Infections, MeningococcalPhase 3NCT04318548
Study to Assess the Safety and Immunogenicity of GSK Meningococcal Group B Vaccine When Administered Concomitantly With GSK Meningococcal MenACWY Conjugate Vaccine in Healthy Subjects of 16-18 Years of Age
A Phase 3 study testing Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ) and Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid) in people with Infections, Meningococcal, run by GlaxoSmithKline at 53 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age. Read more about this study
- Who is it for?
- Ages 16 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Meningococcal
- What is being tested?
- Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ) and Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 945 participants
- Where
- 53 sitesin 2 countries
- Study dates
- 25 Aug 2020to 21 Nov 2023
- Phase
- Phase 3
- 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 16 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and participants' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
- Previous vaccination with 1 dose of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo or Menactra) at least 4 years prior to informed consent and assent as applicable.
- Written or /witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
- Written informed assent obtained from the participant (if applicable) along with informed consent from the participant's parent(s)/LAR(s) prior to performing any study specific procedure.
- A male or female between, and including, 16 and 18 years of age at the time of the first vaccination.
- Healthy participants as established by medical history and clinical examination before entering the study.
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- Female participants 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 participants of childbearing potential may be enrolled in the study if the participant:
- 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 2 months after completion of the vaccination series.
Who cannot join
- Medical conditions
- Progressive, unstable, or uncontrolled clinical conditions.
- 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) for more than 14 consecutive days within 90 days prior to study vaccination. This will mean prednisone ≥ 20 mg/day (for adult participants) or ≥ 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants, or equivalent. Inhaled and topical steroids are allowed.
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- Administration of antineoplastic or immunomodulating agents or radiotherapy within 90 days prior to informed consent.
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- History of any reaction or hypersensitivity likely to be exacerbated by any medicinal products or medical equipment whose use is foreseen in this study.
- Current or previous, confirmed, or suspected disease caused by N. meningitidis.
- Known contact to an individual with any laboratory-confirmed N. meningitidis infection within 60 days, prior to enrolment.
- History of neuroinflammatory or autoimmune condition.
- Recurrent history or un-controlled neurological disorders or seizures.
- Prior/Concomitant therapy
- Use of any investigational or non-registered product other than the study vaccine(s) during the period starting 30 days before the informed consent or planned use during the study period.
- Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 180 days before the informed consent or planned administration during the study period.
- Previous vaccination with any group B meningococcal vaccine at any time prior to informed consent and assent as applicable.
- Previous vaccination with 2 doses of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo, Menactra or MenQuadfi).
- Prior/Concurrent clinical study experience
- Participant concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product, will not be enrolled.
- Other exclusions
- Child in care.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- Any study personnel or immediate dependents, family, or household member.
Trial locations and contacts
53 sites in 2 countries.
53 sites in 2 countries
United States49 sites
GSK Investigational Site
Austin, Texas, 75010
GSK Investigational Site
Austin, Texas, 78613
GSK Investigational Site
Austin, Texas, 78726
GSK Investigational Site
Bardstown, Kentucky, 40004
GSK Investigational Site
Bell Gardens, California, 90201
GSK Investigational Site
Boise, Idaho, 83702
GSK Investigational Site
Charleston, South Carolina, 29414
GSK Investigational Site
Charlotte, North Carolina, 28226
GSK Investigational Site
Cortland, New York, 13045
GSK Investigational Site
Corvallis, Oregon, 97330
GSK Investigational Site
Dallas, Texas, 75230-2571
GSK Investigational Site
Dallas, Texas, 75251
GSK Investigational Site
Erie, Pennsylvania, 16508
GSK Investigational Site
Evansville, Indiana, 47715
GSK Investigational Site
Falls Church, Virginia, 22044
GSK Investigational Site
Hermitage, Pennsylvania, 16148
GSK Investigational Site
Houston, Texas, 77584
GSK Investigational Site
Lafayette, Louisiana, 70508
GSK Investigational Site
Lincoln, Nebraska, 68504
GSK Investigational Site
Lincoln, Nebraska, 68505
GSK Investigational Site
Lincoln, Nebraska, 68516
GSK Investigational Site
Lincoln, Nebraska, 68526
GSK Investigational Site
Los Angeles, California, 90027
GSK Investigational Site
Louisville, Kentucky, 40291
GSK Investigational Site
Nampa, Idaho, 83686
GSK Investigational Site
Nampa, Idaho, 83687
GSK Investigational Site
Oakland, California, 94611
GSK Investigational Site
Orem, Utah, 84057
GSK Investigational Site
Phoenix, Arizona, 85238
GSK Investigational Site
Pittsburgh, Pennsylvania, 15025
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213
GSK Investigational Site
Pittsburgh, Pennsylvania, 15217
GSK Investigational Site
Pittsburgh, Pennsylvania, 15234
GSK Investigational Site
Plano, Texas, 75024
GSK Investigational Site
Plano, Texas, 75093
GSK Investigational Site
Richmond, Virginia, 23294
GSK Investigational Site
Roseville, California, 95661
GSK Investigational Site
Sacramento, California, 95815
GSK Investigational Site
Salt Lake City, Utah, 84107
GSK Investigational Site
San Jose, California, 95119
GSK Investigational Site
Santa Clara, California, 95051
GSK Investigational Site
Sioux Falls, South Dakota, 57108
GSK Investigational Site
South Jordan, Utah, 84095
GSK Investigational Site
Syracuse, Utah, 84075
GSK Investigational Site
Victoria, Texas, 77901
GSK Investigational Site
Walnut Creek, California, 94596
GSK Investigational Site
Waxahachie, Texas, 75165
GSK Investigational Site
Wellington, Florida, 33470
GSK Investigational Site
Winston-Salem, North Carolina, 27103
Italy4 sites
GSK Investigational Site
Chiavari GE, 16043
GSK Investigational Site
Foggia, 71122
GSK Investigational Site
Milan, 20122
GSK Investigational Site
Milan, 20162
About this study
Official title: A Phase IIIB, Randomized, Observer-blind, Multicenter Study to Assess the Safety and Immunogenicity of GSK's Meningococcal Group B Vaccine When Administered Concomitantly With GSK's Meningococcal MenACWY Conjugate Vaccine to Healthy Subjects of 16-18 Years of Age
The purpose of this study is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.
- Conditions
- Infections, Meningococcal
- Being tested
- Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ), Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid), Placebo
- Keywords
- Meningitis, Invasive meningococcal disease, Bexsero, Menveo
- Medical subject headings
- Meningococcal Infections, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ)Combination product
Also called Bexsero
1 dose of rMenB+OMV administered intramuscularly at day 1 and 61 to participants in MenB+MenACWY group and MenB group and as 1 dose at day 91 to participants in MenACWY group.
Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid)Biological
Also called Menveo
1 dose of MenACWY administered intramuscularly at day 1 to participants in MenB+MenACWY group and MenACWY group, 1 dose at day 91 to participants for MenB group.
PlaceboCombination product
Also called NaCl, saline solution
1 dose of Placebo administered intramuscularly at 1 to participants in MenB group and MenACWY group and as 1 dose at day 91 to participants in MenB+MenACWY group.
| Study group | Role | What they receive |
|---|---|---|
| MenB+MenACWY Group | Experimental | Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91. Receives: Combination Product: Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ); Biological: Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid); Combination Product: Placebo |
| MenB Group | Experimental | Participants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91. Receives: Combination Product: Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ); Biological: Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid); Combination Product: Placebo |
| MenACWY Group | Experimental | Participants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91. Receives: Combination Product: Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ); Biological: Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid); Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ
Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.
Measured: During 7 days after the rMenB+OMV NZ vaccination at Day 1
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ
Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.
Measured: During 7 days after the rMenB+OMV NZ vaccination at Day 61
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ
Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.
Measured: During 7 days after the rMenB+OMV NZ vaccination at Day 91
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY
Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade.
Measured: During 7 days after the MenACWY vaccination at Day 1
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY
Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade.
Measured: During 7 days after the MenACWY vaccination at Day 61
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY
Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade.
Measured: During 7 days after the MenACWY vaccination at Day 91
Number of Participants With Solicited Local AEs After the Vaccination With Placebo
Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.
Measured: During 7 days after the Placebo vaccination at Day 1
Number of Participants With Solicited Local AEs After the Vaccination With Placebo
Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.
Measured: During 7 days after the Placebo vaccination at Day 91
Number of Participants With Solicited Systemic AEs
Solicited systemic adverse events assessed are fever [temperature >= 38.0°C], nausea, fatigue, myalgia, arthralgia, and headache.
Measured: During 7 days after the first study intervention administration occurring at Day 1
Number of Participants With Solicited Systemic AEs
Solicited systemic adverse events assessed are fever [temperature >= 38.0°C], nausea, fatigue, myalgia, arthralgia, and headache.
Measured: During 7 days after the second study intervention administration occurring at Day 61
Number of Participants With Solicited Systemic AEs
Solicited systemic adverse events assessed are fever [temperature >= 38.0°C], nausea, fatigue, myalgia, arthralgia, and headache.
Measured: During 7 days after the third study intervention administration occurring at Day 91
Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)
Unsolicited adverse events are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject.
Measured: During 30 days after the first study intervention administration occurring at Day 1
Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)
Unsolicited adverse events are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject.
Measured: During 30 days after the second study intervention administration occurring at Day 61
Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)
Unsolicited adverse events are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject.
Measured: During 30 days after the third study intervention administration occurring at Day 91
Number of Participants With Any AEs/SAEs Leading to Withdrawal
Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact.
Measured: During 30 days after the first study intervention administration occurring at Day 1
Number of Participants With Any AEs/SAEs Leading to Withdrawal
Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact.
Measured: During 30 days after the second study intervention administration occurring at Day 61
Number of Participants With Any AEs/SAEs Leading to Withdrawal
Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact.
Measured: During 30 days after the third study intervention administration occurring at Day 91
Number of Participants With Any Medically Attended AEs
Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.
Measured: During 30 days after the first study intervention administration occurring at Day 1
Number of Participants With Any Medically Attended AEs
Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.
Measured: During 30 days after the second study intervention administration occurring at Day 61
Number of Participants With Any Medically Attended AEs
Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.
Measured: During 30 days after the third study intervention administration occurring at Day 91
Number of Participants With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs
SAEs, AEs leading to withdrawal and medically attended AEs were assessed throughout the study period are reported in this outcome measure.
Measured: Throughout the study period (Day 1 to Day 271)
Number of Participants Who Received rMenB+OMV NZ With Adverse Events of Special Interest (AESI)
AESIs are predefined (serious or non-serious) adverse events of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.
Measured: Throughout the study period (Day 1 to Day 271)
Number of Participants With Any SAEs and AEs Leading to Withdrawal
Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact.
Measured: During safety follow-up (Day 271 to Day 451)
Number of Participants Who Received rMenB+OMV NZ With AESI
AESIs are predefined (serious or non-serious) adverse events of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.
Measured: During safety follow-up (Day 271 to Day 451)
Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at 1 Month After the Second Vaccination With rMenB+OMV NZ (Groups MenB+MenACWY and MenB), and Between-group GMT Ratios
hSBA titers were measured by serum bactericidal assay and expressed as Geometric Mean Titers (GMTs) against N. meningitidis serogroup B indicator strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]).
Measured: At Day 91 (1 month after the second vaccination with rMenB+OMV NZ in MenB+MenACWY and MenB groups)
hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y After Vaccination With MenACWY (Groups MenB+MenACWY and MenACWY), and Between-group GMT Ratios
hSBA titers were measured by serum bactericidal assay and expressed as GMTs against each of the 4 serogroups Men A, Men C, Men W and Men Y.
Measured: At Day 31 (1 month after the vaccination with MenACWY in MenACWY and MenB+MenACWY groups)
Secondary outcomes (11)
hSBA Geometric Mean Concentrations (GMCs) Measured by ECL Against Each of the N. Meningitidis Serogroups After MenACWY Vaccination
Immune response to MenACWY given with or without rMenB+OMV NZ, as measured by ectrochemiluminescence-based multiplex (ECL) GMCs against each of the serogroups A, C, W and Y. ECL (validated assay) was used because ELISA is not validated.
Measured: At Day 31 (1 month after the vaccination of MenACWY in MenACWY and MenB+MenACWY groups)
hSBA GMTs Against Each of the Serogroup B Strains in Both MenB+MenACWY and MenB Groups After First rMenB+OMV NZ Vaccination and Between-group GMT Ratios
hSBA titers were measured by bactericidal activity against N. meningitidis serogroup B indicator strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]) and expressed in GMTs.
Measured: At Day 31 (1 month after first vaccination with rMenB+OMV NZ)
Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination
The immune response to rMenB+OMV NZ was measured by bactericidal activity against N. meningitidis serogroup B indicator strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]) in terms of GMRs (after vaccination/baseline).
Measured: At Dya 31 (1 month after first rMenB+OMV NZ vaccination) compared to the baseline (Day 1)
GMRs Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination
The immune response to rMenB+OMV NZ was measured by bactericidal activity against N. meningitidis serogroup B indicator strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]) in terms of GMRs (after vaccination/baseline).
Measured: At Day 91 (1 month after the second rMenB+OMV NZ vaccination) compared to the baseline (Day 1)
Percentage of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) for Each and All Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination
The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity in terms of participants with hSBA titers >= LLOQ against N. meningitidis serogroup B test strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]).
Measured: At Day 31 (one month after the first rMenB+OMV NZ vaccination)
Percentage of Participants With hSBA Titers >= LLOQ for Each and All of the Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination
The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity in terms of participants with hSBA titers >= LLOQ against N. meningitidis serogroup B test strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]).
Measured: At Day 91 (1 month after the second rMenB+OMV NZ vaccination)
Percentage of Participants With 4-fold Increase in hSBA Titers Relative to Baseline in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination
The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity against each of N. meningitidis serogroup B test strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]) in terms of the Four-fold increase defined as: - For a pre-vaccination titer < limit of detection (LOD), a post-vaccination titer of >= 4-fold the LOD or >= LLOQ, whichever is greater, - For a pre-vaccination titer >= LOD but <LLOQ, a post vaccination titer of at least 4-fold the LLOQ, - For a pre-vaccination titer >= LLOQ, a post vaccination titer of at least 4-fold the pre-vaccination titer.
Measured: At 1 month after the first rMenB+OMV NZ vaccination (i.e at Day 31) relative to baseline (i.e. Day 1)
Percentage of Participants With 4-fold Increase in hSBA Titers Relative to Baseline in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination
The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]) in terms of the Four-fold increase defined as: - For a pre-vaccination titer <LOD, a post-vaccination titer of >= 4-fold the LOD or >= LLOQ, whichever is greater, - For a pre-vaccination titer >=LOD but <LLOQ, a post vaccination titer of at least 4-fold the LLOQ, - For a pre-vaccination titer >=LLOQ, a post vaccination titer of at least 4-fold the pre-vaccination titer.
Measured: At 1 month after the second rMenB+OMV vaccination (i.e at Day 91) relative to baseline (i.e. Day 1)
Percentage of Participants With hSBA Titers >=LLOQ for Each of the Serogroup A, C, W and Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination
The immune response to MenACWY vaccines is expressed in terms of percentage of participants with hSBA titers >=LLOQ for each of the serogroup Men A, Men C, Men W and Men Y.
Measured: At baseline (Day 1) and at one month after the MenACWY vaccination (i.e. Day 31)
GMRs Against Each of the N. Meningitidis Serogroup Men A, Men C, Men W and Men Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination
Immune response to MenACWY given with or without rMenB+OMV NZ was measured by bactericidal activity against the four serogroups Men A, Men C, Men W and Men Y in terms of GMRs at one month after MenACWY vaccination compared to the baseline at Day 1/Month 0. GMR was measured within-group.
Measured: At 1 month after MenACWY vaccination (i.e.at Day 31) compared to the baseline (Day 1)
Percentage of Participants With 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup Men A, Men C, Men W and Men Y Relative to Baseline in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination
The immune response to MenACWY vaccine is evaluated by measuring percentage of participants with 4-fold increase for the four serogroups Men A, Men C, Men W and Men Y. The Four-fold increase defined as: - For a pre-vaccination titer <LOD, a post-vaccination titer of >= 4-fold the LOD or >= LLOQ, whichever is greater, - For a pre-vaccination titer >=LOD but <LLOQ, a post vaccination titer of at least 4-fold the LLOQ, - For a pre-vaccination titer >= LLOQ, a post vaccination titer of at least 4-fold the pre-vaccination titer
Measured: At 1 month after MenACWY vaccination (i.e at Day 31) relative to baseline (i.e. Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start25 Aug 2020
- Primary completion21 Nov 2023
- Study completion21 Nov 2023
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 Infections, 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 945 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
- NCT04318548
- Sponsor's protocol ID
- 205419
- Other IDs
- 2016-003722-16, 2016
- Status last verified
- Feb 2025
- First submitted
- 20 Mar 2020
- Last updated
- 4 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIB, Randomized, Observer-blind, Multicenter Study to Assess the Safety and Immunogenicity of GSK's Meningococcal Group B Vaccine When Administered Concomitantly With GSK's Meningococcal MenACWY Conjugate Vaccine to Healthy Subjects of 16-18 Years of Age
- ClinicalTrials.gov ID
- NCT04318548
- Acronym / sponsor ID
- 205419
- Conditions
- Infections, Meningococcal
- Keywords
- Meningitis, Invasive meningococcal disease, Bexsero, Menveo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 945 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 21 Nov 2023 (actual)
- First posted
- 24 Mar 2020 (actual)
- Results
- Posted 4 Mar 2025
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 is to evaluate the immunogenicity, safety and tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MenB+MenACWY Group | Experimental | Combination Product: Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ), Biological: Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid), Combination Product: PlaceboParticipants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of MenACWY vaccine, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of placebo at Day 91. |
| MenB Group | Experimental | Combination Product: Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ), Biological: Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid), Combination Product: PlaceboParticipants received 1 dose of rMenB+OMV NZ vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day 1, 1 dose of rMenB+OMV NZ vaccine at Day 61 and 1 dose of MenACWY at Day 91. |
| MenACWY Group | Experimental | Combination Product: Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ), Biological: Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid), Combination Product: PlaceboParticipants received 1 dose of MenACWY vaccine administered concomitantly with 1 dose of placebo, as separate injections in each arm at Day1, 1 dose of rMenB+OMV NZ vaccine each administered at Day 61 and at Day 91. |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and participants' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
- Previous vaccination with 1 dose of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo or Menactra) at least 4 years prior to informed consent and assent as applicable.
- Written or /witnessed/thumb printed informed consent obtained from the participant/parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
- Written informed assent obtained from the participant (if applicable) along with informed consent from the participant's parent(s)/LAR(s) prior to performing any study specific procedure.
- A male or female between, and including, 16 and 18 years of age at the time of the first vaccination.
Key exclusion criteria (26 listed)
- Medical conditions
- Progressive, unstable, or uncontrolled clinical conditions.
- Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
- Abnormal function of the immune system resulting from:
- Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.
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 |
|---|---|---|
| Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ)Also: Bexsero1 dose of rMenB+OMV administered intramuscularly at day 1 and 61 to participants in MenB+MenACWY group and MenB group and as 1 dose at day 91 to participants in MenACWY group. | Combination product | MenACWY Group, MenB Group, MenB+MenACWY Group |
| Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid)Also: Menveo1 dose of MenACWY administered intramuscularly at day 1 to participants in MenB+MenACWY group and MenACWY group, 1 dose at day 91 to participants for MenB group. | Biological | MenACWY Group, MenB Group, MenB+MenACWY Group |
| PlaceboAlso: NaCl, saline solution1 dose of Placebo administered intramuscularly at 1 to participants in MenB group and MenACWY group and as 1 dose at day 91 to participants in MenB+MenACWY group. | Combination product | MenACWY Group, MenB Group, MenB+MenACWY Group |
Primary outcome
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ
Time frame: During 7 days after the rMenB+OMV NZ vaccination at Day 1
Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ
Time frame: During 7 days after the rMenB+OMV NZ vaccination at Day 61
Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.
Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ
Time frame: During 7 days after the rMenB+OMV NZ vaccination at Day 91
Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY
Time frame: During 7 days after the MenACWY vaccination at Day 1
Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade.
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY
Time frame: During 7 days after the MenACWY vaccination at Day 61
Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade.
Number of Participants With Solicited Local AEs After the Vaccination With MenACWY
Time frame: During 7 days after the MenACWY vaccination at Day 91
Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs= occurrence of the symptom regardless of intensity grade.
Number of Participants With Solicited Local AEs After the Vaccination With Placebo
Time frame: During 7 days after the Placebo vaccination at Day 1
Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.
Number of Participants With Solicited Local AEs After the Vaccination With Placebo
Time frame: During 7 days after the Placebo vaccination at Day 91
Solicited local adverse events assessed are injection site pain, erythema, swelling, induration. Any solicited local AEs = occurrence of the symptom regardless of intensity grade.
Number of Participants With Solicited Systemic AEs
Time frame: During 7 days after the first study intervention administration occurring at Day 1
Solicited systemic adverse events assessed are fever [temperature >= 38.0°C], nausea, fatigue, myalgia, arthralgia, and headache.
Number of Participants With Solicited Systemic AEs
Time frame: During 7 days after the second study intervention administration occurring at Day 61
Solicited systemic adverse events assessed are fever [temperature >= 38.0°C], nausea, fatigue, myalgia, arthralgia, and headache.
Number of Participants With Solicited Systemic AEs
Time frame: During 7 days after the third study intervention administration occurring at Day 91
Solicited systemic adverse events assessed are fever [temperature >= 38.0°C], nausea, fatigue, myalgia, arthralgia, and headache.
Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)
Time frame: During 30 days after the first study intervention administration occurring at Day 1
Unsolicited adverse events are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject.
Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)
Time frame: During 30 days after the second study intervention administration occurring at Day 61
Unsolicited adverse events are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject.
Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)
Time frame: During 30 days after the third study intervention administration occurring at Day 91
Unsolicited adverse events are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. Serious Adverse Events (SAEs) are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject.
Number of Participants With Any AEs/SAEs Leading to Withdrawal
Time frame: During 30 days after the first study intervention administration occurring at Day 1
Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact.
Number of Participants With Any AEs/SAEs Leading to Withdrawal
Time frame: During 30 days after the second study intervention administration occurring at Day 61
Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact.
Number of Participants With Any AEs/SAEs Leading to Withdrawal
Time frame: During 30 days after the third study intervention administration occurring at Day 91
Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact.
Number of Participants With Any Medically Attended AEs
Time frame: During 30 days after the first study intervention administration occurring at Day 1
Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.
Number of Participants With Any Medically Attended AEs
Time frame: During 30 days after the second study intervention administration occurring at Day 61
Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.
Number of Participants With Any Medically Attended AEs
Time frame: During 30 days after the third study intervention administration occurring at Day 91
Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.
Number of Participants With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs
Time frame: Throughout the study period (Day 1 to Day 271)
SAEs, AEs leading to withdrawal and medically attended AEs were assessed throughout the study period are reported in this outcome measure.
Number of Participants Who Received rMenB+OMV NZ With Adverse Events of Special Interest (AESI)
Time frame: Throughout the study period (Day 1 to Day 271)
AESIs are predefined (serious or non-serious) adverse events of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.
Number of Participants With Any SAEs and AEs Leading to Withdrawal
Time frame: During safety follow-up (Day 271 to Day 451)
Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event. Any solicited AE that has not resolved within 30 days post vaccination and is reported during clinic visits or safety follow-up calls is entered into the subject's electronic Case Report Form (eCRF) as an unsolicited AE. SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. A participant was considered a 'withdrawal' from the study when no study procedure has occurred, no follow-up has been performed and no further information has been collected for this participant from the date of withdrawal/last contact.
Number of Participants Who Received rMenB+OMV NZ With AESI
Time frame: During safety follow-up (Day 271 to Day 451)
AESIs are predefined (serious or non-serious) adverse events of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.
Human Serum Bactericidal Assay (hSBA) Geometric Mean Titers (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at 1 Month After the Second Vaccination With rMenB+OMV NZ (Groups MenB+MenACWY and MenB), and Between-group GMT Ratios
Time frame: At Day 91 (1 month after the second vaccination with rMenB+OMV NZ in MenB+MenACWY and MenB groups)
hSBA titers were measured by serum bactericidal assay and expressed as Geometric Mean Titers (GMTs) against N. meningitidis serogroup B indicator strains (M14459 [fHbp], 96217 [NadA], NZ98/254 [PorA] and M13520 [NHBA]).
hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y After Vaccination With MenACWY (Groups MenB+MenACWY and MenACWY), and Between-group GMT Ratios
Time frame: At Day 31 (1 month after the vaccination with MenACWY in MenACWY and MenB+MenACWY groups)
hSBA titers were measured by serum bactericidal assay and expressed as GMTs against each of the 4 serogroups Men A, Men C, Men W and Men Y.
11 secondary outcomes
hSBA Geometric Mean Concentrations (GMCs) Measured by ECL Against Each of the N. Meningitidis Serogroups After MenACWY Vaccination
Time frame: At Day 31 (1 month after the vaccination of MenACWY in MenACWY and MenB+MenACWY groups)
hSBA GMTs Against Each of the Serogroup B Strains in Both MenB+MenACWY and MenB Groups After First rMenB+OMV NZ Vaccination and Between-group GMT Ratios
Time frame: At Day 31 (1 month after first vaccination with rMenB+OMV NZ)
Geometric Mean Ratios (GMRs) Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination
Time frame: At Dya 31 (1 month after first rMenB+OMV NZ vaccination) compared to the baseline (Day 1)
GMRs Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination
Time frame: At Day 91 (1 month after the second rMenB+OMV NZ vaccination) compared to the baseline (Day 1)
Percentage of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) for Each and All Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination
Time frame: At Day 31 (one month after the first rMenB+OMV NZ vaccination)
Percentage of Participants With hSBA Titers >= LLOQ for Each and All of the Serogroup B Test Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination
Time frame: At Day 91 (1 month after the second rMenB+OMV NZ vaccination)
Percentage of Participants With 4-fold Increase in hSBA Titers Relative to Baseline in Both MenB+MenACWY and MenB Groups After the First rMenB+OMV NZ Vaccination
Time frame: At 1 month after the first rMenB+OMV NZ vaccination (i.e at Day 31) relative to baseline (i.e. Day 1)
Percentage of Participants With 4-fold Increase in hSBA Titers Relative to Baseline in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination
Time frame: At 1 month after the second rMenB+OMV vaccination (i.e at Day 91) relative to baseline (i.e. Day 1)
Percentage of Participants With hSBA Titers >=LLOQ for Each of the Serogroup A, C, W and Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination
Time frame: At baseline (Day 1) and at one month after the MenACWY vaccination (i.e. Day 31)
GMRs Against Each of the N. Meningitidis Serogroup Men A, Men C, Men W and Men Y in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination
Time frame: At 1 month after MenACWY vaccination (i.e.at Day 31) compared to the baseline (Day 1)
Percentage of Participants With 4-fold Increase in hSBA Titers Against Each of the N. Meningitidis Serogroup Men A, Men C, Men W and Men Y Relative to Baseline in Both MenB+MenACWY and MenACWY Groups After MenACWY Vaccination
Time frame: At 1 month after MenACWY vaccination (i.e at Day 31) relative to baseline (i.e. Day 1)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- 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
53 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ) and Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid) in people with Infections, Meningococcal, run by GlaxoSmithKline at 53 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 11 inclusion and 26 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 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 4 Mar 2025). 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 Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ (time frame: During 7 days after the rMenB+OMV NZ vaccination at Day 1). The study lists 26 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 4 Mar 2025.