A phase III randomized, controlled study to assess the immunogenicity and tolerability of DTPw-HBV-Hib, a liquid pentavalent vaccine in Indian infants

Hitt Sharma; Sangita Yadav; Sanjay Lalwani; Vijay Gupta; Subhash Kapre; Suresh Jadhav; Anita Chakravarty; Sameer Parekh; Sonali Palkar

doi:10.1016/j.vaccine.2011.01.054

A phase III randomized, controlled study to assess the immunogenicity and tolerability of DTPw-HBV-Hib, a liquid pentavalent vaccine in Indian infants

Vaccine. 2011 Mar 16;29(13):2359-64. doi: 10.1016/j.vaccine.2011.01.054. Epub 2011 Feb 1.

Authors

Hitt Sharma¹, Sangita Yadav, Sanjay Lalwani, Vijay Gupta, Subhash Kapre, Suresh Jadhav, Anita Chakravarty, Sameer Parekh, Sonali Palkar

Affiliation

¹ Serum Institute of India Ltd., 212/2, Hadapsar, Pune 411028, India. [email protected]

PMID: 21288803
DOI: 10.1016/j.vaccine.2011.01.054

Abstract

Immunogenicity and tolerability of two liquid pentavalent vaccines, Pentavac(®) (new vaccine), and Easyfive(®) (available in the market) was assessed in a multicentre study in India. In all, 484 infants aged 6-8 weeks were enrolled, and their blood samples were assessed prior to the first dose and one month after the third dose. A 100% seroprotection rate was achieved with both vaccines' antigens, except pertussis for which the response was 95% and 96%, respectively, for the two vaccines. A diary-based recording of adverse events showed that the two most common events were pain at the injection site and restricted limb movements and were less frequent (p<0.001) among the recipients of the new vaccine. The new vaccine meets all criteria of childhood vaccination. Its low reactogenicity and low cost are valid reasons to recommend this vaccine for general use.

Publication types

Clinical Trial, Phase III
Comparative Study
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Antibodies, Bacterial / blood
Diphtheria-Tetanus-Pertussis Vaccine / administration & dosage
Diphtheria-Tetanus-Pertussis Vaccine / adverse effects
Diphtheria-Tetanus-Pertussis Vaccine / immunology*
Female
Haemophilus Vaccines / administration & dosage
Haemophilus Vaccines / adverse effects
Haemophilus Vaccines / immunology*
Hepatitis B Antibodies / blood
Hepatitis B Vaccines / administration & dosage
Hepatitis B Vaccines / adverse effects
Hepatitis B Vaccines / immunology*
Humans
India
Infant
Male
Pain / chemically induced
Vaccines, Combined / administration & dosage
Vaccines, Combined / adverse effects
Vaccines, Combined / immunology

Substances

Antibodies, Bacterial
Diphtheria-Tetanus-Pertussis Vaccine
Haemophilus Vaccines
Hepatitis B Antibodies
Hepatitis B Vaccines
Vaccines, Combined