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Evaluation of Immunogenicity, Reactogenicity and Safety of Herpes Simplex (gD) Candidate Vaccine With/Without Adjuvant

NCT00697567 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2008-06-16

No results posted yet for this study

Summary

The purpose of the phase IIa study in healthy HSV seropositive and HSV seronegative adults is to evaluate the immunogenicity, reactogenicity and safety of herpes simplex (gD) candidate vaccine with or without adjuvant administered according to a 0, 1, 6 month schedule.

Conditions

  • Prophylaxis Herpes Simplex

Interventions

BIOLOGICAL

Herpes simplex candidate vaccine GSK208141 - non-MPL-containing adjuvant

Intramuscular injection, 3 doses

BIOLOGICAL

Herpes simplex candidate vaccine GSK208141- MPL-containing adjuvant

Intramuscular injection, 3 doses

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1992-09-30
Primary Completion
1997-12-31
Completion
1997-12-31

Countries

  • Belgium

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 NCT00697567 on ClinicalTrials.gov