A fully liquid DTaP-IPV-HB-PRP-T hexavalent vaccine for primaryand booster vaccination of healthy Turkish infants and toddlers*

Abstract

Background/aim: Immunogenicity and safety of a primary series of a fully liquid, hexavalent DTaP-IPV-HB-PRP-T vaccine given at 2, 3, and 4 months of age compared to licensed comparators and a DTaP-IPV-HB-PRP-T booster at 15-18 months were evaluated. Materials and methods: This was a Phase III, randomized, open-label trial. Primary series (no hepatitis B [HB] at birth) of DTaP-IPV-HB-PRP-T (N = 155) (group 1) or licensed control vaccines (DTaP-IPV//PRP-T and standalone HB: N = 155) (group 2) and DTaP-IPV-HB-PRP-T booster were administered. Noninferiority was evaluated 1 month postprimary series for anti-HB seroprotection (SP). All other analyses were descriptive. Safety was assessed from parental reports.Results: Postprimary series noninferiority of anti-HB ≥ 10 mIU/mL was demonstrated for the DTaP-IPV-HB-PRP-T vaccine (94.0%) compared to the licensed control (96.1%). Postprimary series primary SP and seroconversion (SC) rates were high and similar for both groups. Antibody persistence (prebooster) was high for each antigen and similar between groups except for HB, which was lower for DTaP-IPV-HB-PRP-T than for standalone HB. For each antigen except HB, DTaP-IPV-HB-PRP-T booster responses were high and similar in each group. Safety was good for primary and booster series and similar between groups. Conclusion:The DTaP-IPV-HB-PRP-T vaccine is immunogenic and safe when administered in a challenging primary series schedule without HB vaccination at birth.

DTaP-IPV-HepB-Hib Vaccine (Hexyon®): An Updated Review of its Use in Primary and Booster Vaccination

“…In the study that randomized infants to receive HB vaccination at birth or not (A3L15 [17]), anti-HB post-primary (Table 1) and post-booster (Table 3) seroprotection rates were numerically similar in both groups, although HB vaccination at birth was associated with numerically higher LTPT rates and GMCs at all assessment timepoints. This finding was broadly supported by individual studies which included infants who had [7, 10, 11, 13, 20, 21] or had not [8, 9, 12, 14, 18, 19] received HB vaccination at birth and a pooled analysis of infants who had not received HB vaccination at birth [25]. Post hoc analyses showed that anti-HB post-booster seroprotection rate was independent of pre-booster GMCs (< 10 vs. ≥ 10 mIU/mL) [9, 23].…”

“…Primary series consisted of three vaccine doses administered at age 2, 4, and 6 months (standard schedule; Latin America, Asia) [7, 10, 11, 18–21], 2, 3, and 4 months (‘accelerated’ schedule; Europe) [8, 9, 12] or 6, 10, and 14 weeks (expanded program of immunization schedule; South Africa, India) [Table 1] [13, 17]. The booster dose was administered at 11–24 months [Table 3] [6, 8–10, 21, 23].…”

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

“…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.…”

“…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.…”