Last updated: 06/04/2019 10:30:50

Safety study of herpes simplex vaccine in HSV seronegative and seropositive females between 10 and 17 years old

GSK study ID
208141/040
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Number of subjects with serious adverse events (SAEs)

Timeframe: From Month 0 to Month 12

Secondary outcomes:

Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: Within 7 days (Days 0-6) after each and any vaccination

Number of subjects with any, Grade 3 and related solicited general symptoms

Timeframe: Within 7 days (Days 0-6) after each and any vaccination

Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)

Timeframe: Within 30 days (Day 0-29) after any vaccination

Number of subjects with unsolicited adverse events (AEs) with medically attended visits

Timeframe: Within the 30 Day (Day 0-29) post-vaccination period

Number of subjects with new onset chronic diseases (NOCD)

Timeframe: During the active phase (up to Month 12)

Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed

Timeframe: At months 7 and 12

Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed

Timeframe: At months 7 and 12

Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed

Timeframe: At months 7 and 12

Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed

Timeframe: At months 7 and 12

Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed

Timeframe: At months 7 and 12

Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed

Timeframe: At months 7 and 12

Number of subjects reporting clinically relevant abnormalities in biochemical and haematological laboratory parameters assessed

Timeframe: At months 7 and 12

Number of subjects with unsolicited adverse events (AEs) with medically attended visits

Timeframe: Starting from Day 30 until the end of study (Month 18)

Number of subjects with medically significant conditions (MSC)

Timeframe: During the Extended Safety Follow Up (ESFU) period (Month 12 to Month 18)

Number of subjects with new onset chronic diseases (NOCD)

Timeframe: During the Extended Safety Follow Up (ESFU) period (Month 12 to Month 18)

Number of subjects with serious adverse events (SAEs)

Timeframe: Up to month 18 (during active phase and ESFU period)

Anti-glycoprotein D (anti-gD) antibody concentrations

Timeframe: At months 0, 7 and 12

Anti-deacylated Monophosphoryl lipid A (anti-MPL) antibody concentrations

Timeframe: At months 0, 7 and 12

Interventions:
  • Biological/vaccine: GSK208141
  • Biological/vaccine: Havrix (investigational formulation)
  • Biological/vaccine: Placebo
  • Enrollment:
    5960
    Primary completion date:
    2007-24-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Tavares F et al. (2013) Meta-analysis of pregnancy outcomes in pooled randomized trials on a prophylactic adjuvanted glycoprotein D subunit Herpes Simplex Virus vaccine. Vaccine. 31(13):1759-1764.
    The HSV-040 study group (2013) Safety and immunogenicity of a glycoprotein D genital herpes vaccine in healthy girls 10-17 years of age: Results from a randomised, controlled, double-blind trial. Vaccine. pii: S0264-410X(13)00891-8. doi: 10.1016/j.vaccine.2013.06.081.
    Verstraeten T et al. (2008) Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 26(51):6630–6638.
    Medical condition
    Herpes Simplex
    Product
    SB208109, SB208141
    Collaborators
    Not applicable
    Study date(s)
    April 2004 to July 2007
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female
    Age
    10 - 17 years
    Accepts healthy volunteers
    Yes
    • Subjects who the investigator believes that can and will comply with the requirements of the protocol should be enrolled in the study.
    • Healthy female between, and including, 10 and 17 years of age at the time of the first vaccination.
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
    • Pregnant or lactating female.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bronx, New York, United States, 10467-2490
    Status
    Study Complete
    Location
    GSK Investigational Site
    Paris, France, 75015
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Sandy, Utah, United States, 84070
    Status
    Study Complete
    Location
    GSK Investigational Site
    Madrid, Spain, 28009
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bucharest, Romania
    Status
    Study Complete
    Location
    GSK Investigational Site
    Saint Sebastien sur Loire, France, 44230
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Scientific result summary
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-24-07
    Actual study completion date
    2007-24-07

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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