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HerpeVac Trial for Young Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00057330
First received: March 31, 2003
Last updated: May 9, 2013
Last verified: March 2013
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 or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccine
Biological: Havrix™, GlaxoSmithKline (GSK) Biologicals' licensed 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
8323 subjects were enrolled and vaccinated (4577 in the Herpes Simplex Virus Group and 3746 in the Havrix Group). Out of these, 7850 subjects were followed throughout the entire study, e. a. for safety and adverse event assessment (4488 in the Herpes Simplex Virus Group and 3662 in the Havrix Group).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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                 9                 12  
Death                 1                 0  
Protocol Violation                 1                 1  
Withdrawal by Subject                 115                 84  
Lost to Follow-up                 745                 617  
Physician Decision                 1                 0  
Unspecified                 260                 206  



  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.
Total Total of all reporting groups

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 With Newly Acquired Genital Herpes Disease, Caused by Either Herpes Simplex Virus (HSV)-1 or HSV-2   [ Time Frame: Between Months 2 and 20 ]
  Show Outcome Measure 1

2.  Secondary:   Number of Subjects With Newly Acquired Genital Herpes Disease, Caused by Either Herpes Simplex Virus (HSV)-1 or HSV-2   [ Time Frame: Between Months 7 and 20 ]
  Show Outcome Measure 2

3.  Secondary:   Number of Subjects With Newly Acquired Herpes Simplex Virus (HSV)-2 Infection Confirmed by Either Virus Culture or HSV-2 Seroconversion.   [ Time Frame: Between Months 2 and 20 ]
  Show Outcome Measure 3

4.  Secondary:   Number of Subjects With Newly Acquired Herpes Simplex Virus (HSV)-2 Infection Confirmed by Either Virus Culture or HSV-2 Seroconversion   [ Time Frame: Between Months 7 and 20 ]
  Show Outcome Measure 4

5.  Secondary:   Concentrations for Anti-glycoprotein D (Anti-gD) Antibodies.   [ Time Frame: At Months 0, 2, 6, 7, 12, 16 and 20 ]
  Show Outcome Measure 5

6.  Secondary:   Titers for Anti-herpes Simplex Virus (Anti-HSV) Neutralizing Antibodies.   [ Time Frame: At Months 0, 2, 6, 7, 12, 16 and 20 ]
  Show Outcome Measure 6

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

8.  Secondary:   Number of Subjects Reporting Grade 3 Solicited Local Symptoms   [ Time Frame: Within 7 days (Days 0-6) after vaccination ]
  Show Outcome Measure 8

9.  Secondary:   Number of Subjects Reporting Grade 3 and Related Solicited General Symptoms   [ Time Frame: Within 7 days (Days 0-6) after vaccination ]
  Show Outcome Measure 9

10.  Secondary:   Number of Subjects Reporting Unsolicited Adverse Events (AEs)   [ Time Frame: Within 31 days after vaccination ]
  Show Outcome Measure 10

11.  Secondary:   Number of Subjects With New Onset Chronic Diseases (NOCDs), Medically Significant Conditions (MSCs) and Serious Adverse Events (SAEs)   [ Time Frame: Throughout the study (From Month 0 up to Month 20) ]
  Show Outcome Measure 11

12.  Secondary:   Number of Subjects Reporting Serious Adverse Events (SAEs)   [ Time Frame: Throughout the study (From Month 0 up to Month 20) ]
  Show Outcome Measure 12


  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:
unchecked 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.
unchecked 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.


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
Out of the 8323 subjects enrolled and vaccinated, 7850 subjects were followed throughout the study, e. a. for safety and adverse event assessment (4488 in the Herpes Simplex Virus Group and 3662 in the Havrix Group).  


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:


Responsible Party: GlaxoSmithKline
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: May 9, 2013
Health Authority: United States: Food and Drug Administration