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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03493919
Ethics application status
Date submitted
6/02/2018
Date registered
10/04/2018
Date last updated
13/09/2018

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
Other interventions - Bexsero
Other interventions - Menveo

Experimental: rMenB+OMV NZ Group - Approximately 510 healthy subjects vaccinated intramuscularly with Bexsero vaccine at Day 1 and Day 61 and have blood collected at Day -83, Day 8 and Day 98.

Experimental: MenACWY 1 Group - Approximately 170 healthy subjects vaccinated intramuscularly with Menveo vaccine at Day 1 and have blood collected at Day -83, Day 8 and Day 151.

Experimental: MenACWY 2 Group - Approximately 170 healthy subjects vaccinated intramuscularly with Menveo vaccine at Day 1 and have blood collected at Day -60, Day 31 and Day 151.

Experimental: MenACWY 3 Group - Approximately 170 healthy subjects vaccinated intramuscularly with Menveo vaccine at Day 1 and have blood collected at Day -30, Day 61 and Day 151.


Other interventions: Bexsero
Two doses of Bexsero will be administered on a 0,2-month schedule (Day 1 and Day 61) intramuscularly in the upper deltoid of the non-dominant arm.

Other interventions: Menveo
One dose of Menveo vaccine will be administered intramuscularly in the upper deltoid of the non-dominant arm, at Day 1.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Collection of human blood for conversion into serum. - Blood samples collected from subjects who receive Bexsero vaccine or Menveo vaccine.
Timepoint [1] 0 0
At Visit 1 (Day -83)
Primary outcome [2] 0 0
Collection of human blood for conversion into serum. . - Blood samples collected from subjects who receive Bexsero vaccine or Menveo vaccine.
Timepoint [2] 0 0
At Visit 5 (Day 8)
Primary outcome [3] 0 0
Collection of human blood for conversion into serum. - Blood samples collected from subjects who receive Bexsero vaccine.
Timepoint [3] 0 0
At Visit 8 (Day 98)
Primary outcome [4] 0 0
Collection of human blood for conversion into serum. - Blood samples collected from subjects who receive Menveo vaccine.
Timepoint [4] 0 0
At Visit 9 (Day 151)
Primary outcome [5] 0 0
Collection of human blood for conversion into serum. - Blood samples collected from subjects who receive Menveo vaccine
Timepoint [5] 0 0
At visit 2 (Day -60)
Primary outcome [6] 0 0
Collection of human blood for conversion into serum. - Blood samples collected from subjects who receive Menveo vaccine
Timepoint [6] 0 0
At Visit 6 (Day 31)
Primary outcome [7] 0 0
Collection of human blood for conversion into serum. - Blood samples collected from subjects who receive Menveo vaccine
Timepoint [7] 0 0
At visit 3 (Day -30)
Primary outcome [8] 0 0
Collection of human blood for conversion into serum. - Blood samples collected from subjects who receive Menveo vaccine
Timepoint [8] 0 0
At Visit 7 (Day 61)
Secondary outcome [1] 0 0
Assessment of the occurrence of Serious Adverse Events (SAEs) related to vaccination - An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, results in disability/incapacity in a subject or is a congenital anomaly/ birth defect in the offspring of a study subject. AE(s) considered as SAE(s) also include invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization, as per the medical or scientific judgement of the physician.
Timepoint [1] 0 0
Throughout the study period (approximately 8 months)

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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [2] 0 0
GSK Investigational Site - Geelong
Recruitment hospital [3] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [4] 0 0
GSK Investigational Site - Murdoch
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
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
The purpose of this study is to collect large volumes of matched pairs of pre- and
post-vaccination sera from healthy subjects who will be administered GlaxoSmithKline (GSK)
Biologicals' vaccine against meningitis- MenACWY vaccine (Menveo) or rMenB+OMV NZ vaccine
(Bexsero), which will serve for the development, qualification, validation and maintenance of
immunological assays and will support the preclinical research activities and clinical
development of GSK Biologicals' vaccines. The safety of the subjects given one of the 2
vaccines (Bexsero or Menveo), as per the recommended dosage and schedule will be assessed
during their participation in the study.
Trial website
https://clinicaltrials.gov/show/NCT03493919
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
US GSK Clinical Trials Call Center
Address 0 0
Country 0 0
Phone 0 0
877-379-3718
Fax 0 0
Email 0 0
GSKClinicalSupportHD@gsk.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable