Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.

This study has been terminated.
(Study stopped due to non-approval of IEC to proposed change in locations. Study discontinuation not due to safety/efficacy reasons related to the vaccine.)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00871741
First received: March 26, 2009
Last updated: November 16, 2012
Last verified: November 2012
  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
Haemophilus Influenzae Type b
Poliomyelitis
Hepatitis B
Serogroup C Meningococcal Diseases
Diphtheria
Pertussis
Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b-Neisseria Meningitidis Vaccines
Tetanus
Biological: GSK2202083A vaccine
Biological: Infanrix hexa
Biological: Menjugate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Feasibility Study of GlaxoSmithKline Biologicals' GSK2202083A Vaccine in Healthy Infants at 3, 5 and 11 Months of Age.

Resource links provided by NLM:


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 ]

Enrollment: 16
Study Start Date: April 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combo Group Biological: GSK2202083A vaccine
Intramuscular, three doses
Active Comparator: Control Group Biological: Infanrix hexa
Intramuscular, three doses
Biological: Menjugate
Intramuscular, two 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
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: NCT00871741

Locations
Slovakia
GSK Investigational Site
Bratislava, Slovakia, 841 08
GSK Investigational Site
Bratislava, Slovakia, 851 05
GSK Investigational Site
Dolny Kubin, Slovakia, 026 01
GSK Investigational Site
Dunajska Streda, Slovakia, 929 01
GSK Investigational Site
Nove Zamky, Slovakia, 940 01
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00871741     History of Changes
Other Study ID Numbers: 111761
Study First Received: March 26, 2009
Last Updated: November 16, 2012
Health Authority: Slovakia: State Institute for Drug Control

Keywords provided by GlaxoSmithKline:
Combined vaccine
Primary vaccination

Additional relevant MeSH terms:
Diphtheria
Haemophilus Infections
Hepatitis
Hepatitis A
Hepatitis B
Influenza, Human
Meningococcal Infections
Whooping Cough
Poliomyelitis
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Neisseriaceae Infections

ClinicalTrials.gov processed this record on August 28, 2014