Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
440
Countries
1
Sites
1
Influenza
Determine the effect of the time of day of influenza vaccine administration on influenza vaccine strain-specific serum antibody titers 28 days (+/- 3 days) after vaccination in adults aged 60-85 years.
Key facts
- Sponsor
- Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Virus Diseases [C02]
- Trial duration
- 25 Sep 2024 → 1 May 2025
- Decision date (initial)
- 2024-08-15
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- National Institute for Public Health and the Environment (RIVM)
External identifiers
- EU CT number
- 2024-513558-30-00
- ISRCTN
- ISRCTN65770516
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Pharmacodynamic
Determine the effect of the time of day of influenza vaccine administration on influenza vaccine strain-specific serum antibody titers 28 days (+/- 3 days) after vaccination in adults aged 60-85 years.
Secondary objectives 4
- Determine the effect of the time of day of influenza vaccine administration on influenza-specific T cell responses 28 days (+/- 3 days) after vaccination in adults aged 60-85 years.
- Determine the optimal time of day for administering the influenza vaccine to induce the strongest vaccine strain-specific antibody and T cell responses in adults aged 60-85 years.
- Determine the association between chronotype and both the vaccine-induced immune response and optimal vaccination time.
- Determine the effect of the time of day of influenza vaccine administration on the incidence of influenza virus infection and self-reported ILI symptoms up to six months of follow-up.
Conditions and MedDRA coding
Influenza
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Aged 60-85 years at the time of inclusion.
- Willing and able to come to the vaccination location at a randomly assigned timeslot.
- Available for the follow-up period of 6 months.
- Have provided written informed consent.
Exclusion criteria 10
- Known or suspected allergy to any of the vaccine components or having experienced a previous severe adverse reaction to any vaccine.
- Present evidence of serious diseases demanding either regular use of oral immunosuppressive medical treatment, like corticosteroids, three months prior to study enrolment, or demanding acute use of high dose oral immunosuppressives two weeks prior study to study enrolment.
- Receipt of an organ- or bone marrow transplant
- Receipt of chemotherapy in the previous year.
- Receipt of blood products or immunoglobulins, within 3 months before study entry.
- Known or suspected immunodeficiency, auto-immune disease, any type of cancer.
- Known to be positive for human immunodeficiency virus, and/or hepatitis C virus and/or hepatitis B virus.
- Receipt of any vaccine(s), including the COVID-19 vaccine, less than two weeks prior to or within one month after baseline.
- Receipt of influenza 2024/2025-season vaccine prior to or within one month after baseline.
- Known to have an increased susceptibility to bleeding (bleeding diathesis), and are therefore not suitable for intramuscular vaccination.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The increase in influenza vaccine strain-specific serum antibody titers from pre-vaccination (T0) to 28 days (+/- 3 days) post-vaccination (T1) as measured by HI assay.
Secondary endpoints 3
- The increase in influenza-specific T cell responses in PBMCs from pre-vaccination (T0) to 28 days (+/- 3 days) post-vaccination (T1) as measured by ELISpot.
- Chronotype, assessed via the micro-Munich Chronotype Questionnaire
- The incidence of influenza virus infection, as determined by rapid influenza diagnostic self-tests, and self-reported influenza-like illness symptoms up to six months of follow-up.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD10946721 · 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
- 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
- PA23355/016/001
- MA holder
- VIATRIS HEALTHCARE LTD
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD4633817 · 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
- 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
- MA573/00103
- MA holder
- SANOFI PASTEUR
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PNEUMOVAX 23 solution for injection in pre-filled syringe Pneumococcal Polysaccharide Vaccine
PRD4585859 · Product
- Active substance
- Pneumococcal Polysaccharide Serotype 4
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- 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
- J07AL01 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN
- Marketing authorisation
- PA 1286/055/002
- MA holder
- MERCK SHARP & DOHME IRELAND (HUMAN HEALTH) LIMITED
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Sponsor organisation
- Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Address
- Antonie Van Leeuwenhoeklaan 9
- City
- Bilthoven
- Postcode
- 3721 MA
- Country
- Netherlands
Scientific contact point
- Organisation
- Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Contact name
- Study Team
Public contact point
- Organisation
- Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Contact name
- Study Team
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 440 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
IIM, Antonie Van Leeuwenhoeklaan 9, 3721 MA, Bilthoven
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-09-25 | 2025-05-01 | 2024-11-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of results SUM-131710
|
2026-04-30T13:54:44 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Laymen summary of results_Nederlands | 2026-04-30T13:58:01 | Submitted | Laypersons Summary of Results |
| Laymen summary of results_English | 2026-04-30T13:56:20 | Submitted | Laypersons Summary of Results |
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Laymen summary of results_English | 1 |
| Laypersons summary of results (for publication) | Laymen summary of results_Nederlands | 1 |
| Protocol (for publication) | D1_Protocol 2024-513558-30-00 | 2 |
| Protocol (for publication) | D4_Patient facing documents - Diary | 1 |
| Protocol (for publication) | D4_Patient facing documents - Instructions selftest | 1 |
| Protocol (for publication) | D4_Patient facing documents - Questionnaire | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Influvac Tetra | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Pneumovax-23 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Vaxigrip Tetra | 2 |
| Summary of results (for publication) | Summary of results | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis MS NL 2024-513558-30-00 | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-24 | Netherlands | Acceptable with conditions 2024-08-12
|
2024-08-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-12 | Netherlands | Acceptable with conditions 2024-08-12
|
2024-09-12 |