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Immunogenicity, reactogenicity and consistency of production of a Brazilian combined vaccine against diphtheria, tetanus, pertussis and Haemophilus influenzae type b
Martins, Reinaldo de Menezes; Camacho, Luiz Antonio Bastos; Marcovistz, Rugimar; Noronha, Tatiana Guimarães de; Maia, Maria de Lourdes Sousa; Santos, Eliane Matos dos; Barbosa, Glayse Glayde; Silva, Andrea Marques Vieira da; Souza, Patricia Cristina Neves Feliciano de; Lemos, Maria Cristina Ferreira; Homma, Akira.
  • Martins, Reinaldo de Menezes; Fiocruz. Assessoria Clínica. Rio de Janeiro. BR
  • Camacho, Luiz Antonio Bastos; Fiocruz. Escola Nacional de Saúde Pública. Rio de Janeiro. BR
  • Marcovistz, Rugimar; Fiocruz. Laboratório de Tecnologia Imunológica. Rio de Janeiro. BR
  • Noronha, Tatiana Guimarães de; Fiocruz. Assessoria Clínica. Rio de Janeiro. BR
  • Maia, Maria de Lourdes Sousa; Fiocruz. Assessoria Clínica. Rio de Janeiro. BR
  • Santos, Eliane Matos dos; Fiocruz. Assessoria Clínica. Rio de Janeiro. BR
  • Barbosa, Glayse Glayde; Fiocruz. Assessoria Clínica. Rio de Janeiro. BR
  • Silva, Andrea Marques Vieira da; Fiocruz. Laboratório de Tecnologia Imunológica. Rio de Janeiro. BR
  • Souza, Patricia Cristina Neves Feliciano de; Fiocruz. Laboratório de Tecnologia Imunológica. Rio de Janeiro. BR
  • Lemos, Maria Cristina Ferreira; Secretaria Municipal de Saúde do Rio de Janeiro.
  • Homma, Akira; Fiocruz. Bio-Manguinhos. Rio de Janeiro. BR
Mem. Inst. Oswaldo Cruz ; 103(7): 711-718, Nov. 2008. ilus, tab
Article in English | LILACS | ID: lil-498381
ABSTRACT
A randomized, double-blinded study evaluating the immunogenicity, safety and consistency of production of a combined diphtheria-tetanus-pertussis-Haemophilus influenzae type b vaccine entirely produced in Brazil by Bio-Manguinhos and Instituto Butantan (DTP/Hib-BM) was undertaken. The reference vaccine had the same DTP vaccine but the Hib component was produced using purified materials supplied by GlaxoSmithKline (DTP/Hib-GSK), which is registered and has supplied the Brazilian National Immunization Program for over more than five years. One thousand infants were recruited for the study and received vaccinations at two, four and six months of age. With respect to immunogenicity, the vaccination protocol was followed in 95.6 percent and 98.4 percent of infants in the DTP/Hib-BM and DTP/Hib-GSK groups, respectively. For the Hib component of the study, there was 100 percent seroprotection (>0.15 µg/mL) with all three lots of DTP/Hib-BM and DTP/Hib-GSK. The geometric mean titer (GMT) was 9.3 µg/mL, 10.3 µg/mL and 10.3 µg/mL for lots 1, 2 and 3 of DTP/Hib-BM, respectively, and the GMT was 11.3 g/mL for DTP/Hib-GSK. For diphtheria, tetanus and pertussis, seroprotection was 99.7 percent, 100 percent and 99.9 percent, respectively, for DTP/Hib-BM, three lots altogether and 99.2 percent, 100 percent and 100 percent for DTP/Hib-GSK. GMTs were similar across all lots and vaccines. Adverse events rates were comparable among the vaccine groups. The Brazilian DTP/Hib vaccine demonstrated an immunogenicity and reactogenicity profile similar to that of the reference vaccine.
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Full text: Available Index: LILACS (Americas) Main subject: Tetanus / Diphtheria-Tetanus-Pertussis Vaccine / Whooping Cough / Haemophilus Vaccines / Diphtheria / Haemophilus Infections Type of study: Controlled clinical trial Limits: Female / Humans / Infant / Male Country/Region as subject: South America / Brazil Language: English Journal: Mem. Inst. Oswaldo Cruz Journal subject: Tropical Medicine / Parasitology Year: 2008 Type: Article Affiliation country: Brazil Institution/Affiliation country: Fiocruz/BR

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Full text: Available Index: LILACS (Americas) Main subject: Tetanus / Diphtheria-Tetanus-Pertussis Vaccine / Whooping Cough / Haemophilus Vaccines / Diphtheria / Haemophilus Infections Type of study: Controlled clinical trial Limits: Female / Humans / Infant / Male Country/Region as subject: South America / Brazil Language: English Journal: Mem. Inst. Oswaldo Cruz Journal subject: Tropical Medicine / Parasitology Year: 2008 Type: Article Affiliation country: Brazil Institution/Affiliation country: Fiocruz/BR