Immunogenicity and safety of a liquid hexavalent vaccine in Indian infants

Abstract

The fully liquid DTaP-IPV-HB-PRP~T vaccine is highly immunogenic in infants in India when administered in a 6, 10, 14 week schedule along with HB and OPV administered at birth, and was well tolerated.

Antibody persistence in pre-school children after hexavalent vaccine infant primary and booster administration

“…In both studies, the majority of children had anti-PRP ≥ 0.15 µg/mL and ≥1.0 µg/mL at 3.5 y of age and 4.5 y of age, with no differences between groups (Study 1: ≥98.3% and ≥98.8% [≥0. 15 at 3.5 y of age and 4.5 y of age with no difference between groups in each study ( Table 6).…”

“…Although it is not possible to fully assess any potential impact of the coadministered vaccines in the two studies, the antibody responses post-primary series, pre-booster, and postbooster 16,20,24 are aligned with results from a wide range of studies evaluating the immunogenicity of the DTaP-IPV-HB-PRP~T vaccine in a range of schedules, countries, and with and without coadministered vaccines. [13][14][15][17][18][19][21][22][23] It is therefore unlikely that there would be a clinically important effect of the coadministered vaccines on antibody persistence at 3.5 and 4.5 y of age.…”

“…9 The only other widely available comparable hexavalent vaccine outside the European Union is a DTaP-IPV-HB//PRP~T vaccine, which is reconstituted prior to use (Infanrix hexa™). [10][11][12] The DTaP-IPV-HB-PRP~T vaccine has undergone an extensive global program of clinical studies both prior to and postlicensure, including demonstration of good and consistent immunogenicity and safety in various infant primary series schedules at 2, 3, 4 months of age, 13,14 6, 10, 14 weeks of age, 15,16 2, 4, 6 months of age, [17][18][19][20][21][22] and 3, 5 months of age 23 both with and without the administration of a standalone HB vaccine at birth and followed by a toddler booster as well as in a mixed hexavalent-pentavalent-hexavalent 3-dose infant schedule. Good antibody persistence for all antigens prior to a booster vaccine administered in the second year of life has also been consistently demonstrated as well as good immunogenicity and safety following booster vaccination.…”

Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency

“…Recently, studies examining the immunogenicity and safety of the hexavalent combination in small trials have been published from India (15,16). Also, Indian Pediatrics published an editorial entitled "Hexavalent vaccinations: The future of routine immunization?"…”

Hexavalent vaccinations: The future of routine immunization?

“…The research paper by Chhatwal, et al [7] published in this edition of Indian Pediatrics evaluates the efficacy of one such vaccine that is already approved in many countries, and is being used in their national schedules. The authors demonstrate very good seroconversion for all components even without a control group, and show how it can be integrated into the current immunization schedules.…”