A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Vulvar Cancer; PAP Test Abnormalities; HPV Infections; Vaginal Cancer; Cervical Cancers; Genital Lesions

Treatments: Biological: V503

Study type: Interventional

Funder types: Industry

Identifiers

NCT00943722

2009-011617-25 (EudraCT Number)

2009_611

V503-002

Details and patient eligibility

About

This study will evaluate the immunogenicity and tolerability of V503 (a multivalent human papillomavirus [HPV] L1 virus-like particle [VLP] vaccine) in preadolescent and adolescent participants 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.

The primary hypotheses are as follows:

1. The 9-valent HPV L1 VLP vaccine when administered to preadolescent and adolescent boys and girls 9 to 15 years of age and young women 16 to 26 years of age is generally well-tolerated.
2. 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and adolescent girls 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and polymerase chain reaction (PCR)-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks post-dose 3.
3. The 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and adolescent boys 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and PCR-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3.
4. Three separate final manufacturing process (FMP) lots of the 9-valent HPV L1 VLP vaccine induce similar immune responses, as measured by anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3.

Full description

The base study V503-002 was a 12-month study that collected immunogenicity data through Month 7 and safety data through Month 12.

An optional extension study (V503-002 EXT1) collected safety and immunogenicity information through Month 36. Participants enrolled in the 16- to 26-year-old cohort in the base study were not included in EXT1. Per protocol, EXT1 included immunogenicity data from a subset of 9- to 15-year-old females and safety data from all 9- to 15-year-old females regardless of lot administered.

An optional second extension study (V503-002 EXT2) collected long-term safety and immunogenicity information through approximately Month 126. No study vaccine was administered in the extension studies. Participants enrolled in the 16- to 26-year-old cohort in the base study were not included in EXT2. Per protocol, EXT2 included immunogenicity data from a subset of 9- to 15-year-old females and effectiveness and safety data from all 9- to 15-year-old females regardless of lot administered.

Enrollment: 3,074 patients

Sex: All

Ages: 9 to 26 years old

Volunteers: Accepts Healthy Volunteers

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

Women Age 16 to 26:

• Participant has never had Pap testing or has had only normal results
• Participant 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
• 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

Women Age 16 to 26:

• 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
• Participant has a history of abnormal cervical biopsy result
• Participant has a history of external genital lesions

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,074 participants in 5 patient groups

9- to 15-Year-Old Females (Lot 1)

Experimental group

Description:

9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.

Treatment:

Biological: V503

9- to 15-Year-Old Females (Lot 2)

Experimental group

Description:

9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.

Treatment:

Biological: V503

9- to 15-Year-Old Females (Lot 3)

Experimental group

Description:

9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.

Treatment:

Biological: V503

9- to 15-Year-Old Males (Lot 1)

Experimental group

Description:

9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.

Treatment:

Biological: V503

16- to 26-Year-Old Females (Lot 1)

Experimental group

Description:

9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.

Treatment:

Biological: V503