Concomitant administration of a fully liquid, ready-to-use DTaP-IPV-HB-PRP-T hexavalent vaccine with a meningococcal serogroup C conjugate vaccine in infants.

Abstract

DTaP-IPV-HB-PRP-T or hexavalent vaccines are indicated for primary and booster vaccination of infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The present study evaluates the safety and immunogenicity of a ready-to-use hexavalent vaccine when co-administered with a meningococcal serogroup C conjugate (MenC) vaccine in infants. This was a phase III, open-label, randomised, multicentre study conducted in Finland. Healthy infants, aged 46-74days (n=350), were randomised in a ratio of 1:1 to receive DTaP-IPV-HB-PRP-T vaccine at two, three and four months, either with a MenC vaccine co-administered at two and four months (Group 1; n=175) or without MenC vaccine (Group 2; n=175). All infants also received routine rotavirus and 13-valent pneumococcal conjugate vaccines. The proportion of participants with an anti-HBs concentration ⩾10mIU/mL assessed one month after the third dose of DTaP-IPV-HB-PRP-T vaccine was 97.5% [95%CI: 93.1-99.3] in the coadministration group and 96.1% [95%CI: 91.8-98.6] in the group without MenC vaccine. The proportion of participants with an anti-MenC SBA titre ⩾8 assessed one month after the second dose of MenC vaccine was 100% in the coadministration group. Both primary objectives were achieved. Secondary immunogenicity and safety analyses showed that co-administration of DTaP-IPV-HB-PRP-T and MenC vaccines did not impact the immune response to the antigens of each of the two vaccines. All vaccines were well tolerated and the safety profile of DTaP-IPV-HB-PRP-T vaccine was similar in both groups. ClinicalTrials.gov identifier: NCT01839175; EudraCT number: 2012-005547-24.

• Authors: Timo Vesikari, Ray Borrow, Xavier Da Costa, Patrick Richard, Cécile Eymin, Florence Boisnard, Stephen Lockhart
• Journal: Vaccine (Vaccine) Vol. 35 Issue 3 Pg. 452-458 (01 11 2017) ISSN: 1873-2518 [Electronic] Netherlands
• PMID: 27939054 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Crown Copyright © 2016. Published by Elsevier Ltd. All rights reserved.

Chemical References

• 13-valent pneumococcal vaccine
• Antibodies, Bacterial
• DTaP-IPV-HB-PRP-T vaccine
• Diphtheria-Tetanus-Pertussis Vaccine
• Haemophilus Vaccines
• Hepatitis B Antibodies
• Hepatitis B Vaccines
• Meningococcal Vaccines
• Pneumococcal Vaccines
• Poliovirus Vaccine, Inactivated
• Rotavirus Vaccines
• Vaccines, Combined
• serogroup C meningococcal conjugate vaccine

Topics

• Antibodies, Bacterial (blood)
• Diphtheria-Tetanus-Pertussis Vaccine (administration & dosage, adverse effects, immunology)
• Finland
• Haemophilus Vaccines (administration & dosage, adverse effects, immunology)
• Healthy Volunteers
• Hepatitis B Antibodies (blood)
• Hepatitis B Vaccines (administration & dosage, adverse effects, immunology)
• Humans
• Immunization Schedule
• Infant
• Meningococcal Vaccines (administration & dosage, adverse effects, immunology)
• Pneumococcal Vaccines (administration & dosage)
• Poliovirus Vaccine, Inactivated (administration & dosage, adverse effects, immunology)
• Rotavirus Vaccines (administration & dosage)
• Vaccines, Combined (administration & dosage, adverse effects, immunology)