Immunogenicity and Safety of a Hexavalent DTwP-IPV-HB-PRP~T Vaccine Versus Separate DTwP-HB-PRP~T, bOPV, and IPV Vaccines Administered at 2, 4, 6 Months of Age Concomitantly With Rotavirus and Pneumococcal Conjugate Vaccines in Healthy Infants in Thailand

Pediatr Infect Dis J. 2023 Aug 1;42(8):711-718. doi: 10.1097/INF.0000000000003975. Epub 2023 Apr 27.

Abstract

Background: This study investigated the immunogenicity and safety of a fully liquid, hexavalent, diphtheria (D)-tetanus (T)-whole-cell pertussis (wP)-inactivated poliovirus (IPV)-hepatitis B (HB)- Haemophilus influenzae b (PRP-T) vaccine compared to licensed DTwP-HB-PRP~T, IPV, and bivalent oral poliovirus (bOPV) vaccines following co-administration with other pediatric vaccines [pneumococcal conjugate vaccine (PCV13) and rotavirus vaccine].

Methods: Phase III, randomized, open-label study in Thailand. Healthy infants received DTwP-IPV-HB-PRP~T at 2, 4 and 6 months of age (N = 228), or DTwP-HB-PRP~T and bOPV (2, 4 and 6 months of age) and IPV (4 months of age) (N = 231). All participants received PCV13 (2, 4 and 6 months of age) and rotavirus vaccine (2 and 4 months of age). Immunogenicity for all antigens was assessed using validated assays, and noninferiority post-third dose was evaluated for anti-D, anti-T, anti-pertussis [anti-pertussis toxin (anti-PT) and anti-fimbriae 2/3 (anti-FIM)], anti-polio 1, 2, 3, anti-HB, and anti-PRP~T. Safety was assessed using parental reports.

Results: Noninferiority was demonstrated for each antigen, and overall noninferiority of DTwP-IPV-HB-PRP~T versus DTwP-HB-PRP~T+bOPV+IPV was concluded. Similarity in each group was observed for the GMC ratio for antirotavirus antibodies (20.9 and 17.3, respectively) and anti-PCV13 antibodies (range: 8.46-32.6 and 7.53-33.1, respectively). Two serious adverse events were related to DTwP-IPV-HB-PRP~T (febrile convulsion and acute febrile illness) and 1 was related to DTwP-HB-PRP~T+bOPV+IPV (febrile seizure), but overall there were no safety concerns with similar rates of participants experiencing solicited (99.1% and 98.3%) and unsolicited (19.3% and 19.5%) adverse events in each group.

Conclusions: This study confirmed the suitability of DTwP-IPV-HB-PRP~T primary series vaccination in combination with rotavirus and PCV13 vaccines.

Trial registration: ClinicalTrials.gov NCT04429295.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Bacterial
  • Antibodies, Viral
  • Diphtheria-Tetanus-Pertussis Vaccine* / administration & dosage
  • Diphtheria-Tetanus-Pertussis Vaccine* / immunology
  • Haemophilus Vaccines* / administration & dosage
  • Haemophilus Vaccines* / immunology
  • Hepatitis B
  • Hepatitis B Vaccines* / administration & dosage
  • Hepatitis B Vaccines* / immunology
  • Humans
  • Immunization Schedule
  • Immunogenicity, Vaccine
  • Infant
  • Pneumococcal Vaccines / administration & dosage
  • Pneumococcal Vaccines / immunology
  • Poliovirus Vaccine, Inactivated* / administration & dosage
  • Poliovirus Vaccine, Inactivated* / immunology
  • Rotavirus Vaccines* / administration & dosage
  • Rotavirus Vaccines* / immunology
  • Thailand
  • Vaccines, Combined* / administration & dosage
  • Vaccines, Combined* / immunology
  • Vaccines, Conjugate / administration & dosage
  • Vaccines, Conjugate / immunology

Substances

  • Antibodies, Bacterial
  • Antibodies, Viral
  • Diphtheria-Tetanus-Pertussis Vaccine
  • Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate
  • Haemophilus Vaccines
  • Hepatitis B Vaccines
  • Poliovirus Vaccine, Inactivated
  • Rotavirus Vaccines
  • Vaccines, Combined
  • Vaccines, Conjugate
  • Pneumococcal Vaccines

Associated data

  • ClinicalTrials.gov/NCT04429295