A Phase IIb, Randomized, Observer-Blind Study to Describe the Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents

Status: Active_not_recruiting
Location: See all (27) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The purpose of this study is to assess the safety, tolerability, and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY) vaccine (GSK3536819A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 11
Maximum Age: 14
Healthy Volunteers: t
View:

• Participants 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.

• 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) prior to performing any study specific procedure.

• A male or female between, and including, 11 and 14 years of age (i.e. 14 years + 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, hysterectomy, bilateral-salpingectomy or bilateral ovariectomy.

• Female participants of childbearing potential may be enrolled in the study, if the participant:

‣ has practiced adequate contraception for 30 days prior to first vaccination, and

⁃ has a negative pregnancy test\* on the day of vaccination, and

⁃ has agreed to follow adequate contraception for 30 days before each of the 2 subsequent vaccinations and for 30 days after each vaccination \* Urine samples for pregnancy testing will be collected from female participants of childbearing potential at Visit 1, Visit 3 and Visit 5 prior to the vaccination.

Locations
United States
Alabama
GSK Investigational Site
Birmingham
Colorado
GSK Investigational Site
Grand Junction
Washington, D.c.
GSK Investigational Site
Washington
Florida
GSK Investigational Site
Miami
GSK Investigational Site
Miami
Georgia
GSK Investigational Site
Macon
Kentucky
GSK Investigational Site
Lexington
Louisiana
GSK Investigational Site
Haughton
Montana
GSK Investigational Site
Missoula
North Carolina
GSK Investigational Site
Charlotte
Nebraska
GSK Investigational Site
Hastings
GSK Investigational Site
Lincoln
GSK Investigational Site
Omaha
New York
GSK Investigational Site
Binghamton
GSK Investigational Site
Endwell
Oregon
GSK Investigational Site
Gresham
South Carolina
GSK Investigational Site
Charleston
Tennessee
GSK Investigational Site
Kingsport
Texas
GSK Investigational Site
Galveston
GSK Investigational Site
Plano
Utah
GSK Investigational Site
Kaysville
Other Locations
Germany
GSK Investigational Site
Bramsche
GSK Investigational Site
Herxheim
GSK Investigational Site
Leipzig
GSK Investigational Site
Mannheim
GSK Investigational Site
Schoenau Am Koenigssee
GSK Investigational Site
Schweigen-rechtenbach
Time Frame
Start Date: 2021-12-29
Completion Date: 2027-02-26
Participants
Target number of participants: 300
Treatments
Experimental: ABCWY-24 Group
Participants receive 2 doses of the MenABCWY vaccine at Day 1 and Day 721, 1 dose of Placebo at Day 1441.
Experimental: ABCWY-48 Group
Participants receive 2 doses of the MenABCWY vaccine at Day 1 and Day 1441, 1 dose of Placebo at Day 721.
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov

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