Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
4,000
Countries
1
Sites
1
COVID-19 infection
The main objective of this study is to evaluate immune responses after COVID-19 vaccination with different vaccine formulations
Key facts
- Sponsor
- Finnish Institute For Health And Welfare
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 7 Dec 2021 → 17 Dec 2025
- Decision date (initial)
- 2024-10-18
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-517357-27-00
- EudraCT number
- 2021-004788-29
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Pharmacodynamic, Dose response
The main objective of this study is to evaluate immune responses after COVID-19 vaccination with different vaccine formulations
Secondary objectives 10
- To evaluate the vaccine response after COVID-19 vaccination with a different number of doses , vaccine combinations, vaccine dose intervals and in combination with influenza vaccination
- Follow how immunity is maintained after vaccination
- On the basis of immunity studies to aAssess the need for booster vaccination in different age groups and in different risk groups for COVID19 and in groups with different underlying diseases
- Investigate how COVID-19 infection affects vaccine responses
- Find out how vaccination affects the response to COVID-19 infection
- Evaluate vaccine responses against different virus variants
- Investigate cell-mediated responses after COVID-19 vaccination
- Investigate the relationship between immune responses and clinical protection
- Monitor the prevalence of coronavirus infection in target groups based on antibody testing
- Explore combinations of the above objectives
Conditions and MedDRA coding
COVID-19 infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | PT | 10084268 | COVID-19 | 100000004862 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age 18 years
- Has received or is planning to receive at least one dose of Covid-19 vaccine in accordance with the Finnish national vaccination programme
- Is able to understand the given written and oral information
- Has given written informed consent
Exclusion criteria 1
- none
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Proportion of seropositive subjects with an antibody level above the target level in groups of vaccine recipients receiving different vaccine products at 6 months after two doses against the prevailing virus variant
Secondary endpoints 3
- Antibody and neutralising antibody levels and percentages of those above the target: in the group receiving combinations of different vaccine products,in a group of people who received the vaccine at different dose intervals (e.g. 3 weeks, 8 weeks, 12 weeks), in the group receiving different numbers of vaccine doses , in the COVID19-infected group, in different age groups, in groups at risk of COVID-19 and in immunocompromised groups, against different virus variants
- Cell-mediated immune responses
- Response variables regarding immunity studies against other microbes will be developed according to the epidemic situation
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 10
Comirnaty 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
PRD9317042 · Product
- Active substance
- Tozinameran
- Substance synonyms
- Nucleoside-modified mRNA encoding a modified version of the SARS-CoV-2 S protein, BNT162b2, Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2
- Pharmaceutical form
- DISPERSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 30 µg microgram(s)
- Max total dose
- 60 µg microgram(s)
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- J07BN01 — -
- Marketing authorisation
- EU/1/20/1528/002
- MA holder
- BIONTECH MANUFACTURING GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11459642 · Product
- Active substance
- Bretovameran
- Substance synonyms
- 5'-capped mRNA encoding SARS-CoV-2, Omicron variant JN.1, spike protein
- Pharmaceutical form
- DISPERSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 30 µg microgram(s)
- Max total dose
- 30 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BN01 — -
- Marketing authorisation
- EU/1/20/1528/030
- MA holder
- BIONTECH MANUFACTURING GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9942084 · Product
- Active substance
- Tozinameran
- Substance synonyms
- Nucleoside-modified mRNA encoding a modified version of the SARS-CoV-2 S protein, BNT162b2, Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2
- Pharmaceutical form
- DISPERSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR
- Max daily dose
- 0.3 ml millilitre(s)
- Max total dose
- 0.3 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BN01 — -
- Marketing authorisation
- EU/1/20/1528/008
- MA holder
- BIONTECH MANUFACTURING GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10000345 · Product
- 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)
- Pharmaceutical form
- DISPERSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR USE
- 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
- J07BN01 — -
- Marketing authorisation
- EU/1/20/1507/008
- MA holder
- MODERNA BIOTECH SPAIN S. L.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Nuvaxovid dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted)
PRD9391828 · Product
- Active substance
- SARS-COV-2, Spike Protein, Recombinant, Expressed in SF9 Cells Derived From Spodoptera Frugiperda
- Pharmaceutical form
- DISPERSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 5 µg microgram(s)
- Max total dose
- 10 µg microgram(s)
- Max treatment duration
- 3 Week(s)
- Authorisation status
- Authorised
- ATC code
- J07BX03 — -
- Marketing authorisation
- EU/1/21/1618/001
- MA holder
- NOVAVAX CZ A.S.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Spikevax 50 micrograms dispersion for injection in pre-filled syringe COVID-19 mRNA Vaccine
PRD10000341 · Product
- 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)
- Pharmaceutical form
- DISPERSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR USE
- 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
- J07BN01 — -
- Marketing authorisation
- EU/1/20/1507/003
- MA holder
- MODERNA BIOTECH SPAIN S. L.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
COVID-19 Vaccine Astrazeneca (CHADOX1 NCOV-19)
SCP48123867 · ATC
- Active substance
- COVID-19 Vaccine Astrazeneca (CHADOX1 NCOV-19)
- Substance synonyms
- Covid-19 vaccine NRVV AD (ChAdOx1 nCoV-19), ChAdOx1 nCoV-19, Chimpanzee Adenovirus Oxford 1 containing the transgene encoding the SARS-CoV-2 spike protein, VTP-900, ChAdOx1-SARS-COV-2, AZD-1222
- Route of administration
- INTRAMUSCULAR USE
- Max daily dose
- 250000000 IU international unit(s)
- Max total dose
- 500000000 IU international unit(s)
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BN02 — COVID-19, VIRAL VECTOR, NON-REPLICATING
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
PRD10813392 · Product
- Active substance
- Raxtozinameran
- Substance synonyms
- 5'-capped mRNA encoding SARS-CoV-2, Omicron variant XBB.1.5, Spike protein, pre-fusion stabilised (K981P and V982P)
- Pharmaceutical form
- DISPERSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 30 µg microgram(s)
- Max total dose
- 30 µg microgram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- J07BN01 — -
- Marketing authorisation
- EU/1/20/1528/020
- MA holder
- BIONTECH MANUFACTURING GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comirnaty LP.8.1 30 micrograms/dose dispersion for injection COVID-19 mRNA Vaccine
PRD12738255 · Product
- Active substance
- 5-CAPPED Mrna Encoding SARS-COV-2, Variant LP81, Spike Protein, Pre-Fusion Stabilised (K981P and V982P)
- Substance synonyms
- BNT162 LP.8.1
- Pharmaceutical form
- DISPERSION FOR INJECTION
- Route of administration
- INTRAMUSCULAR INJECTION
- Max daily dose
- 0.3 ml millilitre(s)
- Max total dose
- 0.3 ml millilitre(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- J07BN01 — -
- Marketing authorisation
- EU/1/20/1528/045
- MA holder
- BIONTECH MANUFACTURING GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
BIMERVAX LP.8.1 emulsion for injection COVID-19 Vaccine (recombinant, adjuvanted)
PRD12882625 · Product
- Active substance
- SARS-COV-2 Virus, Variant LP81, Spike Protein, Receptor Binding Domain Fusion Homodimer
- Pharmaceutical form
- EMULSION 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 Week(s)
- Authorisation status
- Authorised
- ATC code
- J07BN — -
- Marketing authorisation
- EU/1/22/1709/008
- MA holder
- HIPRA HUMAN HEALTH S.L.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Finnish Institute For Health And Welfare
- Sponsor organisation
- Finnish Institute For Health And Welfare
- Address
- Mannerheimintie 166
- City
- Helsinki
- Postcode
- 00300
- Country
- Finland
Scientific contact point
- Organisation
- Finnish Institute For Health And Welfare
- Contact name
- Väestö -osasto, Terveysuhkien torjunta -yksikkö
Public contact point
- Organisation
- Finnish Institute For Health And Welfare
- Contact name
- Väestö -osasto, Terveysuhkien torjunta -yksikkö
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ended | 4,000 | 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 |
|---|---|---|---|---|---|
| Finland | 2021-12-07 | 2024-10-18 | 2025-01-08 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 25 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Tutkimussuunnitelma Koronarokoteimmunologia public | 8 |
| Recruitment arrangements (for publication) | Lausuntohakemus_liite 11 13092021 | 1 |
| Recruitment arrangements (for publication) | Lausuntohakemus_liite 9 13092021 | 1 |
| Subject information and informed consent form (for publication) | Ajanvaraus nayteohje yleinen kaynti1 27012023 v4 | 1 |
| Subject information and informed consent form (for publication) | Ajanvarausohje jatkokaynnit yleinen 270123 v5 | 1 |
| Subject information and informed consent form (for publication) | Koronarokoteimmunologia_Tiedote_suostumus_tiedonkeruun laajentamisesta_11052023_v2_final | 1 |
| Subject information and informed consent form (for publication) | Kutsu koronarokoteimmunologia jatkokaynnit 221122 v4 | 1 |
| Subject information and informed consent form (for publication) | Kutsu Koronarokoteimmunologia Kaynti1 221122 v4 | 1 |
| Subject information and informed consent form (for publication) | Palautekirje KOHD-2 otoksen tutkittaville v1 110823 | 1 |
| Subject information and informed consent form (for publication) | Palautekirje otos 3 tutkittaville v1 110823 | 1 |
| Subject information and informed consent form (for publication) | Palautekirje tutkittavalle 27012023 v3 | 1 |
| Subject information and informed consent form (for publication) | Suostumusasiakirja koronarokoteimmunologia 11toukok2023 v6 | 1 |
| Subject information and informed consent form (for publication) | Tiedote tutkittavalle koronarokoteimmunologia 11toukok2023 v6 | 1 |
| Subject information and informed consent form (for publication) | Tietosuojailmoitus Koronarokoteimmunologia v8 22112022 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | bimervax LP_8_1-epar-product-information_en_05122025 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | comirnaty-epar-product-information_fi_10102022 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | comirnaty-epar-product-information_fi_10102022 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | comirnatyJN_1-epar-product-information_en_10_Oct_2022 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | comirnatyLP_8_1-epar-product-information_en_05122025 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | comirnatyXBB 1_5-epar-product-information_en-10_Oct_2022 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | nuvaxovid-epar-product-information_fi | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | spikevax-previously-covid-19-vaccine-moderna-epar-product-information_fi_03102022_ | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | spikevax-previously-covid-19-vaccine-moderna-epar-product-information_fi_03102022_ | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | vaxzevria-previously-covid-19-vaccine-astrazeneca-epar-product-information_fi | 1 |
| Synopsis of the protocol (for publication) | Tutkimussuunnitelma_yhteenveto_THL_v3_04122024_final | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-07 | Finland | Acceptable with conditions 2024-10-18
|
2024-10-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-12 | Finland | Acceptable 2025-02-05
|
2025-02-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-12 | Finland | Acceptable 2026-02-10
|
2026-02-10 |