Meningitis, MeningococcalPhase 4NCT03493919
A Sourcing Study to Collect Human Blood Samples From Healthy Adults
A Phase 4 study testing rMenB+OMV NZ vaccine and Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY) in people with Meningitis, Meningococcal, run by GlaxoSmithKline at 6 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningitis, Meningococcal
- What is being tested?
- rMenB+OMV NZ vaccine and Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,021 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 8 Mar 2018to 27 May 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Australia5 sites
GSK Investigational Site
Adelaide, South Australia, 5000
GSK Investigational Site
Geelong, Victoria, 3220
GSK Investigational Site
Melbourne, Victoria, 3004
GSK Investigational Site
Spearwood, Western Australia, 6163
GSK Investigational Site
Sydney, New South Wales, 2010
About this study
Official title: A Sourcing Study to Collect Human Biological (Serum) Samples From Healthy Adults
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.
- Conditions
- Meningitis, Meningococcal
- Being tested
- rMenB+OMV NZ vaccine, Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
- Keywords
- Immunological assays, Human blood donors, Meningococcal vaccination, Meningococcal disease
- Medical subject headings
- Meningitis, Meningococcal, Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rMenB+OMV NZ vaccineBiological
Also called Bexsero
Two doses of rMenB+OMV NZ vaccine were administered intramuscularly at Day 1 and Day 61.
Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)Biological
Also called Menveo
One dose of MenACWY vaccine were administered intramuscularly at Day 1.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: rMenB+OMV NZ vaccine |
| 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. Receives: Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY) |
| 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. Receives: Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY) |
| 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. Receives: Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Day 61
Secondary outcomes (1)
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.
Measured: Throughout the study period (approximately 4 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2018
- Study start8 Mar 2018
- Primary completion27 May 2022
- Study completion27 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Meningitis, MeningococcalStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,021 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493919
- Sponsor's protocol ID
- 207911
- Other IDs
- 2017-002919-33, 2017
- Status last verified
- Jul 2023
- First submitted
- 6 Feb 2018
- Last updated
- 17 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sourcing Study to Collect Human Biological (Serum) Samples From Healthy Adults
- ClinicalTrials.gov ID
- NCT03493919
- Acronym / sponsor ID
- 207911
- Conditions
- Meningitis, Meningococcal
- Keywords
- Immunological assays, Human blood donors, Meningococcal vaccination, Meningococcal disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,021 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 27 May 2022 (actual)
- First posted
- 11 Apr 2018 (actual)
- Results
- Posted 17 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| rMenB+OMV NZ Group | Experimental | Biological: rMenB+OMV NZ vaccineParticipants 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 | Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)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 | Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)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 | Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -30, Day 61, and Day 151. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rMenB+OMV NZ vaccineAlso: BexseroTwo doses of rMenB+OMV NZ vaccine were administered intramuscularly at Day 1 and Day 61. | Biological | rMenB+OMV NZ Group |
| Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)Also: MenveoOne dose of MenACWY vaccine were administered intramuscularly at Day 1. | Biological | MenACWY 1 Group, MenACWY 2 Group, MenACWY 3 Group |
Primary outcome
Number of Human Blood Samples Collected for Conversion Into Serum at Day -83
Time frame: At Day -83 [83 days before first vaccination (Day 1)]
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At Day -60 [60 days before first vaccination (Day 1)]
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
Time frame: 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
Time frame: At Day -30 [30 days before first vaccination (Day 1)]
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
Time frame: 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.
1 secondary outcome
Number of Participants With Atleast One Serious Adverse Events (SAEs) Related to Vaccination
Time frame: Throughout the study period (approximately 4 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rMenB+OMV NZ vaccine and Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY) in people with Meningitis, Meningococcal, run by GlaxoSmithKline at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Human Blood Samples Collected for Conversion Into Serum at Day -83 (time frame: At Day -83 [83 days before first vaccination (Day 1)]). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2023.