We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

HerpeVac Trial for Young Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00057330
First Posted: April 1, 2003
Last Update Posted: September 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: September 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, 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
  Hide Participant Flow

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 
Other                260                206 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.
Total Total of all reporting groups

Baseline Measures
   Herpes Simplex Virus Group   Havrix Group   Total 
Overall Participants Analyzed 
[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
  Show All Outcome Measures

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 ]

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 ]

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 ]

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 ]

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

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

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

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

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

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

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) ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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).


  More Information
  Hide More Information

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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00057330     History of Changes
Other Study ID Numbers: 208141/039
01-643 ( Other Identifier: GSK )
First Submitted: March 31, 2003
First Posted: April 1, 2003
Results First Submitted: September 29, 2011
Results First Posted: November 3, 2011
Last Update Posted: September 30, 2016