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Evaluation of the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine Influsplit™ Tetra (Fluarix™ Tetra) (GSK2321138A) When Co-administered With Pneumovax™ 23 in Adults 50 Years of Age and Older

NCT02218697 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 357

Last updated 2018-04-03

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Influsplit™ Tetra (Fluarix™ Tetra)

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

BIOLOGICAL

Pneumovax™ 23

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

BIOLOGICAL

Placebo (Saline)

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-01
Primary Completion
2015-01-14
Completion
2015-05-04

Countries

  • Belgium
  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02218697 on ClinicalTrials.gov