Last updated: 11/04/2018 00:48:31
Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results

Safety of Purified Meningococcal Vaccine With Serogroups ACWY, in 3,000 Filipino subjects Aged > 2 Years

GSK study ID
208144/002
See study documents
Clinicaltrials.gov ID
NCT00290329
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Multicentric, Surveillance Study to Monitor Safety of GSK Biologicals' Purified Meningococcal Polysaccharide Vaccine of Serogroups ACWY in 3,000 Filipino Subjects Aged above 2 Years When Administered According to the Prescribing Information.
Trial description: GlaxoSmithKline Philippines has submitted a registration file for its Purified Meningococcal Polysaccharide of Serogroup ACWY Vaccine (Mencevax ACWY). This study is being conducted to collect clinical data in the local target population in order to assess the occurrence of rare adverse events after vaccination as per the requirement of Philippines Bureau of Food and Drugs Directive.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of subjects with severe (Grade 3) unsolicited adverse events

Timeframe: During the 31-day (Days 0-30) post-vaccination period

Secondary outcomes:

Number of subjects with any and Grade 3 solicited local adverse events

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Number of subjects with any, Grade 3 and related solicited general symptoms

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Number of subjects with any, Grade 3 and related solicited general symptoms

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Number of subjects with unsolicited adverse events (AEs)

Timeframe: During the 31-day (Days 0-30) post-vaccination period

Number of subjects with serious adverse events (SAEs)

Timeframe: During the entire study period (from Day 0 to Month 1)

Interventions:
  • Biological/vaccine: Mencevax ACWY
    • Enrollment:
    249
    Primary completion date:
    2006-17-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Meningococcal
    Product
    SB208144
    Collaborators
    Not applicable
    Study date(s)
    January 2006 to October 2006
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    2+ years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • Subjects who the investigator believes that they and/or their parent/guardian can and will comply with the requirements of the protocol.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Inclusion Criteria: •Subjects who the investigator believes that they and/or their parent/guardian can and will comply with the requirements of the protocol. •A Filipino male or female > 2 years of age at the time of the first vaccination. •Free of obvious health problems as established by medical history and clinical examination before entering into the study. •Written informed consent obtained from the subject and/or from the parent/ guardian of the subject. Exclusion criteria: •Subjects suffering from acute severe febrile illness. •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. •Major congenital defects or serious chronic illness. •History of any neurologic disorders or seizures. •Pregnant or lactating female. •Female planning to become pregnant. •History of chronic alcohol consumption and/or intravenous drug abuse. •Any contraindications as stated on the Prescribing Information.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Las Pinas City, Philippines
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Muntinlupa, Philippines, 1781
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Los Banos, Laguna, Philippines, 4027
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Cainta, Rizal, Philippines
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Alabang, Muntinlupa City, Philippines, 1780
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Manila, Philippines, 1000
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 8 Results

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

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

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    2006-17-10
    Actual study completion date
    2006-17-10

    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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