CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 803 enrolled
Drug / intervention
Meningococcal vaccine GSK134612 +1 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/NCT01939158
NCT01939158Phase 3Completed
CompareCT.gov

A PHASE III, RANDOMISED, OPEN, CONTROLLED, MULTICENTRE, PRIMARY VACCINATION STUDY TO EVALUATE THE IMMUNOGENICITY AND PERSISTENCE OF 1 AND 2 DOSES OF MENINGOCOCCAL CONJUGATE VACCINE MENACWY-TT IN TODDLERS (AFTER 1 MONTH AND UP TO 5 YEARS) AND TO DEMONSTRATE NON-INFERIORITY OF CO-ADMINISTRATION OF MENACWY-TT AND 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE PREVENAR 13(REGISTERED) VERSUS SEPARATE ADMINISTRATION OF THE 2 VACCINES

Pfizer·interventional·Posted Sep 11, 2013·Updated Oct 5, 2021

In Brief

A Phase 3 clinical trial evaluating Meningococcal vaccine GSK134612 and Prevenar 13™ for Infections, Meningococcal. Completed, enrolled 803 participants across 51 sites in 6 countries.

Detailed Summary

The purpose of this study is to compare the immediate and long term (up to 5 years) immunogenicity and safety of GSK Biologicals' MenACWY-TT vaccine when given as a single dose or as 2 doses to toddlers aged 12 to 14 months. Also, this study will also assess if co-administration of GSK Biologicals' MenACWY-TT with the booster dose of Pfizer's Prevenar 13 adversely impacts the immunogenicity of either of the vaccines.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Meningococcal
CountriesAustralia, Canada, Czechia, Panama, South Africa, Turkey (Türkiye)
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 11, 2013
Enrollment StartOct 2, 2013
Primary CompletionDec 5, 2019
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 12.8 years ago

Interventions

Meningococcal vaccine GSK134612biological

1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region

Prevenar 13™biological

1 dose administered intramuscularly in the right anterolateral thigh or deltoid region