Last updated: 11/07/2018 04:23:59
Evaluation of non-typable Haemophilus influenzae and pneumococcal protein vaccine formulations in young adults
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A study to evaluate GlaxoSmithKline (GSK) Biologicals’ investigational vaccination regimen in healthy young adults
Trial description: 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 2 times in an observer-blind manner with an interval of 2 months. The subjects receiving Engerix-B will receive in an open-manner a third dose of the vaccine at Month 6. The protocol posting has been updated following a protocol amendment.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of subjects with any solicited local and general symptoms
Timeframe: During a 7-day follow up period after any vaccination
Number of subjects with any unsolicited adverse events (AE)
Timeframe: During a 30-day (Days 0-29) follow up period after any vaccination
Number of subjects with any serious adverse events (SAEs)
Timeframe: From Day 0 to Day 420
Number of subjects with any biochemical laboratory abnormalities
Timeframe: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420
Number of subjects with any hematological laboratory abnormalities
Timeframe: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420.
Number of subjects with any hematological laboratory abnormalities
Timeframe: During a 7-day follow up period after vaccine dose 1 and 2 and at Days 180, 300 and 420.
Secondary outcomes:
Concentrations of antibodies against protein D (anti-PD), pneumolysin (anti-Ply) and pneumococcal histidine triad D (anti-PhtD)
Timeframe: Days 0, 30, 60, 90, 180 and 420.
Mean number of influenza-specific Cluster of Differentiation (CD) 4 T-cells.
Timeframe: Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480.
Mean number of influenza-specific Cluster of Differentiation (CD) 8 T-cells.
Timeframe: Prior to first vaccination (Day 0), at 14 days post vaccination 1 (Day 14) and 2 (Day 74) and at Day 480.
Interventions:
Biological/vaccine: GSK2231395A
Biological/vaccine: Engerix-B
Enrollment:
40
Observational study model:
Not applicable
Primary completion date:
2009-04-05
Time perspective:
Not applicable
Clinical publications:
Berglund J et al. (2014) Safety, immunogenicity, and antibody persistence following an investigational Streptococcus pneumoniae and Haemophilus influenzae triple-protein vaccine in a phase 1 randomized controlled study in healthy adults. Clin Vaccine Immunol. 21(1):56-65.
Medical condition
Streptococcus pneumoniae, Haemophilus influenzae
Product
GSK2231395A
Collaborators
Not applicable
Study date(s)
January 2009 to June 2010
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 40 years
Accepts healthy volunteers
Yes
- 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.
- Pneumonia within 3 years prior to 1st vaccination.
- Invasive Pneumococcal Disease within 3 years prior to 1st vaccination.
Inclusion and exclusion 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 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.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-04-05
Actual study completion date
2010-10-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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