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Immunogenicity of Twice-annual Influenza Vaccination in Older Adults in Hong Kong

NCT02957890 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2023-12-11

No results posted yet for this study

Summary

This study evaluates the immunogenicity of adding inactivated influenza vaccine with southern hemisphere (SH) formulation to standard once-annual influenza vaccination with northern hemisphere (NH) formulation in older adults in Hong Kong over 9 years. Half of participants will receive twice-annual influenza vaccination with NH and SH formulation, while the other half will receive once-annual influenza vaccination with NH formulation and a placebo.

Conditions

  • Influenza, Human

Interventions

BIOLOGICAL

Inactivated influenza vaccine (NH formulation)

Round 1 (November): 0.5mL FluQuadri®, Sanofi Pasteur, containing 60μg antigen - 15μg for each influenza strain included - with strains recommended by the WHO for the northern hemisphere formulation

BIOLOGICAL

Inactivated influenza vaccine (SH formulation)

Round 2 (May): 0.5mL Vaxigrip®, Sanofi Pasteur, containing 45μg antigen - 15μg for each influenza strain included - with strains recommended by the WHO for the southern hemisphere formulation

BIOLOGICAL

Placebo

Round 2 (May): 0.5mL normal saline

Sponsors & Collaborators

Principal Investigators

  • Benjamin COWLING, PhD · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-18
Primary Completion
2025-09-30
Completion
2026-09-30

Countries

  • China

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02957890 on ClinicalTrials.gov