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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03493919




Registration number
NCT03493919
Ethics application status
Date submitted
6/02/2018
Date registered
11/04/2018

Titles & IDs
Public title
A Sourcing Study to Collect Human Blood Samples From Healthy Adults
Scientific title
A Sourcing Study to Collect Human Biological (Serum) Samples From Healthy Adults
Secondary ID [1] 0 0
2017-002919-33
Secondary ID [2] 0 0
207911
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Meningitis, Meningococcal 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - rMenB+OMV NZ vaccine
Treatment: Other - Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)

Experimental: rMenB+OMV NZ Group - Participants vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and blood samples were collected at Day -83, Day 8, and Day 98.

Experimental: MenACWY 1 Group - Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.

Experimental: MenACWY 2 Group - Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -60, Day 31, and Day 151.

Experimental: MenACWY 3 Group - Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.


Treatment: Other: rMenB+OMV NZ vaccine
Two doses of rMenB+OMV NZ vaccine were administered intramuscularly at Day 1 and Day 61.

Treatment: Other: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
One dose of MenACWY vaccine were administered intramuscularly at Day 1.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Human Blood Samples Collected for Conversion Into Serum at Day -83
Timepoint [1] 0 0
At Day -83 [83 days before first vaccination (Day 1)]
Primary outcome [2] 0 0
Number of Human Blood Samples Collected for Conversion Into Serum at Day 8
Timepoint [2] 0 0
At Day 8
Primary outcome [3] 0 0
Number of Human Blood Samples Collected for Conversion Into Serum at Day 98
Timepoint [3] 0 0
At Day 98
Primary outcome [4] 0 0
Number of Human Blood Samples Collected for Conversion Into Serum at Day 151
Timepoint [4] 0 0
At Day 151
Primary outcome [5] 0 0
Number of Human Blood Samples Collected for Conversion Into Serum at Day -60
Timepoint [5] 0 0
At Day -60 [60 days before first vaccination (Day 1)]
Primary outcome [6] 0 0
Number of Human Blood Samples Collected for Conversion Into Serum at Day 31
Timepoint [6] 0 0
At Day 31
Primary outcome [7] 0 0
Number of Human Blood Samples Collected for Conversion Into Serum at Day-30
Timepoint [7] 0 0
At Day -30 [30 days before first vaccination (Day 1)]
Primary outcome [8] 0 0
Number of Human Blood Samples Collected for Conversion Into Serum at Day 61
Timepoint [8] 0 0
At Day 61
Secondary outcome [1] 0 0
Number of Participants With Atleast One Serious Adverse Events (SAEs) Related to Vaccination
Timepoint [1] 0 0
Throughout the study period (approximately 4 years)

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 prior to performing any study specific procedure.
* A male or female between, and including, 18 and 50 years of age at the time of the first study visit.
* Healthy subjects as established by medical history and clinical examination before entering into the study. Healthy subjects with no medical conditions that, in the opinion of the investigator, prevents the subject from participating in the study.
* Subjects must weigh at least 110 pounds (50 kg), but not to present obesity (BMI < 32kg/m2).
* Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
* 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 1 month, after completion of the vaccination series.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Progressive, unstable or uncontrolled clinical conditions.
* Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
* Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
* Abnormal function of the immune system resulting from:

* Clinical conditions.
* Systemic administration of corticosteroids (PO/IV/IM) within 90 days prior to informed consent.
* Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
* Received immunoglobulins or any blood products within 180 days prior to informed consent.
* Received an investigational or non-registered medicinal product within 30 days prior to informed consent.
* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
* Any history of meningococcal vaccination or meningococcal and gonorrhoea diseases.
* Enrolment in any activity requiring a blood donation greater than 50 mL during the period starting 30 days before the first study visit (Day -83, Day -60 or Day -30) or for the duration of the study period.
* Administration of long-acting immune-modifying drugs at any time during the study period
* Subjects with blood disorders.
* Subjects with a history of difficulty in providing blood samples
* Any antibiotic intake 7 days prior to blood collection.
* Subjects who donated >450 mL of blood within 60 days prior to any blood collection visits.
* Subjects who lost >200 mL during a single apheresis or who lost red blood cells on more than one occasion during apheresis within the previous 60 days.
* 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
* Ongoing anaemia as indicated by haemoglobin values below the lower limit of the laboratory-specified reference range. If the finger prick method demonstrates an anaemia, no further protocol procedures will be performed, and the subject will be referred for appropriate medical management. The subject may participate in this study following therapy and evidence that the anaemia has been resolved.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* Pregnant or lactating female.
* Female planning to become pregnant or planning to discontinue contraceptive precautions.
* Any confirmed or suspected immunosuppressive or immunodeficiency condition based on medical history and physical examination
* Family history of congenital or hereditary immunodeficiency.
* Serious chronic illness.
* History of chronic alcohol consumption and/or drug abuse.

Study design
Purpose of the study
Other
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
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
8/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/05/2022
Sample size
Target
Accrual to date
Final
1021
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Sydney
Recruitment hospital [2] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [3] 0 0
GSK Investigational Site - Geelong
Recruitment hospital [4] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [5] 0 0
GSK Investigational Site - Spearwood
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide
Recruitment postcode(s) [3] 0 0
3220 - Geelong
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
6163 - Spearwood
Recruitment outside Australia
Country [1] 0 0
Germany
State/province [1] 0 0
Bayern

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD for this study will be made available via the Clinical Study Data Request site.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
Available to whom?
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://clinicalstudydatarequest.com


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03493919