None listed
Conditions
Interventions
This group will be treated with a dose of the GARDASIL vaccine (against HPV serotypes 6, 11 and 18) on day 1, at 2 months and at 6 months after the first dose.
Group name:ARM 4 Type of group
This group will be treated with a dose of the octavalent VLP vaccine (Against HPV serotypes 6, 11, 16, 18, 31, 45, 52 and 58), dose of HPV-31: 40 mcg
of HPV-45: 40 mcg
of HPV-52: 40mcg
and of HPV-8: 40 mcg. On day 1, at 2 months and at 6 months after the first dose.
Sponsors
MERCK & CO.INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The participant is between 16 years and 0 days and 23 years and 364 days on the day of randomization. 2. The participant fully understands the study procedures, agrees to participate in the study and has given written informed consent. 3. The participant is considered to be in good physical health condition. 4. The participant has had a history of 0 to 4 sexual partners during her life. 5. The participant has refrained from using vaginal shower / wash and using medication or vaginal preparations during the 2 days prior to the Day 1 visit. 6. The participant has abstained from sexual activity for 2 days prior to the Day 1 visit. 7. From the first day of the last menstrual period of the participant until Day 1, the participant has not had sexual intercourse with males or has had sex with males and has used contraceptive methods without failures.
Exclusion criteria
Exclusion criteria: 1. The participant has a history of an abnormal Pap test or an abnormal cervical biopsy result. 2. The participant has never had a history of an abnormal Pap test. 3. The participant has a history of recent or ongoing alcohol abuse or other drug abuse. 4. The participant has a history of severe allergic reaction that requires medical intervention. 5. The participant has a known allergy to any component of the vaccine, including aluminum, yeast or BENZONASE ™. 6. The participant is currently immunocompromised or has been diagnosed with a congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune condition. 7. The participant had a splenectomy. 8. The participant is receiving or has received immunosuppressive therapies in the year prior to enrollment. 9. The participant has received any immunoglobulin product or blood product within 3 months prior to the Day 1 vaccination, or is planning to receive any such product during Day 1 through Month 7 of the study. 10. The participant has received non-replication vaccines within 14 days prior to the Day 1 vaccination or has received replication vaccines within 21 days prior to the Day 1 vaccination. 11. The participant has thrombocytopenia or other coagulatory disorder that would contraindicate intramuscular injections. 12. The participant is currently enrolled in clinical studies of research agents or studies that involve the collection of cervical samples. 13. The participant has a history of participating in a clinical trial of HPV vaccine and has received an active agent or placebo. 14. The participant has a history of any disease or condition that may confuse the results of the study or pose an additional risk to the participant. 15. The participant plans a permanent relocation of the area prior to the completion of the study or absences for an extended period of time when the study visits would need to be scheduled. 16. The participant has had fever within the 24-hour period prior to the Day 1 vaccination. 17. The participant is pregnant. 18. The participant has clinical evidence of macroscopic purulent cervicitis. 19. The participant is in menstrual period. 20. The participant has a history of or clinical evidence in the pelvic examination of Day 1 of external genital lesions related to HPV, external genital cancer, external genital lesions of unknown etiology. 21. The participant does not have an intact cervix or has more than one cervix.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation: Physical examination. Safety follow-up: Observe the participants for 30 minutes after each vaccination. The patient will document temperature 4 hours after vaccination and daily for 4 days after study vaccination, local or systemic adverse events for 15 days. Measure:Safety of the treatment. Timepoints:Clinical evaluation: Day 1, months 2, 3, 6 and 7. Evaluation of information reported by the patient: 15 to 30 days after vaccination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Luminex Competitive Immunoassay (cLIA): Levels of anti HPV antibodies in serum. Measure:Serological response to the vaccine. Timepoints:Day 1 and month 7. ; Outcome name:Multiplex PCR (based on real-time fluorescent PCR) on frozen swab samples and microtomy samples of thin sections of the cervix. Measure:191/5000 HPV detection. Timepoints:Day 1 and month 7. | — |
Countries
Colombia, Peru, United States
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed