- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01657526
Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Non-typeable Haemophilus Influenzae (NTHI) Vaccine
May 12, 2017 updated by: GlaxoSmithKline
An Observer-blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Non-typeable Haemophilus Influenzae (NTHi) Investigational Vaccine (GSK2838497A) in Healthy Adults
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' NTHi candidate vaccine in adults, administered for the first time in humans.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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South Australia
-
Adelaide, South Australia, Australia, 5000
- GSK Investigational Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- A male or female between, and including, 18 and 40 years of age at the time of the first vaccination.
- Healthy subjects as established by medical history, physical examination and laboratory assessment before entering into the study.
- Female subjects of non-childbearing potential may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
- has practiced adequate contraception for 30 days prior to vaccination, and
- has a negative pregnancy test on the day of vaccination, and
- has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the study period.
- 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 vaccine/product.
- Planned administration/administration of a vaccine/product not foreseen by the study protocol in the period starting 30 days before the first vaccine dose and ending 30 days after the last dose of vaccines.
- Previous vaccination with a vaccine containing NTHi antigens.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose, or equivalent. Topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccines or planned administration during the study period.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Laboratory evidence of clinically significant haematological (complete blood cell count [Red Blood Cells (RBC), White Blood Cells (WBC)], WBC differential count, platelets count and haemoglobin level) and biochemical (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], creatinine and lactate dehydrogenase [LDH]) abnormalities as per the opinion of the investigator based on the local laboratory normative data.
- Acute disease and/or fever at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- History of or current condition preventing intramuscular injection as bleeding or coagulation disorder.
- Malignancies within previous 5 years (excluding non-melanic skin cancer) and lymphoproliferative disorders.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of chronic alcohol consumption and/or drug abuse.
- Any other condition that the investigator judges may interfere with study findings.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
Subjects in this group will receive GSK Biologicals' NTHi candidate vaccine in Step 1 of the study
|
Administered intramuscularly (IM) in the deltoid region of non-dominant arm
|
Placebo Comparator: Group B
Subjects in this group will receive placebo in Step 1 of the study
|
2 doses administered IM in the deltoid region of non-dominant arm
|
Experimental: Group C
Subjects in this group will receive GSK Biologicals' NTHi candidate vaccine in Step 2 of the study
|
2 doses administered IM in the deltoid region of non-dominant arm
|
Placebo Comparator: Group D
Subjects in this group will receive placebo in Step 2 of the study
|
2 doses administered IM in the deltoid region of non-dominant arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of solicited local and general adverse event (AE), in all subjects, in all vaccine groups
Time Frame: During a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each vaccination.
|
During a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each vaccination.
|
Occurrence of any unsolicited AE, in all subjects, in all vaccine groups
Time Frame: During a 30-day follow-up period (i.e. day of vaccination and 29 subsequent days) after each vaccination.
|
During a 30-day follow-up period (i.e. day of vaccination and 29 subsequent days) after each vaccination.
|
Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all vaccine groups
Time Frame: At baseline (Screening visit) and after each vaccination.
|
At baseline (Screening visit) and after each vaccination.
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Occurrence of any serious adverse event (SAE), in all subjects, in all vaccine groups
Time Frame: From first vaccination to study conclusion (Day 420).
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From first vaccination to study conclusion (Day 420).
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Occurrence of any potential Immune-Mediated Disease (pIMDs) in all subjects, in all vaccine groups
Time Frame: From first vaccination to study conclusion (Day 420).
|
From first vaccination to study conclusion (Day 420).
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Humoral immune response to components of the NTHi vaccine formulations, in all subjects, in all vaccine groups
Time Frame: Prior to each vaccination and 30 days post each vaccination.
|
Prior to each vaccination and 30 days post each vaccination.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 8, 2012
Primary Completion (Actual)
November 25, 2013
Study Completion (Actual)
November 25, 2013
Study Registration Dates
First Submitted
August 2, 2012
First Submitted That Met QC Criteria
August 2, 2012
First Posted (Estimate)
August 6, 2012
Study Record Updates
Last Update Posted (Actual)
May 15, 2017
Last Update Submitted That Met QC Criteria
May 12, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 116018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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