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Completed

NCT Number: NCT00290329

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

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.

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Key information

Conditions

Infections, Meningococcal Bacterial Infections Bacterial Infections and Mycoses Gram-Negative Bacterial Infections Infections Meningococcal Infections Neisseriaceae Infections

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Alabang, Muntinlupa City, Philippines

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mencevax ACWY

Biological

1 subcutaneous injection.

Other names: Neisseria meningitidis serogroups A, C, W and Y vaccine

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Feb 13, 2006
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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