At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IV, Single-blind, Randomized, Controlled, Monocentric Study to Assess the Interchangeability of Quinvaxem (DTwP-HepB-Hib) as the 2nd and 3rd Dose After Initial Vaccination With Tritanrix HB+Hib (DTwP-HepB/Hib) With Respect to Safety and Immunogenicity in Healthy Infants at 6, 10 and 14 Weeks of Age
In Brief
A Phase 4 clinical trial evaluating Quinvaxem and Quinvaxem/Tritanrix for Diphtheria and 4 related conditions. Completed, enrolled 400 participants across 1 site.
Detailed Summary
This is a study to show that vaccination with 1 dose of Tritanrix HB+Hib followed by Quinvaxem vaccine as the 2nd and 3rd dose is not inferior to vaccination with Quinvaxem for all 3 doses, 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) 1 month after completion of the 6-10-14 week vaccination course.
Study Details
Timeline
Interventions
A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (\>= 30 IU), tetanus antitoxin (\>= 60 IU), whole-cell inactive pertussis bacteria (\>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given at Weeks 6, 10 and 14
A single dose (0.5 mL) of Quinvaxem contains: diphtheria antitoxin (\>= 30 IU), tetanus antitoxin (\>= 60 IU), inactive pertussis bacteria (\>= 4 IU), 10 mcg Hib polysaccharide conjugate (approx. 25 mcg tetanus toxoid), 10 mcg Hepatitis B surface antigen One dose of Quinvaxem given at Weeks 6, 10 and 14