This study will evaluate the immunogenicity and tolerability of V503 ipreadolescent and adolescent subjects between 9 and 15 years old andemonstrate the consistency of the manufactured vaccine throughassessment of 3 different final manufacturing process lots of V503.
- Conditions
- Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified
- Registration Number
- CTRI/2013/09/004012
- Lead Sponsor
- Merck Sharp and Dohme
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 2800
Inclusion Criteria:
Boys and Girls Age 9 to 15:
Participant has not had sexual intercourse prior to the study and does not plan to become sexually active during the study period Day 1 to Month 7
Please note that this is an extension study (V503-002 EXT1) which will collect safety and immunogenicity information through Month 36 for patients in the age group of 9-15 years . No study vaccine will be administered in the extension study. Subjects enrolled in the 16- to 26-year-old cohort in the base study will not be included in the EXTENSION STUDY.
Exclusion Criteria:
Boys and Girls Age 9 to 15:
History of allergic reaction that required medical intervention
Currently enrolled in any other clinical study
Participant is pregnant
Participant is immunocompromised or has taken immunosuppressants in the last year
Participant has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial
Participant has a history of positive test for HPV.
Only patients in the age group of 9-15 years of age ( Male and female ) would be included in the study. All other age groups are excluded in the extension study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of subjects with injection site adverse experiences <br/ ><br> <br/ ><br>Number of subjects with elevated temperature <br/ ><br> <br/ ><br>Number of subjects with systemic adverse experiences <br/ ><br> <br/ ><br>Geometric mean titers (GMTs) to each of the HPV types contained in the vaccineTimepoint: 4 weeks after last dose of vaccination
- Secondary Outcome Measures
Name Time Method