CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,886 enrolled
Drug / intervention
Influsplit Tetra™ vaccine produced by investigational process (IP) +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/NCT02207413
NCT02207413Phase 3Completed
CompareCT.gov

Safety and Immunogenicity Study of GSK Biologicals' Quadrivalent Influenza Candidate Vaccine (GSK23211381A) Manufactured With a New Process in Adults and Children

GlaxoSmithKline·interventional·Posted Aug 4, 2014·Updated Jun 6, 2018

In Brief

A Phase 3 clinical trial evaluating Influsplit Tetra™ vaccine produced by investigational process (IP) and Influsplit Tetra™ vaccine produced by licensed process (LP) for Influenza. Completed, enrolled 1,886 participants across 53 sites in 7 countries.

Detailed Summary

The purpose of this trial is to demonstrate the acceptable safety profile and the immunological non-inferiority of the FLU D-QIV vaccine manufactured with this investigational process (FLU D-QIV Investigational Process \[IP\]) compared to FLU D-QIV manufactured with the current licensed process (FLU D-QIV Licensed Process \[LP\]).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesBangladesh, Czechia, France, Germany, Poland, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 4, 2014
Enrollment StartAug 18, 2014
Primary CompletionApr 18, 2015
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.9 years ago

Interventions

Influsplit Tetra™ vaccine produced by investigational process (IP)biological

Influsplit Tetra™ vaccine using a new manufacturing process administered intramuscularly (IM) in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.

Influsplit Tetra™ vaccine produced by licensed process (LP)biological

Influsplit Tetra™ vaccine using a licensed manufacturing process administered IM in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.