Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old
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.
1 other identifier
interventional
5,960
17 countries
143
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2004
Typical duration for phase_3
143 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 7, 2004
CompletedFirst Submitted
Initial submission to the registry
September 21, 2005
CompletedFirst Posted
Study publicly available on registry
September 23, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 24, 2007
CompletedResults Posted
Study results publicly available
April 10, 2017
CompletedJanuary 7, 2019
January 1, 2019
3.3 years
September 21, 2005
February 24, 2017
January 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
From Month 0 to Month 12
Secondary Outcomes (18)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Within 7 days (Days 0-6) after each and any vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Within 7 days (Days 0-6) after each and any vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Within 30 days (Day 0-29) after any vaccination
Number of Subjects With Unsolicited Adverse Events (AEs) With Medically Attended Visits
Within the 30 Day (Day 0-29) post-vaccination period
Number of Subjects With New Onset Chronic Diseases (NOCD)
During the active phase (up to Month 12)
- +13 more secondary outcomes
Study Arms (3)
GD2-AS04 GROUP
EXPERIMENTALFemale subjects aged 10-17 years, who received 3 doses of gD2-AS04 vaccine, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
HAVRIX GROUP
ACTIVE COMPARATORFemale subjects aged 10-17 years, who received 3 doses of Havrix, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
SALINE GROUP
PLACEBO COMPARATORFemale subjects aged 10-17 years, who received 3 doses of a saline solution, which were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
Interventions
3 intramuscular doses
Eligibility Criteria
You may qualify if:
- 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.
- Written informed assent obtained from the subject and written informed consent obtained from a parent or legal guardian of the subject prior to enrolment. If the subject is above the legal age of consent in her country, written informed consent will only be obtained from the subject.
- Subjects must have a negative urine pregnancy test.
- Subjects of childbearing potential at the time of study entry must be abstinent or must be using an effective method of birth control for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study and therefore are of childbearing potential must agree to follow the same precautions.
You may not qualify if:
- 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.
- Female planning to become pregnant or likely to become pregnant during the first eight months of the study (months 0-8).
- Any previous confirmed history of, or current clinical signs or symptoms of, oro labial herpes (cold sores), herpetic whitlow or genital herpes disease, such as swelling, papules, vesicles, pustules, ulcers, crusts, fissures, erythema, discharge, dysuria or pain, burning, itching, tingling in the ano-genital area.
- History of previous or planned vaccination against hepatitis A or a history of hepatitis A infection.
- Previous vaccination against herpes.
- History of herpetic keratitis.
- History of multiform erythema.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of study vaccine with the following exceptions: administration of routine meningococcal, hepatitis B, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before and 30 days after the first dose of study vaccine.
- History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
- History of a current acute or chronic autoimmune disease.
- History of any neurological disorders or seizures, with the exception of a single febrile seizure during childhood.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality
- Acute disease at the time of enrolment
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (151)
GSK Investigational Site
Birmingham, Alabama, 35209, United States
GSK Investigational Site
Birmingham, Alabama, 35233, United States
GSK Investigational Site
Chandler, Arizona, 85224, United States
GSK Investigational Site
Mesa, Arizona, 85201, United States
GSK Investigational Site
Mesa, Arizona, 85213, United States
GSK Investigational Site
Tempe, Arizona, 85282, United States
GSK Investigational Site
Tucson, Arizona, 85710, United States
GSK Investigational Site
Beverly Hills, California, 90211, United States
GSK Investigational Site
Fountain Valley, California, 92708, United States
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Rolling Hills Estates, California, 90274, United States
GSK Investigational Site
Centennial, Colorado, 80112, United States
GSK Investigational Site
Littleton, Colorado, 80234, United States
GSK Investigational Site
Thornton, Colorado, 80233, United States
GSK Investigational Site
Westminster, Colorado, 80234, United States
GSK Investigational Site
Wheat Ridge, Colorado, 80033, United States
GSK Investigational Site
Norwich, Connecticut, 06360, United States
GSK Investigational Site
Clearwater, Florida, 33759, United States
GSK Investigational Site
Cocoa Beach, Florida, 32931, United States
GSK Investigational Site
Melbourne, Florida, 332901, United States
GSK Investigational Site
Naples, Florida, 34102, United States
GSK Investigational Site
Chicago, Illinois, 60614, United States
GSK Investigational Site
Arkansas City, Kansas, 67005, United States
GSK Investigational Site
Wichita, Kansas, 67207, United States
GSK Investigational Site
Towson, Maryland, 21286, United States
GSK Investigational Site
Fridley, Minnesota, 55432, United States
GSK Investigational Site
St Louis, Missouri, 63104, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Whitehouse Station, New Jersey, 08889, United States
GSK Investigational Site
Albuquerque, New Mexico, 87102, United States
GSK Investigational Site
Stony Brook, New York, 11794-8480, United States
GSK Investigational Site
The Bronx, New York, 10461, United States
GSK Investigational Site
The Bronx, New York, 10467-2490, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Sylva, North Carolina, 28779, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Akron, Ohio, 44308-1062, United States
GSK Investigational Site
Cincinnati, Ohio, 45229, United States
GSK Investigational Site
Cleveland, Ohio, 44121, United States
GSK Investigational Site
Columbus, Ohio, 43214, United States
GSK Investigational Site
Columbus, Ohio, 43235, United States
GSK Investigational Site
Hilliard, Ohio, 43026, United States
GSK Investigational Site
Pickerington, Ohio, 43147, United States
GSK Investigational Site
Westerville, Ohio, 43082, United States
GSK Investigational Site
Portland, Oregon, 97216, United States
GSK Investigational Site
Beaver, Pennsylvania, 15009, United States
GSK Investigational Site
Erie, Pennsylvania, 16505, United States
GSK Investigational Site
Erie, Pennsylvania, 16508, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15227, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Gray, Tennessee, 37615, United States
GSK Investigational Site
Kingsport, Tennessee, 37660, United States
GSK Investigational Site
Austin, Texas, 78752, United States
GSK Investigational Site
Beaumont, Texas, 77701, United States
GSK Investigational Site
Galveston, Texas, 77555-0188, United States
GSK Investigational Site
Lake Jackson, Texas, 77566, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Temple, Texas, 76508, United States
GSK Investigational Site
Magna, Utah, 84044, United States
GSK Investigational Site
Salt Lake City, Utah, 84109, United States
GSK Investigational Site
Salt Lake City, Utah, 84121, United States
GSK Investigational Site
Sandy City, Utah, 84070, United States
GSK Investigational Site
West Jordan, Utah, 84084, United States
GSK Investigational Site
West Jordan, Utah, 84088, United States
GSK Investigational Site
Norfolk, Virginia, 23510, United States
GSK Investigational Site
Marshfield, Wisconsin, 54449, United States
GSK Investigational Site
Garran, Australian Capital Territory, 2606, Australia
GSK Investigational Site
Westmead, New South Wales, 2145, Australia
GSK Investigational Site
South Brisbane, Queensland, 4101, Australia
GSK Investigational Site
Hobart, Tasmania, Australia
GSK Investigational Site
Carlton, Victoria, 3053, Australia
GSK Investigational Site
Ghent, 9000, Belgium
GSK Investigational Site
Wilrijk, 2610, Belgium
GSK Investigational Site
Edmonton, Alberta, T6G 2C8, Canada
GSK Investigational Site
Surrey, British Columbia, V3R 8P8, Canada
GSK Investigational Site
Vancouver, British Columbia, V6H 3N1, Canada
GSK Investigational Site
Ottawa, Ontario, K1S 0G8, Canada
GSK Investigational Site
Beauport, Quebec, G1E 7G9, Canada
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G2, Canada
GSK Investigational Site
Aarhus N, 8200, Denmark
GSK Investigational Site
Tallinn, 10617, Estonia
GSK Investigational Site
Tartu, 50417, Estonia
GSK Investigational Site
Château-Renault, 37110, France
GSK Investigational Site
Derval, 44590, France
GSK Investigational Site
Évreux, 27000, France
GSK Investigational Site
Haute-Goulaine, 44115, France
GSK Investigational Site
La Chapelle-sur-Erdre, 44240, France
GSK Investigational Site
Le Temple-de-Bretagne, 44360, France
GSK Investigational Site
Luynes, 37230, France
GSK Investigational Site
Nantes, 44000, France
GSK Investigational Site
Nantes, 44300, France
GSK Investigational Site
Nort-sur-Erdre, 44390, France
GSK Investigational Site
Paris, 75015, France
GSK Investigational Site
Pont-de-l'Arche, 27340, France
GSK Investigational Site
Saint-Aubin-des-Châteaux, 44110, France
GSK Investigational Site
Saint-Avertin, 37550, France
GSK Investigational Site
Saint-Sébastien-sur-Loire, 44230, France
GSK Investigational Site
Tours, 37000, France
GSK Investigational Site
Athens, 11527, Greece
GSK Investigational Site
Athens, 11528, Greece
GSK Investigational Site
Komotini, 69100, Greece
GSK Investigational Site
Thessaloniki, 54636, Greece
GSK Investigational Site
Bordány, 6795, Hungary
GSK Investigational Site
Budapest, 1089, Hungary
GSK Investigational Site
Győr, 9024, Hungary
GSK Investigational Site
Hódmezővásárhely, 6800, Hungary
GSK Investigational Site
Szeged, 6720, Hungary
GSK Investigational Site
Szeged, 6723, Hungary
GSK Investigational Site
Zsombó, 6792, Hungary
GSK Investigational Site
Garðabaer, 210, Iceland
GSK Investigational Site
Kopavogur, Iceland
GSK Investigational Site
Reykjavik, 112, Iceland
GSK Investigational Site
Kaunas, LT-47144, Lithuania
GSK Investigational Site
Panevezys, LT-37355, Lithuania
GSK Investigational Site
Vilnius, LT-01205, Lithuania
GSK Investigational Site
Vilnius, LT-02169, Lithuania
GSK Investigational Site
Vilnius, LT-07156, Lithuania
GSK Investigational Site
Rotterdam, 3011 EN, Netherlands
GSK Investigational Site
Christchurch, 8001, New Zealand
GSK Investigational Site
Bergen, N-5021, Norway
GSK Investigational Site
Oslo, N-0159, Norway
GSK Investigational Site
Bucharest, 020125, Romania
GSK Investigational Site
Bucharest, 077190, Romania
GSK Investigational Site
Bucharest, Romania
GSK Investigational Site
Blanes, Spain
GSK Investigational Site
Castellon, Spain
GSK Investigational Site
Madrid, 28009, Spain
GSK Investigational Site
Montgat/Barcelona, 08390, Spain
GSK Investigational Site
Valencia, 46017, Spain
GSK Investigational Site
Valencia, 46021, Spain
GSK Investigational Site
Valencia, 46023, Spain
GSK Investigational Site
Valencia, 46024, Spain
GSK Investigational Site
Gothenburg, SE-416 85, Sweden
GSK Investigational Site
Karlskrona, SE-371 41, Sweden
GSK Investigational Site
Linköping, SE-581 85, Sweden
GSK Investigational Site
Malmo, SE-205 02, Sweden
GSK Investigational Site
Örebro, SE-702 11, Sweden
GSK Investigational Site
Umeå, SE-901 85, Sweden
GSK Investigational Site
Southampton, Hampshire, SO14 0YG, United Kingdom
GSK Investigational Site
Blackpool, Lancashire, FY2 9RS, United Kingdom
GSK Investigational Site
Blackpool, Lancashire, FY3 7DG, United Kingdom
GSK Investigational Site
Blackpool, Lancashire, FY4 3AD, United Kingdom
GSK Investigational Site
Bolton, Lancashire, BL4 9QZ, United Kingdom
GSK Investigational Site
Coventry, Warwickshire, CV5 6EU, United Kingdom
GSK Investigational Site
Coventry, Warwickshire, CV6 4DD, United Kingdom
GSK Investigational Site
Coventry, West Midlands, CV2 1AX, United Kingdom
GSK Investigational Site
Bradford, BD5 0JD, United Kingdom
GSK Investigational Site
Doncaster, DN1 2EG, United Kingdom
GSK Investigational Site
Leeds, LS12 1JE, United Kingdom
GSK Investigational Site
London, SW10 9TH, United Kingdom
GSK Investigational Site
Sheffield, S10 2JF, United Kingdom
Related Publications (3)
Tavares F, Cheuvart B, Heineman T, Arellano F, Dubin G. Meta-analysis of pregnancy outcomes in pooled randomized trials on a prophylactic adjuvanted glycoprotein D subunit herpes simplex virus vaccine. Vaccine. 2013 Mar 25;31(13):1759-64. doi: 10.1016/j.vaccine.2013.01.002. Epub 2013 Jan 10.
PMID: 23313657BACKGROUNDHSV-040 Study Group; Abu-Elyazeed RR, Heineman T, Dubin G, Fourneau M, Leroux-Roels I, Leroux-Roels G, Richardus JH, Ostergaard L, Diez-Domingo J, Poder A, Van Damme P, Romanowski B, Blatter M, Silfverdal SA, Berglund J, Josefsson A, Cunningham AL, Flodmark CE, Tragiannidis A, Dobson S, Olafsson J, Puig-Barbera J, Mendez M, Barton S, Bernstein D, Mares J, Ratner P. 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. 2013 Dec 9;31(51):6136-43. doi: 10.1016/j.vaccine.2013.06.081. Epub 2013 Jul 9.
PMID: 23850416BACKGROUNDVerstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.
PMID: 18845199BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2005
First Posted
September 23, 2005
Study Start
April 7, 2004
Primary Completion
July 24, 2007
Study Completion
July 24, 2007
Last Updated
January 7, 2019
Results First Posted
April 10, 2017
Record last verified: 2019-01
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.