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Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.
This study is currently recruiting participants.
Verified by GlaxoSmithKline, April 2009
First Received: March 26, 2009   Last Updated: April 16, 2009   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00871741
  Purpose

This study will evaluate the safety and immunogenicity of GSK Biologicals' GSK2202083A vaccine given as a three-dose vaccination course at 3, 5 and 11 months of age.


Condition Intervention Phase
Diphtheria
Haemophilus Influenzae Type B
Hepatitis B
Pertussis
Poliomyelitis
Serogroup C Meningococcal Diseases
Tetanus
Biological: Menjugate
Biological: GSK2202083A vaccine
Biological: Infanrix hexa
Phase II

MedlinePlus related topics: Diphtheria Hepatitis Hepatitis B Polio and Post-Polio Syndrome Tetanus Whooping Cough
Drug Information available for: Infanrix hexa
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity of study vaccine antigens [ Time Frame: One month after the second vaccine dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity of study vaccine antigens [ Time Frame: One month after the second vaccine dose ] [ Designated as safety issue: No ]
  • Immunogenicity of study vaccine antigens [ Time Frame: One month after the third vaccine dose ] [ Designated as safety issue: No ]
  • Immunogenicity of study vaccine antigens [ Time Frame: Before the third vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of solicited local/general symptoms [ Time Frame: During the 8-day follow-up period after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events. [ Time Frame: From Dose 1 up to study end ] [ Designated as safety issue: No ]

Estimated Enrollment: 468
Study Start Date: April 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Control Group: Active Comparator Biological: Menjugate
Intramuscular, two doses
Biological: Infanrix hexa
Intramuscular, three doses
Combo Group: Experimental Biological: GSK2202083A vaccine
Intramuscular, three doses

  Eligibility

Ages Eligible for Study:   8 Weeks to 16 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female infant between, and including, 8 and 16 weeks at the time of the first vaccination.
  • Born after a gestation period of 36 to 42 weeks inclusive.
  • Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol.
  • 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.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to randomisation, or planned administration from randomisation to study Visit 3, or from 30 days before to 30 days after study Visit 4, with the exception of influenza and human rotavirus vaccines. The administration of other vaccines, including conjugated pneumococcal vaccine, is allowed during the period from one day after study Visit 3 to 31 days before study Visit 4.
  • 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
  • Evidence of previous or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Hib and/or MenC vaccination or disease, including HBV vaccination at birth.
  • History of seizures or progressive neurological disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or serious chronic illness. The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
  • Current febrile illness or axillary temperature >= 38.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00871741

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718

Locations
Slovakia
GSK Investigational Site Not yet recruiting
Banska Bystrica, Slovakia, 974 01
GSK Investigational Site Not yet recruiting
Nitra, Slovakia, 949 01
GSK Investigational Site Recruiting
Dunajska Streda, Slovakia, 929 01
GSK Investigational Site Recruiting
Bratislava, Slovakia, 851 05
GSK Investigational Site Recruiting
Dolny Kubin, Slovakia, 026 01
GSK Investigational Site Recruiting
Nove Zamky, Slovakia, 940 01
GSK Investigational Site Not yet recruiting
Puchov, Slovakia, 020 01
GSK Investigational Site Not yet recruiting
Zvolen, Slovakia, 960 01
GSK Investigational Site Not yet recruiting
Nova Dubnica, Slovakia, 018 51
GSK Investigational Site Not yet recruiting
Povazska Bystrica, Slovakia, 017 01
GSK Investigational Site Not yet recruiting
Trnava, Slovakia, 917 01
GSK Investigational Site Not yet recruiting
Sturovo, Slovakia, 943 01
GSK Investigational Site Not yet recruiting
Ruzomberok, Slovakia, 034 01
GSK Investigational Site Recruiting
Bratislava, Slovakia, 841 08
GSK Investigational Site Not yet recruiting
Nove Mesto nad Vahom, Slovakia, 915 01
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 111761
Study First Received: March 26, 2009
Last Updated: April 16, 2009
ClinicalTrials.gov Identifier: NCT00871741     History of Changes
Health Authority: Slovakia: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:
Primary vaccination
Combined vaccine

Study placed in the following topic categories:
Bacterial Infections
Liver Diseases
Spinal Cord Diseases
Whooping Cough
Hepatitis, Viral, Human
Meningococcal Infection
Healthy
Orthomyxoviridae Infections
Tetanus
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Neuromuscular Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Meningococcal Infections
Hepatitis B
Degenerative Motor System Disease
Motor Neuron Disease
Neisseriaceae Infections
Haemophilus Influenzae
Central Nervous System Diseases
Cough
Picornaviridae Infections
Diphtheria
Hepatitis
Virus Diseases
Digestive System Diseases
Central Nervous System Infections
Poliomyelitis
Influenza, Human

Additional relevant MeSH terms:
Bacterial Infections
Liver Diseases
Spinal Cord Diseases
Whooping Cough
Hepatitis, Viral, Human
Central Nervous System Viral Diseases
Orthomyxoviridae Infections
Infection
Hepadnaviridae Infections
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Neuromuscular Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Corynebacterium Infections
Meningococcal Infections
Hepatitis B
Motor Neuron Disease
Neisseriaceae Infections
RNA Virus Infections
Nervous System Diseases
Central Nervous System Diseases
Picornaviridae Infections
Diphtheria
Actinomycetales Infections
Bordetella Infections
Hepatitis
Virus Diseases
Digestive System Diseases
Central Nervous System Infections

ClinicalTrials.gov processed this record on May 07, 2009