Safety and immunogenicity of a toddler dose following an infant series of a hexavalent diphtheria, tetanus, acellular pertussis, inactivated poliovirus, Haemophilus influenzae type b, hepatitis B vaccine administered concurrently or at separate visits with a heptavalent pneumococcal conjugate vaccine.

Abstract

BACKGROUND:

Combination diphtheria-tetanus-5 component acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine (DTaP5-IPV-Hib-HepB) administered either concurrently with 7-valent pneumococcal conjugate vaccine (PCV7) or 1 month apart was generally safe and immunogenic at 2, 4 and 6 months of age. This study examined the effects of a booster dose at age 15 months.

METHODS:

Participants were randomized to DTaP5-IPV-Hib-HepB plus PCV7, DTaP5-IPV-Hib-HepB with PCV7 administered 1 month later or a pentavalent DTaP5-IPV/Hib plus HepB plus PCV7 at 15 months of age in a randomized, open-label, phase IIb clinical trial. Immunogenicity endpoints were rates of seroresponse to pertussis toxoid, filamentous hemagglutinin, pertactin and fimbriae types 2 and 3; rates of seroprotection against (Hib) polyribosylribitol phosphate capsular polysaccharide, hepatitis B surface antigen, diphtheria toxoid, tetanus toxoid and poliovirus types 1, 2 and 3; and geometric mean titers to all vaccine antigens. Safety endpoints included solicited injection-site reactions and systemic and serious adverse events.

RESULTS:

Seroresponse/seroprotection rates for all antigens exceeded prespecified criteria in both groups that received the hexavalent DTaP5-IPV-Hib-HepB; in the group that received the currently licensed pentavalent vaccine, seroresponse/seroprotection rates exceeded the criteria for all antigens except filamentous hemagglutinin. Seroresponse rates were ≥88.9% for pertussis antigens and seroprotection rates against polyribosylribitol phosphate capsular polysaccharide, hepatitis B surface antigen, diphtheria toxoid, tetanus toxoid and poliovirus antigens were ≥95.1% in recipients of DTaP5-IPV-Hib-HepB.

CONCLUSIONS:

DTaP5-IPV-Hib-HepB administered concomitantly with PCV7 or 1 month apart at 15 months of age following the infant series was well-tolerated and elicited antibody responses to all vaccine antigens, with no significant interference from concomitant PCV7 administration (clinicaltrials.gov registration number NCT00362427).

• Authors: Scott A Halperin, Bruce Tapiéro, Marc Dionne, William Meekison, Francisco Diaz-Mitoma, Paul Zickler, Earl Rubin, Joanne Embree, Prakash Bhuyan, Andrew Lee, Minran Li, Antigona Tomovici
• Journal: The Pediatric infectious disease journal (Pediatr Infect Dis J) Vol. 33 Issue 1 Pg. 73-80 (Jan 2014) ISSN: 1532-0987 [Electronic] United States
• PMID: 24346596 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Bacterial
• Antibodies, Viral
• Diphtheria-Tetanus-Pertussis Vaccine
• Haemophilus Vaccines
• Hepatitis B Vaccines
• Heptavalent Pneumococcal Conjugate Vaccine
• Pneumococcal Vaccines
• Poliovirus Vaccine, Inactivated
• Vaccines, Combined
• diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine

Topics

• Antibodies, Bacterial (blood)
• Antibodies, Viral (blood)
• Diphtheria-Tetanus-Pertussis Vaccine (administration & dosage, adverse effects, immunology)
• Dose-Response Relationship, Immunologic
• Female
• Haemophilus Vaccines (administration & dosage, adverse effects, immunology)
• Hepatitis B Vaccines (administration & dosage, adverse effects, immunology)
• Heptavalent Pneumococcal Conjugate Vaccine
• Humans
• Infant
• Male
• Pneumococcal Vaccines (administration & dosage, adverse effects, immunology)
• Poliovirus Vaccine, Inactivated (administration & dosage, adverse effects, immunology)
• Vaccines, Combined (administration & dosage, adverse effects, immunology)