Overview

This trial is active, not recruiting.

Conditions cervical cancers, vulvar cancer, vaginal cancer, genital lesions, pap test abnormalities, hpv infections
Treatment v503
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date August 2009
End date April 2011
Trial size 3074 participants
Trial identifier NCT00943722, 2009_611, V503-002

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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.
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 manufacturing Lots 1, 2, or 3.
(Experimental)
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.
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 manufacturing Lots 1, 2, or 3.
(Experimental)
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.
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 manufacturing Lots 1, 2, or 3.
(Experimental)
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.
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 manufacturing Lots 1, 2, or 3.
(Experimental)
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.
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 manufacturing Lots 1, 2, or 3.

Primary Outcomes

Measure
Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])
time frame: 4 weeks post-vaccination 3 (Month 7)
GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])
time frame: 4 weeks post-vaccination 3 (Month 7)
GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
time frame: 4 weeks post-vaccination 3 (Month 7)
Percentage of Participants With Injection Site Adverse Experiences (AEs)
time frame: up to 5 days after any vaccination
Percentage of Participants With Systemic AEs
time frame: up to 15 days after any vaccination
Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC)
time frame: up to 5 days after any vaccination

Secondary Outcomes

Measure
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])
time frame: 4 weeks post-vaccination 3 (Month 7)
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] Versus 16- to 26-Year-Old Females [Lot 1])
time frame: 4 weeks post-vaccination 3 (Month 7)
Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study)
time frame: 4 weeks post-vaccination 3 (Month 7)

Eligibility Criteria

Male or female participants from 9 years up to 26 years old.

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

Additional Information

Official title A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, and Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)
Description The base study V503-002 was a 12-month study that is collecting safety and immunogenicity information for six months following the subjects' third dose of study vaccine. An optional extension study (V503-002 EXT1) will collect safety and immunogenicity information through Month 36. Participants enrolled in the 16- to 26-year-old cohort in the base study will not be included in EXT1. An optional second extension study (V503-002 EXT2) will collect long-term safety and immunogenicity information through approximately 10 years. No study vaccine will be administered in the extension studies. Participants enrolled in the 16- to 26-year-old cohort in the base study will not be included in EXT2.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..