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A Randomized Controlled Study of a Fully Liquid DTaP-IPV-HB-PRP-T Hexavalent Vaccine for Primary and Booster Vaccinations of Healthy Infants and Toddlers in Latin America.
- Source :
-
The Pediatric infectious disease journal [Pediatr Infect Dis J] 2017 Nov; Vol. 36 (11), pp. e272-e282. - Publication Year :
- 2017
-
Abstract
- Background: Hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae type b (DTaP-IPV-HB-PRP-T)-containing vaccines are increasingly the standard of care. This study evaluated the primary series (NCT01177722) and booster (NCT01444781) of a fully liquid DTaP-IPV-HB-PRP-T vaccine in Latin America.<br />Methods: Infants (N = 1375) received hepatitis B vaccine at birth and were randomized to one of 3 batches of the investigational DTaP-IPV-HB-PRP-T or licensed control vaccine (DTaP-HB-IPV//PRP-T) at 2-4 to 6 months of age, coadministered with 7-valent pneumococcal conjugate vaccine (PCV7) (2-4-6 months) and rotavirus vaccine (2-4 months). A booster of either DTaP-IPV-HB-PRP-T or control was given at 12-24 months, coadministered with PCV7. Immunogenicity was assessed by validated assays and safety from parental reports.<br />Results: Primary series seroprotection and vaccine response rates were equivalent for DTaP-IPV-HB-PRP-T batches. For pooled batches, noninferiority to the control vaccine was demonstrated for each antigen. There were no descriptive differences in antibody persistence or booster response between DTaP-IPV-HB-PRP-T and the control. The booster responses to either vaccine following DTaP-IPV-HB-PRP-T primary series or to DTaP-IPV-HB-PRP-T following a control vaccine primary series were similar. The anti-aP component (filamentous hemagglutinin [FHA] and pertussis toxin [PT]) vaccine response and anti-Haemophilus influenzae type b (PRP) series seroprotection (≥0.15 µg/mL) rates were ≥73.0% after 2 primary series doses. Antipyretics had no effect on the immune response, and an extra (oral) polio vaccination had no effect on the antipolio booster response. Responses to PCV7 and rotavirus vaccine were similar for each coadministration. There were no safety concerns observed with any vaccine.<br />Conclusions: These results confirm the suitability of the fully liquid DTaP-IPV-HB-PRP-T vaccine for primary and booster vaccination of infants.
- Subjects :
- Child, Preschool
Diphtheria-Tetanus-Pertussis Vaccine adverse effects
Haemophilus Vaccines adverse effects
Hepatitis B Vaccines adverse effects
Humans
Immunization Schedule
Infant
Poliovirus Vaccine, Inactivated adverse effects
Vaccines, Combined administration & dosage
Vaccines, Combined adverse effects
Vaccines, Combined immunology
Antibodies, Bacterial blood
Antibodies, Viral blood
Diphtheria-Tetanus-Pertussis Vaccine administration & dosage
Diphtheria-Tetanus-Pertussis Vaccine immunology
Haemophilus Vaccines administration & dosage
Haemophilus Vaccines immunology
Hepatitis B Vaccines administration & dosage
Hepatitis B Vaccines immunology
Immunization, Secondary methods
Poliovirus Vaccine, Inactivated administration & dosage
Poliovirus Vaccine, Inactivated immunology
Subjects
Details
- Language :
- English
- ISSN :
- 1532-0987
- Volume :
- 36
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- The Pediatric infectious disease journal
- Publication Type :
- Academic Journal
- Accession number :
- 28719500
- Full Text :
- https://doi.org/10.1097/INF.0000000000001682