CompletedPhase 1/2

A Study on the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine in Healthy Adolescents and Adults

United States1,440 participantsStarted 2021-06-14

Plain-language summary

The purpose of this study was to assess the safety, effectiveness, and immune response of the meningococcal combined ABCWY vaccine (GSK4023393A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups. The first time-in-human (FTIH), Phase I part of this study was conducted in healthy adults in a dose-escalating fashion with 2 formulations of the investigational MenABCWY-2Gen vaccine and served as a safety lead-in to the Phase II study. The Phase II part of the study was conducted in 2 parts: The 'formulation and schedule-finding' part followed in healthy adolescents and young adults and was designed to select the vaccine formulation and the schedule to be tested in Phase III. The 'blood sourcing' part was conducted in healthy adults in order to collect sufficient serum samples for the development of assays to be used in the MenABCWY-2Gen vaccine clinical development program.

Who can participate

Age range10 Years – 50 Years

SexALL

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Inclusion Criteria: All inclusion criteria are applicable for both study phases, except where specified otherwise. * Participants and/or participants' parent(s)/Legally Acceptable Representative(s) (LAR) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the eDiaries, return for follow-up visits). * Written or witnessed/thumb printed informed consent obtained from the participant or /parent(s)/LAR(s) of the participant prior to performance of any study specific procedure. * Written informed assent obtained from the participant (if applicable) prior to performing any study specific procedure. * Phase I only: A male or female between, and including, 18 and 40 years of age (i.e. 40 years + 364 days) at the time of the first study intervention administration. * Phase II (Formulation and Schedule-finding) only: A male or female between, and including, 10 and 25 years of age (i.e. 25 years + 364 days) at the time of the first study intervention administration. * Phase II (Sourcing) only: A male or female between, and including, 18 and 50 years of age (i.e. 50 years + 364 days) at the time of the first study intervention administration. * Participants who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine can participate in the study, if they have received it at least 4 years prior to informed consent and assent as applicable (with the exception of meningococcal…

What they're measuring

Number of Participants With Solicited Administration Site Events in Study Phase I (Safety Lead-in)

Timeframe: During the 7 days (including the day of vaccination) following vaccination at Day 1

Number of Participants With Solicited Administration Site Events in Study Phase I (Safety Lead-in)

Timeframe: During the 7 days (including the day of vaccination) following vaccination at Day 31

Number of Participants With Solicited Systemic Events in Study Phase I (Safety Lead-in)

Timeframe: During the 7 days (including the day of vaccination) following vaccination at Day 1

Number of Participants With Solicited Systemic Events in Study Phase I (Safety Lead-in)

Timeframe: During the 7 days (including the day of vaccination) following vaccination at Day 31

Number of Participants With Any Unsolicited Adverse Events (AEs), Including All Serious Adverse Events (SAEs), AEs Leading to Withdrawal and AEs of Special Interest (AESIs) in Study Phase I (Safety Lead-in)

Timeframe: During the 30 days (including the day of vaccination) following vaccination at Day 1

Number of Participants With Any Unsolicited AEs, Including All SAEs, AEs Leading to Withdrawal and AESIs in Study Phase I (Safety Lead-in)

Timeframe: During the 30 days (including the day of vaccination) following vaccination at Day 31

Trial details

NCT IDNCT04886154

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-02

Results submitted2025-01-31

View on ClinicalTrials.gov More Infections, Meningococcal trials