Phase 3
Completed N=1,518
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)
Source: ClinicalTrials.gov NCT01984697 ↗Enrolled (actual)
1,518
Serious AEs
2.5%
Results posted
Apr 2016
Primary outcomePrimary: Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen — 1657.9; 1557.4; 2678.8; 1496.1 mMU/mL — p=<0.001
◆ Published Evidence
Highly cited
210citations · ~21 / year
Immunogenicity of the 9-Valent HPV Vaccine Using 2-Dose Regimens in Girls and Boys vs a 3-Dose Regimen in Women.
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).
Linked Publications (3)
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Immunogenicity of the 9-Valent HPV Vaccine Using 2-Dose Regimens in Girls and Boys vs a 3-Dose Regimen in Women.
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Three-Year Follow-up of 2-Dose Versus 3-Dose HPV Vaccine.
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Term immune memory responses to human papillomavirus (HPV) vaccination following 2 versus 3 doses of HPV vaccine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titers to Human Papillomavirus (HPV) Type 6 After the Last Dose of V503 in the Planned Regimen |
1657.9; 1557.4; 2678.8; 1496.1; 770.9 | <0.001 sig |
| PRIMARY Geometric Mean Titers to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen |
1388.9; 1423.9; 2941.8; 1306.3; 580.5 | <0.001 sig |
| PRIMARY Geometric Mean Titers to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen |
8004.9; 8474.8; 14329.3; 6996.0; 3154.0 | <0.001 sig |
| PRIMARY Geometric Mean Titers to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen |
1872.8; 1860.9; 2810.4; 2049.3; 761.5 | <0.001 sig |
| PRIMARY Geometric Mean Titers to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen |
1436.3; 1498.2; 2117.5; 1748.3; 572.1 | <0.001 sig |
| PRIMARY Geometric Mean Titers to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen |
1030.0; 1040.0; 2197.5; 796.4; 348.1 | <0.001 sig |
| PRIMARY Geometric Mean Titers to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen |
357.6; 352.3; 417.7; 661.7; 213.6 | <0.001 sig |
| PRIMARY Geometric Mean Titers to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen |
581.1; 640.4; 1123.4; 909.9; 364.2 | <0.001 sig |
| PRIMARY Geometric Mean Titers to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen |
1251.2; 1325.7; 2444.6; 1229.3; 491.1 | <0.001 sig |
| SECONDARY Percentage of Participants With Seroconversion to HPV Type 6 at Four Weeks After the Last Dose of V503 in the Planned Regimen |
99.6; 100; 100; 99.2; 99.6 | <0.001 sig |
| SECONDARY Percentage of Participants With Seroconversion to HPV Type 11 at Four Weeks After the Last Dose of V503 in the Planned Regimen |
100; 100; 100; 99.6; 99.6 | <0.001 sig |
| SECONDARY Percentage of Participants With Seroconversion to HPV Type 16 at Four Weeks After the Last Dose of V503 in the Planned Regimen |
100; 100; 100; 100; 99.6 | <0.001 sig |
| SECONDARY Percentage of Participants With Seroconversion to HPV Type 18 at Four Weeks After the Last Dose of V503 in the Planned Regimen |
100; 100; 100; 99.6; 98.5 | <0.001 sig |
| SECONDARY Percentage of Participants With Seroconversion to HPV Type 31 at Four Weeks After the Last Dose of V503 in the Planned Regimen |
99.6; 100; 100; 100; 99.6 | <0.001 sig |
| SECONDARY Percentage of Participants With Seroconversion to HPV Type 33 at Four Weeks After the Last Dose of V503 in the Planned Regimen |
99.6; 100; 100; 100; 99.6 | <0.001 sig |
| SECONDARY Percentage of Participants With Seroconversion to HPV Type 45 at Four Weeks After the Last Dose of V503 in the Planned Regimen |
99.3; 99.3; 100; 99.3; 97.9 | <0.001 sig |
| SECONDARY Percentage of Participants With Seroconversion to HPV Type 52 at Four Weeks After the Last Dose of V503 in the Planned Regimen |
99.6; 100; 100; 99.6; 99.6 | <0.001 sig |
| SECONDARY Percentage of Participants With Seroconversion to HPV Type 58 at Four Weeks After the Last Dose of V503 in the Planned Regimen |
100; 100; 100; 99.6; 99.6 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
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
Exclusion Criteria
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
Data sourced from ClinicalTrials.gov (NCT01984697) and the linked publication. 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. Informational only — not medical advice.