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Phase 3 N=938 Randomized Quadruple-blind Prevention

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

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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