CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 250 enrolled
Drug / intervention
Fluarix Tetra Vaccinebiological
Likely dose
Fluarix Tetra vaccine, single dose administered intramuscularly on day 1AI-extracted
Key inclusion· 2
  • ✓Age ≥65 years
  • ✓Able and willing to comply with protocol requirements including diary cards and follow-up visits
Key exclusion· 10
  • ✕History of severe allergic reaction (including anaphylaxis) to vaccine components, egg protein, or previous influenza vaccine dose
  • ✕Receipt of licensed vaccine, immune sera, blood products, or investigational agent within 30 days or planned during trial
  • ✕Any flu vaccine within 6 months before trial start
  • ✕Any vaccine other than flu within 30 days before trial

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05648357
NCT05648357Phase 4Completed
CompareCT.gov

A Single-arm, Open-label, Multi-center, Phase IV Trial to Evaluate the Reactogenicity, Safety, and Immunogenicity of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India

GlaxoSmithKline·interventional·Posted Dec 13, 2022·Updated Mar 28, 2025

In Brief

A Phase 4 clinical trial evaluating Fluarix Tetra Vaccine for Influenza, Human. Completed, enrolled 250 participants across 6 sites.

Detailed Summary

The purpose of this study is to gather additional evidence of the safety and immunogenicity of 1 dose of Fluarix Tetra (0.5 milliliter \[mL\]) (Northern Hemisphere (NH)2023-2024) in individuals aged 65 years and above to fulfill a post-approval condition imposed by the Indian regulatory authorities (CDSCO) for this age group in India.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Human
CountriesIndia
Collaborators--

Timeline

Phase 4CompletedFinished
2023202420252026
First PostedDec 13, 2022
Enrollment StartDec 14, 2023
Primary CompletionFeb 26, 2024
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 3.6 years ago

Interventions

Fluarix Tetra Vaccinebiological

A single dose of Fluarix Tetra vaccine administered intramuscularly (IM) on day 1.