Back to resultsSafety of Purified Meningococcal Vaccine With Serogroups ACWY, in 3,000 Filipino Subjects Aged > 2 Years
Primary Purpose
Infections, Meningococcal
Status
Completed
Phase
Phase 4
Locations
Philippines
Study Type
Interventional
Intervention
Mencevax ACWY
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Meningococcal focused on measuring Safety, Meningococcal disease, Meningitidis serogroups A, C,W & Y diseases, Meningococcal vaccine
Eligibility 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Group A
Arm Description
Outcomes
Primary Outcome Measures
Number of Subjects With Severe (Grade 3) Unsolicited Adverse Events
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
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
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
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)
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)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00290329
Brief Title
Safety of Purified Meningococcal Vaccine With Serogroups ACWY, in 3,000 Filipino Subjects Aged > 2 Years
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
January 14, 2006 (undefined)
Primary Completion Date
October 1, 2006 (Actual)
Study Completion Date
October 17, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Meningococcal
Keywords
Safety, Meningococcal disease, Meningitidis serogroups A, C,W & Y diseases, Meningococcal vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
249 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Mencevax ACWY
Other Intervention Name(s)
Neisseria meningitidis serogroups A, C, W and Y vaccine
Intervention Description
1 subcutaneous injection.
Primary Outcome Measure Information:
Title
Number of Subjects With Severe (Grade 3) Unsolicited Adverse Events
Description
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.
Time Frame
During the 31-day (Days 0-30) post-vaccination period
Secondary Outcome Measure Information:
Title
Number of Subjects With Any and Grade 3 Solicited Local Adverse Events
Description
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).
Time Frame
During the 4-day (Days 0-3) post-vaccination period
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description
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.
Time Frame
During the 4-day (Days 0-3) post-vaccination period
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description
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.
Time Frame
During the 4-day (Days 0-3) post-vaccination period
Title
Number of Subjects With Unsolicited Adverse Events (AEs)
Description
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.
Time Frame
During the 31-day (Days 0-30) post-vaccination period
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
During the entire study period (from Day 0 to Month 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Alabang, Muntinlupa City
ZIP/Postal Code
1780
Country
Philippines
Facility Name
GSK Investigational Site
City
Binangonan, Rizal
Country
Philippines
Facility Name
GSK Investigational Site
City
Cainta, Rizal
Country
Philippines
Facility Name
GSK Investigational Site
City
Las Pinas City
Country
Philippines
Facility Name
GSK Investigational Site
City
Los Banos, Laguna
ZIP/Postal Code
4027
Country
Philippines
Facility Name
GSK Investigational Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
GSK Investigational Site
City
Muntinlupa
ZIP/Postal Code
1781
Country
Philippines
Facility Name
GSK Investigational Site
City
Pasay City
Country
Philippines
12. IPD Sharing Statement
Learn more about this trial
Safety of Purified Meningococcal Vaccine With Serogroups ACWY, in 3,000 Filipino Subjects Aged > 2 Years
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