Immunogenicity and safety of the Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine co-administered with human rotavirus, hepatitis A and 13-valent pneumococcal conjugate vaccines: results from a phase III, randomized, multicenter study in infants.

Abstract

This phase III, open-label, randomized study (NCT01978093) evaluated the immunogenicity and safety of co-administered Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (Hib-MenCY-TT) with human rotavirus vaccine (HRV), hepatitis A vaccine (HAV) and 13-valent pneumococcal conjugate vaccine (PCV13). We randomized 600 infants (1:1) to receive 4 doses of Hib-MenCY-TT at 2, 4, 6 and 12-15 months of age or 3 doses of Hib vaccine conjugated to N. meningitidis outer membrane protein complex (Hib-OMP) at 2, 4 and 12-15 months of age. All infants received HRV at 2 and 4 months of age, PCV13 at 2, 4, 6 and 12-15 months of age, HAV at 12-15 and 18-21 months of age, and diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus vaccine at 2, 4 and 6 months of age. We measured immune responses against HRV, HAV and Hib with enzyme-linked immunosorbent assays, and against MenC/MenY with serum bactericidal assays using human complement. The 4-dose vaccination series with Hib-MenCY-TT induced a robust immune response against Hib, which was non-inferior to that induced by a 3-dose vaccination series with Hib-OMP, and against MenC and MenY. Hib-MenCY-TT did not interfere with immune responses to concomitantly administered HRV, PCV13 and HAV. We did not identify any safety concern. In conclusion, we showed that 4-dose vaccination series with Hib-MenCY-TT during infancy did not interfere with immune responses of co-administered HRV, PCV13 and HAV, induced robust immune responses against Hib, MenC and MenY, and had a clinically acceptable safety profile.

• Authors: Nicola P Klein, Remon Abu-Elyazeed, Yaela Baine, Brigitte Cheuvart, Marcela Silerova, Narcisa Mesaros
• Journal: Human vaccines & immunotherapeutics (Hum Vaccin Immunother) Vol. 15 Issue 2 Pg. 327-338 ( 2019) ISSN: 2164-554X [Electronic] United States
• PMID: 30252603 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• 13-valent pneumococcal vaccine
• Antibodies, Bacterial
• Antibodies, Viral
• Haemophilus Vaccines
• Hepatitis A Vaccines
• Hib-MenCY-TT vaccine
• Pneumococcal Vaccines
• Rotavirus Vaccines
• Tetanus Toxoid
• Vaccines, Combined
• Vaccines, Conjugate

Topics

• Antibodies, Bacterial (blood)
• Antibodies, Viral (blood)
• Female
• Haemophilus Vaccines (administration & dosage, immunology)
• Hepatitis A Vaccines (administration & dosage)
• Humans
• Immunogenicity, Vaccine
• Infant
• Male
• Pneumococcal Vaccines (administration & dosage)
• Rotavirus Vaccines (administration & dosage)
• Serogroup
• Tetanus Toxoid (administration & dosage, immunology)
• Vaccines, Combined (administration & dosage)
• Vaccines, Conjugate (administration & dosage, immunology)