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.

Phase 4TerminatedNCT00730847

GlaxoSmithKline743 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

743

Conditions

Human Papillomavirus Infection Leading to Cervical Cancer

Interventions

CervarixBIOLOGICAL

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

Eligibility

Sex: FEMALEMin age: 10 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness and swelling above 50 millimeters (mm).

Time frame: During the 7-day follow-up period (Days 0-6) after each dose and across doses

Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms

Solicited general symptoms assessed were arthralgia, fatigue, fever, gastrointestinal, headache, myalgia, rash and urticaria. Any fever = axillary temperature ≥ 37.5 degrees Celsius (°C). For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to study vaccination. Related = symptoms considered by the investigator as causally related to study vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 urticaria = urticaria distributed on at least 4 body areas. Grade 3 fever = axillary temperature \> 39.0°C.

Time frame: During the 7-day follow-up period (Days 0-6) after each dose and across doses

Number of Subjects Reporting Any, Grade 3, Related and Grade 3 and Related Unsolicited Adverse Events (AEs)

An unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination. Grade 3 = event which prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination. Grade 3 and Related = grade 3 event assessed by the investigator as causally related to the study vaccination.

Time frame: During the 30-day (Days 0-29) post-vaccination period

Number of Subjects With Any, Grade 3 and Related Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade. Grade 3 SAE = SAE which prevented normal, everyday activities. Related SAE = SAE assessed by the investigator as causally related to the study vaccination.

Time frame: During the entire study period (from Day 0 up to Month 7)