Journal Article

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

Eymin, Cécile, Boisnard, Florence, Borrow, Ray, Da Costa, Xavier, Lockhart, Stephen, Vesikari, Timo, Richard, Patrick

2017

Overview

•DTaP-IPV-HB-PRP-T immunogenicity is similar when given concomitantly with a meningococcal C conjugate vaccine or alone.•The safety profile of DTaP-IPV-HB-PRP-T is similar when given concomitantly with a meningococcal C conjugate vaccine or alone.•These data support the concomitant use of DTa-IPV-HB-PRP-T vaccine with a meningococcal C conjugate vaccine. 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.

• Publisher: Elsevier Ltd,Elsevier Limited
• Subject: Age / Allergy and Immunology / Antibodies, Bacterial - blood / Antigens / Co-administration / Diphtheria / Diphtheria-Tetanus-Pertussis Vaccine - administration & dosage / Diphtheria-Tetanus-Pertussis Vaccine - adverse effects / Diphtheria-Tetanus-Pertussis Vaccine - immunology / Finland / Haemophilus influenzae / Haemophilus Vaccines - administration & dosage / Haemophilus Vaccines - adverse effects / Haemophilus Vaccines - immunology / Healthy Volunteers / Hepatitis / hepatitis B / Hepatitis B Antibodies - blood / Hepatitis B Vaccines - administration & dosage / Hepatitis B Vaccines - adverse effects / Hepatitis B Vaccines - immunology / Hepatitis B virus / Hexavalent / Humans / Immune response / Immunization / Immunization Schedule / Immunogenicity / Infant / Infants / Meningococcal C / Meningococcal Vaccines - administration & dosage / Meningococcal Vaccines - adverse effects / Meningococcal Vaccines - immunology / Neisseria meningitidis / Pain / Pneumococcal Vaccines - administration & dosage / Poliomyelitis / Poliovirus / Poliovirus Vaccine, Inactivated - administration & dosage / Poliovirus Vaccine, Inactivated - adverse effects / Poliovirus Vaccine, Inactivated - immunology / Public health / Reoviridae / Rotavirus / Rotavirus Vaccines - administration & dosage / Safety / secondary immunization / serotypes / Streptococcus pneumoniae / Tetanus / toddlers / Vaccination / Vaccines / Vaccines, Combined - administration & dosage / Vaccines, Combined - adverse effects / Vaccines, Combined - immunology / Viruses / Whooping cough