Overview
Sponsor-declared trial summary
Prevention of influenza infection in adults aged 65-79 years
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 adults aged 65 to 79 years.
Key facts
- Sponsor
- Complexo Hospitalario Universitario De Santiago
- Participant type
- Patients, Healthy volunteers
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 26 Oct 2023 → ongoing
- Decision date (initial)
- 2023-09-13
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- SANOFI
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
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 adults aged 65 to 79 years.
Secondary objectives 1
- to evaluate the relative vaccine effectiveness of QIV-HD vs. QIV-SD in reducing the risk of the following endpoints in adults aged 65 to 79 years: 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
Conditions and MedDRA coding
Prevention of influenza infection in adults aged 65-79 years
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Age 65-79 years residing in the community (only individuals who are not eligible to receive QIV-HD as part of the standard of care). 2. Informed consent form has been signed and dated
Exclusion criteria 1
- There are no specific exclusion criteria for this study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint of the study is the occurrence of a hospitalization due to influenza or pneumonia [composite endpoint].
Secondary endpoints 1
- The secondary endpoints of the study are as follows: 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
PRD8052631 · 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
- 0.7 ml millilitre(s)
- Max total dose
- 0.7 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BB02 — INFLUENZA, PURIFIED ANTIGEN
- Marketing authorisation
- 85.068
- MA holder
- SANOFI PASTEUR
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
PRD5590776 · 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
- 82600
- MA holder
- MYLAN IRE HEALTHCARE LIMITED
- MA country
- Spain
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Complexo Hospitalario Universitario De Santiago
- Sponsor organisation
- Complexo Hospitalario Universitario De Santiago
- Address
- Calle Choupana Da S/n
- City
- Santiago De Compostela
- Postcode
- 15706
- Country
- Spain
Scientific contact point
- Organisation
- Complexo Hospitalario Universitario De Santiago
- Contact name
- Federico Martinon Torres
Public contact point
- Organisation
- Complexo Hospitalario Universitario De Santiago
- Contact name
- Federico Martinon Torres
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 114,011 | 1 |
| 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 |
|---|---|---|---|---|---|
| Spain | 2023-10-26 | 2023-10-26 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-13 | Spain | Acceptable 2023-09-13
|
2023-09-13 |