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STUDY MOTHER V-501 PROTOCOL 013: A STUDY TO EVALUATE THE EFFECTIVENESS OF THE VACCINE VIRUS-LIKE PARTICULATE (PSV) VERSUS VIRUS (TYPES 6,11,16 AND 18) TO REDUCE THE INCIDENCE OF NIC AND NIVA IN RELATION TO PVH 6 / 11-, 16 AND 18, AS WELL AS EXTERNAL GENITAL WATERS AND NIV IN RELATION TO 16 AND 18 IN WOMEN FROM 16 TO 23 YEARS- FUTURE STUDY (FEMALES UNITED TO UNILATERALLY REDUCE ENDO / ECTOCERVICAL DISEASES, IN ENGLISH). SUB-STUDY V-501 PROTOCOL 011: IMMUNOGENICITY AND SECURITY OF THE VACCINE QUADRIVALENT IN PARTICLES SIMILAR TO VIRUS (PSV) L1 VS. HPV (TYPES 6, 11, 16, 18) IN WOMEN FROM 16 TO 23 YEARS OF AGE, ADMINISTERED INDEPENDENTLY OR CONCOMITATELY WITH VACCINE AGAINST HEPATITIS B (RECOMBINANT)

STUDY MOTHER V-501 PROTOCOL 013: A STUDY TO EVALUATE THE EFFECTIVENESS OF THE VACCINE VIRUS-LIKE PARTICULATE (PSV) VERSUS VIRUS (TYPES 6,11,16 AND 18) TO REDUCE THE INCIDENCE OF NIC AND NIVA IN RELATION TO PVH 6 / 11-, 16 AND 18, AS WELL AS EXTERNAL GENITAL WATERS AND NIV IN RELATION TO 16 AND 18 IN WOMEN FROM 16 TO 23 YEARS- FUTURE STUDY (FEMALES UNITED TO UNILATERALLY REDUCE ENDO / ECTOCERVICAL DISEASES, IN ENGLISH). SUB-STUDY V-501 PROTOCOL 011: IMMUNOGENICITY AND SECURITY OF THE VACCINE QUADRIVALENT IN PARTICLES SIMILAR TO VIRUS (PSV) L1 VS. HPV (TYPES 6, 11, 16, 18) IN WOMEN FROM 16 TO 23 YEARS OF AGE, ADMINISTERED INDEPENDENTLY OR CONCOMITATELY WITH VACCINE AGAINST HEPATITIS B (RECOMBINANT)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-038-02
Enrollment
3900
Registered
2002-05-21
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

GROUP A Type of group
The administration of a 3-dose regimen of the tetravalent VLP L1 vaccine against HPV (Types 6, 11, 16, 18) reduces the combined incidence of cervical dysplasia (any degree of CIN), AIS or cervical cancer related to HPV 11/6/16/18 Group name:PLACEBO Type of group
The administration of a 3-dose regimen (0,2,6 months) of the vaccine of similar characteristics to the experimental group.

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: * Healthy women from 16 to 23 years old with intact uterus. * Negative response to anti-HBc (Qualitative) and anti-HBs (Qualitative) within of the 30 days before the Dose 1. * No clinical evidence of massive purulent cervicitis (if not postponed until after treatment or laboratory confirmation that there is no treatable cause). * Acceptance of the suspension of use of showers or vaginal or use medicines or vaginal preparations for 48 hours before any scheduled visit that includes a pelvic exam.

Exclusion criteria

Exclusion criteria: * Women who are included in parallel clinical studies for the purposes of research or studies that involve the extraction of cervical specimens. * Previous known vaccination history with HPV vaccine. * History of previous infection of Hepatitis B. * History of vaccination with any vaccine against hepatitis B. * Inoculation of inactivated vaccines within 14 days prior to inclusion or of vaccines with live virus within 21 days prior to inclusion.

Design outcomes

Primary

MeasureTime frame
Outcome name:anti-HBc (Qualitative) and anti-HBs (Qualitative) Measure:Immunogenicity measure of the vaccine. Timepoints:7 day—

Secondary

MeasureTime frame
Outcome name:Immediate reaction, paying special attention to any evidence of allergic phenomena. Measure:safety measure of the vaccine Timepoints:30 minutes after the vaccination—

Countries

Peru, United States

Outcome results

None listed

Source: REPEC (via WHO ICTRP)