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Study to Assess the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK1437173A) When Co-administered With GSK Biologicals' Diphtheria, Tetanus and Pertussis Vaccine (Boostrix®) in Adults Aged 50 Years and Older

NCT02052596 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 935

Last updated 2018-04-24

Study results available
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Summary

The purpose of this study is to assess immunogenicity, reactogenicity and safety of GSK Biologicals' HZ/su vaccine when its first dose is co-administered with the Boostrix® vaccine in adults aged 50 years or older compared to administration of vaccines separately.

Conditions

  • Herpes Zoster

Interventions

BIOLOGICAL

Herpes Zoster vaccine GSK 1437173A

2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm at Visit Day 0 and Visit Month 2 for Co-Ad group and at Visit Month 2 and Visit Month 4 for Control group.

BIOLOGICAL

Boostrix

1 dose administered intramuscularly (IM) in the deltoid region of the dominant arm at Visit Day 0 for both Co-Ad and Control groups.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-07
Primary Completion
2015-06-16
Completion
2016-04-21

Countries

  • United States

Study Locations

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Entities

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 NCT02052596 on ClinicalTrials.gov