Clinical Trial: Safety of a Booster Dose of GlaxoSmithKline (GSK) Biologicals' Boostrix™ Vaccine in Healthy Vietnamese Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Safety and Reactogenicity of GSK Biologicals' dTpa Vaccine (Boostrix™) in Healthy Vietnamese Children

Brief Summary: This study will evaluate the safety and reactogenicity of GSK Biologicals' combined reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine, Boostrix™ when given as a single injection to 6-10 year old children. Data that are available globally on the age group from four to six years of age will be used to bridge the age gap in this study and aid in the registration of the vaccine for children from the age of four years.

Detailed Summary:

A phase III, single-group, open-label study of GSK Biologicals' vaccine BoostrixTM administered as a booster vaccine dose in healthy Vietnamese children aged 6-10 years. A single booster dose of BoostrixTM will be administered at Visit 1 (Day 0) and subjects will be observed until Visit 2 (Day 30). Safety will be assessed in terms of solicited adverse events (during 4 days post vaccination), unsolicited adverse events (during 31 days post vaccination) and serious adverse event (during the trial period).

This protocol summary was updated following an administrative change of adding the EudraCT number to this study.


Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Numbers of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: Within 4 days (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 100 millimeters (mm) of injection site. Relationship analysis was not performed.
  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: Within 4 days (Days 0-3) post vaccination period ]
    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. 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: Within 31 days (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.
  • Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: D

    Original Primary Outcome:

    • Occurrence of each solicited local symptom. [ Time Frame: During the 4-day (Day 0-Day 3) follow-up period after booster vaccination. ]
    • Occurrence of each solicited general symptom. [ Time Frame: During the 4-day (Day 0-Day 3) follow-up period after booster vaccination. ]
    • Occurrence of unsolicited symptoms according to the Medical Dictionary for Regulatory Activities (MedDRA) classification. [ Time Frame: During the 31-day (Day 0-Day 30) follow-up period after booster vaccination. ]
    • Occurrence of Serious Adverse Events (SAEs). [ Time Frame: Day 0 up to study end (Day 30). ]


    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: GlaxoSmithKline

    Dates:
    Date Received: November 14, 2013
    Date Started: February 2014
    Date Completion:
    Last Updated: January 9, 2017
    Last Verified: January 2017