Trial intelligence / Profile preview

Efficacy of GSK2186877A Influenza Vaccine in Elderly

NCT00753272Phase 3

Key facts

Status: Completed
Start: Sep 2008
Primary completion: Jun 2010
Countries: 15
Sponsor: GSK
Modality: Whole Inactivated Vaccines

Drugs: GSK2186877A
Conditions: influenza

Overview

Phase 3, randomised, double-blind trial of GSK2186877A in influenza (2 arms), sponsored by GSK. Primary endpoints: Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection and Serum Hemagglutination-inhibition (HI) Antibody Titers at Day 21. Started Sep 2008; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

FluNG Group
Received GSK2186877A vaccine
Fluarix Group
Received Fluarix vaccine

Who it enrols

Adults aged 65 years or older who can comply with protocol requirements and have residence status allowing free mixing with the general community. Excludes bedridden subjects, those with recent influenza vaccination, or history of hypersensitivity to vaccine components.

Endpoints

Primary

Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B InfectionAfter Dose 1 (Nov 2008 - Apr 2009)
Serum Hemagglutination-inhibition (HI) Antibody TitersDay 21

Secondary

Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B InfectionWhole surveillance period (Nov 2008 - Apr 2010)
Number of Subjects Reporting Culture-confirmed Influenza A and/or B InfectionWhole surveillance period (Nov 2008 - Apr 2010)
Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of VaccineInfluenza peak season (Nov 2008 - Apr 2009)
Number of Subjects Reporting All-cause Death After the First Dose of VaccineInfluenza peak season (Nov 2008 - Apr 2009)
Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of VaccineInfluenza peak season (Nov 2008 - Apr 2009)
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID)Day 0 to Day 365 (Year 2)
Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs)Entire study period
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local SymptomsDays 0-6 post-vaccination (Year 2)

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