Clinical Trial: Safety Study of Tritanrix™-HepB/Hib-MenAC, Tritanrix™-HepB/Hiberix™, and Mencevax™ ACWY Vaccines in Children

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

Official Title: Assess Reactogenicity & Safety of a Booster of Either Tritanrix™-HepB/Hib-MenAC or Tritanrix™-HepB/Hiberix™ Given (Single-blind) at 15-18 (Philippine

Brief Summary: This study will be conducted in two stages. In the diphtheria, tetanus, pertussis (DTP) booster phase, subjects will receive a booster dose of Tritanrix™-HepB/Hib-MenAC or Tritanrix™-HepB/Hiberix™ (active control) at 15 to 18 or 24 months in a single-blind manner so that the subjects' parents will not know which vaccine was administered to their child. In the Mencevax ACWY phase at 24-30 months, a dose of Mencevax™ ACWY will be given in an open manner to only those subjects who received less than 4 doses of Tritanrix™-HepB/Hib-MenAC. No blood samples will be taken in this safety study.

Detailed Summary: Subjects previously primed with Tritanrix™-HepB/Hib-MenAC will receive Tritanrix™-HepB/Hib-MenAC or Tritanrix™-HepB/Hiberix™ vaccine (at 15-18/24 m), respectively, without or with Mencevax™ ACWY vaccine at 24 to 30 months of age. Subjects previously primed with Tritanrix™-HepB/Hiberix™ will receive Tritanrix™-HepB/Hib-MenAC or Tritanrix™-HepB/Hiberix™ vaccine (at 15-18/24 m) with Mencevax™ ACWY vaccine at 24 to 30 months of age.
Sponsor: GlaxoSmithKline

Current Primary Outcome: Number of Subjects With Fever >39°C (Rectal Route). [ Time Frame: During the 4-day (Day 0-3) follow-up period after booster vaccination ]

Among solicited general symptoms fever [defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C )] was assessed, post vaccination. Grade 3 fever = fever > 39.0 °C.


Original Primary Outcome: Fever > 38.5 °C (measured under the arm) during the specific follow-up period after each vaccination.

Current Secondary Outcome:

  • Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms, Other Than Fever > 39.0°C [ Time Frame: During the 4-day (Day 0-3) follow-up period after vaccination ]
    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.
  • Number of Subjects With Any and Grade 3 Solicited Local Symptoms. [ Time Frame: During the 4-day (Day 0-3) follow-up period after booster vaccination ]
    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.
  • Number of Subjects With Any Unsolicited Adverse Events (AEs). [ Time Frame: During the 31-day (Day 0-30) following booster vaccination ]
    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: From 15 to 18 months or 15 to 24 months of age and up to 25 to 31 months of age post vaccination ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.


Original Secondary Outcome: After each vaccination: Solicited symptoms other than fever > 38.5°C (i.e. pain,redness and swelling at the injection ite; drowsiness, fever, irritability/ fussiness and loss of appetite) during day 0-3, unsolicited symptoms during day 0-30 & SAEs during

Information By: GlaxoSmithKline

Dates:
Date Received: September 27, 2005
Date Started: June 2005
Date Completion:
Last Updated: February 10, 2017
Last Verified: February 2017