Immunogenicity and reactogenicity of primary immunization with a novel combined Haemophilus influenzae Type b and Neisseria meningitidis Serogroup C-tetanus toxoid conjugate vaccine coadministered with a Diphtheria-tetanus-acellular Pertussis-hepatitis B-inactivated poliovirus vaccine at 2, 4 and 6 months.

Abstract

BACKGROUND:

This phase II study evaluated the immunogenicity and reactogenicity of primary vaccination with a novel Hib-MenC conjugate vaccine (GlaxoSmithKline [GSK] Biologicals) coadministered with DTPa-HBV-IPV (GSK Biologicals) at 2, 4 and 6 months.

METHODS:

Healthy infants were randomized to receive Hib-MenC coadministered with DTPa-HBV-IPV (N = 117) or MenC-CRM (Wyeth) coadministered with DTPa-HBV-IPV/Hib (GSK Biologicals; N = 120) at 2, 4 and 6 months. Antibody concentrations were measured before vaccination and after doses 2 and 3. Solicited local and general symptoms, unsolicited symptoms and serious adverse events (SAEs) were recorded.

RESULTS:

All subjects in the Hib-MenC group had seroprotective titers of anti-PRP antibodies (>or=0.15 microg/mL) and SBA-MenC titers (>or=1:8) 1 month after the third dose. These responses were noninferior to those seen in the control group, in which a 99.1% seroprotection rate was observed for both Hib and MenC. At that time, anti-PRP and SBA-MenC GMTs were significantly higher in the Hib-MenC group (12.8 microg/mL and 2467.1 microg/mL, respectively) than in the control group (3.8 microg/mL and 1833.7 microg/mL). High seroprotection rates were already observed after the second dose of Hib-MenC; 96.4% and 100% of subjects were seroprotected to Hib and MenC, respectively. Immune responses to coadministered antigens were unimpaired; seroprotection/vaccine response rates >or=96.5% were recorded postdose 3 in the Hib-MenC group. No differences in reactogenicity were seen between the 2 study groups.

CONCLUSIONS:

Coadministration of a Hib-MenC conjugate vaccine with DTPa-HBV-IPV is well tolerated and immunogenic, and does not impair the immune response to any of the coadministered antigens.

• Authors: Juan C Tejedor, Manuel Moro, Jesús Ruiz-Contreras, Javier Castro, José Antonio Gómez-Campderá, María Luisa Navarro, José Manuel Merino, Ana Martín-Ancel, Joan Roca, Manuel García-Del-Rí, Antonio Jurado, Francisco Javier Díez-Delgado, Félix Omeñaca, José García-Sicilia, Reyes Boceta, Pilar García-Corbeira, Alix Collard, Dominique Boutriau, Lode Schuerman, Jeanne-Marie Jacquet, Spanish DTPa-HBV-IPV-097 Study Group
• Journal: The Pediatric infectious disease journal (Pediatr Infect Dis J) Vol. 26 Issue 1 Pg. 1-7 (Jan 2007) ISSN: 0891-3668 [Print] United States
• PMID: 17195697 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• DTPa-HBV-IPV combined vaccine
• Diphtheria-Tetanus-Pertussis Vaccine
• Haemophilus Vaccines
• Haemophilus influenzae type b polysaccharide vaccine
• Hepatitis B Vaccines
• Meningococcal Vaccines
• Poliovirus Vaccine, Inactivated
• Polysaccharides, Bacterial
• Vaccines, Combined

Topics

• Bacterial Capsules
• Diphtheria-Tetanus-Pertussis Vaccine
• Female
• Haemophilus Vaccines (administration & dosage, adverse effects, immunology)
• Hepatitis B Vaccines
• Humans
• Infant, Newborn
• Male
• Meningococcal Vaccines (administration & dosage, adverse effects, immunology)
• Neisseria meningitidis, Serogroup C (immunology)
• Poliovirus Vaccine, Inactivated
• Polysaccharides, Bacterial (administration & dosage, adverse effects, immunology)
• Vaccines, Combined (administration & dosage, adverse effects, immunology)