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Vaccine

Instramuscular vaccine for Influenza

Phase 1 & 2
Waitlist Available
Research Sponsored by Medicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have read, understood, and signed the informed consent form (ICF) prior to participating in the study; subjects must also complete study-related procedures and communicate with the study staff at visits and by phone during the study;
Male and female subjects must be 65 years of age and older at the Vaccination visit (Visit 2);
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 up to day 28, day 29 up to day 182, and day 183 up to day 365
Awards & highlights

Study Summary

This study is evaluating whether a vaccine containing a mix of influenza virus strains is safe and effective.

Eligible Conditions
  • Influenza

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 up to day 28, day 29 up to day 182, and day 183 up to day 365
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to day 28, day 29 up to day 182, and day 183 up to day 365 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
GMTs of HI Antibody Response for Each Homologous Influenza Strain on Day 28
Geometric Mean Fold Rise (GMFR) Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 28/Day 0)
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous Influenza Strain on Day 0
+31 more
Secondary outcome measures
GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain
GMFR Measured by HI Antibody Response for Each Heterologous Influenza Strain, Stratified by Prior Influenza Vaccination Status
GMFR Measured by HI Antibody Response for Each Homologous Influenza Strain (Day 182/Day 0 and Day 365/Day 0)
+36 more

Side effects data

From 2022 Phase 1 & 2 trial • 209 Patients • NCT04622592
5%
Alcohol abuse
5%
Chronic obstructive pulmonary disease
5%
Atrial fibrillation
5%
Arthritis
5%
Osteoarthritis
5%
Asthma
5%
Type 2 diabetes mellitus
5%
Toothache
5%
Fall
5%
Headache
5%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
QVLP30+Half AS03
QVLP45+Full AS03
QVLP45+Half AS03
QVLP30 Unadjuvanted
Fluzone HD Quad
QVLP15+Full AS03
QVLP15+Half AS03
QVLP30+Full AS03

Trial Design

8Treatment groups
Experimental Treatment
Active Control
Group I: QVLP45+Half AS03Experimental Treatment1 Intervention
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Group II: QVLP45+Full AS03Experimental Treatment1 Intervention
Participants received one IM injection (total volume 0.7 mL) of 45 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Group III: QVLP30+Half AS03Experimental Treatment1 Intervention
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Group IV: QVLP30+Full AS03Experimental Treatment1 Intervention
Participants received one IM injection (total volume 0.7 mL) of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with full dose of AS03 on Day 0into the deltoid region of the non-dominant arm (if possible).
Group V: QVLP15+Half AS03Experimental Treatment1 Intervention
Participants received one IM injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent VLP Influenza Vaccine adjuvanted with half dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Group VI: QVLP15+Full AS03Experimental Treatment1 Intervention
Participants received one intramuscular (IM) injection (total volume 0.7 mL) of 15 μg/strain of the Quadrivalent virus-like particle (VLP) Influenza Vaccine adjuvanted with full dose of AS03 on Day 0 into the deltoid region of the non-dominant arm (if possible).
Group VII: QVLP30 unadjuvantedActive Control1 Intervention
Participants received one IM injection of 0.7 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine unadjuvanted on Day 0 into the deltoid region of the non-dominant arm (if possible).
Group VIII: Fluzone HD QuadActive Control1 Intervention
Participants received one IM injection of 0.7 mL of 60 μg/strain of the Fluzone high dose (HD) Quadrivalent Influenza Vaccine on Day 0 into the deltoid region of the non-dominant arm (if possible).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Instramuscular vaccine
2020
Completed Phase 2
~210

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

MedicagoLead Sponsor
18 Previous Clinical Trials
59,151 Total Patients Enrolled
Brian J Ward, MDStudy DirectorMedicago
3 Previous Clinical Trials
10,420 Total Patients Enrolled
Medical DirectorStudy DirectorMedicago
2,769 Previous Clinical Trials
8,061,991 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~48 spots leftby Mar 2025