NCT01357720

Study to Assess if Quinvaxem Can be Interchanged With Other Pentavalent Vaccines During Standard Childhood Vaccination

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Crucell Holland BV · Industry
• Sex: All
• Age: 42 Days – 64 Days
• Healthy volunteers: Accepted

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.

Conditions

• Diphtheria
• Pertussis
• Tetanus
• Hepatitis B
• Haemophilus Infections

Interventions

Type	Name	Description
BIOLOGICAL	Quinvaxem	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
BIOLOGICAL	Quinvaxem/Tritanrix	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

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2011-05-23
• Last updated: 2013-09-09
• Results posted: 2013-05-22

Locations

1 site across 1 country: Philippines