Group 1 for Flu

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
FluPanblok + MF59 Dose 1 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

VAM00001 is a Phase I/II, randomized, modified double-blind, multi-center study. The purpose of this study is to compare 2 dose levels of Panblok H7 (dose 1 and dose 2 of rHA) with a standard squalene dose of adjuvant MF59 to Panblok H7 (dose 3) unadjuvanted in approximately 700 adult participants in order to select one dose formulation to be used for further clinical development. The randomization ratio will be 3:3:1 for Panblok H7 (dose 1) + MF59, Panblok H7 (dose 2) + MF59, and Panblok H7 (dose 3) unadjuvanted, respectively. Each study group will be stratified into the age groups 18-64 years and ≥ 65 years of age. The study duration for each participant will be approximately 13 months.

Eligible Conditions
  • Flu

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

12 Primary · 6 Secondary · Reporting Duration: From Day 01 up to Day 387

Day 21
GMR for Group1/Group3, Group2/Group3, and Group2/Group1
Geometric Mean Titers Ratio (GMTR) for Group1/Group3, Group2/Group3, and Group2/Group1
Percentage of participants with fold-increase in NT Ab titer
Percentage of participants with seroconversion
At Day 387
Hemagglutination Inhibition Tests
Geometric Mean of individual Ratio (GMR) of NT Ab titers in participants
Percentage of participants with HAI titer above predefined threshold
Percentage of participants with detectable HAI Ab titer
Percentage of participants with detectable NT Ab titer
At Day 43
Geometric Mean Titers of Hemagglutination inhibition (HAI) Antibody (Ab) titers in participants
Geometric Mean Titers of Neutralization (NT) Ab titer in participants
Percentage of participants with NT Ab titer above predefined threshold
Day 387
Number of participants with adverse events of special interest (AESIs)
Number of participants with medically adverse events (MAAEs)
Number of participants with serious adverse events (SAEs) (including AESIs)
Day 21
Number of participants with unsolicited AEs
Day 7
Number of participants with solicited injection site and systemic reactions
Within 30 minutes after each vaccination
Number of participants with immediate adverse events (AEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

Trial Design

3 Treatment Groups

Group 3
1 of 3
Group 1
1 of 3
Group 2
1 of 3

Active Control

Experimental Treatment

700 Total Participants · 3 Treatment Groups

Primary Treatment: Group 1 · No Placebo Group · Phase 2

Group 1
Biological
Experimental Group · 1 Intervention: Panblok + MF59 Dose 1 · Intervention Types: Biological
Group 2
Biological
Experimental Group · 1 Intervention: Panblok + MF59 Dose 2 · Intervention Types: Biological
Group 3
Biological
ActiveComparator Group · 1 Intervention: Unadjuvanted Panblok Dose 3 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from day 01 up to day 387

Who is running the clinical trial?

Sanofi Pasteur, a Sanofi CompanyLead Sponsor
384 Previous Clinical Trials
4,960,163 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorMCM Vaccines B.V.
802 Previous Clinical Trials
1,633,435 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are healthy as determined by medical evaluation including medical history and physical examination.
You are of non-childbearing potential.
You are of childbearing potential and agree to use a highly effective contraceptive method or abstinence from at least 4 weeks prior to each study intervention administration until at least 12 weeks after the last study intervention administration.