India Registration Study for Quadrivalent HPV Vaccine

Phase 1

• Conditions: vaccination against HPV infection/related disease; MedDRA version: 19.1Level: LLTClassification code 10071147Term: Human papilloma virus immunizationSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-000111-16-Outside-EU/EEA
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-11
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: A
• Sex: Female
• Target Recruitment: 110

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
F.1.3.1 Number of subjects for this age range

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.
i. Any plans to permanently relocate from the area prior to the completion of the
study or to leave for an extended period of time when study visits would need to be scheduled.
j. Individuals who are immunocompromised or have been diagnosed as having HIV infection.
k. History of recent or ongoing alcohol or other drug abuse.
Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and legal problems as a result of alcohol use.
l. Inability to give consent/assent.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified