This study will evaluate the immunogenicity and tolerability of V503 i preadolescent and adolescent subjects between 9 and 15 years old an demonstrate the consistency of the manufactured vaccine through assessment of 3 different final manufacturing process lots of V503.

A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, an Manufacturing Consistency of V503 (A Multivalent Human Papillomav [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 Year Olds) With a Comparison to Young Women to 26 Year Olds)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/09/004012

Enrollment

2800

Registered

2013-09-23

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Boys 9 to 15 years old: Lot 1: Biological: V503 Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Number of subjects with injection site adverse experiences Number of subjects with elevated temperature Number of subjects with systemic adverse experiences Geometric mean titers (GMTs) to each of the HPV types contained in the vaccineTimepoint: 4 weeks after last dose of vaccination	—

Secondary

Measure	Time frame
Geometric mean titers (GMTs) to each of the HPV types contained in the vaccine at 6, 18, and 30 months post dose 3Timepoint: Geometric mean titers (GMTs) to each of the HPV types contained in the vaccine at 6, 18, and 30 months post dose 3 [ Time Frame: Up to 30 months post dose 3 ] [ Designated as safety issue: No ];Number of participants with vaccine-related serious adverse events (SAEs) or death [ Time Frame: Up to 30 months post dose 3 ] [ Designated as safety issue: Yes ]Timepoint: Number of participants with vaccine-related serious adverse events (SAEs) or death [ Time Frame: Up to 30 months post dose 3 ] [ Designated as safety issue: Yes ];Seroconversion percentages to each of the HPV types contained in the vaccineTimepoint: Seroconversion percentages to each of the HPV types contained in the vaccine [ Time Frame: 4 weeks post dose 3 ] [ Designated as safety issue: No ];Seroconversion percentages to each of the HPV types contained in the vaccine at 6, 18, and 30 months post dose 3Timepoint: Seroconversion percentages to each of the HPV types contained in the vaccine at 6, 18, and 30 months post dose 3 [ Time Frame: Up to 30 months post dose 3 ] [ Designated as safety issue: No ]	—

Measure

Time frame

Geometric mean titers (GMTs) to each of the HPV types contained in the vaccine at 6, 18, and 30 months post dose 3Timepoint: Geometric mean titers (GMTs) to each of the HPV types contained in the vaccine at 6, 18, and 30 months post dose 3 [ Time Frame: Up to 30 months post dose 3 ] [ Designated as safety issue: No ];Number of participants with vaccine-related serious adverse events (SAEs) or death [ Time Frame: Up to 30 months post dose 3 ] [ Designated as safety issue: Yes ]Timepoint: Number of participants with vaccine-related serious adverse events (SAEs) or death [ Time Frame: Up to 30 months post dose 3 ] [ Designated as safety issue: Yes ];Seroconversion percentages to each of the HPV types contained in the vaccineTimepoint: Seroconversion percentages to each of the HPV types contained in the vaccine [ Time Frame: 4 weeks post dose 3 ] [ Designated as safety issue: No ];Seroconversion percentages to each of the HPV types contained in the vaccine at 6, 18, and 30 months post dose 3Timepoint: Seroconversion percentages to each of the HPV types contained in the vaccine at 6, 18, and 30 months post dose 3 [ Time Frame: Up to 30 months post dose 3 ] [ Designated as safety issue: No ]

—

Countries

Austria, Belgium, Brazil, Chile, Colombia, Costa Rica, Croatia, Democratic People's Republic of Korea, Denmark, Finland, France, Hong Kong, India, Lithuania, Netherlands, Norway, Peru, Poland, Russian Federation, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom

Contacts

Public ContactDr Monisha Sharma

MSD Pharmaceuticals Pvt Ltd

monisha_sharma@merck.com91-124-4647300

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026