Evaluation of Safety, Tolerability and Immunogenicity of Quadrivalent HPV Vaccine in Healthy Females 9 to 15 Years of Age in India
9 Years
15 Years
Female
Papillomavirus Infections
Trial Information
Evaluation of Safety, Tolerability and Immunogenicity of Quadrivalent HPV Vaccine in Healthy Females 9 to 15 Years of Age in India
Inclusion Criteria:
- Healthy Females Age 9 To 15 Years
- Females Not Sexually Active And Not Plan On Becoming Sexually Active During The Study
- No Fevers 24 Hours Prior To The First Injection
Exclusion Criteria:
- Subject Had Received A Prior Vaccination With A HPV Vaccine
- Subject Has Allergies To Vaccine Component Including Aluminum And Yeast
- Subject Has (Human Immunodeficiency Virus) HIV Infection
- Subject Is Immunocompromised
- Subject Received Or Plans To Receive Blood-Derived Product Within 6 Months Prior To
The First Injection
- Subject Received Or Plans To Receive Immune Globulin Preparation Within 6 Months To
The First Injection
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Percentage of Subjects Who Serologically Convert to Each of Human Papilloma Virus (HPV) 6, 11, 16, 18 at Week 4 Postdose 3 (Month 7)
Outcome Description:
Month 7 HPV cLIA seroconversion rates among subjects who received Quadrivalent Human Papilloma Virus (HPV) (Types 6, 11, 16, 18) L 1 VLP vaccine (per‐protocol immunogenicity population ).
Outcome Time Frame:
7 months
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
India: Ministry of Health
Study ID:
2006_038
NCT ID:
NCT00380367
Start Date:
May 2007
Completion Date:
February 2008
Related Keywords:
- Papillomavirus Infections
- Papillomavirus Infections
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