Immunogenicity and reactogenicity of a combined fully liquid DTPw–HepB–Hib pentavalent vaccine in healthy infants: no clinically relevant impact of a birth dose of hepatitis B vaccine

Abstract

The present study demonstrated that the fully liquid DTPw-HepB-Hib vaccine was safe and immunogenic when administered using a 2-4-6 months immunization schedule, regardless of whether or not infants had received a dose of HepB vaccine at birth.

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

“…18 In most emerging and developing countries, DTP vaccination in infants. 7,[9][10][11] No study vaccine-related SAE or death was reported. The study demonstrated that Quinvaxem was immunogenic and well tolerated when administered to 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.…”

Lot-to-lot consistency study of the fully liquid pentavalent DTwP-HepB-Hib vaccine Quinvaxem ® demonstrating clinical equivalence, suitability of the vaccine as a booster and concomitant administration with measles vaccine

“…The incidence of AEs were consistent with previous Quinvaxem ® reports and other pentavalent vaccines in infants. [18][19][20]30 All three vaccine lots demonstrated similar AE profiles; the majority of AE were mild in severity. The incidence of solicited AEs tended to decrease from the first to the third vaccination as seen in earlier studies with Quinvaxem ® .…”

“…Seroprotection rates fell during the period between the end of the core study and the pre-vaccination time point for the booster phase (12 ± 3 mo 18 One study indicated that Quinvaxem ® was immunogenic when given to infants regardless of whether they had or had not received a hepatitis B vaccine at birth. 19 Another study showed that Quinvaxem ® could be administered as a booster to infants who have received a primary vaccination course with another combination vaccine. 20 Hib antibodies induced by vaccination during the first year of life tend to wane progressively over the 2-3 y following primary vaccination.…”

“…The incidence of solicited AEs tended to decrease from the first to the third vaccination as seen in earlier studies with Quinvaxem ® . 19 habits (26.5%), sleepiness (25.6%) and irritability (22.8%). Fever was reported for 16.7% of infants overall and was slightly more common after vaccination with Quinvaxem ® with concomitant measles vaccine, however, there was a general trend toward more reporting of AEs in this group.…”