A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject

Summary

This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials, with respect to protection against all antibodies (anti-hepatitis B surface antibodies, anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella pertussis) one (1) month after completion of the 6-10-14 week vaccination course.

Timeline

Start

2013-09

Primary completion

2014-04

Completion

2014-04

Drugs

Indications