Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previ… (NCT04707391) | Clinical Trial Compass
CompletedPhase 3
Immunogenicity and Safety Study of GSK's MenABCWY Vaccine in Healthy Adolescents and Adults Previously Primed With MenACWY Vaccine
United States1,250 participantsStarted 2021-01-25
Plain-language 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.
Who can participate
Age range15 Years – 25 Years
SexALL
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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:
Exclusion criteria
✕. Current or previous, confirmed or suspected disease caused by N. meningitidis.
What they're measuring
1
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
Timeframe: At 1 month after vaccination schedule (i.e., Day 211 for ABCWY group and Day 31 for ACWY group) compared to Day 1 (Baseline)
2
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
Timeframe: At 1 month after the first vaccination (i.e., Day 31) compared to Day 1 (Baseline)
3
Number of Participants With Solicited Administration Site Events Following Vaccination at Day 1 for ABCWY Group and ACWY Group
Timeframe: During the 7 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group
4
Number of Participants With Solicited Administration Site Events Following Vaccination at Day 181 for ABCWY Group
Timeframe: During the 7 days (including day of vaccination) following vaccination at Day 181 for ABCWY group
5
Number of Participants With Solicited Systemic Events Following Vaccination at Day 1 for the ABCWY Group and ACWY Group
Timeframe: During the 7 days (including day of vaccination) following vaccination at day 1 for the ABCWY group and ACWY group
✕. 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:
✕. 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.
Number of Participants With Solicited Systemic Events Following Vaccination at Day 181 for the ABCWY Group
Timeframe: During the 7 days (including day of vaccination) following vaccination at day 181 for the ABCWY group
7
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)
Timeframe: During the 30 days (including day of vaccination) following vaccination at day 1 for ABCWY group and ACWY group
8
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
Timeframe: During the 30 days (including day of vaccination) following vaccination at day 181 for ABCWY group
9
Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs
Timeframe: From Day 1 to Day 361 (throughout the study period)