CompletedNCT04318548Updated Mar 4, 2025Results posted

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 interventional study of Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ) and Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid) in Infections, Meningococcal, sponsored by GlaxoSmithKline. Completed at 53 sites in 2 countries. Open to participants aged 16 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-04.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 945
Allocation: Randomized
Ages: 16 Years to 18 Years
Sex: All

Study 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.

Conditions studied

Infections, Meningococcal

Browse trials for

Meningococcal Infections 219

Keywords

Meningitis
Invasive meningococcal disease
Bexsero
Menveo

In context

Meningococcal Infections

219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.

This study's enrollment of 945 is above the median of 450 across 190 interventional studies indexed under Meningococcal Infections.

Browse Meningococcal Infections studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 16 Years to 18 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.
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.

Exclusion criteria

Exclusion Criteria:

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.
- 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.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 945 participants (actual)

Study arms

Experimental
MenB+MenACWY Group
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.
Combination Product: Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ) · Biological: Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid) · Combination Product: Placebo
Experimental
MenB Group
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.
Combination Product: Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ) · Biological: Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid) · Combination Product: Placebo
Experimental
MenACWY Group
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.
Combination Product: Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ) · Biological: Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid) · Combination Product: Placebo

Interventions

Combination productMeningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ)
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.
Also known as: Bexsero
BiologicalMeningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid)
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.
Also known as: Menveo
Combination productPlacebo
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.
Also known as: NaCl, saline solution

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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 \[NHBA\]).
Time frame: 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.
Time frame: At Day 31 (1 month after the vaccination with MenACWY in MenACWY and MenB+MenACWY groups)

Secondary outcomes

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.
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
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.
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
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).
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
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).
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
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 \[NHBA\]).
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
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 \[NHBA\]).
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
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.
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
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.
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
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.
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
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.
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
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
Time frame: At 1 month after MenACWY vaccination (i.e at Day 31) relative to baseline (i.e. Day 1)

Results

Posted Mar 4, 2025

Participant flow

The study ended on Day 271 for participants who had not reached Day 271 when Protocol Amendment 7 took effect, and on Day 451 for those who had already passed Day 271. Safety follow-up period for each participant was from Day 1 up to Day 451 or Day 271 for participants who have not reached Day 271 at the time Protocol Amendment 7 took effect.

Participant flow — Overall Study
Milestone	MenB+MenACWY Group	MenB Group	MenACWY Group
Started	310	308	320
Completed	297	284	298
Not completed	13	24	22
Withdrew: Adverse event	0	0	1
Withdrew: Lost to follow-up	6	13	9
Withdrew: Protocol violation	1	0	2
Withdrew: Consent withdrawal, not due to a (s)ae	5	9	6
Withdrew: Migrated / moved from the study area	0	0	1
Withdrew: Other	1	2	3

Outcome measures

PrimaryNumber 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.

Time frame:: During 7 days after the rMenB+OMV NZ vaccination at Day 1
Reported as:: Count of participants · Participants

Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Erythema	12	12	—
Induration	14	22	—
Pain	246	247	—
Swelling	15	18	—

PrimaryNumber 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.

Time frame:: During 7 days after the rMenB+OMV NZ vaccination at Day 61
Reported as:: Count of participants · Participants

Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Erythema	17	17	8
Induration	18	19	6
Pain	240	228	238
Swelling	16	16	7

PrimaryNumber 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.

Time frame:: During 7 days after the rMenB+OMV NZ vaccination at Day 91
Reported as:: Count of participants · Participants

Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Erythema	—	—	14
Induration	—	—	11
Pain	—	—	205
Swelling	—	—	13

PrimaryNumber 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.

Time frame:: During 7 days after the MenACWY vaccination at Day 1
Reported as:: Count of participants · Participants

Number of Participants With Solicited Local AEs After the Vaccination With MenACWY
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Erythema	5	—	6
Induration	7	—	7
Pain	93	—	104
Swelling	5	—	5

PrimaryNumber 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.

Time frame:: During 7 days after the MenACWY vaccination at Day 61
Reported as:: Count of participants · Participants

Number of Participants With Solicited Local AEs After the Vaccination With MenACWY
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Erythema	—	0	—
Induration	—	0	—
Pain	—	1	—
Swelling	—	0	—

PrimaryNumber 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.

Time frame:: During 7 days after the MenACWY vaccination at Day 91
Reported as:: Count of participants · Participants

Number of Participants With Solicited Local AEs After the Vaccination With MenACWY
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Erythema	—	4	—
Induration	—	1	—
Pain	—	38	—
Swelling	—	5	—

PrimaryNumber 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.

Time frame:: During 7 days after the Placebo vaccination at Day 1
Reported as:: Count of participants · Participants

Number of Participants With Solicited Local AEs After the Vaccination With Placebo
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Erythema	—	2	2
Induration	—	5	0
Pain	—	78	77
Swelling	—	2	1

PrimaryNumber 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.

Time frame:: During 7 days after the Placebo vaccination at Day 91
Reported as:: Count of participants · Participants

Number of Participants With Solicited Local AEs After the Vaccination With Placebo
Participants	MenB+MenACWY Group	MenB Group
Erythema	1	—
Induration	1	—
Pain	25	—
Swelling	0	—

PrimaryNumber of Participants With Solicited Systemic AEs

Solicited systemic adverse events assessed are fever \[temperature \>= 38.0°C\], nausea, fatigue, myalgia, arthralgia, and headache.

Time frame:: During 7 days after the first study intervention administration occurring at Day 1
Reported as:: Count of participants · Participants

Number of Participants With Solicited Systemic AEs
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Arthralgia	24	32	24
Fatigue	114	118	108
Headache	128	135	134
Myalgia	36	49	31
Nausea	46	57	51
Fever	7	10	2

PrimaryNumber of Participants With Solicited Systemic AEs

Solicited systemic adverse events assessed are fever \[temperature \>= 38.0°C\], nausea, fatigue, myalgia, arthralgia, and headache.

Time frame:: During 7 days after the second study intervention administration occurring at Day 61
Reported as:: Count of participants · Participants

Number of Participants With Solicited Systemic AEs
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Arthralgia	28	24	27
Fatigue	96	101	88
Headache	112	103	93
Myalgia	41	42	43
Nausea	37	37	40
Fever	4	8	6

PrimaryNumber of Participants With Solicited Systemic AEs

Solicited systemic adverse events assessed are fever \[temperature \>= 38.0°C\], nausea, fatigue, myalgia, arthralgia, and headache.

Time frame:: During 7 days after the third study intervention administration occurring at Day 91
Reported as:: Count of participants · Participants

Number of Participants With Solicited Systemic AEs
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Arthralgia	7	8	24
Fatigue	38	59	86
Headache	56	53	84
Myalgia	7	16	39
Nausea	20	18	31
Fever	2	2	6

PrimaryNumber 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.

Time frame:: During 30 days after the first study intervention administration occurring at Day 1
Reported as:: Count of participants · Participants

Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)	49	54	55

PrimaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)	51	47	44

PrimaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events)	37	37	38

PrimaryNumber 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.

Time frame:: During 30 days after the first study intervention administration occurring at Day 1
Reported as:: Count of participants · Participants

Number of Participants With Any AEs/SAEs Leading to Withdrawal
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Number of Participants With Any AEs/SAEs Leading to Withdrawal	0	0	1

PrimaryNumber of Participants With Any AEs/SAEs Leading to Withdrawal

Time frame:: During 30 days after the second study intervention administration occurring at Day 61
Reported as:: Count of participants · Participants

Number of Participants With Any AEs/SAEs Leading to Withdrawal
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Number of Participants With Any AEs/SAEs Leading to Withdrawal	0	0	0

PrimaryNumber of Participants With Any AEs/SAEs Leading to Withdrawal

Time frame:: During 30 days after the third study intervention administration occurring at Day 91
Reported as:: Count of participants · Participants

Number of Participants With Any AEs/SAEs Leading to Withdrawal
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Number of Participants With Any AEs/SAEs Leading to Withdrawal	0	0	0

PrimaryNumber 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.

Time frame:: During 30 days after the first study intervention administration occurring at Day 1
Reported as:: Count of participants · Participants

Number of Participants With Any Medically Attended AEs
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Number of Participants With Any Medically Attended AEs	28	36	26

PrimaryNumber 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.

Time frame:: During 30 days after the second study intervention administration occurring at Day 61
Reported as:: Count of participants · Participants

Number of Participants With Any Medically Attended AEs
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Number of Participants With Any Medically Attended AEs	28	32	25

PrimaryNumber 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.

Time frame:: During 30 days after the third study intervention administration occurring at Day 91
Reported as:: Count of participants · Participants

Number of Participants With Any Medically Attended AEs
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Number of Participants With Any Medically Attended AEs	19	21	17

PrimaryNumber 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.

Time frame:: Throughout the study period (Day 1 to Day 271)
Reported as:: Count of participants · Participants

Number of Participants With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
SAEs	2	3	5
AEs leading to withdrawal	0	0	1
Medically attended AEs	93	103	96

PrimaryNumber 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.

Time frame:: Throughout the study period (Day 1 to Day 271)
Reported as:: Count of participants · Participants

Number of Participants Who Received rMenB+OMV NZ With Adverse Events of Special Interest (AESI)
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Number of Participants Who Received rMenB+OMV NZ With Adverse Events of Special Interest (AESI)	0	0	0

PrimaryNumber of Participants With Any SAEs and AEs Leading to Withdrawal

Time frame:: During safety follow-up (Day 271 to Day 451)
Reported as:: Count of participants · Participants

Number of Participants With Any SAEs and AEs Leading to Withdrawal
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
SAEs	0	1	2
AEs leading to withdrawal	0	0	0

PrimaryNumber of Participants Who Received rMenB+OMV NZ With AESI

Time frame:: During safety follow-up (Day 271 to Day 451)
Reported as:: Count of participants · Participants

Number of Participants Who Received rMenB+OMV NZ With AESI
Participants	MenB+MenACWY Group	MenB Group	MenACWY Group
Number of Participants Who Received rMenB+OMV NZ With AESI	0	0	0

PrimaryHuman 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 \[NHBA\]).

Time frame:: At Day 91 (1 month after the second vaccination with rMenB+OMV NZ in MenB+MenACWY and MenB groups)
Reported as:: Geometric mean · Titers

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
Titers	MenB+MenACWY Group	MenB Group
fHbp (M14459)	16.9 (14.4 to 19.8)	18.7 (15.9 to 21.9)
NadA (96217)	239.6 (202.9 to 283.0)	272.4 (231.1 to 321.0)
PorA (NZ98/254)	18.8 (15.6 to 22.6)	21.3 (17.7 to 25.6)
NHBA (M13520)	19.0 (15.6 to 23.1)	20.5 (16.9 to 24.9)

Statistical analysis

MenB+MenACWY Group vs MenB Group · ANOVA · Gmt ratio: 0.90 · 95% CI 0.77 to 1.06The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.
MenB+MenACWY Group vs MenB Group · ANOVA · Gmt ratio: 0.88 · 95% CI 0.75 to 1.04The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.
MenB+MenACWY Group vs MenB Group · ANOVA · Gmt ratio: 0.93 · 95% CI 0.76 to 1.12The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.
MenB+MenACWY Group vs MenB Group · ANOVA · Gmt ratio: 0.88 · 95% CI 0.73 to 1.06The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.

PrimaryhSBA 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.

Time frame:: At Day 31 (1 month after the vaccination with MenACWY in MenACWY and MenB+MenACWY groups)
Reported as:: Geometric mean · Titers

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
Titers	MenB+MenACWY Group	MenACWY Group
Men A	2388.8 (1977.2 to 2886.1)	2536.1 (2095.7 to 3069.1)
Men C	2075.9 (1602.5 to 2689.3)	1867.6 (1438.7 to 2424.2)
Men W	2299.3 (1902.5 to 2778.9)	2305.7 (1905.3 to 2790.4)
Men Y	2897.3 (2359.2 to 3558.3)	2802.0 (2278.3 to 3446.2)

Statistical analysis

MenB+MenACWY Group vs MenACWY Group · ANOVA · Gmt ratio: 0.94 · 95% CI 0.78 to 1.14The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.
MenB+MenACWY Group vs MenACWY Group · ANOVA · Gmt ratio: 1.11 · 95% CI 0.86 to 1.44The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.
MenB+MenACWY Group vs MenACWY Group · ANOVA · Gmt ratio: 1.00 · 95% CI 0.82 to 1.21The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.
MenB+MenACWY Group vs MenACWY Group · ANOVA · Gmt ratio: 1.03 · 95% CI 0.84 to 1.27The ratio of GMTs (MenB+MenACWY/MenACWY) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.

SecondaryhSBA 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.

Time frame:: At Day 31 (1 month after the vaccination of MenACWY in MenACWY and MenB+MenACWY groups)

Results for this outcome have not been posted.

SecondaryhSBA 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.

Time frame:: At Day 31 (1 month after first vaccination with rMenB+OMV NZ)
Reported as:: Geometric mean · Titers

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
Titers	MenB+MenACWY Group	MenB Group
fHbp (M14459)	4.3 (3.6 to 5.1)	5.6 (4.7 to 6.7)
NadA (96217)	45.2 (36.0 to 56.9)	73.4 (58.5 to 91.9)
PorA (NZ98/254)	4.2 (3.5 to 5.0)	5.6 (4.7 to 6.6)
NHBA (M13520)	6.4 (5.1 to 8.1)	8.8 (7.0 to 11.1)

Statistical analysis

MenB+MenACWY Group vs MenB Group · ANOVA · Gmt ratio: 0.76 · 95% CI 0.64 to 0.91The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.
MenB+MenACWY Group vs MenB Group · ANOVA · Gmt ratio: 0.62 · 95% CI 0.49 to 0.77The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.
MenB+MenACWY Group vs MenB Group · ANOVA · Gmt ratio: 0.73 · 95% CI 0.58 to 0.91The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.
MenB+MenACWY Group vs MenB Group · ANOVA · Gmt ratio: 0.76 · 95% CI 0.64 to 0.90The ratio of GMTs (MenB+MenACWY/MenB) and the corresponding CI is constructed by exponentiating the mean difference and the confidence limits in log10 (titer), using ANOVA with study centre included as an independent variable.

SecondaryGeometric 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).

Time frame:: At Dya 31 (1 month after first rMenB+OMV NZ vaccination) compared to the baseline (Day 1)
Reported as:: Geometric mean · Ratio

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
Ratio	MenB+MenACWY Group	MenB Group
fHbp (M14459)	1.6 (1.4 to 1.9)	2.0 (1.7 to 2.4)
NadA (96217)	5.9 (4.7 to 7.4)	9.3 (7.5 to 11.6)
PorA (NZ98/254)	1.4 (1.2 to 1.6)	1.8 (1.5 to 2.1)
NHBA (M13520)	1.8 (1.5 to 2.2)	2.3 (1.9 to 2.8)

SecondaryGMRs 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)
Reported as:: Geometric mean · Ratio

GMRs Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination
Ratio	MenB+MenACWY Group	MenB Group
fHbp (M14459)	6.4 (5.5 to 7.5)	7.0 (5.9 to 8.1)
NadA (96217)	30.7 (25.8 to 36.6)	35.1 (29.5 to 41.7)
PorA (NZ98/254)	6.0 (5.0 to 7.2)	6.9 (5.8 to 8.3)
NHBA (M13520)	5.2 (4.4 to 6.2)	5.6 (4.7 to 6.6)

SecondaryPercentage 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 \[NHBA\]).

Time frame:: At Day 31 (one month after the first rMenB+OMV NZ vaccination)
Reported as:: Number · Percentage of participants

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
Percentage of participants	MenB+MenACWY Group	MenB Group
fHbp (M14459)	32.3 (27.0 to 38.0)	44.9 (39.1 to 50.8)
NadA (96217)	77.9 (72.7 to 82.5)	85.7 (81.2 to 89.5)
PorA ( NZ98/254)	21.1 (16.6 to 26.2)	30.4 (25.2 to 36.0)
NHBA (M13520)	37.1 (31.5 to 42.9)	44.4 (38.6 to 50.3)

SecondaryPercentage 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)
Reported as:: Number · Percentage of participants

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
Percentage of participants	MenB+MenACWY Group	MenB Group
fHbp (M14459 )	92.3 (88.5 to 95.2)	92.5 (88.6 to 95.3)
NadA (96217)	99.6 (98.0 to 100)	99.6 (97.9 to 100)
PorA (NZ98/254)	83.2 (78.2 to 87.4)	85.0 (80.1 to 89.0)
NHBA (M13520)	84.2 (79.4 to 88.4)	90.2 (86.0 to 93.5)

SecondaryPercentage 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.

Time frame:: At 1 month after the first rMenB+OMV NZ vaccination (i.e at Day 31) relative to baseline (i.e. Day 1)
Reported as:: Number · Percentage of participants

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
Percentage of participants	MenB+MenACWY Group	MenB Group
fHbp (M14459)	14.7 (10.8 to 19.3)	21.0 (16.4 to 26.1)
NadA (96217)	68.9 (63.3 to 74.2)	78.4 (73.3 to 83.0)
PorA (NZ98/254)	8.9 (5.9 to 12.7)	16.4 (12.4 to 21.2)
NHBA (M13520)	17.4 (13.2 to 22.2)	25.3 (20.4 to 30.6)

SecondaryPercentage 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.

Time frame:: At 1 month after the second rMenB+OMV vaccination (i.e at Day 91) relative to baseline (i.e. Day 1)
Reported as:: Number · Percentage of participants

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
Percentage of participants	MenB+MenACWY Group	MenB Group
fHbp (M14459)	57.1 (51.0 to 63.1)	64.6 (58.5 to 70.4)
NadA (96217)	96.0 (92.9 to 98.0)	98.9 (96.7 to 99.8)
PorA (NZ98/254)	51.5 (45.4 to 57.5)	56.6 (50.4 to 62.7)
NHBA (M13520)	55.1 (49.0 to 61.2)	53.0 (46.8 to 59.1)

SecondaryPercentage 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.

Time frame:: At baseline (Day 1) and at one month after the MenACWY vaccination (i.e. Day 31)
Reported as:: Number · Percentage of participants

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
Percentage of participants	MenB+MenACWY Group	MenACWY Group
Men A, Baseline (Day 1)	28.1 (22.8 to 33.9)	30.0 (24.7 to 35.9)
Men A, Day 31	99.7 (98.1 to 100)	99.3 (97.5 to 99.9)
Men C, Baseline (Day 1)	46.3 (40.5 to 52.1)	44.4 (38.7 to 50.3)
Men C, Day 31	99.0 (97.1 to 99.8)	98.7 (96.6 to 99.6)
Men W, Baseline (Day 1)	27.4 (22.4 to 32.9)	28.4 (23.3 to 34.0)
Men W, Day 31	100 (98.8 to 100)	100 (98.8 to 100)
Men Y, Baseline (Day 1)	23.4 (18.6 to 28.7)	23.0 (18.3 to 28.2)
Men Y, Day 31	99.7 (98.1 to 100)	99.7 (98.2 to 100)

SecondaryGMRs 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.

Time frame:: At 1 month after MenACWY vaccination (i.e.at Day 31) compared to the baseline (Day 1)
Reported as:: Geometric mean · Ratio

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
Ratio	MenB+MenACWY Group	MenACWY Group
Men A	150.2 (120.1 to 187.8)	145.0 (115.4 to 182.2)
Men C	130.0 (97.7 to 173.1)	131.9 (98.8 to 176.1)
Men W	294.2 (229.0 to 378.1)	279.3 (216.6 to 360.1)
Men Y	324.3 (252.2 to 417.0)	300.0 (232.9 to 386.4)

SecondaryPercentage 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

Time frame:: At 1 month after MenACWY vaccination (i.e at Day 31) relative to baseline (i.e. Day 1)
Reported as:: Number · Percentage of participants

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
Percentage of participants	MenB+MenACWY Group	MenACWY Group
Men A	98.5 (96.1 to 99.6)	98.1 (95.6 to 99.4)
Men C	95.2 (92.1 to 97.4)	95.6 (92.6 to 97.6)
Men W	98.6 (96.5 to 99.6)	97.9 (95.6 to 99.2)
Men Y	98.6 (96.5 to 99.6)	98.3 (96.1 to 99.4)

Adverse events

Collected over Solicited AEs: collected during the 7-day follow-up after each vaccination Unsolicited AEs: collected during the 30-day follow-up after each vaccination All-cause mortality, SAEs, MAAEs, AEs leading to withdrawal, and AESIs: - For participants not reaching Day 271 by Protocol Amendment 7: from the first vaccination (Day 1) to Day 271 - For participants past Day 271 by the amendment: from the first vaccination (Day 1) to Day 451. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
MenB+MenACWY Group	0/310 (0%)	2/310 (0.6%)	293/310 (94.5%)
MenB Group	0/308 (0%)	4/308 (1.3%)	293/308 (95.1%)
MenACWY Group	0/320 (0%)	7/320 (2.2%)	289/320 (90.3%)

Most frequent serious events

Showing 10 of 12

Most frequent serious events
Event	MenB+MenACWY Group	MenB Group	MenACWY Group
Suicidal ideationPsychiatric disorders	0/310	2/308	0/320
AppendicitisInfections and infestations	0/310	1/308	0/320
HypoglycaemiaMetabolism and nutrition disorders	0/310	1/308	0/320
Lumbar vertebral fractureInjury, poisoning and procedural complications	1/310	0/308	0/320
DepressionPsychiatric disorders	1/310	0/308	0/320
Fibula fractureInjury, poisoning and procedural complications	0/310	0/308	1/320
Pain in extremityMusculoskeletal and connective tissue disorders	0/310	0/308	1/320
RhabdomyolysisMusculoskeletal and connective tissue disorders	0/310	0/308	1/320
Abortion spontaneousPregnancy, puerperium and perinatal conditions	0/310	0/308	1/320
Adjustment disorder with depressed moodPsychiatric disorders	0/310	0/308	1/320

Most frequent other events

Showing 10 of 191

Most frequent other events
Event	MenB+MenACWY Group	MenB Group	MenACWY Group
Administration site painGeneral disorders	281/310	282/308	268/320
HeadacheNervous system disorders	178/310	185/308	185/320
FatigueGeneral disorders	152/310	160/308	159/320
NauseaGastrointestinal disorders	74/310	90/308	94/320
MyalgiaMusculoskeletal and connective tissue disorders	73/310	81/308	88/320
ArthralgiaMusculoskeletal and connective tissue disorders	53/310	46/308	58/320
Administration site indurationGeneral disorders	31/310	35/308	25/320
Administration site swellingGeneral disorders	31/310	32/308	26/320
Administration site erythemaGeneral disorders	28/310	31/308	28/320
PyrexiaGeneral disorders	14/310	23/308	19/320

Baseline characteristics

Age, Continuous
Age, Continuous(years)	MenB+MenACWY Group	MenB Group	MenACWY Group	Total
Mean	16.4 ± 0.7	16.4 ± 0.7	16.5 ± 0.7	16.4 ± 0.7

Sex: Female, Male
Sex: Female, Male(Participants)	MenB+MenACWY Group	MenB Group	MenACWY Group	Total
Female	156	138	163	457
Male	154	170	157	481

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	MenB+MenACWY Group	MenB Group	MenACWY Group	Total
Hispanic or Latino	46	38	37	121
Not Hispanic or Latino	263	270	282	815
Unknown or Not Reported	1	0	1	2

Study locations

53 sites

GSK Investigational Site
Phoenix, Arizona 85238, United States
GSK Investigational Site
Bell Gardens, California 90201, United States
GSK Investigational Site
Los Angeles, California 90027, United States
GSK Investigational Site
Oakland, California 94611, United States
GSK Investigational Site
Roseville, California 95661, United States
GSK Investigational Site
Sacramento, California 95815, United States
GSK Investigational Site
San Jose, California 95119, United States
GSK Investigational Site
Santa Clara, California 95051, United States
GSK Investigational Site
Walnut Creek, California 94596, United States
GSK Investigational Site
Wellington, Florida 33470, United States
GSK Investigational Site
Boise, Idaho 83702, United States
GSK Investigational Site
Nampa, Idaho 83686, United States
GSK Investigational Site
Nampa, Idaho 83687, United States
GSK Investigational Site
Evansville, Indiana 47715, United States
GSK Investigational Site
Bardstown, Kentucky 40004, United States
GSK Investigational Site
Louisville, Kentucky 40291, United States
GSK Investigational Site
Lafayette, Louisiana 70508, United States
GSK Investigational Site
Lincoln, Nebraska 68504, United States
GSK Investigational Site
Lincoln, Nebraska 68505, United States
GSK Investigational Site
Lincoln, Nebraska 68516, United States
GSK Investigational Site
Lincoln, Nebraska 68526, United States
GSK Investigational Site
Cortland, New York 13045, United States
GSK Investigational Site
Charlotte, North Carolina 28226, United States
GSK Investigational Site
Winston-Salem, North Carolina 27103, United States
GSK Investigational Site
Corvallis, Oregon 97330, United States
GSK Investigational Site
Erie, Pennsylvania 16508, United States
GSK Investigational Site
Hermitage, Pennsylvania 16148, United States
GSK Investigational Site
Pittsburgh, Pennsylvania 15025, United States
GSK Investigational Site
Pittsburgh, Pennsylvania 15213, United States
GSK Investigational Site
Pittsburgh, Pennsylvania 15217, United States
GSK Investigational Site
Pittsburgh, Pennsylvania 15234, United States
GSK Investigational Site
Charleston, South Carolina 29414, United States
GSK Investigational Site
Sioux Falls, South Dakota 57108, United States
GSK Investigational Site
Austin, Texas 75010, United States
GSK Investigational Site
Austin, Texas 78613, United States
GSK Investigational Site
Austin, Texas 78726, United States
GSK Investigational Site
Dallas, Texas 75230-2571, United States
GSK Investigational Site
Dallas, Texas 75251, United States
GSK Investigational Site
Houston, Texas 77584, United States
GSK Investigational Site
Plano, Texas 75024, United States
GSK Investigational Site
Plano, Texas 75093, United States
GSK Investigational Site
Victoria, Texas 77901, United States
GSK Investigational Site
Waxahachie, Texas 75165, United States
GSK Investigational Site
Orem, Utah 84057, United States
GSK Investigational Site
Salt Lake City, Utah 84107, United States
GSK Investigational Site
South Jordan, Utah 84095, United States
GSK Investigational Site
Syracuse, Utah 84075, United States
GSK Investigational Site
Falls Church, Virginia 22044, United States
GSK Investigational Site
Richmond, Virginia 23294, United States
GSK Investigational Site
Chiavari GE, 16043, Italy
GSK Investigational Site
Foggia, 71122, Italy
GSK Investigational Site
Milano, 20122, Italy
GSK Investigational Site
Milano, 20162, Italy

References and documents

Study documents

Study protocol · Oct 14, 2022
Statistical analysis plan · Jun 3, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Sap, Icf, Csr

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04318548
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Mar 24, 2020
Start date: Aug 25, 2020
Primary completion: Nov 21, 2023
Completion: Nov 21, 2023
Results posted: Mar 4, 2025
Last update: Mar 4, 2025

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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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

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