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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002919-33 | EudraCT Number |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rMenB+OMV NZ Group | Experimental | 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. |
|
| MenACWY 1 Group | Experimental | Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151. |
|
| MenACWY 2 Group | Experimental | Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -60, Day 31, and Day 151. |
|
| MenACWY 3 Group | Experimental | Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rMenB+OMV NZ vaccine | Biological | Two doses of rMenB+OMV NZ vaccine were administered intramuscularly at Day 1 and Day 61. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Day -83 [83 days before first vaccination (Day 1)] |
| 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. | At Day 8 |
| 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. | At Day 98 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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:
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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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Sydney | New South Wales | 2010 | Australia | ||
| GSK Investigational Site |
IPD for this study will be made available via the Clinical Study Data Request site.
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
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.
Out of 1021 participants enrolled, 60 participants did not receive vaccination as they did not meet the eligibility criteria or withdrew from the study, therefore only 961 participants were included in the Exposed Set and started the study.
To comply with the local health authorities and guidelines [Australian Red Cross, 2016] with a minimum 90-day interval between blood draws, 3 MenACWY groups were formed to ensure blood draw at Days -83 [83 days before first vaccination (Day 1)], -60 [60 days before first vaccination (Day 1), -30 [30 days before first vaccination (Day 1), 31, 61, and 151. The rMenB+OMV NZ group was not split due to sufficient intervals between the post-vaccination blood sampling time points (Day 8 and Day 98).](streamdown:incomplete-link)
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | MenACWY 1 Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints. | Posted | Number | Blood samples | At Day -83 [83 days before first vaccination (Day 1)] | Samples | Samples |
|
Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years)
According to the pre-specified protocol, only serious adverse events and pregnancy-related events were to be collected. As no pregnancies have been reported in this study, the total number of participants at risk and affected by any other adverse events is zero.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Immune thrombocytopenia | Blood and lymphatic system disorders | MedDRA 25.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 5, 2020 | May 26, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 3, 2021 | May 26, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D008585 | Meningitis, Meningococcal |
| D008589 | Meningococcal Infections |
| ID | Term |
|---|---|
| D016920 | Meningitis, Bacterial |
| D020806 | Central Nervous System Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C570015 | 4CMenB vaccine |
| C525703 | MenACWY |
| D022401 | Meningococcal Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY) | Biological | One dose of MenACWY vaccine were administered intramuscularly at Day 1. |
|
|
| At Day 151 |
| 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. | At Day -60 [60 days before first vaccination (Day 1)] |
| 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. | At Day 31 |
| 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. | At Day -30 [30 days before first vaccination (Day 1)] |
| 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. | At Day 61 |
| Throughout the study period (approximately 4 years) |
| Adelaide |
| South Australia |
| 5000 |
| Australia |
| GSK Investigational Site | Geelong | Victoria | 3220 | Australia |
| GSK Investigational Site | Melbourne | Victoria | 3004 | Australia |
| GSK Investigational Site | Spearwood | Western Australia | 6163 | Australia |
| GSK Investigational Site | Würzburg | Bavaria | 97070 | Germany |
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Adverse Event |
|
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| YEARS |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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.
| OG001 | 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. |
|
|
| Primary | 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. | Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints. | Posted | Number | Blood samples | At Day 8 | Samples | Samples |
|
|
|
| Primary | 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. | Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints. | Posted | Number | Blood samples | At Day 98 | Samples | Samples |
|
|
|
| Primary | 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. | Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints. | Posted | Number | Blood samples | At Day 151 | Samples | Samples |
|
|
|
| Primary | 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. | Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints. | Posted | Number | Blood samples | At Day -60 [60 days before first vaccination (Day 1)] | Samples | Samples |
|
|
|
| Primary | 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. | Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints. | Posted | Number | Blood samples | At Day 31 | Samples | Samples |
|
|
|
| Primary | 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. | Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints. | Posted | Number | Blood samples | At Day -30 [30 days before first vaccination (Day 1)] | Samples | Samples |
|
|
|
| Primary | 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. | Analysis was performed on blood samples collected from exposed set, which included all participants in the enrolled set who received a study vaccination. The participants included in this outcome measure are based on the data collected at specific blood sampling timepoints. | Posted | Number | Blood samples | At Day 61 | Samples | Samples |
|
|
|
| Secondary | 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. | Analysis was performed on blood samples collected from exposed set, which included all participants subjects in the exposed set who provide safety data. | Posted | Count of Participants | Participants | Throughout the study period (approximately 4 years) |
|
|
|
| 0 |
| 470 |
| 3 |
| 470 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 165 | 1 | 165 | 0 | 0 |
| EG002 | 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. | 0 | 165 | 1 | 165 | 0 | 0 |
| EG003 | 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. | 0 | 161 | 0 | 161 | 0 | 0 |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 25.0 | Non-systematic Assessment |
|
| Adnexal torsion | Reproductive system and breast disorders | MedDRA 25.0 | Non-systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| D007239 | Infections |
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008581 | Meningitis |
| D000090862 | Neuroinflammatory Diseases |