Immunogenicity and reactogenicity of a three-dose primary vaccination course with a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-haemophilus influenzae type b vaccine coadministered with a meningococcal C conjugate vaccine.

Abstract

AIM:

To evaluate the immunogenicity and safety of 3 doses of the combined diphtheria-tetanus toxoids-acellular pertussis-hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine (Infanrix hexa) when coadministered with a CRM197-conjugated meningococcal C vaccine (Meningitec) at different injection sites during the same visit or during separate visits.

METHODS:

Healthy infants were randomized in an open randomized multicenter study to receive either the DTPa-HBV-IPV/Hib and meningococcal C conjugate vaccines during the same vaccination visit at 2, 4 and 6 months of age (coadministration group) or the DTPa-HBV-IPV/Hib vaccine at 2, 4 and 6 months of age and the meningococcal C conjugate vaccine at 3, 5 and 7 months of age (separate administration group).

RESULTS:

The immunogenicity analysis included 452 infants, 228 in the coadministration group and 224 in the separate administration group. One month after primary vaccination, 99.1% of subjects in both groups achieved anti-polyribosylribitol phosphate antibody concentrations >/=0.15 microg/mL. The vaccine response against pertussis antigens was at least 99.1% in both groups. For all other DTPa-HBV-IPV/Hib vaccine antigens, at least 97.8% of all subjects of both groups were seroprotected. In addition, 99.5% of all subjects had meningococcal C bactericidal antibody titers >/=1/8 and 99.1% >/=1/128. Coadministration of both vaccines did not result in an increased local or general reactogenicity compared with separate administration.

CONCLUSION:

Coadministration of the combined DTPa-HBV-IPV/Hib vaccine and the meningococcal C conjugate vaccine during the same vaccination visit was immunogenic and safe.

• Authors: Juan C Tejedor, Félix Omeñaca, José García-Sicilia, Joaquim Verdaguer, Diego Van Esso, Carlos Esporrín, Vicente Molina, Marta Muro, Josep Marés, Manuel Enrubia, Fernando Moraga, Pilar García-Corbeira, Kurt Dobbelaere, Lode Schuerman, Spanish DTPa-HBV-IPV/Hib-076 Study Group
• Journal: The Pediatric infectious disease journal (Pediatr Infect Dis J) Vol. 23 Issue 12 Pg. 1109-15 (Dec 2004) ISSN: 0891-3668 [Print] United States
• PMID: 15626947 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Bacterial
• Antibodies, Viral
• 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
• serogroup C meningococcal conjugate vaccine

Topics

• Antibodies, Bacterial (blood)
• Antibodies, Viral (blood)
• Bacterial Capsules
• Diphtheria-Tetanus-Pertussis Vaccine
• Female
• Haemophilus Vaccines (administration & dosage, adverse effects, immunology)
• Hepatitis B Vaccines
• Humans
• Infant
• Male
• Meningococcal Vaccines (administration & dosage, adverse effects, immunology)
• Poliovirus Vaccine, Inactivated
• Polysaccharides, Bacterial (administration & dosage, adverse effects, immunology)
• Vaccines, Combined (administration & dosage, adverse effects, immunology)