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
    Location
    GSK Investigational Site
    South Brisbane, Queensland, Australia, 4101
    Status
    Study Complete
    Location
    GSK Investigational Site
    Clearwater, Florida, United States, 33759
    Status
    Study Complete
    Location
    GSK Investigational Site
    Towson, Maryland, United States, 21286
    Status
    Study Complete
    Location
    GSK Investigational Site
    Rolling Hills Estates, California, United States, 90274
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cocoa Beach, Florida, United States, 32931
    Status
    Study Complete
    Location
    GSK Investigational Site
    Norwich, Connecticut, United States, 06360
    Status
    Study Complete
    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35209
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    GÖTEBORG, Sweden, SE-416 85
    Status
    Study Complete
    Location
    GSK Investigational Site
    Arkansas City, Kansas, United States, 67005
    Status
    Study Complete
    Location
    GSK Investigational Site
    Budapest, Hungary, 1089
    Status
    Study Complete
    Location
    GSK Investigational Site
    Marshfield, Wisconsin, United States, 54449
    Status
    Study Complete
    Location
    GSK Investigational Site
    Naples, Florida, United States, 34102
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tucson, Arizona, United States, 85710
    Status
    Study Complete
    Location
    GSK Investigational Site
    Vilnius, Lithuania, LT-07156
    Status
    Study Complete
    Location
    GSK Investigational Site
    Castellon, Spain
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hódmezővásárhely, Hungary, 6800
    Status
    Study Complete
    Location
    GSK Investigational Site
    Westminster, Colorado, United States, 80234
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hobart, Tasmania, Australia
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44121
    Status
    Study Complete
    Location
    GSK Investigational Site
    Montgat/Barcelona, Spain, 08390
    Status
    Study Complete
    Location
    GSK Investigational Site
    UMEÅ, Sweden, SE-901 85
    Status
    Study Complete
    Location
    GSK Investigational Site
    Reykjavik, Iceland, 112
    Status
    Study Complete
    Location
    GSK Investigational Site
    Salt Lake City, Utah, United States, 84121
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bergen, Norway, N-5021
    Status
    Study Complete
    Location
    GSK Investigational Site
    Columbus, Ohio, United States, 43214
    Status
    Study Complete
    Location
    GSK Investigational Site
    Coventry, West Midlands, United Kingdom, CV2 1AX
    Status
    Study Complete
    Location
    GSK Investigational Site
    Melbourne, Florida, United States, 332901
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Derval, France, 44590
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kingsport, Tennessee, United States, 37660
    Status
    Study Complete
    Location
    GSK Investigational Site
    Westerville, Ohio, United States, 43082
    Status
    Study Complete
    Location
    GSK Investigational Site
    Salt Lake City, Utah, United States, 84109
    Status
    Study Complete
    Location
    GSK Investigational Site
    Norfolk, Virginia, United States, 23510
    Status
    Study Complete
    Location
    GSK Investigational Site
    Albuquerque, New Mexico, United States, 87102
    Status
    Study Complete
    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97216
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tartu, Estonia, 50417
    Status
    Study Complete
    Location
    GSK Investigational Site
    Coventry, Warwickshire, United Kingdom, CV5 6EU
    Status
    Study Complete
    Location
    GSK Investigational Site
    Vancouver, British Columbia, Canada, V6H 3N1
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bradford, United Kingdom, BD5 0JD
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Valencia, Spain, 46021
    Status
    Study Complete
    Location
    GSK Investigational Site
    Aarhus N, Denmark, 8200
    Status
    Study Complete
    Location
    GSK Investigational Site
    Komotini, Greece, 69100
    Status
    Study Complete
    Location
    GSK Investigational Site
    Columbus, Ohio, United States, 43235
    Status
    Study Complete
    Location
    GSK Investigational Site
    Akron, Ohio, United States, 44308-1062
    Status
    Study Complete
    Location
    GSK Investigational Site
    West Jordan, Utah, United States, 84088
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    KARLSKRONA, Sweden, SE-371 41
    Status
    Study Complete
    Location
    GSK Investigational Site
    Gray, Tennessee, United States, 37615
    Status
    Study Complete
    Location
    GSK Investigational Site
    Garran, Australian Capital Territory, Australia, 2606
    Status
    Study Complete
    Location
    GSK Investigational Site
    Valencia, Spain, 46023
    Status
    Study Complete
    Location
    GSK Investigational Site
    Centennial, Colorado, United States, 80112
    Status
    Study Complete
    Location
    GSK Investigational Site
    Blanes, Spain
    Status
    Study Complete
    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15227
    Status
    Study Complete
    Location
    GSK Investigational Site
    Coventry, Warwickshire, United Kingdom, CV6 4DD
    Status
    Study Complete
    Location
    GSK Investigational Site
    Leeds, United Kingdom, LS12 1JE
    Status
    Study Complete
    Location
    GSK Investigational Site
    Szeged, Hungary, 6720
    Status
    Study Complete
    Location
    GSK Investigational Site
    Beverly Hills, California, United States, 90211
    Status
    Study Complete
    Location
    GSK Investigational Site
    Surrey, British Columbia, Canada, V3R 8P8
    Status
    Study Complete
    Location
    GSK Investigational Site
    Blackpool, Lancashire, United Kingdom, FY3 7DG
    Status
    Study Complete
    Location
    GSK Investigational Site
    Sheffield, United Kingdom, S10 2JF
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Raleigh, North Carolina, United States, 27609
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bucuresti, Romania
    Status
    Study Complete
    Location
    GSK Investigational Site
    Thornton, Colorado, United States, 80233
    Status
    Study Complete
    Location
    GSK Investigational Site
    Beauport, Québec, Canada, G1E 7G9
    Status
    Study Complete
    Location
    GSK Investigational Site
    Nantes, France, 44300
    Status
    Study Complete
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hilliard, Ohio, United States, 43026
    Status
    Study Complete
    Location
    GSK Investigational Site
    Blackpool, Lancashire, United Kingdom, FY2 9RS
    Status
    Study Complete
    Location
    GSK Investigational Site
    Gardabaer, Iceland, 210
    Status
    Study Complete
    Location
    GSK Investigational Site
    Fountain Valley, California, United States, 92708
    Status
    Study Complete
    Location
    GSK Investigational Site
    Nantes, France, 44000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tallinn, Estonia, 10617
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kaunas, Lithuania, LT-47144
    Status
    Study Complete
    Location
    GSK Investigational Site
    ROTTERDAM, Netherlands, 3011 EN
    Status
    Study Complete
    Location
    GSK Investigational Site
    Southampton, Hampshire, United Kingdom, SO14 0YG
    Status
    Study Complete
    Location
    GSK Investigational Site
    Saint Avertin, France, 37550
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Doncaster, United Kingdom, DN1 2EG
    Status
    Study Complete
    Location
    GSK Investigational Site
    Valencia, Spain, 46024
    Status
    Study Complete
    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60614
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Vilnius, Lithuania, LT-02169
    Status
    Study Complete
    Location
    GSK Investigational Site
    Whitehouse Station, New Jersey, United States, 08889
    Status
    Study Complete
    Location
    GSK Investigational Site
    Westmead, New South Wales, Australia, 2145
    Status
    Study Complete
    Location
    GSK Investigational Site
    Fridley, Minnesota, United States, 55432
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bolton, Lancashire, United Kingdom, BL4 9QZ
    Status
    Study Complete
    Location
    GSK Investigational Site
    Kopavogur, Iceland
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tours, France, 37000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Thessaloniki, Greece, 54636
    Status
    Study Complete
    Location
    GSK Investigational Site
    Evreux, France, 27000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Château Renault, France, 37110
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Le Temple De Bretagne, France, 44360
    Status
    Study Complete
    Location
    GSK Investigational Site
    Beaver, Pennsylvania, United States, 15009
    Status
    Study Complete
    Location
    GSK Investigational Site
    Panevezys, Lithuania, LT-37355
    Status
    Study Complete
    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63104
    Status
    Study Complete
    Location
    GSK Investigational Site
    Mesa, Arizona, United States, 85201
    Status
    Study Complete
    Location
    GSK Investigational Site
    Zsombó, Hungary, 6792
    Status
    Study Complete
    Location
    GSK Investigational Site
    Ottawa, Ontario, Canada, K1S 0G8
    Status
    Study Complete
    Location
    GSK Investigational Site
    Long Beach, California, United States, 90806
    Status
    Study Complete
    Location
    GSK Investigational Site
    Vilnius, Lithuania, LT-01205
    Status
    Study Complete
    Location
    GSK Investigational Site
    Austin, Texas, United States, 78752
    Status
    Study Complete
    Location
    GSK Investigational Site
    Oslo, Norway, N-0159
    Status
    Study Complete
    Location
    GSK Investigational Site
    Sylva, North Carolina, United States, 28779
    Status
    Study Complete
    Location
    GSK Investigational Site
    London, United Kingdom, SW10 9TH
    Status
    Study Complete
    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63141
    Status
    Study Complete
    Location
    GSK Investigational Site
    Luynes, France, 37230
    Status
    Study Complete
    Location
    GSK Investigational Site
    Pickerington, Ohio, United States, 43147
    Status
    Study Complete
    Location
    GSK Investigational Site
    Erie, Pennsylvania, United States, 16508
    Status
    Study Complete
    Location
    GSK Investigational Site
    Athens, Greece, 11527
    Status
    Study Complete
    Location
    GSK Investigational Site
    Lake Jackson, Texas, United States, 77566
    Status
    Study Complete
    Location
    GSK Investigational Site
    Beaumont, Texas, United States, 77701
    Status
    Study Complete
    Location
    GSK Investigational Site
    La Chapelle sur Erdre, France, 44240
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bronx, New York, United States, 10461
    Status
    Study Complete
    Location
    GSK Investigational Site
    Edmonton, Alberta, Canada, T6G 2C8
    Status
    Study Complete
    Location
    GSK Investigational Site
    West Jordan, Utah, United States, 84084
    Status
    Study Complete
    Location
    GSK Investigational Site
    Athens, Greece, 11528
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Magna, Utah, United States, 84044
    Status
    Study Complete
    Location
    GSK Investigational Site
    Valencia, Spain, 46017
    Status
    Study Complete
    Location
    GSK Investigational Site
    Győr, Hungary, 9024
    Status
    Study Complete
    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15241
    Status
    Study Complete
    Location
    GSK Investigational Site
    Blackpool, Lancashire, United Kingdom, FY4 3AD
    Status
    Study Complete
    Location
    GSK Investigational Site
    Saint Aubin des Chateaux, France, 44110
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Chandler, Arizona, United States, 85224
    Status
    Study Complete
    Location
    GSK Investigational Site
    ÖREBRO, Sweden, SE-702 11
    Status
    Study Complete
    Location
    GSK Investigational Site
    Winston-Salem, North Carolina, United States, 27103
    Status
    Terminated/Withdrawn
    Location
    GSK Investigational Site
    Christchurch, New Zealand, 8001
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bordány, Hungary, 6795
    Status
    Study Complete
    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35233
    Status
    Study Complete
    Location
    GSK Investigational Site
    Nort sur Erdre, France, 44390
    Status
    Study Complete
    Location
    GSK Investigational Site
    Wilrijk, Belgium, 2610
    Status
    Study Complete
    Location
    GSK Investigational Site
    Pont de L'Arche, France, 27340
    Status
    Study Complete
    Location
    GSK Investigational Site
    Littleton, Colorado, United States, 80234
    Status
    Study Complete
    Location
    GSK Investigational Site
    Szeged, Hungary, 6723
    Status
    Study Complete
    Location
    GSK Investigational Site
    Erie, Pennsylvania, United States, 16505
    Status
    Study Complete
    Location
    GSK Investigational Site
    Carlton, Victoria, Australia, 3053
    Status
    Study Complete
    Location
    GSK Investigational Site
    Bucharest, Romania, 077190
    Status
    Study Complete
    Location
    GSK Investigational Site
    Stony Brook, New York, United States, 11794-8480
    Status
    Study Complete
    Location
    GSK Investigational Site
    Tempe, Arizona, United States, 85282
    Status
    Study Complete
    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45229
    Status
    Study Complete
    Location
    GSK Investigational Site
    Sainte-Foy, Québec, Canada, G1V 4G2
    Status
    Study Complete
    Location
    GSK Investigational Site
    LINKÖPING, Sweden, SE-581 85
    Status
    Study Complete
    Location
    GSK Investigational Site
    Galveston, Texas, United States, 77555-0188
    Status
    Study Complete
    Location
    GSK Investigational Site
    Temple, Texas, United States, 76508
    Status
    Study Complete
    Location
    GSK Investigational Site
    MALMÖ, Sweden, SE-205 02
    Status
    Study Complete
    Location
    GSK Investigational Site
    Gent, Belgium, 9000
    Status
    Study Complete
    Location
    GSK Investigational Site
    Wheat Ridge, Colorado, United States, 80033
    Status
    Study Complete
    Location
    GSK Investigational Site
    Haute Goulaine, France, 44115
    Status
    Study Complete
    Location
    GSK Investigational Site
    Wichita, Kansas, United States, 67207
    Status
    Study Complete
    Location
    GSK Investigational Site
    Mesa, Arizona, United States, 85213
    Status
    Study Complete

    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.

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