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 GSK’s Clinical Study Register is no longer maintained for this study.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
Observational study model:
Not applicable
Primary completion date:
2006-17-10
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
  • 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.
  • Subjects suffering from acute severe febrile illness.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Inclusion and exclusion 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
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Location
GSK Investigational Site
Las Pinas City, Philippines
Status
Study Complete
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Location
GSK Investigational Site
Muntinlupa, Philippines, 1781
Status
Study Complete
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Location
GSK Investigational Site
Los Banos, Laguna, Philippines, 4027
Status
Study Complete
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Location
GSK Investigational Site
Cainta, Rizal, Philippines
Status
Study Complete
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Location
GSK Investigational Site
Alabang, Muntinlupa City, Philippines, 1780
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Manila, Philippines, 1000
Status
Study Complete
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Location
GSK Investigational Site
Pasay City, Philippines
Status
Study Complete
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Location
GSK Investigational Site
Binangonan, Rizal, Philippines
Status
Study Complete
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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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