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Virus Therapy

High-Dose Vaccine for Flu

Phase 3
Recruiting
Research Sponsored by Sanofi Pasteur, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Aged 50 to 64 years on the day of inclusion.
* Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study, approximately 180 days
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial aims to test whether a high-dose influenza vaccine is effective and safe for adults aged 50 to 64 years old.

Who is the study for?
This trial is for adults aged 50 to 64 who are in good health and can commit to the study schedule. Women must either be postmenopausal, surgically sterile, or willing to use effective contraception. Participants need a negative pregnancy test if applicable and must provide informed consent.
What is being tested?
The study compares two flu vaccines: a high-dose version versus a standard-dose one. It aims to assess how well these vaccines work (immunogenicity) and their safety in adults aged 50 through 64.
What are the potential side effects?
Possible side effects from both flu vaccines may include pain at the injection site, fatigue, headache, muscle pain, feverish feelings or actual fever, joint pain, and other mild reactions typical of influenza vaccinations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 50 and 64 years old.
Select...
I am not able to have children because I am postmenopausal or have been surgically sterilized.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout the study, approximately 180 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study, approximately 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Geometric mean titers (GMTs) against influenza vaccine antibodies (Ab)
Percentage of participants with seroconversion for influenza vaccine antibodies
Secondary study objectives
Geometric Mean of Individual Titer Ratio (GMTR)
Number of participants with adverse events of special interest (AESIs)
Number of participants with immediate adverse events (AEs)
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IIV-HDExperimental Treatment1 Intervention
Participants will receive a single intramuscular (IM) injection of IIV-HD at Day 1
Group II: IIV-SDActive Control1 Intervention
Participants will receive a single intramuscular (IM) injection of IIV-SD at Day 1

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Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
418 Previous Clinical Trials
6,107,874 Total Patients Enrolled
~589 spots leftby Jan 2025
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