Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
30
Countries
1
Sites
1
Adults seeking active immunisation against the seasonal influenza virus
To assess the impact of influenza vaccination on resident memory lymphocyte responses in the nasal mucosa and peripheral memory lymphocyte responses with respiratory tropism.
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Saint Etienne
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 2 Dec 2025 → 22 Jan 2026
- Decision date (initial)
- 2025-12-02
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Université Jean Monnet, Saint-Etienne, France · Sanofi Pasteur, Lyon, France · CHU de Saint-Etienne, France
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess the impact of influenza vaccination on resident memory lymphocyte responses in the nasal mucosa and peripheral memory lymphocyte responses with respiratory tropism.
Secondary objectives 2
- Determining resident nasal and peripheral respiratory memory signatures before and after an influenza vaccine booster
- At each visit, correlate the nasal resident memory signature and the peripheral respiratory tropism memory signature with the mucosal and systemic humoral response, as well as the systemic cellular response and transcriptome signature.
Conditions and MedDRA coding
Adults seeking active immunisation against the seasonal influenza virus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | LLT | 10016794 | Flu vaccination | 10042613 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-519293-39-00 | Impact of influenza vaccination on nasal resident memory immune responses and respiratory peripheral memory immune responses - MUCOVAC 2 | Centre Hospitalier Universitaire De Saint Etienne |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Having decided to have a flu vaccination
- Having signed the consent form for participation in the study
Exclusion criteria 9
- History of recurrent nosebleeds or systemic haemorrhages
- Accident or surgery that altered the ENT sphere, including the nasal cavity
- On anti-coagulant therapy
- Severe respiratory infection in the last 6 months requiring hospitalisation
- Immunosuppressed or on immunosuppressive therapy
- Persons deprived of their liberty
- Persons under guardianship or curatorship
- Having received a vaccination in the last 30 days
- Pregnant or breast-feeding women
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Frequency of resident memory lymphocytes in the nasal mucosa and expression rate of migration markers towards the respiratory mucosa on peripheral memory lymphocytes before and after intramuscular influenza vaccination: variation in frequency between before and after vaccination
Secondary endpoints 2
- The frequencies of resident memory T and B lymphocytes in the nasal cavity and the percentage of migration markers specific to the respiratory mucosa expressed on peripheral memory T and B lymphocytes.
- Correlation coefficients between the frequency of nasal resident memory lymphocytes, the percentage of migration markers expressed on peripheral memory lymphocytes, as well as anti-Influenza titers and Influenza neutralising antibody titers in mucosa and serum, the systemic cellular response specific to Influenza and the percentage of expression of genes involved in the systemic immune response.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD4385781 · Product
- Active substance
- BPHUKET30732013-LIKE Virus (BPHUKET30732013, Wild Type)
- Substance synonyms
- B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE), B/Phuket/3073/2013-like strain (B/Yamagata/16/88 lineage) (B/Phuket/3073/2013, wild type)
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 0.5 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BB02 — INFLUENZA, PURIFIED ANTIGEN
- Marketing authorisation
- 34009 300 677 2 7
- MA holder
- SANOFI WINTHROP INDUSTRIE
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11784070 · Product
- Active substance
- BAUSTRIA13594172021-LIKE Strain (BSINGAPOREWUH46182021)
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 0.5 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BB02 — INFLUENZA, PURIFIED ANTIGEN
- Marketing authorisation
- EU/1/24/1879/001
- MA holder
- SEQIRUS NETHERLANDS B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD5372696 · Product
- Active substance
- BPHUKET30732013-LIKE Virus (BPHUKET30732013, Wild Type)
- Substance synonyms
- B/PHUKET/3073/2013-LIKE STRAIN (B/PHUKET/3073/2013, WILD TYPE), B/Phuket/3073/2013-like strain (B/Yamagata/16/88 lineage) (B/Phuket/3073/2013, wild type)
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.5 ml millilitre(s)
- Max total dose
- 0.5 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BB02 — INFLUENZA, PURIFIED ANTIGEN
- Marketing authorisation
- 34009 301 177 1 2
- MA holder
- VIATRIS MEDICAL
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Saint Etienne
- Sponsor organisation
- Centre Hospitalier Universitaire De Saint Etienne
- Address
- St Priest En Jarez, 25 Boulevard Pasteur 25 Boulevard Pasteur
- City
- St Etienne Cedex 2
- Postcode
- 42055
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Saint Etienne
- Contact name
- Elisabeth BOTELHO-NEVERS
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Saint Etienne
- Contact name
- Elisabeth BOTELHO-NEVERS
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Saint Etienne
Infectiology, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2025-12-02 | 2026-01-22 | 2025-12-05 | 2025-12-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_PROTOCOLE_2025-521217-46-00 | 1.1 |
| Protocol (for publication) | D1_PROTOCOLE_2025-521217-46-00_TC | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements MUCOVAC2 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adults | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Adults_TC | 1.3 |
| Subject information and informed consent form (for publication) | L2_Other subject information_recruitment poster | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_FLUCELVAX | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_INFLUVAC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_VAXIGRIP | 1 |
| Synopsis of the protocol (for publication) | D1_PROTOCOLE SYNOPSIS_2025-521217-46-00 | 1.1 |
| Synopsis of the protocol (for publication) | D1_PROTOCOLE SYNOPSIS_2025-521217-46-00_TC | 1.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-22 | France | Acceptable 2025-11-27
|
2025-12-02 |