NCT00224471 is a Phase 3 clinical trial of GSK208141 vaccine in Herpes Simplex, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00224471?

NCT00224471 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00224471?

Interventions in NCT00224471: GSK208141 vaccine.

What condition does NCT00224471 study?

NCT00224471 studies Herpes Simplex.

Is NCT00224471 still recruiting?

NCT00224471 is currently completed. Last updated 20 September 2016.

Last reviewed 2016-09-20 · How we verify

NCT00224471

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase III, Double-blind, Randomized, Study to Compare: 1) the Immunogenicity and Safety of 3 Commercial Scale Consistency Lots of GlaxoSmithKline (GSK) Biologicals' Herpes Simplex Candidate Vaccine in Healthy HSV-1 and -2 Seronegative (HSV 1-/2-) Female Subjects Aged 10 - 17 Years, and 2) Vaccine Immunogenicity in Healthy HSV 1-/2- Females Aged 10 - 17 Years With Healthy HSV 1-/2- Adult Females

Completed Phase 3 Last updated 20 September 2016

What this trial tests

Phase 3 trial testing GSK208141 vaccine in Herpes Simplex in 671 participants. Completed in 1 January 2006.

Timeline

1 December 2003

Primary endpoint
1 September 2005

1 January 2006

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	671
Start date	1 December 2003
Primary completion	1 September 2005
Estimated completion	1 January 2006
Sites	13 locations across United States, Belgium, Canada

Drugs / interventions tested

GSK208141 vaccine — full drug profile →

Conditions studied

Herpes Simplex — all drugs for Herpes Simplex →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 10 to 17, female only, with Herpes Simplex. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Anti-gD antibody titre in the entire cohort (10-17 yrs)
Time frame: At month 7

Sponsor's own description

Evaluate, one month after the third dose, the lot-to-lot consistency of 3 different commercial scale production lots of the candidate vaccine in healthy HSV 1-/2- females aged 10-17 years, determined by ELISA. Absence in significant variation for both parameters among the tested lots was hypothesized.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

A review of HSV pathogenesis, vaccine development, and advanced applications.
Bai L, Xu J, Zeng L, Zhang L, et al · · 2024 · cited 30× · PMID 39207577 · DOI 10.1186/s43556-024-00199-7
The Current State of Vaccine Development for Ocular HSV-1 Infection.
Royer DJ, Cohen A, Carr D. · · 2015 · cited 21× · PMID 25983856 · DOI 10.1586/17469899.2015.1004315

Verify or expand the search:

Other recruiting trials for Herpes Simplex

Currently open trials in the same condition.

NCT04065971 — Randomized, Placebo-controlled, Double-blind Study of 2LHERP® in Orofacial Herpes Infections. · Phase 4 · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00224471 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 20 September 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00224471.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing