A phase III single arm, multicenter, open-label study to assess the immunogenicity and tolerability of a pentavalent DTwP–HepB–Hib vaccine in indian infants

Comparison of the immunogenicity and safety of pentavalent vaccine Quinvaxem in a compact prefilled auto-disabled (cPAD) injection system versus single-dose vials in healthy infants: a phase 3, open-label, randomized, parallel-group, non-inferiority study

“…[27][28][29] However, the safety and immunogenicity of two different presentations of Quinvaxem had not been studied to date. In this study, the seroconversion/seroprotection rates were similar in the cPAD and single-dose vial groups.…”

“…14,28 In many industrialized countries, the DTP-based combination vaccines incorporate acellular pertussis (aP). For several decades, inactivated whole-cell pertussis (wP) vaccines have been part of the national childhood vaccination programs, dramatically reducing the considerable public health impact of pertussis.…”

The immunogenicity and safety of the new, Indonesian DTwP-HB-Hib vaccine compared to the DTwP/HB vaccine given with the Hib vaccine

“…11 Furthermore, another Indian study in 165 infants at 6, 10, and 14 weeks of age found results similar to our study: at one month after the third vaccination, percentages of infants achieving predefined protective antibody levels were 99% diphtheria; 100% tetanus; 98% hepatitis B; 100% Hib short-term (≥ 0.15 µg/mL); 95% Hib long-term (≥ 1.0 µg/mL) protection; and 99% for pertussis (relevant immune response). 12 These three studies were conducted without control groups.…”

“…Fever was found in 21%, 18%, and 15%, after the 1 st , 2 nd and 3 rd injections, respectively. 12 Rao et al compared a new pentavalent vaccine to the DTPHB+Hib vaccine (separate injection) and another registered pentavalent vaccine. They also found that pain was the most frequent local reaction in all groups, with 35.54%-36.26% of subjects.…”

The quantity and quality of anti-PRP induced by the new Indonesian DTwP-HB-Hib vaccine compared to the Hib vaccine given with the DTwP-HB vaccine

“…12 Another Indian study in 165 infants at 6, 10, and 14 weeks of age also found similar results to our study: at one month after the third vaccination, the percentages of infants who achieved the predefined protective antibody levels were 100% Hib short-term (≥ 0.15 µg/mL) and 95% Hib long-term (≥ 1.0 µg/mL) protection. 13 These three studies were conducted without control groups.…”