Clinical trial • Phase IV • Infectious Disease

PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE for Pneumococcal infection

Phase IV trial of PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F CO…

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Pneumococcal infection
Trial Stage
Phase IV
Drug Modality
Vaccine

Key dates

Initial CTIS Submission Date
15-04-2025
First CTIS Authorization Date
01-07-2025

Trial design

open-label, none/not specified-controlled Phase IV trial across 1 site in Netherlands.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
120
Trial Duration For Participant
335

Eligibility

Recruits 120 Participants are older adults (born 1941-1947). isVulnerablePopulationSelected: false. Informed consent required: "Having signed the Informed Consent"; subject information and informed consent form for adults is provided (L1_SIS and ICF adults VIVO-2_Redacted). No assent process described..

Vulnerable Population
Participants are older adults (born 1941-1947). isVulnerablePopulationSelected: false. Informed consent required: "Having signed the Informed Consent"; subject information and informed consent form for adults is provided (L1_SIS and ICF adults VIVO-2_Redacted). No assent process described.

Inclusion criteria

  • {"criterion_text":"- Born between 1941-1947"}
  • {"criterion_text":"- Participating in the VIVO study in 2020"}
  • {"criterion_text":"- Having had PPSV23 vaccine in 2020"}
  • {"criterion_text":"- Willing to receive the PCV20 vaccine as part of the National Immunization Program in 2025"}
  • {"criterion_text":"- Having signed the Informed Consent"}
  • {"criterion_text":"- Understanding the goal of the study, according to the study team"}

Exclusion criteria

  • {"criterion_text":"- 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"}
  • {"criterion_text":"- 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"}
  • {"criterion_text":"- Receipt of an organ- or bone marrow transplant during the last 5 years"}
  • {"criterion_text":"- Having an anatomical or functional asplenia"}
  • {"criterion_text":"- Receipt of blood products or immunoglobulin, within one month of study entry"}
  • {"criterion_text":"- Known or suspected serious coagulation disorder that in the judgement of the investigator would contraindicate against frequent blood sampling"}
  • {"criterion_text":"- 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)"}
  • {"criterion_text":"- Start of a treatment with chemotherapy within the last three months of study entry"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- PCV20 specific serum IgG, IgM and IgA concentrations pre-PCV20 and 1 month post-PCV20 vaccination","definition_or_measurement_approach":"Measurement of PCV20-specific serum IgG, IgM and IgA concentrations at baseline (pre-PCV20) and 1 month after PCV20 vaccination to determine increase in pneumococcal antibody responses."}

Secondary endpoints

  • {"endpoint_text":"- PCV20 specific serum IgG, IgM and IgA pre-PCV20, 1 month and 11 months post-PCV20 vaccination","definition_or_measurement_approach":"Measurement of PCV20-specific serum IgG, IgM and IgA at baseline, 1 month and 11 months post-PCV20 vaccination to assess persistence."}
  • {"endpoint_text":"- IgG, IgM and IgA in serum one month post-PCV20 and one month post PPSV23 vaccination","definition_or_measurement_approach":"Comparative measurement of serum IgG, IgM and IgA one month after PCV20 and one month after prior PPSV23 to compare responses."}
  • {"endpoint_text":"- PCV20 specific IgG and IgA concentrations pre-, 1 month and 11 months post-PCV20 vaccination in mucosal lining fluid","definition_or_measurement_approach":"Measurement of PCV20-specific IgG and IgA in mucosal lining fluid (e.g., nasal mucosal samples) at baseline, 1 month and 11 months post-vaccination."}

Recruitment

Digital Remote Recruitment
True, recruitment materials include website text for VIVO-2 (document titles reference website text), indicating use of web-based information for recruitment.
Planned Sample Size
120
Recruitment Window Months
16
Consent Approach
Informed consent is required from each participant: "Having signed the Informed Consent". Subject information and informed consent form for adults are provided (L1_SIS and ICF adults VIVO-2_Redacted). Participants are adults; no assent described. Documents/translations available in Dutch (Netherlands).

Methods

  • Recruitment from participants of the VIVO study (participants who participated in the VIVO study in 2020) in the Netherlands.
  • Documented recruitment materials include invitation letters, reply card and website text (K2_Recruitment material_Tekst website VIVO-2, K2_Recruitment material_wervingsbrief, K2_Recruitment material_Antwoordkaart) indicating use of mailed invitation and website information directed at eligible VIVO participants in the Netherlands.

Geography

Total Number Of Sites
1
Total Number Of Participants
120

Netherlands

Earliest CTIS Part Ii Submission Date
12-06-2025
Latest Decision Or Authorization Date
07-08-2025
Processing Time Days
56
Number Of Sites
1
Number Of Participants
120

Sites

Site Name
Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
Department Name
Centre Immunology of Infectious Diseases and Vaccines, Department Clinical Immunology
Contact Person Name
Alienke Wijmenga-Monsuur
Contact Person Email
Alienke.Wijmenga@rivm.nl
Number Of Participants
120

Sponsor

Primary sponsor

Full Name
Rijksinstituut voor Volksgezondheid en Milieu (RIVM)
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)
Active Substance
PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 22F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 15B CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 11A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 10A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 12F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 33F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 8 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE; PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE
Modality
Vaccine
Routes Of Administration
INTRAMUSCULAR INJECTION
Route
INTRAMUSCULAR INJECTION
Authorisation Status
Authorised (marketing authorisation EU/1/21/1612/001)
Starting Dose
0.5 ml
Dose Levels
0.5 ml
Frequency
Single dose (one vaccination)
Maximum Dose
0.5 ml

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