HerpeVac Trial for Young Women

This study has been completed.

Study NCT00057330 Information provided by GlaxoSmithKline

First Received on March 31, 2003. Last Updated on January 31, 2012 History of Changes

Results First Received: September 29, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Herpes Simplex Infection
Interventions:	Biological: HSV Vaccine Biological: Hepatitis A Vaccine

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Herpes Simplex Virus Group	Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Havrix Group	Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.

Participant Flow: Overall Study

	Herpes Simplex Virus Group	Havrix Group
STARTED	4577	3746
COMPLETED	3445	2826
NOT COMPLETED	1132	920
Adverse Event	10	12
Unspecified	1122	908

Baseline Characteristics

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Reporting Groups

	Description
Herpes Simplex Virus Group	Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
Havrix Group	Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.

Baseline Measures

	Herpes Simplex Virus Group	Havrix Group	Total
Number of Participants [units: participants]	4577	3746	8323
Age [units: Years] Mean ± Standard Deviation	22.3 ± 3.30	22.3 ± 3.23	22.3 ± 3.27
Gender [units: Subjects]
Female	4577	3746	8323
Male	0	0	0

Outcome Measures

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1. Primary:

Number of Subjects Reporting Genital Herpes Disease [ Time Frame: Between Months 2 and 20 ]

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2. Secondary:

Number of Subjects Reporting Genital Herpes Disease [ Time Frame: Between Months 7 and 20 ]

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3. Secondary:

Number of Subjects Reporting Herpes Simplex Virus (HSV)-2 Infection [ Time Frame: Between Months 2 and 20 ]

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4. Secondary:

Number of Subjects Reporting Herpes Simplex Virus (HSV)-2 Infection [ Time Frame: Between Months 7 and 20 ]

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5. Secondary:

Number of Subjects Reporting Solicited Local and General Symptoms [ Time Frame: Within 7 days (Days 0-6) after vaccination ]

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6. Secondary:

Number of Subjects Reporting Grade 3 Solicited Local Symptoms [ Time Frame: Within 7 days (Days 0-6) after vaccination ]

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7. Secondary:

Number of Subjects Reporting Grade 3 and Related Solicited General Symptoms [ Time Frame: Within 7 days (Days 0-6) after vaccination ]

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8. Secondary:

Number of Subjects Reporting Unsolicited Adverse Events (AEs) [ Time Frame: Within 31 days after vaccination ]

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9. Secondary:

Number of Subjects Reporting New Onset Chronic Disease (NOCDs), Serious Unsolicited Symptoms and Medically Significant Conditions (MSCs) [ Time Frame: Throughout the study (From Month 0 up to Month 20) ]

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10. Secondary:

Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: Throughout the study (From Month 0 up to Month 20) ]

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11. Secondary:

Anti-glycoprotein D (Anti-gD) Antibodies (By ELISA) [ Time Frame: At Months 0, 2, 6, 7, 12, 16 and 20 ]

Results not yet posted. Anticipated Posting Date: 08/2012 Safety Issue: No

12. Secondary:

HSV Neutralizing Antibodies [ Time Frame: At Months 0, 2, 6, 7, 12, 16 and 20 ]

Results not yet posted. Anticipated Posting Date: 08/2012 Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Belshe RB, Leone PA, Bernstein DI, Wald A, Levin MJ, Stapleton JT, Gorfinkel I, Morrow RL, Ewell MG, Stokes-Riner A, Dubin G, Heineman TC, Schulte JM, Deal CD; Herpevac Trial for Women. Efficacy results of a trial of a herpes simplex vaccine. N Engl J Med. 2012 Jan 5;366(1):34-43.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00057330 History of Changes
Other Study ID Numbers:	01-643, 208141/039
Study First Received:	March 31, 2003
Results First Received:	September 29, 2011
Last Updated:	January 31, 2012
Health Authority:	United States: Food and Drug Administration