A Phase III Study of a 2-dose Regimen of a Multivalent Human Papillomavirus (HPV) Vaccine (V503), Administered to 9 to 14 Year-olds and Compared to Young Women, 16 to 26 Years Old (V503-010)
- Conditions
- Human Papillomavirus Infection
- Interventions
- Biological: V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)
- Registration Number
- NCT01984697
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This was a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. From this study, the goal was to establish that the investigational 2-dose regimens (0, 6 months and 0, 12 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who received the standard 3-dose regimen of V503 (i.e., the population and dose regimen used to establish V503 efficacy).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1518
All Participants:
-Judged to be in good physical health on the basis of medical history, physical examination and laboratory results
Boys and Girls 9 to 14 Years:
-Must not have had coitarche and does not plan on becoming sexually active during the vaccination period
Women 16 to 26 Years:
- Has never had a Papanicolaou (Pap) test or only had normal Pap test results
- A lifetime history of 0 to 4 male and/or female sexual partners
All Participants:
- Known allergy to any vaccine component
- History of severe allergic reaction that required medical intervention
- Thrombocytopenia or any coagulation disorder
- Females only: participant is pregnant or expecting to donate eggs during day 1 through month 7
- Currently immunocompromised, or been diagnosed with immunodeficiency
- Had a splenectomy
- Receiving or has received immunosuppressive therapies within the last year
- Received any immunoglobulin product or blood-derived product within 3 months
- Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Girls and Boys 9 to 14 Years V503 at Months 0 and 12 V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine) Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 12. An additional dose of V503 0.5 mL IM was administered at Month 36. Boys 9 to 14 Years V503 at Months 0 and 6 V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine) Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL IM injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. Young Women 16 to 26 Years V503 at Months 0, 2, and 6 V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine) Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants. Girls 9 to 14 Years V503 at Months 0 and 6 V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine) Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular (IM) injection at Months 0 and 6. An additional dose of V503 0.5 mL IM was administered at Month 36. Girls 9 to 14 Years V503 at Months 0, 2, and 6 V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine) Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL IM injection at Months 0, 2, and 6. An additional dose of V503 0.5 mL IM was administered at Month 36 for a subset of participants.
- Primary Outcome Measures
Name Time Method Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) Antibodies to HPV virus-like particles (VLP) type 6 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Antibody titers were expressed as milli Merck units/mL (mMU/mL).
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Seroconversion to HPV Type 6 at Four Weeks After the Last Dose of V503 in the Planned Regimen 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) Antibodies to HPV VLP type 6 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 6 was defined as a titer \>=30 mMU/mL.
Percentage of Participants With Seroconversion to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) Antibodies to HPV VLP type 11 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 11 was defined as a titer \>=16 mMU/mL.
Percentage of Participants With Seroconversion to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) Antibodies to HPV VLP type 16 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 16 was defined as a titer \>=20 mMU/mL.
Percentage of Participants With Seroconversion to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) Antibodies to HPV VLP type 33 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 33 was defined as a titer \>=8 mMU/mL.
Percentage of Participants With Seroconversion to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) Antibodies to HPV VLP type 45 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 45 was defined as a titer \>=8 mMU/mL.
Percentage of Participants With Seroconversion to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) Antibodies to HPV VLP type 52 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 52 was defined as a titer \>=8 mMU/mL.
Percentage of Participants With Seroconversion to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) Antibodies to HPV VLP type 18 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 18 was defined as a titer \>=24 mMU/mL.
Percentage of Participants With Seroconversion to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) Antibodies to HPV VLP type 31 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 31 was defined as a titer \>=10 mMU/mL.
Percentage of Participants With Seroconversion to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen 4 weeks after the last dose of V503 in the planned regimen (Month 7 or Month 13) Antibodies to HPV VLP type 58 were measured using a competitive Luminex immunoassay. Seroconversion to HPV type 58 was defined as a titer \>=8 mMU/mL.