Other Clinical Trial - GARDASIL Reexamination Study (V501-059)

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of Gardasil through collecting the safety information according to the Re-examination Regulation for New Drugs.

See also
	Status	Clinical Trial	Phase
	Completed	`NCT00481767` - Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (GSK580299) in Healthy Female Subjects 10-25 Years of Age.	Phase 3
	Completed	`NCT00456807` - Complementary Testing to Evaluate Immunogenicity of Human Papillomavirus (HPV) Vaccine (580299) in Healthy Female Subjects Aged >/= 26 Years	Phase 3

NCT number	NCT01062074
Study type	Observational
Source	Merck Sharp & Dohme Corp.
Contact
Status	Completed
Phase	N/A
Start date	September 2007
Completion date	May 2013

GARDASIL Reexamination Study (V501-059)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms