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Evaluation of Non-Typable Haemophilus Influenzae and Pneumococcal Protein Vaccine Formulations in Young Adults
This study is not yet open for participant recruitment.
Verified by GlaxoSmithKline, December 2008
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00814489
  Purpose

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 formulations of a non-typable Haemophilus influenzae and pneumococcal candidate vaccine in young adults. Subjects will be vaccinated 3 times with an interval of respectively 2 and 4 months.


Condition Intervention Phase
Diseases Caused by Streptococcus Pneumoniae and Nontypable Haemophilus Influenzae
Biological: Engerix-B
Biological: GSK Biologicals' investigational HIP vaccine GSK2254232A
Biological: GSK Biologicals' investigational HIP vaccine GSK2254233A
Phase I

MedlinePlus related topics: Flu Pneumonia
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Safety Study
Official Title: A Study to Evaluate GSK Biologicals' Candidate Non-Typable Haemophilus Influenzae (NTHi) and S. Pneumoniae Formulation Vaccines (GSK2254232A and GSK2254233A) in Healthy Young Adults

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of any solicited local and general adverse events [ Time Frame: During a 7-day follow up period after each vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of any unsolicited adverse events [ Time Frame: During a 30-day follow up period after each vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of any laboratory abnormalities [ Time Frame: During 7 days after each vaccine dose ] [ Designated as safety issue: No ]
  • Occurrence of any serious adverse events (SAE) [ Time Frame: From first vaccine dose to study conclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anti-NTHi and anti-pneumococcal candidate vaccine antigens [ Time Frame: Prior to and at 14 and 30 days after each vaccine dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2009
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group C: Active Comparator Biological: Engerix-B
Three doses administered intramuscularly.
Group A: Experimental Biological: GSK Biologicals' investigational HIP vaccine GSK2254232A
Three doses administered intramuscularly;
Group B: Experimental Biological: GSK Biologicals' investigational HIP vaccine GSK2254233A
Three doses administered intramuscularly;

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including, 18 and 40 years of age at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • Subject without medical history, clinical finding or laboratory finding, which, in the opinion of the investigator, could pose a safety concern or interfere with the protocol.
  • If the subject is female, and of childbearing potential, she agrees to use adequate contraception and not become pregnant for the duration of the study.

Exclusion Criteria:

  • Pneumonia within 3 years prior to 1st vaccination.
  • Invasive Pneumococcal Disease within 3 years prior to 1st vaccination.
  • 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 or participation to another pharmaceutical/vaccine study.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccines, with the exception of the influenza vaccine which can be administered >14 days prior to or >14 days following each vaccine dose.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
  • History of reaction or hypersensitivity to any component of the vaccine.
  • Any serious, uncontrolled disease likely to interfere with the study as determined by history, physical examination or laboratory screening, as per the judgment of the Investigator.
  • Inflammatory processes such as known chronic infections.
  • All past or current malignancies and lymphoproliferative disorders.
  • Laboratory evidence of haematological and biochemical abnormalities.
  • Acute disease at the time of enrolment/vaccination.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • History of chronic alcohol consumption and/or drug abuse.
  • Other conditions that the principal investigator judges may interfere with study findings.
  • Previous vaccination for hepatitis B. As a portion of the subjects will be randomized to receive Engerix-B comparator, it is important that all subjects meet Engerix-B eligibility criteria.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814489

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

Locations
Sweden
GSK Investigational Site
KARLSKRONA, Sweden, SE-371 41
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GSK ( Study Director )
Study ID Numbers: 112076
Study First Received: December 23, 2008
Last Updated: December 23, 2008
ClinicalTrials.gov Identifier: NCT00814489  
Health Authority: Sweden: Medical Products Agency

Keywords provided by GlaxoSmithKline:
Non-typable Haemophilus influenzae
protein vaccine
Streptococcus pneumoniae
young adults

Study placed in the following topic categories:
Virus Diseases
Haemophilus influenzae
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
Influenza, Human
Healthy
Orthomyxoviridae Infections
Pneumonia

Additional relevant MeSH terms:
RNA Virus Infections

ClinicalTrials.gov processed this record on January 15, 2009