A Study of V503 (Multivalent HPV Vaccine) in Preadolescents and Adolescents. This study will evaluate the immunogenicity and tolerability of V503 in preadolescent and adolescent subjects between 9 and 15 years old and demonstrate the consistency of the manufactured vaccine through assessment of 3 different final manufacturing process lots of V503.

Phase 3

Completed

• Conditions: Health Condition 1: C539- Malignant neoplasm of cervix uteri, unspecified

• Registration Number: CTRI/2009/091/000767
• Lead Sponsor: Merck Sharp and Dohme

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 2800

Inclusion Criteria

Boys and Girls Age 9 to 15:
?Subject is not sexually active
Women Age 16 to 26:
?Subject has never had Pap testing or has had only normal results
?Subject has had 0 to 4 sexual partners at the time of enrollment

Exclusion Criteria

Boys and Girls Age 9 to 15:
?History of allergic reaction that required medical intervention
?Currently enrolled in any other clinical study
?Subject is pregnant
?Subject is immunocompromised or has taken immunosuppressants in the last year
?Subject has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial
?Subject has a history of positive test for HPV
Women Age 16 to 26:
?History of allergic reaction that required medical intervention
?Currently enrolled in any other clinical study
?Subject is pregnant
?Subject is immunocompromised or has taken immunosuppressants in the last year
?Subject has received a marketed HPV vaccine or participated in an HPV vaccine clinical trial
?Subject has a history of positive test for HPV
?Subject has a history of abnormal cervical biopsy result
?Subject has a history of external genital lesions

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Geometric mean titers (GMTs) to each of the HPV types contained in the vaccineTimepoint: Time Frame: 4 weeks post dose 3;Number of subjects with elevated temperatureTimepoint: Time Frame: Day 1 to 5 post-vaccination;Number of subjects with injection site adverse experiencesTimepoint: Time Frame: Day 1 to 5 post-vaccination;Number of subjects with systemic adverse experiencesTimepoint: Time Frame: Day 1 to 5 post-vaccination

Secondary Outcome Measures

Name	Time	Method
Seroconversion percentages to each of the HPV types contained in the vaccineTimepoint: Time Frame: 4 weeks post dose 3 ]