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

Abstract

These results confirm the suitability of the fully liquid DTaP-IPV-HB-PRP-T vaccine for primary and booster vaccination of infants.

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

“…The results confirm good antibody persistence up to preschool age following a primary series of the DTaP-IPV-HB-PRP T vaccine with a booster in the second year of life, even following the less immunogenic 6, 10, 14 week infant primary series schedule. 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.…”

“…Phase III, randomized, observer-blind, controlled, primary vaccination and booster clinical studies that are reported elsewhere were conducted separately in South Africa (Study 1) 16,24 and Colombia and Costa Rica (Study 2). 20 In Study 1, participants in South Africa who had not received standalone HB vaccine at birth were randomized to receive a 6, 10, 14 week primary series of either DTaP-IPV-HB-PRP~T or DTwP/PRP~T + HB + OPV, and a third group of participants who had received a standalone HB vaccine at birth received a 6, 10, 14 week primary series of DTaP-IPV-HB-PRP~T; 16 all participants were to receive a booster vaccination of the same vaccine-(s) administered in the primary series, co-administered with measles, mumps, rubella, and varicella vaccines (MMR-V). 24 In Study 2, all participants in Colombia and Costa Rica received a standalone HB vaccination at birth and were randomized to receive a primary series of either DTaP-IPV-HB-PRP~T or DTaP-HB-IPV//PRP-T at 2, 4, 6 months of age coadministered with pneumococcal (PCV) 7 vaccine (2, 4, 6 months) and rotavirus vaccine (2 and 4 months); in the second year of life, participants who had received DTaP-IPV-HB-PRP~T in the primary series were randomized to receive a booster of DTaP-IPV-HB-PRP~T or DTaP-HB-IPV//PRP-T, and those who had received a primary series of DTaP-HB-IPV//PRP-T were to receive a booster of DTaP-IPV-HB-PRP~T (booster vaccines were co-administered with PCV7; additionally, MMR-V and PCV13 vaccines were available at 15 months of age in Costa Rica, but not in Colombia, in accordance with the national recommendations).…”

“…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. 13,17,20,24 The long-term persistence of HB antibodies at 9-10 y of age and strong anti-HB response to subsequent HB vaccination have recently been reported following administration of the DTaP-IPV-HB-PRP~T vaccine in a 2, 4, 6 month of age primary series with a standalone HB vaccine at birth but no booster. 25 However, no long-term immunogenicity data for the other antigens contained in the DTaP-IPV-HB-PRP~T vaccine have previously been published.…”

“…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.…”

“…Two clinical studies from the clinical development program were chosen since they represented two different primary series and booster vaccine regimens, with different comparator vaccines, and were conducted in geographically distinct locations, thereby providing a broad perspective on pre-school antibody persistence to each antigen at 3.5 and 4.5 y of age in two distinct situations. 16,20,24…”