CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 313 enrolled
Drug / intervention
Menitorix™ +3 morebiological
Likely dose
Not stated in 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/NCT00586612
NCT00586612Phase 3Completed
CompareCT.gov

Immunogenicity & Safety Study in Preterm & Full-term Infants of GSK Biologicals' Hib-MenC Vaccine, Menitorix™ Co-administered With Infanrix™ Penta & Prevenar™ at 2, 4, 6 Months & as a Booster With Infanrix™ IPV & Prevenar™ at 16-18 Months

GlaxoSmithKline·interventional·Posted Jan 4, 2008·Updated Aug 27, 2018

In Brief

A Phase 3 clinical trial evaluating Menitorix™, Infanrix™ penta, and 2 other interventions for Haemophilus Influenzae Type b and Neisseria Meningitidis. Completed, enrolled 313 participants across 8 sites.

Detailed Summary

The purpose of this Phase IIIb study is to evaluate the immunogenicity, reactogenicity \& safety of GSK Biologicals' Hib-MenC vaccine (Menitorix™) when co-administered with GSK Biologicals' DTPa-HBV-IPV vaccine (Infanrix™ penta) \& Wyeth's 7-valent pneumococcal conjugate vaccine (Prevenar™) in preterm infants as a 3-dose primary vaccination course during the first 6 months of life (at 2, 4, 6 months of age) and of a booster dose of Menitorix™ when co-administered with GSK Biologicals' DTPa-IPV vaccine (Infanrix IPV) and Wyeth's Prevenar in the second year of life (16-18 months of age). The control is a group of full-term infants receiving the same vaccines. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHaemophilus Influenzae Type b, Neisseria Meningitidis
CountriesSpain
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 4, 2008
Enrollment StartDec 1, 2007
Primary CompletionDec 30, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 18.5 years ago

Interventions

Menitorix™biological

Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.

Infanrix™ pentabiological

Intramuscular injection, 3 doses in the primary study

Prevenar™biological

Intramuscular injection, 3 doses in the primary study and 1 dose in the Booster study.

Infanrix™ IPVbiological

Intramuscular injection, 1 dose in the Booster study.