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Phase 3 N=1,247 Randomized Quadruple-blind Prevention

Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine

Meningitis, Meningococcal

Enrolled (actual)
1,247
Serious AEs
2.0%
Results posted
Jul 2024
Primary outcome: Primary: Percentages of Participants With a 4-fold Rise in Human Serum Bactericidal Assay (hSBA) Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline — 95.3; 95.0; 94.5; 94.0 Percentage of Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
MenABCWY vaccine (Combination_product); Placebo (Combination_product); MenACWY vaccine (Biological); MenB vaccine (Combination_product)
Age
Pediatric, Adult · 15+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
May 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentages of Participants With a 4-fold Rise in Human Serum Bactericidal Assay (hSBA) Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline
95.3; 95.0; 94.5; 94.0; 95.6; 93.9
PRIMARY
Percentages of Participants With a 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and the Single MenACWY Vaccination, Relative to Baseline
92.5; 95.0; 94.0; 94.0; 94.3; 93.9
PRIMARY
Number of Participants With Solicited Administration Site Events Following Vaccination at Day 1 for ABCWY Group and ACWY Group
486; 191; 29; 9; 26; 13
PRIMARY
Number of Participants With Solicited Administration Site Events Following Vaccination at Day 181 for ABCWY Group
377; 31; 30; 22
PRIMARY
Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group
12; 7; 88; 75; 244; 222
PRIMARY
Number of Participants With Solicited Systemic Events Following Vaccination at Day 181 for the ABCWY Group
9; 58; 167; 67; 30; 167
PRIMARY
Number of Participants With Any Unsolicited Adverse Events (AEs) (Including All Serious Adverse Events [SAEs], AEs Leading to Withdrawal, AEs of Special Interest [AESIs] and Medically Attended AEs)
96; 93
PRIMARY
Number of Participants With Any Unsolicited Adverse Events (AEs) (Including All Serious Adverse Events [SAEs], AEs Leading to Withdrawal, AEs of Special Interest [AESIs] and Medically Attended AEs) Following Vaccination at Day 181 for ABCWY Group
72
PRIMARY
Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs
18; 7; 4; 6; 0; 4
SECONDARY
Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination
27.7; 28.8; 98.3; 98.1; 57.7; 56.2
SECONDARY
Percentages of Participants With hSBA Titers >= Lower Limit of Quantitation (LLOQ) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination
99.5; 100.0; 100.0; 100.0
SECONDARY
hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at Day 1, 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination
15.30; 16.34; 670.78; 1282.56; 31.90; 29.76
SECONDARY
hSBA Geometric Mean Titers (GMTs) Against Serogroups A, C, W, and Y at 1 Month After the Second MenABCWY Vaccination
645.24; 2350.14; 1173.61; 1130.54
SECONDARY
Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After the First MenABCWY Vaccination and After the Single MenACWY Vaccination
43.98; 76.91; 92.87; 86.36; 154.09; 150.83
SECONDARY
Geometric Mean Ratios (GMRs) Against Serogroups A, C, W, and Y at 1 Month After Second MenABCWY Vaccination
44.74; 68.33; 97.66; 82.45
SECONDARY
Percentages of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After the Second Dose of MenABCWY Vaccination
8.7; 88.5; 7.7; 95.8; 20.2; 96.3
SECONDARY
Percentages of Participants With 4-fold Rise in hSBA Titers Against Each N. Meningitidis Serogroup B Indicator Strains at 1 Month After the Second MenABCWY Vaccination
68.1; 90.1; 64.6; 45.7
SECONDARY
GMTs Against Each Serogroup B Indicator Strains at Day 1 and at 1 Month After Second MenABCWY Vaccination
2.84; 17.56; 8.62; 143.61; 3.28; 24.82
SECONDARY
GMRs Against Each Serogroup B Indicator Strains at 1 Month After Second Dose of MenABCWY Vaccination
6.29; 16.67; 7.69; 3.65

Summary

The purpose of this study was to assess immunogenicity and safety of MenABCWY vaccine in healthy adolescents and adults aged 15 to 25 years previously vaccinated with MenACWY vaccine.

Eligibility Criteria

Inclusion Criteria

  • Participants and/or participants' parents/LARs, who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits).
  • Written or witnessed/thumb printed informed consent obtained from the participant/participant's parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
  • Written or witnessed/thumb printed informed assent obtained from participants below the legal age of consent prior to performance of any study specific procedure.
  • Previous vaccination with 1 dose of MenACWY vaccine at an age of 10 years or older, with an interval of at least 4 years between the previous MenACWY vaccine and enrollment (informed consent and assent [as applicable]) into this study.
  • A male or female between, and including, 15 and 25 years of age (i.e., 25 years and 364 days) at the time of the first vaccination.
  • Healthy participants as established by medical history, physical examination, and clinical judgment of the investigator before entering into 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 intervention period and for 30 days after completion of the vaccination series.

Exclusion Criteria

  • Current or previous, confirmed or suspected disease caused by N. meningitidis.
  • Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection within 60 days of enrollment.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product.
  • Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM 197) and latex medicinal products or medical equipment whose use is foreseen in this study.
  • Progressive, unstable or uncontrolled clinical conditions
  • Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
  • Abnormal function or modification of the immune system resulting from:
  • Autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders; lupus erythematosus and associated conditions; rheumatoid arthritis and associated conditions; scleroderma and associated disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes).
  • Systemic administration of corticosteroids (oral/intravenous/intramuscular) for more than 14 consecutive days within 90 days prior to study vaccination until the following post vaccination blood sample. This will mean prednisone ≥20 mg/day (for adult participants and ≥0.5 mg/kg/day with maximum ≥20 mg/day for pediatric participants. Inhaled and topical steroids are allowed.
  • Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination.
  • Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
  • Any neuroinflammatory (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), congenital neurological conditions, encephalopathies, seizures (including all subtypes such as: absence seizures, generalized tonic-clonic seizures, partial complex seizures, partial simple seizures). History of febrile convulsions should not lead to exclusion.
  • Any other clinical condition that, in the op
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04707391). 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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