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Assess Lot-to-lot Consistency of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Following Manufacturing Adjustments Administered Intramuscularly According to a 0,1,6-mth Schedule in Healthy Female Subjects (18-25 y)


Phase 3
18 Years
25 Years
Not Enrolling
Female
Human Papillomavirus (HPV) Infection, Cervical Neoplasia

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Trial Information

Assess Lot-to-lot Consistency of GSK Biologicals' HPV-16/18 L1/AS04 Vaccine Following Manufacturing Adjustments Administered Intramuscularly According to a 0,1,6-mth Schedule in Healthy Female Subjects (18-25 y)


Inclusion Criteria:



- A female subject between, and including, 18 and 25 years of age at the time of the
first vaccination.

- Written informed consent obtained from the subject prior to enrolment.

- Subject must have a negative urine pregnancy test.

- Healthy subject before entering the study entry as established by medical history and
physical examination.

- Subject must be of non-childbearing potential.

Exclusion Criteria:

- pregnant or breastfeeding subject.

- previous vaccination against human papillomavirus (HPV).

- Known acute or chronic, clinically significant neurologic, hepatic or renal
functional abnormality.

- History of chronic condition(s) requiring treatment such as cancer, chronic hepatic
or kidney disease(s), diabetes or autoimmune disease.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

"• Demonstration of lot-to-lot consistency in terms of immunogenicity between different lots of HPV-16/18 L1/AS04 vaccine.

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

104772

NCT ID:

NCT00250276

Start Date:

October 2005

Completion Date:

March 2007

Related Keywords:

  • Human Papillomavirus (HPV) Infection
  • Cervical Neoplasia
  • Neoplasms

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