A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)

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Brief Title

A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)

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)

Brief 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.
    

Detailed 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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

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])

Secondary Outcome

 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])

Condition

Cervical Cancers

Intervention

V503

Study Arms / Comparison Groups

 9- to 15-Year-Old Females (Lot 1)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

3074

Start Date

August 27, 2009

Completion Date

April 22, 2021

Primary Completion Date

April 30, 2011

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
      

Gender

All

Ages

9 Years - 26 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Director, , 



Administrative Informations


NCT ID

NCT00943722

Organization ID

V503-002

Secondary IDs

2009_611

Responsible Party

Sponsor

Study Sponsor

Merck Sharp & Dohme Corp.


Study Sponsor

Medical Director, Study Director, Merck Sharp & Dohme Corp.


Verification Date

May 2021