A Study to Assess the Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine (Cervarix) in Healthy Female Filipino Subjects Vaccinated According to the Prescribing Information From the Age of 10 Years Onwards.

NCT ID: NCT00730847

Last Updated: 2019-11-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 743 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-17
• Study Completion Date: 2012-01-16

Brief Summary

The purpose of this study was to assess the safety and reactogenicity of GSK Biologicals' Cervarix vaccine in healthy female Filipino subjects from the age of 10 years onwards, as per the Bureau of Food and Drugs Directive of Philippines.

Conditions

Human Papillomavirus Infection Leading to Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cervarix Group

Healthy female subjects who received three doses of the Cervarix vaccine, administered intramuscularly in the deltoid region according to a 0, 1 and 6-month schedule.

Group Type: EXPERIMENTAL

Cervarix

Intervention Type: BIOLOGICAL

Three doses of Cervarix administered intramuscularly in the deltoid region, according to a 0, 1, 6-month vaccination schedule.

Interventions

Cervarix

Three doses of Cervarix administered intramuscularly in the deltoid region, according to a 0, 1, 6-month vaccination schedule.

Intervention Type: BIOLOGICAL

Other Intervention Names

HPV-16/18 VLP/AS04 vaccine

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes that they and/or their LAR's can and will comply with the requirements of the protocol should be enrolled in the study.
• A female 10 years of age and above at the time of the first vaccination.
• Written informed consent obtained from the subject. For subjects below the legal age of consent, written informed consent must be obtained from the parent or legal guardian (legally acceptable representative -LAR) of the subject and informed assent must be obtained from the subject.
• Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study.
• Subjects of childbearing potential must not be pregnant.
• Subjects must be of non-childbearing potential, or if the subject is of childbearing potential, she must be abstinent (and if so, this must be documented in the source documents at each vaccination visit) or must be using adequate contraception for 30 days prior to vaccination and continue for 2 months after completion of the vaccination series.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or non-investigational product (pharmaceutical product or device).
• Pregnant or breastfeeding.
• Planning to become pregnant or likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive prevention during the study period and up to two months after the last vaccine dose.
• History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.
• Hypersensitivity to latex (found in syringe-tip cap and plunger).
• Known acute or chronic, clinically significant neurologic, haematological, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
• Cancer or autoimmune disease under treatment.
• Previous vaccination against HPV or planned administration of another HPV vaccine during the study.
• Acute disease at the time of enrolment.

• Minimum Eligible Age: 10 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Ermita, Manila, , Philippines

GSK Investigational Site

Makati City, , Philippines

Countries

Philippines

Other Identifiers

2017-000458-20

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

108160

Identifier Type: -

Identifier Source: org_study_id