Phase 3
N=938
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
Infections, Meningococcal
Bottom Line
View on ClinicalTrials.gov: NCT04318548 ↗Enrolled (actual)
938
Serious AEs
1.4%
Results posted
Mar 2025
Primary outcome: Primary: Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ — 12; 12; 14; 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Meningococcal Group B Vaccine (GSK3536829A) (rMenB+OMV NZ) (Combination_product); Meningococcal MenACWY Conjugate Vaccine (GSK3536820A) (MenA lyo + MenCWY liquid) (Biological); Placebo (Combination_product)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ |
14; 11; 205; 13 | — |
| PRIMARY Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ |
14; 11; 205; 13 | — |
| PRIMARY Number of Participants With Solicited Local Adverse Events (AEs) After the Vaccination With rMenB+OMV NZ |
14; 11; 205; 13 | — |
| PRIMARY Number of Participants With Solicited Local AEs After the Vaccination With MenACWY |
4; 1; 38; 5 | — |
| PRIMARY Number of Participants With Solicited Local AEs After the Vaccination With MenACWY |
4; 1; 38; 5 | — |
| PRIMARY Number of Participants With Solicited Local AEs After the Vaccination With MenACWY |
4; 1; 38; 5 | — |
| PRIMARY Number of Participants With Solicited Local AEs After the Vaccination With Placebo |
1; 0; 1; 0; 25; 0 | — |
| PRIMARY Number of Participants With Solicited Local AEs After the Vaccination With Placebo |
1; 0; 1; 0; 25; 0 | — |
| PRIMARY Number of Participants With Solicited Systemic AEs |
7; 8; 24; 38; 59; 86 | — |
| PRIMARY Number of Participants With Solicited Systemic AEs |
7; 8; 24; 38; 59; 86 | — |
| PRIMARY Number of Participants With Solicited Systemic AEs |
7; 8; 24; 38; 59; 86 | — |
| PRIMARY Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events) |
37; 37; 38 | — |
| PRIMARY Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events) |
37; 37; 38 | — |
| PRIMARY Number of Participants With Any Unsolicited AEs (Including All Serious Adverse Events) |
37; 37; 38 | — |
| PRIMARY Number of Participants With Any AEs/SAEs Leading to Withdrawal |
0; 0; 0 | — |
| PRIMARY Number of Participants With Any AEs/SAEs Leading to Withdrawal |
0; 0; 0 | — |
| PRIMARY Number of Participants With Any AEs/SAEs Leading to Withdrawal |
0; 0; 0 | — |
| PRIMARY Number of Participants With Any Medically Attended AEs |
19; 21; 17 | — |
| PRIMARY Number of Participants With Any Medically Attended AEs |
19; 21; 17 | — |
| PRIMARY Number of Participants With Any Medically Attended AEs |
19; 21; 17 | — |
| PRIMARY Number of Participants With Any SAEs, AEs Leading to Withdrawal and Medically Attended AEs |
2; 3; 5; 0; 0; 1 | — |
| PRIMARY Number of Participants Who Received rMenB+OMV NZ With Adverse Events of Special Interest (AESI) |
0; 0; 0 | — |
| PRIMARY Number of Participants With Any SAEs and AEs Leading to Withdrawal |
0; 1; 2; 0; 0; 0 | — |
| PRIMARY Number of Participants Who Received rMenB+OMV NZ With AESI |
0; 0; 0 | — |
| PRIMARY 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 |
16.9; 18.7; 239.6; 272.4; 18.8; 21.3 | — |
| PRIMARY 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 |
2388.8; 2536.1; 2075.9; 1867.6; 2299.3; 2305.7 | — |
| SECONDARY hSBA Geometric Mean Concentrations (GMCs) Measured by ECL Against Each of the N. Meningitidis Serogroups After MenACWY Vaccination |
— | — |
| SECONDARY 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 |
4.3; 5.6; 45.2; 73.4; 4.2; 5.6 | — |
| SECONDARY 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 |
1.6; 2.0; 5.9; 9.3; 1.4; 1.8 | — |
| SECONDARY GMRs Against Each of the N. Meningitidis Serogroup B Strains in Both MenB+MenACWY and MenB Groups After the Second rMenB+OMV NZ Vaccination |
6.4; 7.0; 30.7; 35.1; 6.0; 6.9 | — |
| SECONDARY 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 |
32.3; 44.9; 77.9; 85.7; 21.1; 30.4 | — |
| SECONDARY 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 |
92.3; 92.5; 99.6; 99.6; 83.2; 85.0 | — |
| SECONDARY 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 |
14.7; 21.0; 68.9; 78.4; 8.9; 16.4 | — |
| SECONDARY 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 |
57.1; 64.6; 96.0; 98.9; 51.5; 56.6 | — |
| SECONDARY 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 |
28.1; 30.0; 99.7; 99.3; 46.3; 44.4 | — |
| SECONDARY 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 |
150.2; 145.0; 130.0; 131.9; 294.2; 279.3 | — |
| SECONDARY 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 |
98.5; 98.1; 95.2; 95.6; 98.6; 97.9 | — |
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.
Eligibility Criteria
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
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 stu
Data sourced from ClinicalTrials.gov (NCT04318548). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.