Safety and Immunogenicity Study of a Candidate Tuberculosis Vaccine in Healthy Infants

This study has been completed.
Sponsor:
Collaborator:
Aeras
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01098474
First received: March 18, 2010
Last updated: August 16, 2012
Last verified: July 2012
  Purpose

This purpose of the study is to assess the safety and immunogenicity of a GSK Biologicals' candidate tuberculosis vaccine (692342) when administered concomitantly with or after the Expanded Programme of Immunisation vaccines regimen to healthy infants aged between and including 2 and 7 months, living in a tuberculosis endemic region.


Condition Intervention Phase
Tuberculosis
Biological: GSK's investigational vaccine 692342
Biological: Tritanrix™ HB+Hib
Biological: Prevnar™
Biological: Polio Sabin™
Biological: Menjugate™
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Study of GSK Biologicals' Candidate Tuberculosis Vaccine (692342) When Administered to Healthy Infants

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of grade 3 solicited local and general adverse events [ Time Frame: During the 7-day follow-up period after each vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of grade 3 unsolicited adverse events [ Time Frame: During the 30-day follow-up period after each vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: From study start up till 1 month after the last vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of grade 3 haematological and biochemical levels [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]
  • Occurrence of grade 3 haematological and biochemical levels [ Time Frame: Seven days after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of grade 3 haematological and biochemical levels [ Time Frame: One month after the last vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of grade 3 haematological and biochemical levels [ Time Frame: Six months after the last vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of grade 3 haematological and biochemical levels [ Time Frame: One year after the last vaccine dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cell-mediated immunogenicity with respect to components of the investigational vaccine [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]
  • Cell-mediated immunogenicity with respect to components of the investigational vaccine [ Time Frame: One week after the last vaccine dose ] [ Designated as safety issue: No ]
  • Cell-mediated immunogenicity with respect to components of the investigational vaccine [ Time Frame: One month after the last vaccine dose ] [ Designated as safety issue: No ]
  • Cell-mediated immunogenicity with respect to components of the investigational vaccine [ Time Frame: Six months after the last vaccine dose ] [ Designated as safety issue: No ]
  • Cell-mediated immunogenicity with respect to components of the investigational vaccine [ Time Frame: One year after the last vaccine dose ] [ Designated as safety issue: No ]
  • Humoral immune response to components of the investigational vaccine [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]
  • Humoral immune response to components of the investigational vaccine [ Time Frame: One week after the last vaccine dose ] [ Designated as safety issue: No ]
  • Humoral immune response to components of the investigational vaccine [ Time Frame: One month after the last vaccine dose ] [ Designated as safety issue: No ]
  • Humoral immune response to components of the investigational vaccine [ Time Frame: Six months after the last vaccine dose ] [ Designated as safety issue: No ]
  • Humoral immune response to components of the investigational vaccine [ Time Frame: One year after the last vaccine dose ] [ Designated as safety issue: No ]
  • Immune response to components of the Expanded Programme on Immunisation vaccines [ Time Frame: Before the first vaccination (At day 0) ] [ Designated as safety issue: No ]
  • Immune response to components of the Expanded Programme on Immunisation vaccines [ Time Frame: One month after the last vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general adverse events [ Time Frame: During the 7-day follow-up period after each vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: During the 30-day follow-up period after each vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]
  • Haematological and biochemical levels [ Time Frame: At day 0 ] [ Designated as safety issue: No ]
  • Haematological and biochemical levels [ Time Frame: Seven days after each vaccine dose ] [ Designated as safety issue: No ]
  • Haematological and biochemical levels [ Time Frame: One month after the last vaccine dose ] [ Designated as safety issue: No ]
  • Haematological and biochemical levels [ Time Frame: Six months after the last vaccine dose ] [ Designated as safety issue: No ]
  • Haematological and biochemical levels [ Time Frame: One year after the last vaccine dose ] [ Designated as safety issue: No ]

Enrollment: 302
Study Start Date: July 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects will receive 1 dose of GSK's investigational vaccine 692342.
Biological: GSK's investigational vaccine 692342
Intramuscular, 1 or 2 doses
Experimental: Group B
Subjects will receive 2 doses of GSK's investigational vaccine 692342.
Biological: GSK's investigational vaccine 692342
Intramuscular, 1 or 2 doses
Active Comparator: Group C
Subjects will receive 3 doses of a Menjugate™.
Biological: Menjugate™
Intramuscular, 3 doses
Experimental: Group D
Subjects will receive 1 dose of GSK's investigational vaccine 692342 concomitantly with the last dose of their primary Expanded Programme on Immunisation vaccines regimen.
Biological: GSK's investigational vaccine 692342
Intramuscular, 1 or 2 doses
Biological: Tritanrix™ HB+Hib
Intramuscular, 3 doses
Biological: Prevnar™
Intramuscular, 3 doses
Biological: Polio Sabin™
Oral, 3 doses
Experimental: Group E
Subjects will receive 2 doses of GSK's investigational vaccine 692342, one month apart, concomitantly with the last two doses of their primary Expanded Programme on Immunisation vaccines regimen.
Biological: GSK's investigational vaccine 692342
Intramuscular, 1 or 2 doses
Biological: Tritanrix™ HB+Hib
Intramuscular, 3 doses
Biological: Prevnar™
Intramuscular, 3 doses
Biological: Polio Sabin™
Oral, 3 doses
Active Comparator: Group F
Subjects will receive the primary Expanded Programme on Immunisation vaccines regimen.
Biological: Tritanrix™ HB+Hib
Intramuscular, 3 doses
Biological: Prevnar™
Intramuscular, 3 doses
Biological: Polio Sabin™
Oral, 3 doses

  Eligibility

Ages Eligible for Study:   2 Months to 7 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female subjects who the investigator believes that their parent(s)/ Legally Acceptable Representative (LAR(s)) can and will comply with the requirements of the protocol.
  • Written or oral, signed or thumb-printed and witnessed informed consent obtained from the subject's parent(s)/LAR(s).
  • Subjects who received their birth dose of Bacille Calmette Guerrin.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

For the 'Outside Expanded Programme on Immunisation' cohort:

  • Must have documented evidence that he/she has completed the primary Expanded Programme on Immunisation regimen at least 1 month prior to planned vaccination with investigational vaccination regimen.
  • Aged between 5 and 7 months at the time of the first study vaccination.

For the 'Within EPI' cohort:

  • Must have received the birth dose of Bacille Calmette Guerrin, oral polio vaccine and Hepatitis B vaccine but NO further Expanded Programme on Immunisation vaccines.
  • Aged between 2 and 4 months at the time of the first study vaccination with diphtheria, tetanus, whole cell pertussis/ Haemophilus influenzae type b vaccine + pneumococcal conjugate vaccine + oral polio vaccine.

Exclusion Criteria:

  • Child in care
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal abnormality, as determined by physical examination and/or laboratory screening tests.
  • Laboratory screening tests out of range, which in the investigator's opinion affects the ability of the child to take part in the study.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects.
  • History of any neurological disorders or seizures.
  • Any condition or illness or medication, which in the opinion of the investigator might interfere with the evaluation of the safety or immunogenicity of the study vaccine.
  • Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
  • Acute disease and/or fever at the time of enrolment.
  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • For the 'Within Expanded Programme on Immunisation' Cohort only: Previous vaccination with diphtheria, tetanus, pertussis, Haemophilus influenzae type b and pneumococcal conjugate vaccine.
  • History of previous administration of experimental Mycobacterium tuberculosis vaccines.
  • Administration of immunoglobulins, blood transfusions and/or other blood products since birth to the first dose of study vaccine or planned administration during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned participation or concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Any chronic drug therapy to be continued during the study period, with the exception of vitamins and/or dietary supplements
  • History of allergic reactions or anaphylaxis to any vaccine.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccines.
  • Severe malnutrition at screening defined as weight-for-age Z-score < -3 standard deviation.
  • Children will not be enrolled if any maternal, obstetrical or neonatal event that has occurred might, in the judgment of the investigator, result in increased neonatal/infant morbidity.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01098474

Locations
Gambia
GSK Investigational Site
Banjul, Gambia
Sponsors and Collaborators
GlaxoSmithKline
Aeras
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01098474     History of Changes
Other Study ID Numbers: 112899
Study First Received: March 18, 2010
Last Updated: August 16, 2012
Health Authority: Gambia: Gambia Government/MRC Joint Ethics Committee

Keywords provided by GlaxoSmithKline:
Tuberculosis vaccine

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on April 22, 2014