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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/NCT03493919
Registration number
NCT03493919
Ethics application status
Date submitted
6/02/2018
Date registered
11/04/2018
Date last updated
17/07/2023
Titles & IDs
Public title
A Sourcing Study to Collect Human Blood Samples From Healthy Adults
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Scientific title
A Sourcing Study to Collect Human Biological (Serum) Samples From Healthy Adults
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Secondary ID [1]
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2017-002919-33
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Secondary ID [2]
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207911
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Meningitis, Meningococcal
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Condition category
Condition code
Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - rMenB+OMV NZ vaccine
Other interventions - 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.
Other interventions: rMenB+OMV NZ vaccine
Two doses of rMenB+OMV NZ vaccine were administered intramuscularly at Day 1 and Day 61.
Other interventions: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
One dose of MenACWY vaccine were administered intramuscularly at Day 1.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Human Blood Samples Collected for Conversion Into Serum at Day -83
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Assessment method [1]
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The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. For Day -83, blood samples were collected only for rMenB+OMV NZ group and MenACWY 1 group.
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Timepoint [1]
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At Day -83 [83 days before first vaccination (Day 1)]
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Primary outcome [2]
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Number of Human Blood Samples Collected for Conversion Into Serum at Day 8
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Assessment method [2]
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The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. For Day 8, blood samples were collected only for rMenB+OMV NZ group and MenACWY 1 group.
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Timepoint [2]
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At Day 8
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Primary outcome [3]
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Number of Human Blood Samples Collected for Conversion Into Serum at Day 98
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Assessment method [3]
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The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. For Day 98, blood samples were collected only for rMenB+OMV NZ group.
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Timepoint [3]
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At Day 98
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Primary outcome [4]
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Number of Human Blood Samples Collected for Conversion Into Serum at Day 151
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Assessment method [4]
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The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. For Day 151, blood samples were collected only for MenACWY 1, 2 and 3 group.
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Timepoint [4]
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At Day 151
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Primary outcome [5]
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Number of Human Blood Samples Collected for Conversion Into Serum at Day -60
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Assessment method [5]
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The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. For Day -60, blood samples were collected only for MenACWY 2 group.
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Timepoint [5]
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At Day -60 [60 days before first vaccination (Day 1)]
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Primary outcome [6]
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Number of Human Blood Samples Collected for Conversion Into Serum at Day 31
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Assessment method [6]
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The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. For Day 31, blood samples were collected only for MenACWY 2 group.
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Timepoint [6]
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At Day 31
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Primary outcome [7]
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Number of Human Blood Samples Collected for Conversion Into Serum at Day-30
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Assessment method [7]
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The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. For Day -30, blood samples were collected only for MenACWY 3 group.
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Timepoint [7]
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At Day -30 [30 days before first vaccination (Day 1)]
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Primary outcome [8]
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Number of Human Blood Samples Collected for Conversion Into Serum at Day 61
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Assessment method [8]
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The Serum Bactericidal Assay (SBA) using human serum used to measure the induction of functional bactericidal antibodies directed against Neisseria meningitidis. To comply with local health authorities and guidelines [Australian Red Cross, 2016], blood samples were collected with the minimum interval of approximately 90 days. For Day 61, blood samples were collected only for MenACWY 3 group.
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Timepoint [8]
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At Day 61
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Secondary outcome [1]
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Number of Participants With Atleast One Serious Adverse Events (SAEs) Related to Vaccination
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Assessment method [1]
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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. Related=AE assessed by the investigator as related to the vaccination.
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Timepoint [1]
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Throughout the study period (approximately 4 years)
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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.
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/03/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/05/2022
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Sample size
Target
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Accrual to date
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Final
1021
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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GSK Investigational Site - Sydney
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Recruitment hospital [2]
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GSK Investigational Site - Adelaide
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Recruitment hospital [3]
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GSK Investigational Site - Geelong
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Recruitment hospital [4]
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GSK Investigational Site - Melbourne
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Recruitment hospital [5]
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GSK Investigational Site - Spearwood
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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3220 - Geelong
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Recruitment postcode(s) [4]
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3004 - Melbourne
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Recruitment postcode(s) [5]
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6163 - Spearwood
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Recruitment outside Australia
Country [1]
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Germany
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State/province [1]
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Bayern
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study was to collect large volumes of matched pairs of pre- and
post-vaccination sera from healthy subjects who administered GlaxoSmithKline (GSK)
Biologicals' vaccine against meningitis- MenACWY vaccine (Menveo) or rMenB+OMV NZ vaccine
(Bexsero), which serves for the development, qualification, validation, and maintenance of
immunological assays which supports the preclinical research activities and clinical
development of GSK Biologicals' vaccines. The safety of the subjects given one of the two
vaccines (Bexsero or Menveo), as per the recommended dosage and schedule were assessed during
their participation in the study.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03493919
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03493919
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