Trials / Completed
CompletedNCT03433482
A Study to Investigate the Safety and Immunogenicity of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) Administered to Healthy Adolescents and Young Adults 10 to 40 Years of Age
Immunogenicity, Reactogenicity and Safety Study of Different Formulations of GSK Biologicals' Meningococcal ACWY Conjugate Vaccine (GSK3536820A and Menveo) When Administered to Healthy Adolescents and Young Adults 10 to 40 Years of Age
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 1,707 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 10 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
MenACWY (Menveo) is a GSK vaccine intended for protection against disease caused by meningococcal bacteria groups A, C, W and Y in infants, children and adults, licensed in more than 60 countries. The purpose of this study is to compare the immunogenicity of the currently licensed MenACWY vaccine with the investigational MenACWY liquid vaccine aged for different lengths of time by storage at 2-8ºC.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MenACWY liquid | At visit 1 (day 1), each subject will receive a single dose of the investigational MenACWY liquid vaccine (GSK3536820A) aged for approximately 24 months in Phase 1 of the study (subjects randomized to study arm ACWY\_Liq24) or vaccine aged for 30 months in Phase 2 of the study (subjects randomized to study arm ACWY\_Liq30), administered by intramuscular injection in the deltoid of the non-dominant arm. |
| BIOLOGICAL | MenACWY | At visit 1 (day 1), each subject will receive a single dose of the MenACWY vaccine in the Phase1 of the study (subjects randomized to study arm ACWY\_1) or in phase 2 of the study (subjects randomized to study arm ACWY\_2), administered by intramuscular injection in the deltoid of the non-dominant arm. |
Timeline
- Start date
- 2018-08-30
- Primary completion
- 2019-07-26
- Completion
- 2019-12-17
- First posted
- 2018-02-14
- Last updated
- 2021-02-17
- Results posted
- 2021-02-17
Locations
49 sites across 9 countries: Brazil, Estonia, Finland, France, Mexico, Russia, South Africa, Spain, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03433482. Inclusion in this directory is not an endorsement.