Clinical Trials Logo
  1. Home
  2. Herpes Simplex
  3. NCT00224484

Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old

Herpes Simplex Clinical Trial

Official title:
A Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Herpes Simplex Candidate Vaccine (gD2‑AS04) in Healthy HSV Seronegative and Seropositive Female Subjects Aged 10-17 Years.

Clinical Trial Summary

Main goal of this study is to compare the occurrence of serious adverse events (SAEs) between the herpes simplex (gD2-AS04) vaccine group and the Saline control group throughout the study period (up to month 12).

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Clinical Trial Description

Three groups of females (3000, 1500 and 1500 subjects, respectively) were injected 3 times (at months 0, 1 and 6) with the herpes simplex vaccine, the HavrixTM vaccine (control) and a Saline solution (placebo), respectively. Subjects were followed over 18 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00224484
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date April 7, 2004
Completion date July 24, 2007
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05468619 - Neonatal Phase 1 Valacyclovir Study Phase 1
Withdrawn NCT02349828 - Antiviral Prophylaxis in a Burn Population Phase 2/Phase 3
Recruiting NCT01176409 - Can Valacyclovir Attenuate Inflammation in Antiretroviral-Treated HIV-Infected Individuals With Herpes Simplex Virus Type 2? Phase 3
Completed NCT04664127 - Study of the Efficacy and Safety of Combined Treatment of Patients With Severe Herpes Simplex (HSV) Infection by Valacyclovir and Interferon Inducer Kagocel
Completed NCT00448227 - Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection Phase 2
Completed NCT00000139 - Herpetic Eye Disease Study (HEDS) II Phase 3
Completed NCT04239521 - The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata
Completed NCT02209324 - Open-label Study of ASP2151 in Herpes Simplex Patients Phase 3
Completed NCT00855309 - Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia Phase 3
Completed NCT01602562 - Valaciclovir Hydrochloride Phase III for Hematopoietic Stem Cell Transplantation Patients Phase 3
Completed NCT00973466 - Prevalence of Sexually Transmitted Infections (STIs) in HIV-infected Patients N/A
Completed NCT00698893 - Evaluation of Safety of Candidate gD Vaccine, With or Without MPL in Healthy Herpes Simplex Virus-positive Adults Phase 1
Active, not recruiting NCT05298254 - A Study on the Reactogenicity, Safety, Immune Response, and Efficacy of a Targeted Immunotherapy Against HSV in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes Phase 1/Phase 2
Recruiting NCT03178747 - Tzanck Smear With Methylene Blue Stain for Herpes Phase 3
Completed NCT00164424 - Episodic Acyclovir Therapy for Genital Ulcers Phase 2/Phase 3
Completed NCT00161434 - A Study of Valacyclovir to Suppress HSV and HIV Shedding in Coinfected Persons Phase 4
Terminated NCT04762511 - A Study on the Reactogenicity, Safety and Immune Response of a Vaccine Against Herpes Simplex Virus (HSV)-2 in Healthy Participants Aged 18-40 Years Phase 1
Completed NCT00699764 - Safety of a Herpes Simplex Candidate Vaccine (gD2t) With MPL and Its Efficacy to Prevent Genital Herpes Disease Phase 3
Recruiting NCT04065971 - Randomized, Placebo-controlled, Double-blind Study of 2LHERP® in Orofacial Herpes Infections. Phase 4
Active, not recruiting NCT00005663 - A Study of Valacyclovir as Treatment for Genital Herpes Simplex Virus in HIV-Infected Patients Phase 3