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Safety and Immunogenicity of Extended 2-dose Regimens of 9-valent Human Papillomavirus (9vHPV) Vaccine (V503-069)

ClinicalTrials.gov Identifier: NCT04708041 (view full study on clinicaltrials.gov)
Condition:  Papillomavirus Infections
Status:  Active, not recruiting


Official Title: A Phase 3 International, Multicenter, Open-label Study to Evaluate the Safety and Immunogenicity of 9vHPV Vaccine Administered as 2-dose Regimen with Extended Dosing Intervals in 9- to 14-Year Old Boys and Girls Compared with a Standard 3-dose Regimen in 16- to 26-Year Old Women

This is a 96-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 is to establish that the investigational extended 2-dose regimens (0, 12 months; 0, 24 months; 0, 36 months; and 0, 60 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 receive the standard 3-dose regimen of 9-valent human papillomavirus (9vHPV) vaccine at 0, 2, and 6 months (i.e., the population and dose regimen used to establish 9vHPV vaccine efficacy).

Study Type:
Interventional
Study Phase:
Phase 3
Estimated Enrollment:
700
Study Start Date:
March 2021
Estimated Study Completion Date:
June 2029
Estimated Primary Completion Date:
June 2029
Ages Eligible for Study:
9 years to 26 years
Genders Eligible for Study:
All
Accepts Healthy Volunteers:
Yes


CRITERIA

Inclusion Criteria:

Boys and Girls 9 to 15 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

Cohort 0 Participants:

  • Received 1 dose of 9vHPV vaccine at least 1 year prior to enrollment and did not receive a second dose of any HPV vaccine

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
  • Has received more than 1 dose of an HPV vaccine (Cohort 0)
  • Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial (Cohorts 1-5)

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