None listed
Conditions
Interventions
PSV vaccine Type of group
Patients will receive quadrivalent PSV L1 vaccine (types 6, 11,16,18) against HPV.
Group name:placebo Type of group
Patients will receive the placebo of the quadrivalent PSV L1 vaccine (types 6, 11,16,18) against HPV.
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: a. Healthy women from 16 to 23 years old with intact uteri. b. Not having clinical evidence of severe purulent cervicitis. c. They must agree to abstain from douching or vaginal cleansing or to use any medication or vaginal preparation for 48 hours before any visit that includes the pelvic exam. d. They should not be pregnant now and. Women who have had from 0 to 4 sexual partners
Exclusion criteria
Exclusion criteria: a. People who are enrolled in several studies at the same time about agents in research or studies involving the collection of cervical specimens. b. Women who have previously been vaccinated with HPV vaccines. c. Women who have received inactivated virus vaccines within 14 days before enrollment in the study or live virus vaccines within 21 days before enrollment. d. Women with any abnormal Pap test result showing a squamous intraepithelial lesion (IEL), CEASI, CEA, or a biopsy showing cervical intraepithelial neoplasia (CIN). e. Women with a history of allergic reaction (e.g. edema of the mouth or throat, difficulty breathing, hypotension or shock) that required medical intervention.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:CPR Measure:Show that a 3-dose regimen of quadrivalent PSV L1 vaccine against HPV is generally well tolerated. Timepoints:month 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Percentages of colposcopic biopsy and final excisional cervical procedures Measure:Calculate the impact of the administration of the quadrivalent PSV L1 vaccine against HPV Timepoints:month 7 | — |
Countries
Peru
Outcome results
None listed