Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruitment ended
Participants planned
120
Countries
1
Sites
1
Healthy adults receiving a profylactic vaccine to prevent pneumococcal infection
Determine the increase in Pneumococcal antibody responses one month after PCV20 vaccination.
Key facts
- Sponsor
- Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Participant type
- Healthy volunteers
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 11 Aug 2025 → ongoing
- Decision date (initial)
- 2025-07-01
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Dutch Ministry of Health, Welfare and Sport
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Determine the increase in Pneumococcal antibody responses one month after PCV20 vaccination.
Secondary objectives 3
- Determine the persistence of antibody responses to PCV20 till 11 month post vaccination
- Comparison of the Pneumococcal booster PCV20 vaccine responses to that after primary PPSV23 vaccination 5 years earlier
- Determine mucosal PCV20 antibody responses
Conditions and MedDRA coding
Healthy adults receiving a profylactic vaccine to prevent pneumococcal infection
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | PCV20 vaccination Pneumococcal booster vaccine responsiveness to PCV20 in persons of 78-84 years of age
|
Not Applicable | None | Participants receiving the PCV20 vaccination: Participants are persons born between 1941-1947, who received PPSV23 in 2020 and will receive the PCV20 vaccination in 2025 as part of the National Immunization Program. |
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- We are not planning to share any participant-level data to other institutions/organization. All data analyses will be performed by the study team at the RIVM.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2020-003620-16 | Vaccine immunogenicity in Dutch frail versus non-frail older individuals (participating in the Doetinchem Cohort study) , Vaccin immuniteit in Dutch kwetsbare versus niet-kwetsbare ouderen (deelnemend aan de Doetinchem Cohort study), Vaccin immuniteit in Dutch kwetsbare versus niet-kwetsbare ouderen (deelnemend aan de Doetinchem Cohort study), Vaccin immuniteit in Dutch kwetsbare versus niet-kwetsbare ouderen (deelnemend aan de Doetinchem Cohort study) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Born between 1941-1947
- Participating in the VIVO study in 2020
- Having had PPSV23 vaccine in 2020
- Willing to receive the PCV20 vaccine as part of the National Immunization Program in 2025
- Having signed the Informed Consent
- Understanding the goal of the study, according to the study team
Exclusion criteria 8
- Receipt of any high-dose (≥ 20 mg of prednisone daily or equivalent) corticosteroids (locally applied including inhaled steroids are acceptable) within 2 weeks of study entry
- Repeated use of any high dose of corticosteroids (a dose of > 30 mg of prednisone or equivalent per day for multiple days) in the last month
- Receipt of an organ- or bone marrow transplant during the last 5 years
- Having an anatomical or functional asplenia
- Receipt of blood products or immunoglobulin, within one month of study entry
- Known or suspected serious coagulation disorder that in the judgement of the investigator would contraindicate against frequent blood sampling
- Known to be positive for human immunodeficiency virus (HIV), and/or hepatitis C virus (HCV) and/or hepatitis B virus (HBV) (presence of HBsAg or anti HBc antibodies)
- Start of a treatment with chemotherapy within the last three months of study entry
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PCV20 specific serum IgG, IgM and IgA concentrations pre-PCV20 and 1 month post-PCV20 vaccination
Secondary endpoints 3
- PCV20 specific serum IgG, IgM and IgA pre-PCV20, 1 month and 11 months post-PCV20 vaccination
- IgG, IgM and IgA in serum one month post-PCV20 and one month post PPSV23 vaccination
- PCV20 specific IgG and IgA concentrations pre-, 1 month and 11 months post-PCV20 vaccination in mucosal lining fluid
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD9493438 · Product
- Active substance
- Pneumococcal Polysaccharide Serotype 1 Conjugated to CRM197 Adsorbed on Aluminium Phosphate
- 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
- J07AL02 — PNEUMOCOCCUS, PURIFIED POLYSACCHARIDES ANTIGEN CONJUGATED
- Marketing authorisation
- EU/1/21/1612/001
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- Iceland
- 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
- P. O. Box 1
- City
- Bilthoven
- Postcode
- 3720 BA
- Country
- Netherlands
Scientific contact point
- Organisation
- Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Contact name
- Info RIVM
Public contact point
- Organisation
- Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
- Contact name
- Info RIVM
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruitment ended | 120 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
Centre Immunology of Infectious Diseases and Vaccines, Department Clinical Immunology, P. O. Box 1, 3720 BA, 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 | 2025-08-11 | 2025-09-08 | 2025-09-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-521616-19_redacted | 3.0 |
| Protocol (for publication) | D4_Patient Facing Documents_Questionnaires_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Antwoordkaart_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Tekst website VIVO-2_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_wervingsbrief_groep geen deelname R8_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_wervingsbrief_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults VIVO-2_Redacted | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC prevenar-20 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MS NL 2025-521616-19 | 2.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-15 | Netherlands | Acceptable 2025-07-01
|
2025-07-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-21 | Netherlands | Acceptable 2025-08-07
|
2025-08-07 |