Clinical study of safety and immunogenicity of pentavalent DTP-HB-Hib vaccine administered by disposable-syringe jet injector in India.

ABSTRACT:

Introduction

We conducted a randomized, observer-blind, non-inferiority, parallel-group clinical study of diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b conjugate (pentavalent) vaccination of infants in India. Goals were to determine whether the seropositivity rate after vaccination via disposable-syringe jet injector (DSJI) was non-inferior to that via needle and syringe (N-S), and to compare the safety of vaccination by the two methods.

Methods

Healthy children received a three-dose series of vaccine intramuscularly by DSJI or N-S beginning at 6-8 weeks of age. Immunoglobulin G antibody levels were measured by ELISA at 4-6 weeks after the third dose. The main secondary endpoint was safety, measured as injection site and systemic react

SUBMITTER: Bavdekar A 

PROVIDER: S-EPMC6406170 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature