Last updated: 07/17/2024 15:13:20

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.

GSK study ID
108160
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Terminated (halted prematurely)
Terminated (halted prematurely)
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A post-marketing surveillance (PMS) study to monitor the safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ human papillomavirus (HPV) vaccine (Cervarix) in 3,000 healthy female Filipino subjects when administered according to the Prescribing Information from the age of 10 years onwards.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Number of subjects reporting any and Grade 3 solicited local symptoms

Timeframe: 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

Timeframe: 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)

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

Number of subjects with any, Grade 3 and related serious adverse events (SAEs)

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

Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Cervarix
Enrollment:
743
Observational study model:
Not applicable
Primary completion date:
2012-16-01
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Human papillomavirus infection leading to cervical cancer
Product
SB580299
Collaborators
Not applicable
Study date(s)
September 2008 to January 2012
Type
Interventional
Phase
4

Participation criteria

Sex
Female
Age
10+ years
Accepts healthy volunteers
Yes
  • 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.
  • 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).

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Ermita, Manila, Philippines
Status
Study Complete
Location
GSK Investigational Site
Makati City, Philippines, 1231
Status
Study Complete

Study documents

Scientific result summary
Available language(s): English
Protocol
Available language(s): English
Clinical study report
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Terminated (halted prematurely)
Actual primary completion date
2012-16-01
Actual study completion date
2012-16-01

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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