Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01106092
First received: April 1, 2010
Last updated: December 8, 2011
Last verified: December 2011
  Purpose

The purpose of the study is to assess the immunogenicity and safety of three formulations of GSK Biologicals' GSK2036874A vaccine compared to Zilbrix™/Hib and Poliorix™ vaccines administered concomitantly, when administered as a single booster dose to healthy poliovirus-primed toddlers aged 12-24 months.


Condition Intervention Phase
Haemophilus Influenzae Type b
Poliomyelitis
Hepatitis B
Diphtheria
Pertussis
Tetanus
Biological: GSK2036874A vaccine
Biological: Zilbrix™/Hib vaccine
Biological: Poliorix™
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Immunogenicity and Reactogenicity of a Booster Dose of GlaxoSmithKline Biologicals' GSK2036874A Vaccine in Healthy Toddlers

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to components of the study vaccines in terms of number of seroprotected/seropositive subjects [ Time Frame: One month after booster vaccination (At Month 1) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccine in terms of antibody titres [ Time Frame: Prior booster vaccination (At Month 0) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccine in terms of antibody titres [ Time Frame: One month after booster vaccination (At Month 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to components of the study vaccines in terms of number of seroprotected/seropositive subjects [ Time Frame: Prior to and one month after booster vaccination (At Month 0 and Month 1) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccine in terms of antibody concentrations [ Time Frame: Prior to and one month after booster vaccination (At Month 0 and Month 1) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the study vaccine in terms of booster response to Bordetella pertussis [ Time Frame: One month after booster vaccination (At Month 1) ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: From the booster dose up to study end (From Day 0 to Month 1) ] [ Designated as safety issue: No ]
  • Solicited local and general symptoms [ Time Frame: During the 8-day (Day 0-7) follow-up period after booster vaccination ] [ Designated as safety issue: No ]
  • Unsolicited symptoms [ Time Frame: During the 31-day (Day 0-30) follow-up period after booster vaccination ] [ Designated as safety issue: No ]

Enrollment: 312
Study Start Date: May 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects will receive formulation 1 of GSK2036874A vaccine.
Biological: GSK2036874A vaccine
Intramuscular, single dose
Experimental: Group B
Subjects will receive formulation 2 of GSK2036874A vaccine.
Biological: GSK2036874A vaccine
Intramuscular, single dose
Experimental: Group C
Subjects will receive formulation 3 of GSK2036874A vaccine.
Biological: GSK2036874A vaccine
Intramuscular, single dose
Active Comparator: Control Group
Subjects will receive Zilbrix™/Hib and Poliorix™.
Biological: Zilbrix™/Hib vaccine
Intramuscular, single dose
Biological: Poliorix™
Intramuscular, single dose

Detailed Description:

The study will be conducted in a partially double-blinded manner. The study will be double-blinded with respect to the three GSK2036874A formulation groups and open-label with respect to the Control Group.

  Eligibility

Ages Eligible for Study:   12 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female subject, between and including 12 and 24 months of age at the time of booster vaccination.
  • Subjects who have received three doses of polio vaccine as primary vaccination along with the routine vaccinations indicated during the first year of life.
  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (s) can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the parent(s)/Legally Acceptable Representative (s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster dose.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period (up to Visit 2).
  • 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.
  • History of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenza type b diseases.
  • Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • History of neurologic disorders or seizures.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
  • Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
  • Child in care.
  • Occurrence of any of the following adverse events after a previous administration of a diphtheria-tetanus-pertussis vaccine:

    • encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,
    • fever >= 40 °C within 48 hours of vaccination not due to another identifiable cause,
    • collapse or shock-like state within 48 hours of vaccination,
    • convulsions with or without fever, occurring within 3 days of vaccination.
  • Acute disease and/or fever at the time of enrolment.

    • Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38.0°C on rectal setting.
    • Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
  • Other conditions which, in the opinion of the investigator, may potentially interfere with interpretation of study results.
  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: NCT01106092

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

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01106092     History of Changes
Other Study ID Numbers: 113264
Study First Received: April 1, 2010
Last Updated: December 8, 2011
Health Authority: Philippines: Bureau of Food and Drugs

Additional relevant MeSH terms:
Hepatitis B
Poliomyelitis
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis
Hepatitis, Viral, Human
Liver Diseases
Myelitis
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 21, 2014