vaccine (PHiD-CV) in Malian children. This phase III, open-label study (NCT00985465) was conducted in Ouelessebougou, Mali, between November 2009 and July 2010. The study population consisted of PHiD-CV unprimed Malian children previously enrolled in the control group of study NCT00678301 receiving a 2-dose catch-up vaccination with PHiD-CV in the second year of life. Adverse events were recorded following each PHiD-CV dose. Antibody responses and opsonophagocytic activity (OPA) were measured pre-vaccination and after the second PHiD-CV catch-up dose. Swelling and fever (axillary temperature ≥ 37.5°C) were the most frequently reported solicited symptoms following either PHiD-CV dose. Few grade 3 solicited symptoms were reported. Large swelling reactions and serious adverse events were not reported. Post-catch-up vaccination, for each vaccine pneumococcal serotype, at least 94.7% of subjects had antibody concentrations ≥ 0.2 µg/ml, except for serotypes 6B (82.5%) and 23F (87.7%). At least 94.0% of subjects had OPA titres ≥ 8, except for serotype 19F (89.4%). The geometric mean concentration for antibodies against protein D was 839.3 (95% CI: 643.5-1094.6) EL.U/ml. Two-dose PHiD-CV catch-up regimen in the second year of life was well-tolerated and immunogenic for all vaccine pneumococcal serotypes and NTHi protein D when administered to Malian children.


Subject(s)
Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/pathology , Pneumococcal Vaccines/adverse effects , Pneumococcal Vaccines/immunology , Pneumonia, Pneumococcal/prevention & control , Antibodies, Bacterial/blood , Blood Bactericidal Activity , Child, Preschool , Edema/chemically induced , Edema/epidemiology , Edema/pathology , Female , Fever/chemically induced , Fever/epidemiology , Fever/pathology , Humans , Infant , Male , Mali , Opsonin Proteins/blood , Pneumococcal Vaccines/administration & dosage
4.
Vaccine ; 33(28): 3200-7, 2015 Jun 22.
Article in English | MEDLINE | ID: mdl-25981490

ABSTRACT

PURPOSE: In April 2007, Panama introduced Hepatitis A universal vaccination using a two-dose schedule (Havrix(®)junior; GSK Vaccines, Belgium). We assessed the impact of this hepatitis A vaccine three years after it was recommended for universal mass vaccination in Panama. MATERIALS AND METHODS: Hepatitis A vaccination impact was assessed using two different approaches. The first approach used retrospective data (incidence and number of cases for all age groups), collected from the passive surveillance of the Epidemiologic Surveillance System of the Ministry of Health of hepatitis A and unspecified hepatitis before (2000-2006) and after (2008-2010) introduction of hepatitis A vaccine. The second approach was a prospective hospital-based active surveillance for hepatitis cases conducted in subjects (0-14 years) during 2009-2011 at three sentinel hospitals in Panama. RESULTS: Overall, the annual incidence of hepatitis A and unspecified hepatitis in 2008, 2009 and 2010 were 13.1, 7.9 and 3.7 per 100,000 subjects, lower than the baseline incidence of 51.1 per 100,000 subjects. In comparison to the mean baseline period (2000-2006), there was an 82% mean reduction in the overall hepatitis-related outcomes (hepatitis A and unspecified hepatitis) after vaccine introduction (2008-2010) in all age groups. In the hospital-based surveillance (2009-2011), of the 42 probable viral hepatitis A cases, nine cases were confirmed as acute hepatitis A (8 in 2009, 1 in 2010). Of these confirmed cases, two belonged to the targeted vaccine group (1-4 years) but were not vaccinated. CONCLUSIONS: Our study suggests that the introduction of two-dose hepatitis A vaccines in Panama has contributed to the reduction in the incidence of overall hepatitis-related outcomes for all age groups, suggesting herd protection. Additional monitoring is required to document a sustained long-term effect.


Subject(s)
Epidemiological Monitoring , Hepatitis A Vaccines/administration & dosage , Hepatitis A/prevention & control , Immunization Schedule , Vaccination/statistics & numerical data , Adolescent , Child , Child, Preschool , Female , Hepatitis A/epidemiology , Hepatitis A Vaccines/immunology , Humans , Immunity, Herd , Incidence , Infant , Infant, Newborn , Male , Panama/epidemiology , Prospective Studies , Retrospective Studies , Time Factors , Transaminases/blood , Vaccination/trends
5.
Hum Vaccin Immunother ; 11(4): 826-37, 2015.
Article in English | MEDLINE | ID: mdl-25830489

ABSTRACT

This phase III, randomized, open-label, multicenter study (NCT01027845) conducted in Japan assessed the immunogenicity, safety, and reactogenicity of 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV, given intramuscularly) co-administered with diphtheria-tetanus-acellular pertussis vaccine (DTPa, given subcutaneously). Infants (N=360 ) were randomized (2:1) to receive either PHiD-CV and DTPa (PHiD-CV group) or DTPa alone (control group) as 3-dose primary vaccination (3-4-5 months of age) and booster vaccination (17-19 months of age). Immune responses were measured before and one month after primary/booster vaccination and adverse events (AEs) were recorded. Post-primary immune responses were non-inferior to those in pivotal/efficacy European or Latin American pneumococcal protein D-conjugate vaccine studies. For each PHiD-CV serotype, at least 92.6% of infants post-primary vaccination and at least 97.7% of children post-booster had pneumococcal antibody concentrations ≥0.2 µg/ml, and at least 95.4% post-primary and at least 98.1% post-booster had opsonophagocytic activity (OPA) titers ≥8 . Geometric mean antibody concentrations and OPA titers (except OPA titer for 6B) were higher post-booster than post-priming for each serotype. All PHiD-CV-vaccinated children had anti-protein D antibody concentrations ≥100 EL.U/ml one month post-primary/booster vaccination and all were seroprotected/seropositive against each DTPa antigen. Redness and irritability were the most common solicited AEs in both groups. Incidences of unsolicited AEs were comparable between groups. Serious AEs were reported for 47 children (28 in PHiD-CV group); none were assessed as vaccine-related. In conclusion, PHiD-CV induced robust immune responses and was well tolerated when co-administered with DTPa in a 3-dose priming plus booster regimen to Japanese children.


Subject(s)
Diphtheria-Tetanus-acellular Pertussis Vaccines/immunology , Diphtheria-Tetanus-acellular Pertussis Vaccines/therapeutic use , Pneumococcal Infections/prevention & control , Pneumococcal Vaccines/immunology , Pneumococcal Vaccines/therapeutic use , Adolescent , Child , Child, Preschool , Female , Haemophilus influenzae/immunology , Haemophilus influenzae/pathogenicity , Humans , Male , Pneumococcal Infections/immunology , Young Adult
6.
BMC Infect Dis ; 14: 530, 2014 Oct 02.
Article in English | MEDLINE | ID: mdl-25278086

ABSTRACT

BACKGROUND: The immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines were evaluated among infants from Singapore and Malaysia, where PHiD-CV has been licensed. METHODS: In the primary vaccination phase, 298 infants from Singapore and 168 infants from Malaysia were randomised to receive the Phase III Clinical (Clin) or the Commercial (Com) lot of PHiD-CV at 2, 3, and 5 months of age. In the booster vaccination phase, 238 toddlers from Singapore received one dose of the PHiD-CV Commercial lot at 18-21 months of age. Immune responses to pneumococcal polysaccharides were measured using 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and functional opsonophagocytic activity (OPA) assay and to protein D, using ELISA. RESULTS: Immune responses induced by primary vaccination with the PHiD-CV Commercial lot were non-inferior to the Phase III Clinical lot in terms of adjusted antibody geometric mean concentration (GMC) ratios for each vaccine pneumococcal serotype and protein D. For each vaccine pneumococcal serotype, ≥93.6% and ≥88.5% of infants from Malaysia and Singapore had post-primary vaccination antibody concentrations ≥0.2 µg/mL and OPA titres ≥8, in the Clin and Com groups, respectively. For each vaccine pneumococcal serotype, ≥60.8% and ≥98.2% of toddlers from Singapore had pre- and post-booster antibody concentrations ≥0.2 µg/mL, in the Clin and Com groups, respectively. All children, except one, had measurable anti-protein D antibodies and the primary and booster doses of the co-administered vaccines were immunogenic. The incidence of each grade 3 solicited symptom was ≤11.1% in both study phases. No serious adverse events considered causally related to vaccination were reported throughout the study. CONCLUSIONS: PHiD-CV given as three-dose primary vaccination to infants in Singapore and Malaysia and booster vaccination to toddlers in Singapore was shown to be immunogenic with a clinically acceptable-safety profile.This study has been registered at http://www.clinicaltrials.govNCT00808444 and NCT01119625.


Subject(s)
Pneumococcal Infections/prevention & control , Pneumococcal Vaccines/administration & dosage , Streptococcus pneumoniae/immunology , Vaccination , Vaccines, Conjugate/administration & dosage , Antibodies, Bacterial/blood , Antibodies, Bacterial/immunology , Bacterial Proteins/administration & dosage , Carrier Proteins/administration & dosage , Female , Humans , Immunization, Secondary , Immunoglobulin D/administration & dosage , Immunoglobulin D/blood , Infant , Lipoproteins/administration & dosage , Malaysia , Male , Polysaccharides, Bacterial/immunology , Singapore , Vaccine Potency
7.
Hum Vaccin Immunother ; 10(3): 757-66, 2014.
Article in English | MEDLINE | ID: mdl-24356787

ABSTRACT

In a previous study, 3-dose primary vaccination of Nigerian infants with the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) was immunogenic for vaccine pneumococcal serotypes, with comparable tolerability between PHiD-CV and control groups. In an open-label study (ClinicalTrials.gov, NCT01153893), 68 primed children received a PHiD-CV booster dose co-administered with a diphtheria-tetanus-acellular pertussis (DTPa) booster dose at 15-21 months and 36 children unprimed for pneumococcal vaccination received two PHiD-CV catch-up doses (first dose co-administered with DTPa booster dose) at 15-21 and 17-23 months. Adverse events were recorded and immune responses were measured before and one month after vaccination. In both groups, pain was the most frequent solicited local symptom and fever was the most frequent solicited general symptom after the booster dose and each catch-up dose. Few grade 3 solicited symptoms and no vaccine-related serious adverse events were reported. After booster vaccination, for each vaccine serotype, at least 98.5% of children had an antibody concentration ≥ 0.2 µg/ml and at least 94.0% had an opsonophagocytic activity (OPA) titer ≥ 8. After 2-dose catch-up, for each vaccine serotype, at least 97.1% had an antibody concentration ≥ 0.2 µg/ml, except for serotypes 6B (82.9%) and 23F (88.6%), and at least 91.4% had an OPA titer ≥8, except for serotypes 6B (77.4%) and 19F (85.3%). PHiD-CV induced antibody responses against protein D in both groups. In conclusion, PHiD-CV administered to Nigerian toddlers as a booster dose or 2-dose catch-up was well tolerated and immunogenic for vaccine pneumococcal serotypes and protein D.


Subject(s)
Haemophilus Infections/prevention & control , Pneumococcal Infections/prevention & control , Pneumococcal Vaccines/adverse effects , Pneumococcal Vaccines/immunology , Vaccination/adverse effects , Vaccination/methods , Antibodies, Bacterial/blood , Cohort Studies , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/pathology , Female , Fever/chemically induced , Fever/epidemiology , Humans , Infant , Male , Nigeria , Opsonin Proteins/blood , Pain/chemically induced , Pain/epidemiology , Phagocytosis , Pneumococcal Vaccines/administration & dosage
8.
Clin Epidemiol ; 5: 269-75, 2013.
Article in English | MEDLINE | ID: mdl-23950659

ABSTRACT

PURPOSE: Rotavirus (RV) is the leading cause of morbidity and mortality in children under 5 years of age worldwide. This study assessed the role of RV as a cause of gastroenteritis (GE)-associated hospitalization in children, generating baseline information to evaluate the potential impact of the RV vaccine in reducing RVGE disease burden in the Kingdom of Bahrain. METHODS: This single, pediatric hospital-based surveillance study was conducted over a period of 12 months beginning April 1, 2006. A total of 314 children aged under 5 years and hospitalized due to GE were enrolled in the study, following collection of written informed consent from parents/guardians. Stool samples were tested for the presence of RV using enzyme immunoassay, and a random subset of RV-positive samples was further genotyped using reverse transcriptase-polymerase chain reaction and reverse hybridization assay. RESULTS: Of 314 enrolled children, 239 were included in the final analysis. RV was detected in 107 children (44.8%), mostly in the 6-23 months age group (82/107; 76.6%). RVGE occurred throughout the year, with the highest proportion occurring during April (26/42; 61.9%). G1P[8[ was the most commonly detected RV strain (10/17; 58.8%) in the limited number of samples analyzed. Vomiting and severe RVGE were more commonly observed in RV-positive than RV-negative children before hospitalization (P = 0.0008 and 0.0204, respectively). CONCLUSION: In our study, RV accounted for over 40% of GE-associated hospitalizations and particularly affected children under 2 years of age. These data will serve as a baseline for assessing the potential changes in the epidemiology of RV disease and for evaluating the potential impact of the introduction of RV vaccination.

9.
Article in English | MEDLINE | ID: mdl-23682437

ABSTRACT

We conducted a hospital-based study from June 2002 to December 2006 of Thai children aged 1-15 years with acute hepatic failure (AHF) to determine the causes and outcomes. Eleven children were included in the study. Hepatitis B virus was the cause of AHF in one child, infection-associated hemophagocytic syndrome was the cause in 1 child, Wilson's disease was the cause in 1 child and dengue fever was suspected to be the cause in 2 children. In 6 children the cause of AHF was unknown. Jaundice was reported in 9 of 11 children. Ten of 11 children had mild to moderate encephalopathy on admission. Five of 11 children died due to AHF. No liver transplantations were performed among the children in this study. Further studies into the relationship between dengue infection and AHF are needed.


Subject(s)
Child, Hospitalized/statistics & numerical data , Liver Failure, Acute/diagnosis , Liver Failure, Acute/etiology , Adolescent , Antibodies, Viral , Child , Child, Preschool , Enzyme-Linked Immunosorbent Assay , Female , Humans , Infant , Liver Failure, Acute/virology , Male , Prognosis , Thailand/epidemiology
10.
BMC Infect Dis ; 13: 95, 2013 Feb 21.
Article in English | MEDLINE | ID: mdl-23432812

ABSTRACT

BACKGROUND: Pneumococcal infections are major causes of child mortality and morbidity worldwide and antibiotic resistance of Streptococcus pneumoniae is a major concern, especially in Asian countries. The present study was designed to evaluate the reactogenicity and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when co-administered with the licensed diphtheria, tetanus, acellular pertussis, hepatitis B virus, inactivated poliovirus and H. influenzae type b vaccine (DTPa-HBV-IPV/Hib) in a 3-dose primary vaccination course in Vietnamese infants. METHODS: This phase III, open, randomised study was conducted in one centre in Ho Chi Minh City between February and July 2011. Healthy infants (N=300) were randomised (2:1) to receive either PHiD-CV co-administered with DTPa-HBV-IPV/Hib (PHiD-CV group) or DTPa-HBV-IPV/Hib alone (Control group) at 2, 3, and 4 months of age. RESULTS: Within 31 days post-vaccination, 8.2% of overall doses in the PHiD-CV group and 3.0% of overall doses in the Control group were followed by at least one solicited and/or unsolicited, local and/or general adverse event of grade 3 intensity. Pain at injection site was the most common grade 3 solicited symptom, which was reported following 6.5% and 1.0% of overall doses in the PHiD-CV and Control groups, respectively. Within 4 days post-vaccination, the most common solicited local and general symptoms reported with any intensity were pain (48.9% and 31.0% of doses in the PHiD-CV and Control groups) and irritability (58.0% and 40.4% of doses in the PHiD-CV and Control groups). Within 31 days post-vaccination, the incidence of unsolicited symptoms was comparable in both groups (following 12.3% and 14.8% of doses in the PHiD-CV and Control groups, respectively). Throughout the study, 13 serious adverse events (SAEs) were reported in 9 infants in the PHiD-CV group and 11 SAEs in 6 infants in the Control group. None of them were fatal or considered causally related to vaccination. CONCLUSIONS: PHiD-CV had a clinically acceptable safety profile when co-administered with DTPa-HBV-IPV/Hib in Vietnamese infants. The reactogenicity of PHiD-CV was comparable to that observed in other South-East Asian populations.


Subject(s)
Pneumococcal Vaccines/administration & dosage , Pneumococcal Vaccines/adverse effects , Bacterial Proteins/immunology , Carrier Proteins/immunology , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Drug-Related Side Effects and Adverse Reactions/etiology , Female , Hepatitis B Vaccines/administration & dosage , Hepatitis B Vaccines/adverse effects , Humans , Immunoglobulin D/immunology , Infant , Infant, Newborn , Lipoproteins/immunology , Male , Poliovirus Vaccine, Inactivated/administration & dosage , Poliovirus Vaccine, Inactivated/adverse effects , Vaccines, Combined/administration & dosage , Vaccines, Combined/adverse effects , Vaccines, Conjugate/administration & dosage , Vaccines, Conjugate/adverse effects , Vietnam
11.
Hum Vaccin Immunother ; 9(2): 382-8, 2013 Feb.
Article in English | MEDLINE | ID: mdl-23291945

ABSTRACT

BACKGROUND: Primary vaccination with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) was previously shown to be immunogenic and well tolerated in Malian children. Data on booster vaccination with a fourth consecutive dose of PHiD-CV are available for Europe, Asia and Latin America but are lacking for Africa. The present study evaluated further the safety, reactogenicity and immunogenicity of a fourth consecutive (booster) dose of PHiD-CV. RESULTS: Low incidences of AEs with grade 3 intensity (2.1% of subjects) were observed. There were no reports of large swelling reactions and serious adverse events. One month post-booster vaccination, for each vaccine pneumococcal serotype, at least 97.8% of subjects had antibody concentrations ≥ 0.2 µg/ml, and at least 97.1% of subjects had opsonophagocytic activity ≥ 8. From pre- to post-booster, a 12.3-fold increase in anti-protein D geometric mean concentration was observed. METHODS: This phase III, open-label study was conducted in Ouelessebougou, Mali, between November 2009 and June 2010. The study population consisted of Malian children previously primed (3 doses) with PHiD-CV in study NCT00678301 receiving a fourth consecutive (booster) dose of PHiD-CV in the second year of life. The incidences of adverse events (AEs) with grade 3 intensity (primary objective) or of any intensity (secondary objective), and the immunogenicity (secondary objective) of the PHiD-CV booster dose were assessed. CONCLUSION: A booster dose of PHiD-CV was well tolerated when administered to Malian children in the second year of life and was highly immunogenic for all 10 vaccine pneumococcal serotypes and NTHi protein D. (ClinicalTrials.gov identifier: NCT00985465).


Subject(s)
Haemophilus Infections/prevention & control , Immunization, Secondary/adverse effects , Immunization, Secondary/methods , Pneumococcal Vaccines/adverse effects , Pneumococcal Vaccines/immunology , Antibodies, Bacterial/blood , Drug-Related Side Effects and Adverse Reactions/epidemiology , Drug-Related Side Effects and Adverse Reactions/pathology , Female , Humans , Incidence , Infant , Male , Mali , Opsonin Proteins/blood , Phagocytosis , Pneumococcal Vaccines/administration & dosage
12.
Article in English | MEDLINE | ID: mdl-23077857

ABSTRACT

Data on the epidemiology of acute hepatic failure (AHF) among pediatric Filipinos is limited. This study investigated the etiology, outcomes and incidence of AHF among 0-18 year old Filipino children. A hospital-based retrospective and prospective surveillance study was conducted at Philippine General Hospital between January 2000 and December 2006. AHF was defined as onset of coagulopathy and/or encephalopathy < or = 28 days after the onset of symptoms, a patient/ laboratory prothrombin time >2, an elevated bilirubin level and evidence of liver failure complicated by encephalopathy. Blood samples were tested for viral hepatitis antibodies using ELISA (Abbott Lab). AHF incidence rates were calculated with 95% confidence intervals (CI). Twenty-seven subjects were recruited and 26 included in the analysis. The mean age of AHF subjects at the time of hospital admission was 6.9 years (SD:6.09 years). The most frequent etiological agents for AHF were hepatitis A virus (HAV) (19.2%; 5/26) and hepatitis B virus (3.8%; 1/26). Incidence of AHF was 11.05 per 100,000 subject years (95% CI 6.81-15.30). Jaundice was observed in 84.6% (22/26) of subjects and encephalopathy on admission (any grade) was reported in 72.0% of subjects: AHF was fatal in 84.6% (22/26) of subjects. HAV was the most common etiological agent for AHF. Indeterminate causes for AHF indicate the need for further investigation.


Subject(s)
Liver Failure, Acute/complications , Liver Failure, Acute/epidemiology , Adolescent , Child , Child, Preschool , Enzyme-Linked Immunosorbent Assay , Female , Hepacivirus , Hepatic Encephalopathy/etiology , Hepatitis A virus , Hepatitis Antibodies , Humans , Incidence , Infant , Infant, Newborn , Jaundice/etiology , Liver Failure, Acute/etiology , Liver Failure, Acute/virology , Male , Philippines/epidemiology , Prospective Studies , Retrospective Studies
13.
Hum Vaccin Immunother ; 8(5): 612-22, 2012 May.
Article in English | MEDLINE | ID: mdl-22634448

ABSTRACT

In India, pneumococcal diseases are major causes of child mortality, and effective vaccines against Streptococcus pneumoniae are needed. This single-blind, randomized study assessed the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Hemophilus influenzae (NTHi) protein D conjugate vaccine (PHiD-CV) co-administered with DTPw-HBV/Hib in Indian infants as 3-dose primary vaccination course. A total of 360 infants were randomized (2:1) to receive either PHiD-CV co-administered with DTPw-HBV/Hib (PHiD-CV group) or a Hib vaccine co-administered with DTPw-HBV (control group) at 6, 10, and 14 weeks of age. For each vaccine pneumococcal serotype, the percentage of infants in the PHiD-CV group with antibody concentrations ≥ 0.2 µg/mL one month after the third vaccine dose was at least 98.3%, except for serotypes 6B (77.7%) and 23F (89.5%), and opsonophagocytic activity titers ≥ 8 were measured in at least 95.7% of infants, except for serotypes 1 (90.5%) and 6B (84.5%). In addition, all the infants in the PHiD-CV group were seroprotected against diphtheria, tetanus, Hib, and hepatitis B or seropositive for antibodies against pertussis and NTHi protein D (except one infant). Incidences of solicited local and general symptoms were comparable between groups, except for fever (axillary temperature ≥ 37.5°C), which seemed to occur more frequently in the PHiD-CV group. In conclusion, PHiD-CV was shown to be immunogenic and well-tolerated when co-administered with DTPw-HBV/Hib in Indian infants.


Subject(s)
Pneumococcal Infections/prevention & control , Pneumococcal Vaccines/adverse effects , Pneumococcal Vaccines/immunology , Antibodies, Bacterial/blood , Antibodies, Viral/blood , Bacterial Capsules/immunology , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Diphtheria-Tetanus-Pertussis Vaccine/immunology , Drug-Related Side Effects and Adverse Reactions/epidemiology , Female , Haemophilus Vaccines/administration & dosage , Haemophilus Vaccines/adverse effects , Haemophilus Vaccines/immunology , Hepatitis B Vaccines/administration & dosage , Hepatitis B Vaccines/adverse effects , Hepatitis B Vaccines/immunology , Humans , India , Infant , Male , Opsonin Proteins/blood , Phagocytosis , Pneumococcal Vaccines/administration & dosage , Single-Blind Method , Vaccination/adverse effects , Vaccination/methods , Vaccines, Combined/administration & dosage , Vaccines, Combined/adverse effects , Vaccines, Combined/immunology
14.
Pediatr Infect Dis J ; 30(5): 396-401, 2011 May.
Article in English | MEDLINE | ID: mdl-21150692

ABSTRACT

BACKGROUND: Brazil initiated universal immunization of infants with the G1P[8] human rotavirus (RV) vaccine in March 2006. This study evaluated vaccine effectiveness (VE) against severe rotavirus gastroenteritis (RVGE) hospitalizations. METHODS: Matched case-control study conducted at 4 hospitals in Belém from May 2008 to May 2009. Cases were children hospitalized with RVGE age-eligible to have received 2 doses of the human RV vaccine (≥ 12 weeks of age and born after March 6, 2006). For each case, 1 neighborhood and 1 hospital control without gastroenteritis was selected, matching by birth date (± 8 and ± 6 weeks, respectively). Matched odds ratio of 2-dose RV vaccination in cases versus controls was used to estimate VE (1 - odds ratio × 100%). RESULTS: Of 538 RVGE cases, 507 hospital controls and 346 neighborhood controls included, 54%, 61%, and 74% had received both RV vaccine doses. VE against RVGE hospitalization was 75.8% (95% confidence interval [CI]: 58.1-86.0) using neighborhood controls and 40.0% (95% CI: 14.2-58.1) using hospital controls. VE in children 3 to 11 months and ≥ 12 months of age was 95.7% (95% CI: 67.8-99.4) and 65.1% (95% CI: 37.2-80.6) using neighborhood controls, and 55.6% (95% CI: 12.3-77.5) and 32.1% (95% CI: -3.7-55.5) using hospital controls. G2P[4] accounted for 82.0% of RVGE hospitalizations. G2P[4]-specific VE was 75.4% (95% CI: 56.7-86.0) using neighborhood controls and 38.9% (95% CI: 11.1-58.0) using hospital controls. CONCLUSIONS: Although fully heterotypic G2P[4] was the predominant RV strain, good VE was demonstrated. VE was highest in children aged 3 to 11 months. However, protection in children ≥ 12 months of age, important for optimal public health impact, was significantly sustained based on estimates obtained using neighborhood controls.


Subject(s)
Gastroenteritis/epidemiology , Gastroenteritis/prevention & control , Hospitalization/statistics & numerical data , Rotavirus Infections/epidemiology , Rotavirus Infections/prevention & control , Rotavirus Vaccines/immunology , Brazil/epidemiology , Case-Control Studies , Child, Preschool , Female , Genotype , Humans , Infant , Male , Rotavirus/classification , Rotavirus/genetics , Rotavirus/immunology , Rotavirus Vaccines/administration & dosage
15.
Pediatr Infect Dis J ; 29(7): 673-5, 2010 Jul.
Article in English | MEDLINE | ID: mdl-20300045

ABSTRACT

Rotavirus vaccination was introduced in Brazil in March 2006. We describe trends in hospitalizations from all-cause gastroenteritis in children younger than 5 years during pre- and postvaccination periods using hospital discharge data from Brazil Hospital Information System (SIH-SUS). A reduction in gastroenteritis hospitalizations of 26% and 48% in 2006 and in 2007, respectively, was observed among children younger than 1 year compared with prevaccination period (1998-2005). The largest reduction rates among children younger than 1 year were noted in the South and Southeast regions, approximately 56% in 2007, where vaccine coverage was the highest.


Subject(s)
Gastroenteritis/epidemiology , Gastroenteritis/pathology , Hospitalization/trends , Rotavirus Vaccines/administration & dosage , Rotavirus Vaccines/immunology , Brazil/epidemiology , Child, Preschool , Geography , Humans , Infant , Infant, Newborn
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