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Immune Response & Safety of GSK Biologicals' Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00291343
First received: February 13, 2006
Last updated: November 3, 2011
Last verified: November 2011
  Purpose

This study will be conducted in three stages. In the DTP booster stage at 15 to 24 months of age, all subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™. In the Mencevax™ ACWY "full dose" stage at 24 to 30 months of age all subjects will receive a dose of Mencevax™ ACWY. In the Mencevax™ ACWY "small dose" stage at 30 to 36 months of age, the first 75 subjects in each of the two centers will be tested for boostability of the MenA and MenC immune response by giving a fifth of a dose of a Mencevax™ ACWY vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
Hib Disease
Hepatitis B
Diphtheria
Pertussis
Neisseria Meningitidis Serogroup Diseases
Tetanus
Biological: Tritanrix™- HepB
Biological: Hiberix™
Biological: Mencevax™ ACWY
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Booster Vaccination Study to Assess Immunogenicity & Safety of a Dose of GSK Biologicals' Mencevax™ ACWY & 1/5th of a Dose of Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • SBA-MenA and SBA-MenC titres [ Time Frame: At 25 tot 31 months of age, i.e., one month after Mencevax™ ACWY vaccine at 24 to 30 months of age ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SBA-MenA and SBA-MenC titres [ Time Frame: At 24 to 30 months of age ] [ Designated as safety issue: No ]
  • Anti-PSA and Anti-PSC concentrations [ Time Frame: At 24 to 30 months of age, prior to full dose of Mencevax™ ACWY vaccine and at 25 to 31 months of age ] [ Designated as safety issue: No ]
  • Anti-HBs concentration [ Time Frame: At 24 to 30 months of age ] [ Designated as safety issue: No ]
  • Booster/vaccine response to meningococcal antigens [ Time Frame: At 25 to 31 months of age ] [ Designated as safety issue: No ]
  • SBA-MenA and SBA-MenC titres [ Time Frame: At 30 to 36 months of age, prior to small dose of Mencevax™ ACWY vaccine and at 31 to 37 months of age ] [ Designated as safety issue: No ]
  • Anti-PSA and Anti-PSC concentrations [ Time Frame: At 30 to 36 months of age, prior to small dose of Mencevax™ ACWY vaccine and at 31 to 37 months of age ] [ Designated as safety issue: No ]
  • Anti-HBs concentration [ Time Frame: At 30 to 36 months of age ] [ Designated as safety issue: No ]
  • Booster/vaccine response to meningococcal antigens [ Time Frame: At 31 to 37 months of age ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: During the 4-day follow-up period after a full dose of Mencevax™ ACWY vaccine, at 24 to 30 months of age and after a small dose of Mencevax™ ACWY vaccine, at 30 to 36 months ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after a full dose of Mencevax™ ACWY vaccine, at 24 to 30 months of age and after a small dose of Mencevax™ ACWY vaccine, at 30 to 36 months of age ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]

Enrollment: 296
Study Start Date: February 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
AC primed group
Biological: Tritanrix™- HepB
One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months
Biological: Hiberix™
One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months
Biological: Mencevax™ ACWY
One full subcutaneous dose in subjects aged 24 to 30 months or 1/5th of a dose intramuscular in subjects aged 30 to 36 months
Active Comparator: Group B
AC unprimed group
Biological: Tritanrix™- HepB
One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months
Biological: Hiberix™
One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months
Biological: Mencevax™ ACWY
One full subcutaneous dose in subjects aged 24 to 30 months or 1/5th of a dose intramuscular in subjects aged 30 to 36 months

Detailed Description:

Subjects in the group that was previously primed with Tritanrix™-HepB/Hiberix™ will be the control group for the group that was previously primed with Tritanrix™-HepB/Hib-MenAC.

Blood samples will be drawn from subjects as follows:

  • prior to and one month after the full dose of the Mencevax™ ACWY vaccine.
  • prior to and one month after 1/5th of a dose of Mencevax™ ACWY vaccine (only for the first 75 subjects in each of the two centers).
  Eligibility

Ages Eligible for Study:   15 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • A male or female between, and including, 15 and 24 months of age at the time of vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-011 (eTrack No. 100478) in Center No. 4328 or Center No.4329.

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 (defined as more 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; with the exception of oral poliovirus vaccine (OPV).
  • Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-011 (eTrack No. 100478).
  • History of diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
  • Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • 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 including febrile seizures in infancy.
  • Acute disease at the time of enrolment.
  • Planned or actual administration of immunoglobulins and/or any blood products within the three months preceding Mencevax™ ACWY vaccination.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291343

Locations
Philippines
GSK Investigational Site
Manila, Philippines, 1000
GSK Investigational Site
Sampaloc, Manila, Philippines, 1008
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00291343     History of Changes
Other Study ID Numbers: 105239 (mth24-30), 105245
Study First Received: February 13, 2006
Last Updated: November 3, 2011
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by GlaxoSmithKline:
hepatitis B
meningococcal vaccine
pertussis
Prophylaxis diphtheria
meningococcal serogroups A and C diseases
tetanus
Haemophilus influenzae type b

Additional relevant MeSH terms:
Diphtheria
Hepatitis
Hepatitis B
Actinomycetales Infections
Bacterial Infections
Corynebacterium Infections
DNA Virus Infections
Digestive System Diseases
Gram-Positive Bacterial Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014