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Panblok+ MF59 Dose 1

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |Sanofi|Last Updated: Sep 24, 2025

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment581

FDA Designations

No designations recorded

Clinical trial landscape

Panblok+ MF59 Dose 1 · 1 trial · 2 indications

Phase 1 1
NCT05608005Study on Two Adjuvanted Dose Levels of Panblok H7+MF59 Compared for Immunogenicity and Safety With an Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and OlderInfluenza
COMPLETED581 Analytics
PHASE1COMPLETED
Study on Two Adjuvanted Dose Levels of Panblok H7+MF59 Compared for Immunogenicity and Safety With an Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and Older
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

Geometric Mean of Hemagglutination Inhibition (HAI) Antibody (Ab) Titer at Day 22
Day 22

The HAI antibody was measured by hemagglutination inhibition using horse red blood cells (HIH) measurement method. The 95% confidence interval (CI) was based on the Student t-distribution of log10-transformed values.

Geometric Mean of Hemagglutination Inhibition Antibody Titer at Day 43
Day 43

The HAI antibody was measured by HIH measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.

Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 22
Days 1 and 22

The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.

Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 43
Days 1 and 43

The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.

Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 202
Days 1 and 202

The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.

Geometric Mean Ratio of Hemagglutination Inhibition Antibody Titer at Day 387
Days 1 and 387

The HAI antibody was measured by HIH measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.

Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 22
Day 22

The seroconversion was defined as titer \<10 on Day 1 and post-injection titer \>=40 on Day 22 or Day 43; or defined as titer \>=10 on Day 1 and a \>=4-fold increase in titer on Day 22 or Day 43. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Percentage of Participants With Seroconversion of Hemagglutination Inhibition Antibody Titer at Day 43
Day 43

The seroconversion was defined as titer \<10 on Day 1 and post-injection titer \>=40 on Day 22 or Day 43; or defined as titer \>=10 on Day 1 and a \>=4-fold increase in titer on Day 22 or Day 43. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 1
Day 1

The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 22
Day 22

The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 43
Day 43

The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 202
Day 202

The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Percentage of Participants With Hemagglutination Inhibition Antibody Titer >=1:40 at Day 387
Day 387

The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 1
Day 1

The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 22
Day 22

The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 43
Day 43

The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 202
Day 202

The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Percentage of Participants With Detectable Hemagglutination Inhibition Antibody Titer >=1:10 at Day 387
Day 387

The HAI antibody was measured by HIH measurement method. The 95% CI for the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Geometric Mean of Neutralization Test (NT) Antibody Titer at Day 22
Day 22

The NT antibody was measured by seroneutralization (SN) measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.

Geometric Mean of Neutralization Test Antibody Titer at Day 43
Day 43

The NT antibody was measured by SN measurement method. The 95% CI was based on the Student t-distribution of log10-transformed values.

Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 22
Days 1 and 22

The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.

Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 43
Days 1 and 43

The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.

Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 202
Days 1 and 202

The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.

Geometric Mean Ratio of Neutralization Test Antibody Titer at Day 387
Days 1 and 387

The NT antibody was measured by SN measurement method. The geometric mean ratio of antibody titer at post-vaccination over pre-vaccination is reported. The 95% CI was based on the Student t-distribution of log10-transformed values.

Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 22
Day 22

The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Percentage of Participants With Neutralization Test Antibody Titer >=1:20, >=1:40, and >=1:80 at Day 43
Day 43

The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 22
Day 22

The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Percentage of Participants With >=2 and >=4 Fold Increase in Neutralization Test Antibody Titer at Day 43
Day 43

The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 1
Day 1

The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 22
Day 22

The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 43
Day 43

The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 202
Day 202

The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Percentage of Participants With Detectable Neutralization Test Antibody Titer >=1:10 at Day 387
Day 387

The NT antibody was measured by SN measurement method. The 95% CI was the single percentage was based on the Clopper-Pearson method. The percentages are rounded off to the tenth decimal place.

Secondary Endpoints

Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
Up to 30 minutes after each vaccination
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
Up to 7 days after each vaccination
Number of Participants With Unsolicited AEs
Up to 21 days after each vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTAL2 doses, 21 days apart, of Panblok H7 dose 1 + MF59
Group 2EXPERIMENTAL2 doses, 21 days apart, of Panblok H7 dose 2 + MF59
Group 3ACTIVE_COMPARATOR2 doses, 21 days apart, of Panblok H7 dose 3 unadjuvanted

Interventions

NameTypeDescription
Panblok + MF59 Dose 1BIOLOGICALPharmaceutical form: suspension for injection Route of administration: intramuscular
Panblok + MF59 Dose 2BIOLOGICALPharmaceutical form: suspension for injection Route of administration: intramuscular
Unadjuvanted Panblok Dose 3BIOLOGICALPharmaceutical form: liquid for injection Route of administration: intramuscular
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites16

Inclusion Criteria: * Aged 18 years or older on the day of inclusion * Participants who are healthy as determined by medical evaluation including medical history and physical examination * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the followi...

Countries:United States
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Frequently asked questions about Panblok+ MF59 Dose 1

What is Panblok+ MF59 Dose 1 used for?

Panblok+ MF59 Dose 1 is an investigational influenza vaccine being studied for the prevention of influenza. It is a monovalent H7 vaccine combined with the MF59 adjuvant, intended to generate an immune response against the H7 influenza strain. It is currently in Phase 1 clinical development.

Who makes Panblok+ MF59 Dose 1?

Panblok+ MF59 Dose 1 is developed by Sanofi, a multinational pharmaceutical company traded on the stock exchange under the ticker SNY. Sanofi is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in adult participants.

What phase is Panblok+ MF59 Dose 1 in?

Panblok+ MF59 Dose 1 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. A Phase 1 clinical trial has been completed to assess its safety and immune response in healthy adults.

What clinical trials is Panblok+ MF59 Dose 1 in?

Panblok+ MF59 Dose 1 was evaluated in a completed Phase 1 clinical trial with the identifier NCT05608005. This randomized, double-blind, active-controlled study enrolled 581 participants aged 18 years and older in the United States to compare two adjuvanted dose levels of Panblok H7+MF59 with an unadjuvanted dose.

Is Panblok+ MF59 Dose 1 the same as Panblok H7?

Panblok+ MF59 Dose 1 is a formulation of the Panblok H7 vaccine that includes the MF59 adjuvant. The clinical trial NCT05608005 compares adjuvanted dose levels of Panblok H7+MF59 against an unadjuvanted dose of Panblok H7, indicating they are related but distinct formulations.