Status:
COMPLETED
Evaluation of Non-typable Haemophilus Influenzae and Pneumococcal Protein Vaccine Formulations in Young Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Streptococcus Pneumoniae
Haemophilus Influenzae
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
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. Sub...
Detailed Description
This Protocol Posting has been updated following amendment of the Protocol, January 2010. The sections impacted are: study design and study endpoints.
Eligibility Criteria
Inclusion
- 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
- 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 vaccine doses 1 and 2.
- 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.
Key Trial Info
Start Date :
January 8 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 10 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00814489
Start Date
January 8 2009
End Date
June 10 2010
Last Update
August 8 2018
Active Locations (1)
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1
GSK Investigational Site
Karlskrona, Sweden, SE-371 41