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NCT03439657 · ClinicalTrials.gov registry record · Phase 3

Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older

A Phase 3 study of Herpes Zoster, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
913
Enrollment target
13
Study locations

NCT03439657: Completed Phase 3 study of Herpes Zoster, sponsored by GlaxoSmithKline.

NCT03439657 is a Phase 3 study of Herpes Zoster that has completed, run by GlaxoSmithKline. The registered enrollment target is 913 participants, below the 2,116-participant average among 16 other Herpes Zoster trials with a reported enrollment target (57% lower). The trial reports 13 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03439657, a Phase 3 study of Herpes Zoster, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
913 participants
Enrollment target
13
Study locations

Study Summary

The purpose of this study is to assess immunogenicity and safety of GSK Biologicals' HZ vaccine when its first dose is co-administered with a pneumococcal polysaccharide conjugate vaccine (Prevenar13) in adults aged ≥50 YOA, as compared to the control group where the two HZ/su doses are administered subsequent to Prevenar13.

Primary Outcome

Vaccine response rate (VRR) for Varicella Zoster Virus (VZV) anti-glycoprotein E (gE) humoral immunogenicity was determined by Enzyme Limked Immunosorbent Assay (ELISA). The VRR for anti-gE is defined as the percentage of subjects who had at least: a 4-fold increase in the anti-gE antibodies concentration as compared to the pre-vaccination anti-gE antibodies concentration, for subjects who are seropositive at baseline, or, a 4-fold increase in the anti-gE antibodies concentration as compared to

Conditions Studied

Interventions

  • BIOLOGICAL HZ/su vaccine GSK1437173A
  • BIOLOGICAL Prevenar13

Study Locations (13)

Other

  • GSK Investigational Site - Rakvere
  • GSK Investigational Site - Tallinn
  • GSK Investigational Site - Tartu

North Rhine-Westphalia

  • GSK Investigational Site - Essen
  • GSK Investigational Site - Goch

Massachusetts

  • GSK Investigational Site - Marlborough

North Carolina

  • GSK Investigational Site - Salisbury

South Carolina

  • GSK Investigational Site - Spartanburg

Nova Scotia

  • GSK Investigational Site - Truro

Quebec

  • GSK Investigational Site - Sherbrooke

Baden-Wurttemberg

  • GSK Investigational Site - Weinheim

Trial Details

FieldValue
Enrollment Target 913 participants
Start Date 2018-04-12
Est. Completion 2020-03-03
Phase Phase 3
GlaxoSmithKline

1,345 total trials

What the finished NCT03439657 record still lists

NCT03439657 is an interventional study that assigns participants to a tested intervention. The registered 913 participants enrollment target is mid-sized for trials with a published cap, below the 2,116-participant average among 16 other Herpes Zoster trials with a reported enrollment target (57% lower).

The record links to 1 condition, with Herpes Zoster appearing as the primary indexed condition, and to 2 interventions - of which HZ/su vaccine GSK1437173A is the first listed.

NCT03439657 lists 13 locations in 10 states (Other, North Rhine-Westphalia, Massachusetts).

Frequently Asked Questions

What is clinical trial NCT03439657 about?

NCT03439657 is a clinical study titled "Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A When Co-administered With Prevenar13 in Adults Aged 50 Years and Older". The purpose of this study is to assess immunogenicity and safety of GSK Biologicals' HZ vaccine when its first dose is co-administered with a pneumococcal polysaccharide conjugate vaccine (Prevenar13) in adults aged ≥50 YOA, as compared to the control group where the two HZ/su doses are administered...

What is the current status of trial NCT03439657?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 913 participants. The study started on 2018-04-12. Estimated completion is 2020-03-03.

What conditions does trial NCT03439657 study?

This clinical trial studies the following conditions: Herpes Zoster.

What interventions are being tested in trial NCT03439657?

The interventions under investigation include: HZ/su vaccine GSK1437173A (BIOLOGICAL), Prevenar13 (BIOLOGICAL).

Who is sponsoring clinical trial NCT03439657?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03439657 being conducted?

This trial has 13 study locations across Massachusetts, North Carolina, South Carolina, Nova Scotia, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Herpes Zoster

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03439657's enrollment target sits among peer trials

913 6th of 16 higher than 11 of 16 other Herpes Zoster trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Herpes Zoster trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03439657, the US trial registry maintained by the National Library of Medicine. NCT03439657 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.