Phase 3
N=3,074
A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)
Cervical Cancers · Vulvar Cancer · Vaginal Cancer · Genital Lesions · PAP Test Abnormalities
Bottom Line
View on ClinicalTrials.gov: NCT00943722 ↗Enrolled (actual)
3,074
Serious AEs
0.7%
Results posted
Jan 2015
Primary outcome: Primary: Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1]) — 1715.4; 900.8; 1295.1; 706.6 milli Merck Units/mL — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- V503 (Biological)
- Age
- Pediatric, Adult · 9+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Base Study: Geometric Mean Titers (GMTs) for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1]) |
1715.4; 900.8; 1295.1; 706.6; 6979.8; 3522.6 | < 0.001 sig |
| PRIMARY Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Males [Lot 1] and 16- to 26-Year-Old Females [Lot 1]) |
2084.7; 900.8; 1487.1; 706.6; 8628.9; 3522.6 | < 0.001 sig |
| PRIMARY Base Study: GMTs for Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) |
1715.4; 1763.3; 1659.9; 1295.1; 1311.7; 1232.0 | — |
| PRIMARY Base Study: Percentage of Participants With Injection Site Adverse Experiences (AEs) |
81.9; 72.8; 85.4 | — |
| PRIMARY Base Study: Percentage of Participants With Systemic AEs |
45.0; 41.8; 57.1 | — |
| PRIMARY Base Study: Percentage of Participants With Body Temperature ≥100.0°F (≥37.8ºC) |
8.4; 10.0; 8.4 | — |
| PRIMARY Extension Study: GMTs For Each of the HPV Types Contained in the Vaccine |
122.3; 129.5; 80.2; 91.0; 403.0; 414.3 | — |
| PRIMARY Extension Study: Percentage of Participants Who Are Seropositive to Each of the HPV Types Contained in the Vaccine |
82.7; 84.1; 85.2; 87.0; 97.3; 98.3 | — |
| SECONDARY Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (9- to 15-Year-Old Females [Lot 1] and 16- to 26-Year-Old Females [Lot 1]) |
99.8; 99.7; 100; 100; 100; 100 | < 0.001 sig |
| SECONDARY Base Study: 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]) |
99.8; 99.7; 100.0; 100.0; 100.0; 100.0 | < 0.001 sig |
| SECONDARY Base Study: Percentage of Participants Who Seroconvert to Each of the HPV Types Contained in the Vaccine (Lot Consistency Study) |
99.8; 99.8; 99.3; 100.0; 100.0; 99.6 | — |
| SECONDARY Extension Study: Combined Incidence of HPV 6/11/16/18/31/33/45/52/58-Related Persistent Infection in Females |
52.4 | — |
| SECONDARY Extension Study: Combined Incidence of HPV 6/11/16/18/31/33/45/52/58-Related Persistent Infection in Males |
54.6 | — |
| SECONDARY Extension Study: Combined Incidence of Cervical Intraepithelial Neoplasia, Vulvar Intraepithelial Neoplasia, Vaginal Intraepithelial Neoplasia, Genital Warts, and Cervical/Vulvar/Vaginal Cancers Related to HPV 6/11/16/18/31/33/45/52/58 in Females |
2.2 | — |
| SECONDARY Extension Study: Combined Incidence of Penile Intraepithelial Neoplasia, Penile/Perineal/Perianal Cancers and Genital Warts Related to HPV 6/11/16/18/31/33/45/52/58 in Males |
0.0 | — |
| SECONDARY Extension Study: Percentage of Participants With Vaccine-Related or Procedure-Related Serious Adverse Events |
0.0; 0.0 | — |
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.
Eligibility 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
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
Data sourced from ClinicalTrials.gov (NCT00943722). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.