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A Sourcing Study to Collect Human Blood Samples From Healthy Adults

Primary Purpose

Meningitis, Meningococcal

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
rMenB+OMV NZ vaccine
Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Meningitis, Meningococcal focused on measuring Immunological assays, Human blood donors, Meningococcal vaccination, Meningococcal disease

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

rMenB+OMV NZ Group

MenACWY 1 Group

MenACWY 2 Group

MenACWY 3 Group

Arm Description

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.

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

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

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

Outcomes

Primary Outcome Measures

Number of Human Blood Samples Collected for Conversion Into Serum at Day -83
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.
Number of Human Blood Samples Collected for Conversion Into Serum at Day 8
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.
Number of Human Blood Samples Collected for Conversion Into Serum at Day 98
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.
Number of Human Blood Samples Collected for Conversion Into Serum at Day 151
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.
Number of Human Blood Samples Collected for Conversion Into Serum at Day -60
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.
Number of Human Blood Samples Collected for Conversion Into Serum at Day 31
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.
Number of Human Blood Samples Collected for Conversion Into Serum at Day-30
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.
Number of Human Blood Samples Collected for Conversion Into Serum at Day 61
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.

Secondary Outcome Measures

Number of Participants With Atleast One 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. Related=AE assessed by the investigator as related to the vaccination.

Full Information

First Posted
February 6, 2018
Last Updated
July 12, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT03493919
Brief Title
A Sourcing Study to Collect Human Blood Samples From Healthy Adults
Official Title
A Sourcing Study to Collect Human Biological (Serum) Samples From Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 8, 2018 (Actual)
Primary Completion Date
May 27, 2022 (Actual)
Study Completion Date
May 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningitis, Meningococcal
Keywords
Immunological assays, Human blood donors, Meningococcal vaccination, Meningococcal disease

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1021 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rMenB+OMV NZ Group
Arm Type
Experimental
Arm Description
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.
Arm Title
MenACWY 1 Group
Arm Type
Experimental
Arm Description
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.
Arm Title
MenACWY 2 Group
Arm Type
Experimental
Arm Description
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -60, Day 31, and Day 151.
Arm Title
MenACWY 3 Group
Arm Type
Experimental
Arm Description
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151.
Intervention Type
Biological
Intervention Name(s)
rMenB+OMV NZ vaccine
Other Intervention Name(s)
Bexsero
Intervention Description
Two doses of rMenB+OMV NZ vaccine were administered intramuscularly at Day 1 and Day 61.
Intervention Type
Biological
Intervention Name(s)
Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
Other Intervention Name(s)
Menveo
Intervention Description
One dose of MenACWY vaccine were administered intramuscularly at Day 1.
Primary Outcome Measure Information:
Title
Number of Human Blood Samples Collected for Conversion Into Serum at Day -83
Description
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.
Time Frame
At Day -83 [83 days before first vaccination (Day 1)]
Title
Number of Human Blood Samples Collected for Conversion Into Serum at Day 8
Description
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.
Time Frame
At Day 8
Title
Number of Human Blood Samples Collected for Conversion Into Serum at Day 98
Description
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.
Time Frame
At Day 98
Title
Number of Human Blood Samples Collected for Conversion Into Serum at Day 151
Description
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.
Time Frame
At Day 151
Title
Number of Human Blood Samples Collected for Conversion Into Serum at Day -60
Description
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.
Time Frame
At Day -60 [60 days before first vaccination (Day 1)]
Title
Number of Human Blood Samples Collected for Conversion Into Serum at Day 31
Description
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.
Time Frame
At Day 31
Title
Number of Human Blood Samples Collected for Conversion Into Serum at Day-30
Description
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.
Time Frame
At Day -30 [30 days before first vaccination (Day 1)]
Title
Number of Human Blood Samples Collected for Conversion Into Serum at Day 61
Description
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.
Time Frame
At Day 61
Secondary Outcome Measure Information:
Title
Number of Participants With Atleast One Serious Adverse Events (SAEs) Related to Vaccination
Description
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.
Time Frame
Throughout the study period (approximately 4 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
GSK Investigational Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
GSK Investigational Site
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
GSK Investigational Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
GSK Investigational Site
City
Spearwood
State/Province
Western Australia
ZIP/Postal Code
6163
Country
Australia
Facility Name
GSK Investigational Site
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97070
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
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
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://clinicalstudydatarequest.com

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A Sourcing Study to Collect Human Blood Samples From Healthy Adults

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