Immunogenicity and safety of a combined DTPa-IPV/Hib vaccine administered as a three-dose primary vaccination course and a booster dose in healthy children in Russia: a phase III, non-randomized, open-label study

Abstract

We assessed the immunogenicity and safety of the combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus/ Haemophilus influenzae type b vaccine (DTPa-IPV/Hib) in children in Russian Federation aiming to support the registration of the vaccine in Russia. In this phase 3, non-randomized, open-label study (NCT02858440), healthy children received three primary doses at 3, 4.5, and 6 months of age (N = 235) and a booster dose at 18 months of age (N = 225). Seroprotection rates against diphtheria, tetanus, Hib, and poliovirus 1–3, seropositivity rates against pertussis antigens, and antibody geometric mean concentrations/titers for all antigens were evaluated one month post-primary and post-booster vaccinations. Solicited local and general adverse events (AEs) were collected during a 4-day period and unsolicited AEs during a 31-day period post-vaccination. Serious AEs were recorded throughout the study. At post-primary vaccination, all infants were seroprotected against diphtheria, tetanus, and poliovirus 1 and 2, 99.3% against poliovirus 3, and 98.4% against Hib. At least 98.9% of participants were seropositive for the three pertussis antigens. At post-booster vaccination, all toddlers were seroprotected/seropositive against all vaccine components. The most frequent local and general solicited AEs were redness, reported for 52.6% and 44.9% of children, and irritability, reported for 64.7% and 39.1% of children, post-primary and post-booster vaccination, respectively. Unsolicited AEs were reported for 20.4% (post-primary) and 5.8% of children (post-booster vaccination). Most AEs were mild or moderate in intensity. Six serious AEs were reported in three (0.4%) children; none were fatal or assessed as vaccination-related. DTPa-IPV/Hib proved immunogenic and well tolerated in the Russian pediatric population.

Cost‐minimization analysis of DTaP‐IPV‐Hib combination vaccine in China: A nationwide cross‐sectional study

“…16 The use of the DTaP-IPV-Hib combination vaccine might contribute to enhancing Hib coverage. 17 The US center for disease control and prevention indicated that using combination vaccines to immunize against several diseases simultaneously is a recognized strategy for increasing vaccine coverage in childhood vaccination programs. 18 In addition, the DTaP-IPV-Hib combination vaccine has several advantages, including a reduced number of clinic visits and injections, decreased duration of infant distress, increased parental willingness to vaccination, and reduced operational and stocking costs.…”

“…However, it is estimated that 19 000 childhood deaths from Hib occur in China each year as a result of the absence of formal national recommendations regarding its use affects vaccination coverage 16 . The use of the DTaP‐IPV‐Hib combination vaccine might contribute to enhancing Hib coverage 17 . The US center for disease control and prevention indicated that using combination vaccines to immunize against several diseases simultaneously is a recognized strategy for increasing vaccine coverage in childhood vaccination programs 18 .…”