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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2007-24-07
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
Completed
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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