A Phase 4 interventional study of rMenB+OMV NZ vaccine and Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY) in Meningitis, Meningococcal, sponsored by GlaxoSmithKline. Completed at 6 sites in 2 countries. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-17.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Other
Among 11 studies testing 4CMenB vaccine in Meningitis, Meningococcal — 1 open to participants now, 2 under way, none of them phase 3. 4CMenB vaccine · Meningitis, Meningococcal.
Among the 11 studies testing 4CMenB vaccine in Meningitis, Meningococcal, this one is the 3rd largest by enrollment, is the only one that started in 2018, is one of 4 in phase 4, and was the 8th registered.
125 studies on the registry are indexed under Meningitis, Meningococcal; 10 are open to participants now.
This study's enrollment of 1,021 is above the median of 538 across 113 interventional studies indexed under Meningitis, Meningococcal.
Browse Meningitis, Meningococcal studies →1 of the 11 studies testing 4CMenB vaccine in Meningitis, Meningococcal is open now, in 1 country. Each count lists the studies.
4CMenB vaccine: first FDA approval 2014 (Trumenba). What it is approved for, and how studies give it, is on its page →
Of the 5 Meningitis, Meningococcal studies recruiting now, 0 (0%) set no upper age limit and 5 (100%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.
This study: 18 Years to 50 Years · all sexes · healthy volunteers too.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2018.
Median enrollment 250 across the 11 interventional studies. Of the 8 that completed or were terminated, 7 (88%) have results posted.
9 of 11 have an industry lead sponsor. The 6 most frequent:
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
GlaxoSmithKline has 9 studies filed under Meningitis, Meningococcal — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 11 studies testing 4CMenB vaccine in Meningitis, Meningococcal, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female subjects of childbearing potential may be enrolled in the study, if the subject:
Exclusion Criteria:
Abnormal function of the immune system resulting from:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: rMenB+OMV NZ vaccine
Participants vaccinated intramuscularly with Menveo vaccine at Day 1 and blood samples were collected at Day -83, Day 8, and Day 151.
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.
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.
Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)
Drug page: 4CMenB vaccine
Two doses of rMenB+OMV NZ vaccine were administered intramuscularly at Day 1 and Day 61.
Also known as: Bexsero
Drug page: MenACWY
One dose of MenACWY vaccine were administered intramuscularly at Day 1.
Also known as: Menveo
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Day 61
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.
Time frame: Throughout the study period (approximately 4 years)
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).
| Milestone | rMenB+OMV NZ Group | MenACWY 1 Group | MenACWY 2 Group | MenACWY 3 Group |
|---|---|---|---|---|
| Started | 470 | 165 | 165 | 161 |
| Completed | 454 | 161 | 163 | 157 |
| Not completed | 16 | 4 | 2 | 4 |
| Withdrew: Other | 2 | 0 | 1 | 0 |
| Withdrew: Withdrawal by subject | 9 | 3 | 1 | 1 |
| Withdrew: Lost to follow-up | 5 | 0 | 0 | 3 |
| Withdrew: Adverse event | 0 | 1 | 0 | 0 |
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.
| Blood samples | rMenB+OMV NZ Group | MenACWY 1 Group |
|---|---|---|
| Number of Human Blood Samples Collected for Conversion Into Serum at Day -83 | 5578 | 1936 |
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.
| Blood samples | rMenB+OMV NZ Group | MenACWY 1 Group |
|---|---|---|
| Number of Human Blood Samples Collected for Conversion Into Serum at Day 8 | 5396 | 1907 |
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.
| Blood samples | rMenB+OMV NZ Group |
|---|---|
| Number of Human Blood Samples Collected for Conversion Into Serum at Day 98 | 5204 |
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.
| Blood samples | MenACWY 1 Group | MenACWY 2 Group | MenACWY 3 Group |
|---|---|---|---|
| Number of Human Blood Samples Collected for Conversion Into Serum at Day 151 | 1869 | 1866 | 1752 |
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.
| Blood samples | MenACWY 2 Group |
|---|---|
| Number of Human Blood Samples Collected for Conversion Into Serum at Day -60 | 1957 |
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.
| Blood samples | MenACWY 2 Group |
|---|---|
| Number of Human Blood Samples Collected for Conversion Into Serum at Day 31 | 1920 |
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.
| Blood samples | MenACWY 3 Group |
|---|---|
| Number of Human Blood Samples Collected for Conversion Into Serum at Day-30 | 1894 |
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.
| Blood samples | MenACWY 3 Group |
|---|---|
| Number of Human Blood Samples Collected for Conversion Into Serum at Day 61 | 1809 |
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.
| Participants | rMenB+OMV NZ Group | MenACWY 1 Group | MenACWY 2 Group | MenACWY 3 Group |
|---|---|---|---|---|
| Number of Participants With Atleast One Serious Adverse Events (SAEs) Related to Vaccination | 0 | 0 | 0 | 0 |
Collected over Serious Adverse Events (SAEs) were collected throughout the study period (Up to 4 years). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| rMenB+OMV NZ Group | 0/470 (0%) | 3/470 (0.6%) | — |
| MenACWY 1 Group | 0/165 (0%) | 1/165 (0.6%) | — |
| MenACWY 2 Group | 0/165 (0%) | 1/165 (0.6%) | — |
| MenACWY 3 Group | 0/161 (0%) | 0/161 (0%) | — |
| Event | rMenB+OMV NZ Group | MenACWY 1 Group | MenACWY 2 Group | MenACWY 3 Group |
|---|---|---|---|---|
| Immune thrombocytopeniaBlood and lymphatic system disorders | 0/470 | 1/165 | 0/165 | 0/161 |
| Depressed level of consciousnessNervous system disorders | 0/470 | 0/165 | 1/165 | 0/161 |
| Inguinal herniaGastrointestinal disorders | 1/470 | 0/165 | 0/165 | 0/161 |
| DepressionPsychiatric disorders | 1/470 | 0/165 | 0/165 | 0/161 |
| Adnexal torsionReproductive system and breast disorders | 1/470 | 0/165 | 0/165 | 0/161 |
| Age, Continuous(YEARS) | rMenB+OMV NZ Group | MenACWY 1 Group | MenACWY 2 Group | MenACWY 3 Group | Total |
|---|---|---|---|---|---|
| Mean | 32.8 ± 8.8 | 33.3 ± 9.1 | 33.3 ± 9.0 | 32.9 ± 8.8 | 33.0 ± 8.9 |
| Sex: Female, Male(Participants) | rMenB+OMV NZ Group | MenACWY 1 Group | MenACWY 2 Group | MenACWY 3 Group | Total |
|---|---|---|---|---|---|
| Female | 295 | 99 | 105 | 109 | 608 |
| Male | 175 | 66 | 60 | 52 | 353 |
| Race (NIH/OMB)(Participants) | rMenB+OMV NZ Group | MenACWY 1 Group | MenACWY 2 Group | MenACWY 3 Group | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 29 | 13 | 15 | 8 | 65 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 0 |
| White | 430 | 150 | 149 | 147 | 876 |
| More than one race | 9 | 2 | 1 | 6 | 18 |
| Unknown or Not Reported | 2 | 0 | 0 | 0 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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
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.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Mar 2018 to primary completion in May 2022, 50 months.
Results were first posted in Jul 2023, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: 4CMenB vaccine · MenACWY