Evaluation of Safety, Tolerability and Immunogenicity of Quadrivalent HPV Vaccine in healthy females 9 to 15 years of age in India. - Safety, Tolerability and Immunogenicity of Quadrivalent HPV Vaccine in healthy females in India

Merck & Co., Inc.0 sites110 target enrollmentJanuary 11, 2017

DrugsGARDASIL

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Merck & Co., Inc.
Enrollment: 110
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 11, 2017

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

Merck & Co., Inc.

Eligibility Criteria

Inclusion Criteria

•a. Healthy females age 9 to 15 years.
•b. Must not yet have had coitarche and does not plan on becoming sexually active through the course of the study.
•c. Must agree to provide study personnel with a primary telephone number as well as an alternate telephone number for follow\-up purposes.
•d. No feverish feeling within 24 hours prior to the first injection and no temperature \=100°F or \=37\.8°C (oral or oral equivalent) at first vaccination.
•e. Not pregnant now (as determined by a serum pregnancy test or urine pregnancy test sensitive to 25 IU HCG).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 110
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no

Exclusion Criteria

•a. Individuals concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical/genital specimens.
•b. History of known prior vaccination with an HPV vaccine.
•c. Subject has received non\-replicating (inactivated) vaccine within 14 days prior to the Day 1 vaccination or has received replicating (live virus) vaccine within 21 days prior to the Day 1 vaccination.
•d. Individuals allergic to any vaccine component, including aluminum, yeast, or BENZONASE™ (nuclease, Nycomed \[used to remove residual nucleic acids from this and other vaccines]).
•e. Individuals who have received any immune globulin preparation or blood derived
•products within the 6 months prior to the first injection, or plan to receive any through the completion of the study.
•f. Individuals with a history of splenectomy, known immune disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis), or receiving immunosuppressives (e.g., substances or treatments known to diminish immune response such as radiation therapy, administration of antimetabolites, antilymphocytic sera, systemic corticosteroids). Individuals who have received periodic treatments with immunosuppressives, defined as at least 3 courses of systemic corticosteroids each lasting at least 1 week in duration for the year prior to enrollment, will be excluded. Subjects using topical steroids (i.e., inhaled or nasal) will be eligible for vaccination.
•g. Individuals with known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections.
•h. Any condition which in the opinion of the investigator might interfere with the
•evaluation of the study objectives.