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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00290329
First received: February 10, 2006
Last updated: January 23, 2017
Last verified: November 2012
  Purpose
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.

Condition Intervention Phase
Infections, Meningococcal
Biological: Mencevax ACWY
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of Subjects With Severe (Grade 3) Unsolicited Adverse Events [ Time Frame: During the 31-day (Days 0-30) post-vaccination period ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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. Grade 3 AE = an AE which prevented normal, everyday activities.


Secondary Outcome Measures:
  • Number of Subjects With Any and Grade 3 Solicited Local Adverse Events [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ]
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site (Mencevax ACWY 2-5 YOA Group) and beyond 50 millimeters (mm) of injection site (Mencevax ACWY 6-17 YOA Group and Mencevax ACWY ≥ 18 YOA Group).

  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ]
    Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination.

  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 4-day (Days 0-3) post-vaccination period ]
    Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms and headache. Any = occurrence of the symptom reported irrespective of intensity grade and causal relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

  • Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During the 31-day (Days 0-30) post-vaccination period ]
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 vaccination.

  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Day 0 to Month 1) ]
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.


Enrollment: 249
Study Start Date: January 2006
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: Mencevax ACWY
1 subcutaneous injection.
Other Names:
  • Neisseria meningitidis serogroups A
  • C
  • W and Y vaccine

Detailed Description:

All subjects will receive a single dose of GSK Biologicals' Mencevax ACWY vaccine according to the prescribing information. Subjects will be stratified into the following age groups:

2 to 5 years 6 to 17 years > 18 years The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

  Eligibility

Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290329

Locations
Philippines
GSK Investigational Site
Alabang, Muntinlupa City, Philippines, 1780
GSK Investigational Site
Binangonan, Rizal, Philippines
GSK Investigational Site
Cainta, Rizal, Philippines
GSK Investigational Site
Las Pinas City, Philippines
GSK Investigational Site
Los Banos, Laguna, Philippines, 4027
GSK Investigational Site
Manila, Philippines, 1000
GSK Investigational Site
Muntinlupa, Philippines, 1781
GSK Investigational Site
Pasay City, Philippines
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00290329     History of Changes
Other Study ID Numbers: 208144/002
Study First Received: February 10, 2006
Results First Received: January 23, 2017
Last Updated: January 23, 2017

Keywords provided by GlaxoSmithKline:
Safety
Meningococcal disease
Meningitidis serogroups A, C,W & Y diseases
Meningococcal vaccine

Additional relevant MeSH terms:
Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 24, 2017