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Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old

NCT ID: NCT00224484

Last Updated: 2019-01-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

5960 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-07

Study Completion Date

2007-07-24

Brief Summary

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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.

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Detailed Description

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Three groups of females (3000, 1500 and 1500 subjects, respectively) were injected 3 times (at months 0, 1 and 6) with the herpes simplex vaccine, the HavrixTM vaccine (control) and a Saline solution (placebo), respectively. Subjects were followed over 18 months.

Conditions

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Herpes Simplex

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GD2-AS04 GROUP

Female 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.

Group Type EXPERIMENTAL

GSK208141

Intervention Type BIOLOGICAL

3 intramuscular doses

HAVRIX GROUP

Female 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.

Group Type ACTIVE_COMPARATOR

Havrix (investigational formulation)

Intervention Type BIOLOGICAL

3 intramuscular doses

SALINE GROUP

Female 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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

3 intramuscular doses

Interventions

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GSK208141

3 intramuscular doses

Intervention Type BIOLOGICAL

Havrix (investigational formulation)

3 intramuscular doses

Intervention Type BIOLOGICAL

Placebo

3 intramuscular doses

Intervention Type BIOLOGICAL

Other Intervention Names

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Herpes simplex vaccine gD2-AS04 vaccine

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
* Oral temperature \>= 37.5°C (99.5°F) / axillary temperature \>= 37.5°C (99.5°F) at the time of enrolment.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Chandler, Arizona, United States

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Mesa, Arizona, United States

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Mesa, Arizona, United States

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Tempe, Arizona, United States

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Tucson, Arizona, United States

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Beverly Hills, California, United States

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Fountain Valley, California, United States

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Long Beach, California, United States

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Rolling Hills Estates, California, United States

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Centennial, Colorado, United States

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Littleton, Colorado, United States

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Thornton, Colorado, United States

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Westminster, Colorado, United States

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Wheat Ridge, Colorado, United States

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Norwich, Connecticut, United States

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Clearwater, Florida, United States

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Cocoa Beach, Florida, United States

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Melbourne, Florida, United States

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Naples, Florida, United States

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Chicago, Illinois, United States

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Arkansas City, Kansas, United States

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Wichita, Kansas, United States

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Towson, Maryland, United States

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Fridley, Minnesota, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Whitehouse Station, New Jersey, United States

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Albuquerque, New Mexico, United States

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Stony Brook, New York, United States

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The Bronx, New York, United States

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The Bronx, New York, United States

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Raleigh, North Carolina, United States

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Sylva, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Columbus, Ohio, United States

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Hilliard, Ohio, United States

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Pickerington, Ohio, United States

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Westerville, Ohio, United States

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Portland, Oregon, United States

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Beaver, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Erie, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Gray, Tennessee, United States

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Kingsport, Tennessee, United States

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Austin, Texas, United States

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Beaumont, Texas, United States

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Galveston, Texas, United States

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Lake Jackson, Texas, United States

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San Antonio, Texas, United States

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Temple, Texas, United States

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Magna, Utah, United States

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Salt Lake City, Utah, United States

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Salt Lake City, Utah, United States

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Sandy City, Utah, United States

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West Jordan, Utah, United States

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West Jordan, Utah, United States

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Norfolk, Virginia, United States

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Marshfield, Wisconsin, United States

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Garran, Australian Capital Territory, Australia

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Westmead, New South Wales, Australia

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South Brisbane, Queensland, Australia

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Hobart, Tasmania, Australia

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Carlton, Victoria, Australia

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Ghent, , Belgium

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Wilrijk, , Belgium

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Edmonton, Alberta, Canada

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Surrey, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Ottawa, Ontario, Canada

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Beauport, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Aarhus N, , Denmark

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Tallinn, , Estonia

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Tartu, , Estonia

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Château-Renault, , France

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Derval, , France

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Évreux, , France

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Haute-Goulaine, , France

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La Chapelle-sur-Erdre, , France

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Le Temple-de-Bretagne, , France

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Luynes, , France

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Nantes, , France

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Nantes, , France

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Nort-sur-Erdre, , France

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Paris, , France

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Pont-de-l'Arche, , France

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Saint-Aubin-des-Châteaux, , France

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Saint-Avertin, , France

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Saint-Sébastien-sur-Loire, , France

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Tours, , France

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Athens, , Greece

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Athens, , Greece

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Komotini, , Greece

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Thessaloniki, , Greece

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Bordány, , Hungary

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Budapest, , Hungary

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Győr, , Hungary

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Hódmezővásárhely, , Hungary

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Szeged, , Hungary

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Szeged, , Hungary

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Zsombó, , Hungary

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Garðabaer, , Iceland

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Kopavogur, , Iceland

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Reykjavik, , Iceland

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Kaunas, , Lithuania

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Panevezys, , Lithuania

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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Vilnius, , Lithuania

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Rotterdam, , Netherlands

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Christchurch, , New Zealand

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Bergen, , Norway

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Oslo, , Norway

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Bucharest, , Romania

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Bucharest, , Romania

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Bucharest, , Romania

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Blanes, , Spain

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Castellon, , Spain

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Madrid, , Spain

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Montgat/Barcelona, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Gothenburg, , Sweden

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Karlskrona, , Sweden

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Linköping, , Sweden

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Malmo, , Sweden

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Örebro, , Sweden

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Umeå, , Sweden

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Southampton, Hampshire, United Kingdom

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Blackpool, Lancashire, United Kingdom

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Blackpool, Lancashire, United Kingdom

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Blackpool, Lancashire, United Kingdom

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Bolton, Lancashire, United Kingdom

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Coventry, Warwickshire, United Kingdom

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Coventry, Warwickshire, United Kingdom

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Coventry, West Midlands, United Kingdom

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Bradford, , United Kingdom

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Doncaster, , United Kingdom

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Leeds, , United Kingdom

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London, , United Kingdom

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Sheffield, , United Kingdom

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Countries

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United States Australia Belgium Canada Denmark Estonia France Greece Hungary Iceland Lithuania Netherlands New Zealand Norway Romania Spain Sweden United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 23313657 (View on PubMed)

HSV-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.

Reference Type BACKGROUND
PMID: 23850416 (View on PubMed)

Verstraeten 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.

Reference Type BACKGROUND
PMID: 18845199 (View on PubMed)

Study Documents

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Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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208141/040

Identifier Type: -

Identifier Source: org_study_id

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