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Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients ≥65 Years

NCT03233217 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2022-04-04

Study results available
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Summary

This phase I/II, randomized, modified double-blind, multi-center study assessed the safety and immunogenicity of a high-dose Quadrivalent influenza vaccine (QIV-HD) in older adults (greater than or equal to \[\>=\] 65 years).

Conditions

Interventions

BIOLOGICAL

QIV-HD by IM

IM, injected into the upper arm (deltoid area)

BIOLOGICAL

QIV-SD by SC

SC, injected into the upper arm (posterior region)

BIOLOGICAL

QIV-HD by SC

SC, injection into the upper arm (posterior region)

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2017-11-28
Completion
2017-11-28
FDA Drug
Yes

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases
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 NCT03233217 on ClinicalTrials.gov