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GSK1557484A H5N1 Vaccine in Children 6-36 Months
NCT02719743Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2016
- Primary completion
- Feb 2018
- Countries
- 2
- Sponsor
- GSK
- Modality
- Vaccines & Immunotherapeutics
- Drugs
- influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia)
- Conditions
- Influenza A H5N1 (H5N1)
01
Overview
Phase 2, randomised, single-blind trial of influenza A (Q-Pan H5N1) virus monovalent vaccine (A/Indonesia) in Influenza A H5N1 (H5N1) (5 arms), sponsored by GSK. Primary endpoints: Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers at Day 42, Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers at Day 42 and 4 more. Started Jul 2016; status: completed.
02
Design
5 arms- Study design
- RandomizedSingle-blind
H5N1 Formulation 1
GSK1557484A Formulation 1
H5N1 Formulation 2
GSK1557484A Formulation 2
H5N1 Formulation 3
GSK1557484A Formulation 3
H5N1 Formulation 4
GSK1557484A Formulation 4
H5N1 Formulation 5
GSK1557484A Formulation 5
03
Who it enrols
Healthy children aged 6 to less than 36 months without prior H5N1 vaccination or infection, and no history of significant neurological or immune-mediated conditions.
04
Endpoints
Primary
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers
Humoral Immune Response for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers
Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Haemagglutination Inhibition (HI) Antibody Titers
Evaluation of Fever Index for A/Indonesia/05/2005 (H5N1) Strain in Terms of Vaccine-homologous Microneutralization (MN) Antibody Titers
Mean Geometric Increase (MGI) for Vaccine Homologous and Heterologous HI Antibody Titers
Secondary
Number of Seroconverted Subjects for HI Antibodies
Number of Subjects Who Were Seroprotected for HI Antibodies
Number of Subjects Reporting Solicited Local Symptoms
Number of Subjects Reporting Solicited General Symptoms
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Number of Subjects Reporting Serious Adverse Events (SAEs)
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