Last updated: 09/22/2020 09:20:05

Study to compare safety and immunogenicity of commercial scale consistency lots of herpes simplex vaccine

GSK study ID
208141/042
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 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
Trial 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Anti-gD antibody titre in the entire cohort (10–17 yrs)

Timeframe: At month 7

Secondary outcomes:

Anti-gD antibody titre

Timeframe: At months 2 and 12

Anti-HSV neutralizing antibodies

Timeframe: At months 2, 7 and 12

Occurrence and intensity of solicited local symptoms. Resulting school absenteeism will also be evaluated.

Timeframe: Within 7 days after each vaccination

Occurrence, intensity, relationship to vaccination and resulting school absenteeism of solicited general symptoms

Timeframe: Within 7 days after each vaccination

Occurrence, intensity, relationship to vaccination and resulting school absenteeism of unsolicited adverse events

Timeframe: Within 30 days after any vaccination

Occurrence of new onset chronic diseases and other medically significant conditions, regardless of causal relationship to vaccination and intensity

Timeframe: Throughout the study

Occurrence and relationship to vaccination of SAEs

Timeframe: Throughout the study period

Anti-gD antibody titre in sera from HSV-042 subjects and in an equally sized subset of sera from adults from study 208141/039

Timeframe: At month 7

Seroconversion rate by anti-gD ELISA. in HSV-042 subjects and in an equally sized subset of adults from study 208141/039

Timeframe: At month 7

In the event that a cell-mediated immune correlate of protection is identified in study 208141/039: assessment of the immune correlate of protection in a random subset of HBV-042 subjects

Timeframe: At months 0, 2, 7, and 12

Interventions:
  • Biological/vaccine: GSK208141 vaccine
  • Enrollment:
    671
    Primary completion date:
    2005-07-09
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Leroux-Roels G et al. (2013) Clinical evaluation to confirm the manufacturing consistency of three lots of an adjuvanted glycoprotein D genital herpes vaccine in healthy seronegative pre-teen and adolescent girls: A phase III multi-center double-blind randomized trial. Trials in Vaccinology. NA(2):10-18.
    Medical condition
    Herpes Simplex
    Product
    SB208141
    Collaborators
    Not applicable
    Study date(s)
    December 2003 to January 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female
    Age
    10 - 17 years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • Healthy female between, and including, 10 and 17 years of age at the time of the first vaccination.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Beauport, Québec, Canada, G1E 7G9
    Status
    Study Complete
    Location
    GSK Investigational Site
    Seattle, Washington, United States, 98105
    Status
    Study Complete
    Location
    GSK Investigational Site
    Mesa, Arizona, United States, 85201
    Status
    Study Complete
    Location
    GSK Investigational Site
    Vancouver, British Columbia, Canada, V6H 3N1
    Status
    Study Complete
    Location
    GSK Investigational Site
    Galveston, Texas, United States, 77555-0188
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45229
    Status
    Study Complete
    Showing 1 - 6 of 13 Results

    Study documents

    Protocol
    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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2005-07-09
    Actual study completion date
    2006-11-01

    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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