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NO DISPONIBLE

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)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-069-10
Enrollment
310
Registered
2010-12-06
Start date
2010-12-18
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

Arm 1 (Experimental): 9- to 15-Year-Old Females (Lot 1) 9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administ

Sponsors

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

Eligibility

Age
9 Years to 26 Years

Inclusion criteria

Inclusion criteria: A. Inclusion Criteria Children from 9 to 15 years:  Male or female participant between the ages 9 years 0 days and 15 years and 364 days on the day of enrollment.  The participant is considered to be in good health based on HCl, physical examination and lab results.  The participant (or parent / legal guardian) fully understands study procedures; available alternative treatments, the risks involved with the study, and voluntarily agrees to participate by providing written informed consent.  The participant agrees to provide the study staff with a primary telephone number as well as an alternative telephone number for tracking purposes.  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 B. Inclusion Criteria Young women aged 16 to 26:  Participants enrolled in this group will not participate in extension V503-002-10.

Exclusion criteria

Exclusion criteria: Exclusion criteria Children and Girls aged 9 to 15:  The participant presents a known allergy to any component of the vaccine including aluminum, yeast or BENZONASE.  The participant has a history of severe allergic reaction.  The participant has thrombocytopenia or any coagulation disorder that may contraindicate MI.  The participant is currently enroll in research agent studies.  (Girls only) Participant is pregnant  The participant has donated blood within 1 week prior to the vaccination on day 1 or intends to do so during the period from day 1 to month 7 of the study.  The participant is currently immunocompromised.  The participant has undergone a splenectomy,  The participant is receiving or has received in the year prior to enrollment any immunosuppressive therapy listed  The participant has received or plans to receive any immunoglobulin or blood product products within 3 months prior to vaccination from day 1 through month 7 of the study.  Participant has received non-replicative (inactive) vaccines within 14 days prior to vaccination on day 1 or received replicative vaccines within 21 days prior to vaccination on day 1.  The participant has received a commercially available HPV vaccine.  Participant has experienced fever within 24 hours prior to vaccination on day 1.  Current history or evidence of any condition, therapy, or abnormality of the lab that could confuse the study results.  Participant cannot give consent / assent.

Contacts

Public ContactJorge Timoteo

MERCK SHARP & DOHME PERU S.R.L

jorge.timoteo@merck.com4115955

Outcome results

None listed

Source: REPEC (via WHO ICTRP)