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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00228917
First Posted: September 29, 2005
Last Update Posted: June 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
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.

Condition Intervention Phase
Whole Cell Pertussis Tetanus Hepatitis B Diphtheria Haemophilus Influenzae Type b Biological: Tritanrix-HepB/Hiberix Biological: Trianrix-Hepb Biological: Mencevax-ACWY Biological: Hib-MenAC-TT Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Assess Reactogenicity & Safety of a Booster of Either Tritanrix™-HepB/Hib-MenAC or Tritanrix™-HepB/Hiberix™ Given (Single-blind) at 15-18 (Philippines)/15-24 Mths (Thailand) & a Dose of Mencevax™ ACWY at 24-30 Mths (Open Label)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 1290
Actual Study Start Date: June 1, 2005
Study Completion Date: January 20, 2006
Primary Completion Date: January 1, 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TRIANRIX-HEPB/HIB-MENAC-TT GROUP
Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm.
Biological: Tritanrix-HepB/Hiberix
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine
Experimental: TRIANRIX-HEPB/MENCEVAX+TRIANRIX-HEPB/HIBERIX GROUP
Subjects vaccinated with 3 doses of Trianrix-Hepb co-administrated with Mencevax vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of Tritanrix™-HepB/Hiberix™ at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
Biological: Tritanrix-HepB/Hiberix
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine
Biological: Trianrix-Hepb
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine
Biological: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
Experimental: TRITANRIX-HEPB/ HIBERIX +MENCEVAX GROUP
Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
Biological: Tritanrix-HepB/Hiberix
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine
Biological: Trianrix-Hepb
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine
Biological: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine
Biological: Hib-MenAC-TT
Haemophilus influenzae type b, Meningococcal Serogroups A and C -Tetanus toxoid conjugate vaccine
Experimental: TRITANRIX-HEPB+MENCEVAX GROUP
Subjects vaccinated with 3 doses of Tritanrix™-HepB/Hiberix™ vaccine in the primary study (NCT00317135/ NCT00317187) were boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) and 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects were also administered one booster dose of Mencevax™ ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm.
Biological: Tritanrix-HepB/Hiberix
Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine
Biological: Mencevax-ACWY
Meningococcal Serogroups A, C, W-135 and Y Vaccine

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   427 Days to 577 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written informed consent obtained from the parent or guardian of a healthy male or female child between, and including 15 and 18 months age (Philippines)/ 15 and 24 months age (Thailand) at the time of vaccination and who have previously received a 3-dose primary vaccination in the studies DTPwHB/HibMenAC-TT-004 (CPMS No. 759346/004) or DTPW-HBV=HIB-MENAC-TT-013 (eTrack No. 100791).

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the vaccination, or planned use during the study period.
  • Chronic administration (> than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of vaccination. Note: Oral poliovirus vaccine can be given concomitantly.
  • Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and C disease, after the date of the study conclusion visit of the primary vaccination study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228917


Locations
Philippines
GSK Investigational Site
Muntinlupa, Philippines, 1781
Thailand
GSK Investigational Site
Bangkok, Thailand, 10400
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 103812
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 103812
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 103812 are summarised with study 104727 on the GSK Clinical Study Register.
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 103812
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 103812
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 103812
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 103812
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00228917     History of Changes
Other Study ID Numbers: 103812
104171 ( Other Identifier: GSK )
First Submitted: September 27, 2005
First Posted: September 29, 2005
Results First Submitted: February 10, 2017
Results First Posted: March 29, 2017
Last Update Posted: June 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Hib & Neisseria meningitidis serogroups A & C diseases

Additional relevant MeSH terms:
Hepatitis B
Diphtheria
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs