| Autor: |
Gandhi DJ; a Department of Pediatrics , SBKS Medical College , Vadodara , India., Dhaded SM; b Department of Pediatrics , Jawaharlal Nehru Medical College , Belgaum , India., Ravi MD; c Department of Pediatrics , JSS Medical College , Mysore , India., Dubey AP; d Department of Pediatrics , Maulana Azad Medical College , Delhi , India., Kundu R; e Department of Pediatrics , Institute of Child Health , Kolkata , India., Lalwani SK; f Department of Pediatrics , Bharati Vidyapeeth Deemed University Medical College , Pune , India., Chhatwal J; g Department of Pediatrics , Christian Medical College , Ludhiana , India., Mathew LG; h Department of Pediatrics , Christian Medical College , Vellore , India., Gupta M; i Department of Community Medicine , School of Public Health, Post Graduate Institute of Medical Education & Research , Chandigarh , India., Sharma SD; j Department of Pediatrics , Sawai Man Singh Medical College , Jaipur , India., Bavdekar SB; k Department of Pediatrics , Topiwala Nair Medical College , Mumbai , India., Jayanth MV; l Shantha Biotechnics Private Limited , Hyderabad , India., Ravinuthala S; l Shantha Biotechnics Private Limited , Hyderabad , India., Sil A; l Shantha Biotechnics Private Limited , Hyderabad , India., Dhingra MS; l Shantha Biotechnics Private Limited , Hyderabad , India. |
| Abstrakt: |
Pentavalent combination vaccines are important tools to strengthen the immunization programs in numerous countries throughout the world. A large number of countries have recognized the value of combination vaccines and have introduced whole cell pentavalent vaccines into their immunization programs. A phase III, multi-center, randomized, single blinded study of a fully liquid pentavalent DTwP-HepB-Hib investigational vaccine (Shan5™) was conducted across India in 2 cohorts: 15 toddlers were evaluated for safety and immunogenicity following a single booster dose (Cohort 1) followed by 1085 infants (Cohort 2) evaluated for immunogenicity and safety following 3-dose primary immunization of the investigational vaccine or a locally licensed comparator vaccine (Pentavac SD). Immune consistency analysis among 3 lots of the investigational vaccine, and immune non-inferiority analysis of pooled (3 lots) data of investigational vaccine vs. comparator vaccine were carried out in cohort 2. The vaccines demonstrated comparable safety and immune responses in cohort 1. In cohort 2, equivalent immune consistency among 3 lots was observed for all antigens except whole cell pertussis antigens, where a marginal variation was observed which was linked to the low power of the test and concluded to not have any clinical significance. Immune non-inferiority against the comparator vaccine was demonstrated for all 5 antigens. Safety results were comparable between vaccine groups. This investigational, fully-liquid, whole-cell pertussis (wP) containing new pentavalent vaccine was found to be safe and immunologically non-inferior to the licensed comparator vaccine. |
