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.

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 4

Conditions: Human Papillomavirus Infection Leading to Cervical Cancer

Treatments: Biological: Cervarix

Study type: Interventional

Funder types: Industry

Identifiers

NCT00730847

108160

2017-000458-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 743 patients

Sex: Female

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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743 participants in 1 patient group

Cervarix Group

Experimental group

Description:

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.

Treatment:

Biological: Cervarix