CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 357 enrolled
Drug / intervention
Influsplit™ Tetra (Fluarix™ Tetra) +2 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/NCT02218697
NCT02218697Phase 3Completed
CompareCT.gov

Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine 2014/2015 Influsplit™ Tetra (Fluarix™ Tetra) (GSK2321138A) When Co-administered With Pneumovax™ 23 in Adults 50 Years of Age and Older

GlaxoSmithKline·interventional·Posted Aug 18, 2014·Updated Apr 3, 2018

In Brief

A Phase 3 clinical trial evaluating Influsplit™ Tetra (Fluarix™ Tetra), Pneumovax™ 23, and 1 other intervention for Influenza. Completed, enrolled 357 participants across 6 sites in 2 countries.

Detailed Summary

The purpose of this study is to investigate the immunogenicity and safety when GSK Biologicals' influenza vaccine Influsplit™ Tetra (Fluarix™ Tetra) is co-administered with Merck \& Co. Inc.'s pneumococcal vaccine (Pneumovax™23/Pneumovax) in adults 50 years of age and older at risk for complications from influenza and pneumococcal infections.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesBelgium, France
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 18, 2014
Enrollment StartOct 1, 2014
Primary CompletionJan 14, 2015
Study CompletionMay 4, 2015
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 11.9 years ago

Interventions

Influsplit™ Tetra (Fluarix™ Tetra)biological

Intramuscular injection, 1 dose each in Control and Co-Ad groups.

Pneumovax™ 23biological

Intramuscular injection, 1 dose each in Control and Co-Ad groups.

Placebo (Saline)biological

Intramuscular injection, 1 dose each in Control and Co-Ad groups.