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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01657526




Registration number
NCT01657526
Ethics application status
Date submitted
2/08/2012
Date registered
6/08/2012
Date last updated
15/05/2017

Titles & IDs
Public title
Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Non-typeable Haemophilus Influenzae (NTHI) Vaccine
Scientific title
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
Secondary ID [1] 0 0
116018
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Disorders 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A)
Treatment: Other - GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A)
Treatment: Other - Saline placebo

Experimental: Group A - Subjects in this group will receive GSK Biologicals' NTHi candidate vaccine in Step 1 of the study

Placebo comparator: Group B - Subjects in this group will receive placebo in Step 1 of the study

Experimental: Group C - Subjects in this group will receive GSK Biologicals' NTHi candidate vaccine in Step 2 of the study

Placebo comparator: Group D - Subjects in this group will receive placebo in Step 2 of the study


Treatment: Other: GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A)
Administered intramuscularly (IM) in the deltoid region of non-dominant arm

Treatment: Other: GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A)
2 doses administered IM in the deltoid region of non-dominant arm

Treatment: Other: Saline placebo
2 doses administered IM in the deltoid region of non-dominant arm
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Occurrence of solicited local and general adverse event (AE), in all subjects, in all vaccine groups
Timepoint [1] 0 0
During a 7-day follow-up period (i.e. day of vaccination and 6 subsequent days) after each vaccination.
Primary outcome [2] 0 0
Occurrence of any unsolicited AE, in all subjects, in all vaccine groups
Timepoint [2] 0 0
During a 30-day follow-up period (i.e. day of vaccination and 29 subsequent days) after each vaccination.
Primary outcome [3] 0 0
Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all vaccine groups
Timepoint [3] 0 0
At baseline (Screening visit) and after each vaccination.
Primary outcome [4] 0 0
Occurrence of any serious adverse event (SAE), in all subjects, in all vaccine groups
Timepoint [4] 0 0
From first vaccination to study conclusion (Day 420).
Primary outcome [5] 0 0
Occurrence of any potential Immune-Mediated Disease (pIMDs) in all subjects, in all vaccine groups
Timepoint [5] 0 0
From first vaccination to study conclusion (Day 420).
Secondary outcome [1] 0 0
Humoral immune response to components of the NTHi vaccine formulations, in all subjects, in all vaccine groups
Timepoint [1] 0 0
Prior to each vaccination and 30 days post each vaccination.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/11/2013
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
GSK Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01657526