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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Other interventions - GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A)
Other interventions - GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A)
Other interventions - 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


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

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

Other interventions: Saline placebo
2 doses administered IM in the deltoid region of non-dominant arm
Intervention code [1] 0 0
Other interventions
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
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01657526
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01657526