CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 131 enrolled
Drug / intervention
Quinvaxembiological
Likely dose
Quinvaxem 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01362517
NCT01362517Phase 3Completed
CompareCT.gov

Assessment of the Immunogenicity and Safety of Quinvaxem Vaccine (DTwP-HepB-Hib) Against Diphtheria, Pertussis, Tetanus, Hepatitis B and Diseases Caused by H. Influenzae Among Healthy Vietnamese Children

Crucell Holland BV·interventional·Posted May 30, 2011·Updated Sep 9, 2013

In Brief

A Phase 3 clinical trial evaluating Quinvaxem for Diphtheria and 4 related conditions. Completed, enrolled 131 participants across 1 site.

Detailed Summary

The aim of this study was to evaluate the immunogenicity and safety of the Quinvaxem vaccine (a liquid combination vaccine against diphtheria, tetanus, B. pertussis, hepatitis B and H. influenzae Type B). Healthy Vietnamese infants received three doses of vaccine at 2, 3 and 4 months of age according to the local Expanded Programme on Immunisation (EPI) schedule

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiphtheria, Pertussis, Tetanus, Hepatitis B, Haemophilus Influenzae Infections
CountriesVietnam
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 30, 2011
Enrollment StartApr 1, 2010
Primary CompletionJul 1, 2010
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 15.1 years ago

Interventions

Quinvaxembiological

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 2, 3 and 4 months of age