O DISPONIBLE

Not Applicable

• Registration Number: PER-069-10
• Lead Sponsor: MERCK SHARP & DOHME PERU S.R.L.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-06
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 156

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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified