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Home > Protocol Summaries: Compounds > Herpes Simplex Vaccine > Protocol Summary for HSV Meta analyses

Protocol Summary for HSV Meta analyses

Protocol Summary
Protocol Id: HSV Meta analyses
Secondary Ids:
Title: Meta analyses on pregnancy outcomes with respect to the effect of Herpes Simplex Virus (HSV) antigen and of the adjuvant (AS04)
Phase: n\a
Acronym:
FDA Regulated Intervention?: No
Section 801 Clinical Trial?:
Delayed Posting:
IND/IDE Protocol?: no
Study Type: Observational
Oversight Authority:
  • France: Ministry of Health
  • Austria: Ethikkommission
  • Switzerland: Ethikkommission
  • South Africa: Department of Health
  • Germany: Ministry of Health
  • US: Food and Drug Administration
  • Australia: Human Research Ethics Committee
  • Italy: Ministry of Health
  • Spain: Ministry of Health
  • United States: Institutional Review Board
  • Denmark: National Board of Health
  • Canada: Health Canada
  • Belgium: Institutional Review Board
Collaborators:
Brief Summary: The aim of this meta analyses on pregnancy outcomes was to assess the effect of HSV antigen and of the adjuvant AS04 on spontaneous abortion, as requested by GSK Vaccine Safety Monitoring Board (VSMB).
Detailed Description: In this meta-analysis, two investigations were considered: • The effect of HSV antigen : - Control= Hepatitis A Vaccine (HAV) or placebo regardless of AS04 content - Investigational product=HSV • The effect of HSV antigen & AS04 adjuvant: - Control= group without AS04 ie HAV or placebo without AS04 - Investigational= HSV
Record Verification Date:
Status: Completed
Why Study Stopped:
Study Start Date: September 2010
Study Completion Date: September 2010
Study Completion Date Type: Actual
Primary Completion Date: September 2010
Primary Completion Date Type: Actual
Study Design: Cohort
Time Perspective: Retrospective
Biospecimen Retention: None retained
Biospecimen Description:
Primary Outcomes:
  • Relative risk assessment for the percentage of subjects with first pregnancy in the vaccination exposure window leading to spontaneous abortion Not Applicable
Secondary Outcomes:
  • Relative risk assessment for the percentage of subjects with first pregnancy leading to spontaneous abortion Not Applicable
  • Relative risk assessment for the percentage of subjects with first pregnancy leading to elective termination Not Applicable
  • Relative risk assessment for the percentage of subjects with first pregnancy the vaccination exposure window leading to elective termination Not Applicable
  • Relative risk assessment for the percentage of subjects with pregnancy Not Applicable
Conditions:
  • abortion
  • Abortion occurred after HSV vaccination
Keywords:
  • Pregnancy
  • Adjuvant
  • Herpes Simplex Virus (HSV)
  • Abortion
  • Spontaneous
  • Integrated Summary Output (ISO)
Study Population: Subjects with or without pregnancy and with first pregnancy in the vaccination exposure window leading to elective termination or spontaneous abortion.
Sampling Method: Non probability
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Female
Minimum Age: 13 Year
Maximum Age: 45 Year
Enrollment: 20985
Enrollment Type: Actual
Healthy Volunteers?: yes
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: No locations currently recruiting for this study.