Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
339,700
Countries
1
Sites
2
Prevention of influenza infection in older adults
The primary objective of the study is to evaluate the relative vaccine effectiveness of QIV-HD vs. QIV-SD in reducing the risk of hospitalization for influenza or pneumonia [composite endpoint] in older adults.
Key facts
- Sponsor
- Gentofte Hospital, Sanofi Pasteur
- Participant type
- Healthy volunteers, Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 10 Sep 2022 → 31 Aug 2025
- Decision date (initial)
- 2022-06-28
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Sanofi
External identifiers
- EU CT number
- 2022-500657-17-00
- ClinicalTrials.gov
- NCT05517174
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy, Prophylaxis
The primary objective of the study is to evaluate the relative vaccine effectiveness of QIV-HD vs. QIV-SD in reducing the risk of hospitalization for influenza or pneumonia [composite endpoint] in older adults.
Secondary objectives 5
- To evaluate the relative vaccine effectiveness of QIV-HD vs. QIV-SD in reducing the risk of hospitalization for any cardio-respiratory disease [composite endpoint] in older adults.
- To evaluate the relative vaccine effectiveness of QIV-HD vs. QIV-SD in reducing the risk of all-cause hospitalization in older adults.
- To evaluate the relative vaccine effectiveness of QIV-HD vs. QIV-SD in reducing the risk of all-cause mortality in older adults.
- To evaluate the relative vaccine effectiveness of QIV-HD vs. QIV-SD in reducing the risk of hospitalization for influenza in older adults.
- To evaluate the relative vaccine effectiveness of QIV-HD vs. QIV-SD in reducing the risk of hospitalization for pneumonia in older adults.
Conditions and MedDRA coding
Prevention of influenza infection in older adults
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10022000 | Influenza | 100000004862 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1) Age 65 years and above (this inclusion criterion will be modified according to the Danish government’s official recommendations for the 2022/2023 and 2023/2024 influenza seasons – i.e. if the Danish government decides to offer QIV-HD to persons aged 80 and above, the trial will only recruit persons aged 65-79 years. If the Danish government does not offer QIV-HD to anyone, the trial will continue to recruit persons aged 65 and above with no upper limit to participation)
Exclusion criteria 1
- There are no specific exclusion criteria for this study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Hospitalization due to influenza or pneumonia [composite endpoint]
Secondary endpoints 1
- 1) Hospitalization for any cardio-respiratory disease [composite endpoint], 2) All-cause hospitalization, 3) All-cause mortality, 4) Hospitalization for influenza, 5) Hospitalization for pneumonia
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Efluelda, injektionsvæske, suspension i fyldt injektionssprøjte
PRD8034148 · Product
- Active substance
- BPHUKET30732013-LIKE Virus (BPHUKET30732013, Wild Type)
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 240 µg microgram(s)
- Max total dose
- 240 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BB02 — INFLUENZA, PURIFIED ANTIGEN
- Marketing authorisation
- 62663
- MA holder
- SANOFI PASTEUR
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 2
Vaxigriptetra, injektionsvæske, suspension i fyldt injektionssprøjte
PRD4465707 · Product
- Active substance
- BPHUKET30732013-LIKE Virus (BPHUKET30732013, Wild Type)
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 60 µg microgram(s)
- Max total dose
- 60 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BB02 — INFLUENZA, PURIFIED ANTIGEN
- Marketing authorisation
- 56583
- MA holder
- SANOFI PASTEUR EUROPE
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Influvactetra, injektionsvæske, suspension i fyldt injektionssprøjte
PRD7189235 · 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
- Max daily dose
- 60 µg microgram(s)
- Max total dose
- 60 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BB02 — INFLUENZA, PURIFIED ANTIGEN
- Marketing authorisation
- 61929
- MA holder
- VIATRIS APS
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
SCP107973396 · ATC
- Active substance
- Elasomeran
- Substance synonyms
- mRNA-1273, CX-024414 (single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2), CX-024414, COVID-19 mRNA vaccine Moderna (CX-024414)
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 50 µg microgram(s)
- Max total dose
- 50 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BN01 — COVID-19, RNA-BASED VACCINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Gentofte Hospital
- Sponsor organisation
- Gentofte Hospital
- Address
- Kildegaardsvej 28
- City
- Hellerup
- Postcode
- 2900
- Country
- Denmark
Scientific contact point
- Organisation
- Gentofte Hospital
- Contact name
- Niklas Dyrby Johansen
Public contact point
- Organisation
- Gentofte Hospital
- Contact name
- Niklas Dyrby Johansen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Sanofi Pasteur
- Sponsor organisation
- Sanofi Pasteur
- Address
- 14 Espace Henry Vallee
- City
- Lyon
- Postcode
- 69007
- Country
- France
Sponsor responsibilities
- Article 77 compliance
- Gentofte Hospital
- Contact point sponsor
- Gentofte Hospital
- Article 77 implementation
- Gentofte Hospital
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 339,700 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Denmark | 2022-09-10 | 2025-08-31 | 2022-09-22 | 2024-10-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 22 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | DANFLU-2 protocol | 4.7 |
| Protocol (for publication) | DANFLU-2 protocol tracked changes | 4.7 |
| Recruitment arrangements (for publication) | Consent and recruitment procedure | 3.0 |
| Recruitment arrangements (for publication) | Invitation letter | 3.2 |
| Recruitment arrangements (for publication) | Video transcript | 4.7 |
| Recruitment arrangements (for publication) | Video transcript tracked changes | 4.7 |
| Recruitment arrangements (for publication) | Website advertisement | 4.6 |
| Recruitment arrangements (for publication) | Website advertisement tracked changes | 4.6 |
| Subject information and informed consent form (for publication) | Consent form | 1 |
| Subject information and informed consent form (for publication) | EQ-5D-5L Danish | 1 |
| Subject information and informed consent form (for publication) | HomeSwab-PRO consent form | 1 |
| Subject information and informed consent form (for publication) | HomeSwab-PRO information sheet | 1 |
| Subject information and informed consent form (for publication) | RiiQ_ENGLISH | 1 |
| Subject information and informed consent form (for publication) | Subject information | 4.7 |
| Subject information and informed consent form (for publication) | Subject information tracked changes | 4.7 |
| Subject information and informed consent form (for publication) | Subject rights | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | French SmPC VaxigripTetra | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Efluelda | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Influvactetra | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Vaxigriptetra | 1 |
| Synopsis of the protocol (for publication) | Protocol synopsis | 4.2 |
| Synopsis of the protocol (for publication) | Protocol synopsis tracked changes | 4.2 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-04-26 | Denmark | Acceptable 2022-06-28
|
2022-06-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-4 | 2022-09-05 | Denmark | Acceptable 2022-09-06
|
2022-09-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-5 | 2022-09-06 | Denmark | Acceptable 2022-09-20
|
2022-09-20 |
| 4 | SUBSTANTIAL MODIFICATION | SM-6 | 2022-10-03 | Denmark | Acceptable | 2022-10-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-7 | 2023-06-18 | Denmark | Acceptable 2023-07-07
|
2023-07-07 |
| 6 | SUBSTANTIAL MODIFICATION | SM-8 | 2023-08-23 | Denmark | Acceptable 2023-09-20
|
2023-09-20 |
| 7 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-04-01 | Denmark | Acceptable with conditions 2024-06-04
|
2024-06-04 |
| 8 | SUBSTANTIAL MODIFICATION | SM-10 | 2024-06-18 | Denmark | Acceptable 2024-07-09
|
2024-07-10 |
| 9 | SUBSTANTIAL MODIFICATION | SM-11 | 2024-07-11 | Denmark | Acceptable 2024-08-26
|
2024-08-26 |
| 10 | SUBSTANTIAL MODIFICATION | SM-12 | 2024-09-02 | Denmark | Acceptable 2024-09-26
|
2024-09-27 |