CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 230 enrolled
Drug / intervention
Haemophilus influenzae type b- and meningococcal (vaccine) +6 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/NCT00322335
NCT00322335Phase 3Completed
CompareCT.gov

Phase III, Open, Multicenter Study to Assess the Long-Term Persistence of a Booster Dose of GSK Biologicals' Hib-MenC Compared to a Booster Dose of Infanrix™ Hexa When Given to 14 Month-old Subjects Primed in Study DTPa-HBV-IPV-097 & Boosted in Study Hib-MenC-TT-010 BST: DTPa-HBV-IPV-097

GlaxoSmithKline·interventional·Posted May 5, 2006·Updated Oct 20, 2016

In Brief

A Phase 3 clinical trial evaluating Haemophilus influenzae type b- and meningococcal (vaccine), Infanrix™ penta, and 5 other interventions for Haemophilus Influenzae Type b and Neisseria Meningitidis. Completed, enrolled 230 participants across 12 sites.

Detailed Summary

This protocol posting deals with objectives \& outcome measures of the extension phase at Months 18, 30, 42, 54 and 66 post booster. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00352963). The objectives \& outcome measures of the Booster phase/study are presented in a separate protocol posting (NCT number =NCT00323050). The purpose of this study is to evaluate the persistence of meningococcal serogroup C and Hib antibodies on a yearly basis for a period of 5.5 years after booster vaccination. 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
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 5, 2006
Enrollment StartMay 1, 2006
Primary CompletionJul 1, 2006
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 20.2 years ago

Interventions

Haemophilus influenzae type b- and meningococcal (vaccine)biological

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).

Infanrix™ pentabiological

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age

Infanrix™ hexabiological

Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).

Engerix-Bbiological

Intramuscular injection into the thigh as a birth dose

NeisVac-C™biological

Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.

Infanrix™ IPV/HIBbiological

Intramuscular injection into the thigh as primary vaccination at 4 months of age

Meningitec™biological

Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age