title: Safety, immune lot-to-lot consistency and non-inferiority of a fully liquid pentavalent DTwp-HepB-Hib vaccine in healthy Indian toddlers and infants.
abstract: 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.
authors.affiliation: a Department of Pediatrics , SBKS Medical College , Vadodara , India.
authors.forename: Dulari J
authors.initials: DJ
authors.lastname: Gandhi
authors.affiliation: b Department of Pediatrics , Jawaharlal Nehru Medical College , Belgaum , India.
authors.forename: Sangappa M
authors.initials: SM
authors.lastname: Dhaded
authors.affiliation: c Department of Pediatrics , JSS Medical College , Mysore , India.
authors.forename: Mandyam D
authors.initials: MD
authors.lastname: Ravi
authors.affiliation: d Department of Pediatrics , Maulana Azad Medical College , Delhi , India.
authors.forename: Anand P
authors.initials: AP
authors.lastname: Dubey
authors.affiliation: e Department of Pediatrics , Institute of Child Health , Kolkata , India.
authors.forename: Ritabrata
authors.initials: R
authors.lastname: Kundu
authors.affiliation: f Department of Pediatrics , Bharati Vidyapeeth Deemed University Medical College , Pune , India.
authors.forename: Sanjay K
authors.initials: SK
authors.lastname: Lalwani
authors.affiliation: g Department of Pediatrics , Christian Medical College , Ludhiana , India.
authors.forename: Jugesh
authors.initials: J
authors.lastname: Chhatwal
authors.affiliation: h Department of Pediatrics , Christian Medical College , Vellore , India.
authors.forename: Leni G
authors.initials: LG
authors.lastname: Mathew
authors.affiliation: i Department of Community Medicine , School of Public Health, Post Graduate Institute of Medical Education & Research , Chandigarh , India.
authors.forename: Madhu
authors.initials: M
authors.lastname: Gupta
authors.affiliation: j Department of Pediatrics , Sawai Man Singh Medical College , Jaipur , India.
authors.forename: Shiv D
authors.initials: SD
authors.lastname: Sharma
authors.affiliation: k Department of Pediatrics , Topiwala Nair Medical College , Mumbai , India.
authors.forename: Sandeep B
authors.initials: SB
authors.lastname: Bavdekar
authors.affiliation: l Shantha Biotechnics Private Limited , Hyderabad , India.
authors.forename: Midde V
authors.initials: MV
authors.lastname: Jayanth
authors.affiliation: l Shantha Biotechnics Private Limited , Hyderabad , India.
authors.forename: Suresh
authors.initials: S
authors.lastname: Ravinuthala
authors.affiliation: l Shantha Biotechnics Private Limited , Hyderabad , India.
authors.forename: Arijit
authors.initials: A
authors.lastname: Sil
authors.affiliation: l Shantha Biotechnics Private Limited , Hyderabad , India.
authors.forename: Mandeep S
authors.initials: MS
authors.lastname: Dhingra
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D005260:Female; D006192:Haemophilus Infections / Q000276:immunology / Q000517:prevention & control*; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007117:Immunization, Secondary / Q000706:statistics & numerical data; D000071497:Immunogenicity, Vaccine; D007194:India; D007223:Infant; D008297:Male; D016037:Single-Blind Method; D014611:Vaccination; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000592:standards; D014917:Whooping Cough / Q000276:immunology / Q000517:prevention & control*
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D015721:Diphtheria-Tetanus-Pertussis Vaccine; C524361:DtwP-HepB-Hib vaccine; D018073:Haemophilus Vaccines; D017325:Hepatitis B Vaccines; D017778:Vaccines, Combined
keywords: DTwP-HepB-Hib; India; immunogenicity; lot-to-lot consistency; pentavalent vaccine; safety; whole-cell pertussis