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A PHASE III CLINICAL TRIAL TO STUDY THE IMMUNOGENICITY, TOLERABILITY, AND MANUFACTURING CONSISTENCY OF V503 (A MULTIVALENT HUMAN PAPILLOMAVIRUS [HPV] L1 VIRUS-LIKE PRTICLE [VLP] VACCINE) IN PREADOLESCENTS AND ADOLESCENTS (9 TO 15 YEAR OLDS) WITH A COMPARISON TO YOUNG WOMEN (16 TO 26 YEAR OLDS)

A PHASE III CLINICAL TRIAL TO STUDY THE IMMUNOGENICITY, TOLERABILITY, AND MANUFACTURING CONSISTENCY OF V503 (A MULTIVALENT HUMAN PAPILLOMAVIRUS [HPV] L1 VIRUS-LIKE PRTICLE [VLP] VACCINE) IN PREADOLESCENTS AND ADOLESCENTS (9 TO 15 YEAR OLDS) WITH A COMPARISON TO YOUNG WOMEN (16 TO 26 YEAR OLDS)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-120-12
Enrollment
160
Registered
2013-04-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

UNDER THE BASE STUDY (PROTOCOL V503-002), SUBJECTS WERE ADMINISTERED A 3-DOSE REGIMEN OF 9-VALENT HPV L1 VLP VACCINE AND ASSESSED FOR IMMUNOGENICITY (AT DAY 1 AND MONTH 7) AND SAFETY (DAY 1 THROUGH MO

Sponsors

MERCK SHARP & DOHME PERU S.R.L.,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
9 Years to 26 Years

Inclusion criteria

Inclusion criteria: . SUBJECTS WHO ARE ENROLLED IN PROTOCOL 002 BETWEEN 9 AND 15 YEARS OF AGE AND RECEIVED 3 DOSES OF 9-VALENT HPV L1 VLP VACCINE.

Exclusion criteria

Exclusion criteria: . SUBJECTS WHO ARE CONCURRENTLY ENROLLED IN CLINICAL STUDIES THAT WOULD INVOLVE OR INTERFERE WITH THE COLLECTION OF GENITAL SPECIMENS.

Countries

Peru

Contacts

Public ContactNelva Garcia

MERCK SHARP & DOHME PERU S.R.L

nelva.garcia.coral@merck.com4115187

Outcome results

None listed

Source: REPEC (via WHO ICTRP)