Study of 20-valent pneumococcal conjugate vaccine (PCV20) booster response in healthy adults aged 78-84 years

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What is this study about?

This clinical trial aims to study immune responses to Prevenar 20, a vaccine that helps prevent pneumococcal infection. The vaccine contains 20 different types of pneumococcal bacteria and is given as an injection into the muscle. The study focuses on healthy adults between 78 and 84 years old who previously received a different pneumococcal vaccine called PPSV23 in 2020.

The study will evaluate how well the immune system responds to Prevenar 20 when given as a booster vaccination. Participants will receive a single 0.5 milliliter dose of the vaccine. Blood samples will be collected before vaccination, one month after, and eleven months after to measure the body’s immune response to the vaccine.

The research will also examine immune responses in the mucous membranes, which are the body’s natural protective barriers. These measurements will help determine how effectively the vaccine stimulates both general and localized immunity against pneumococcal bacteria, which can cause serious infections like pneumonia.

1 Initial vaccination

You will receive one dose of Prevenar 20 vaccine through an injection in your muscle

This vaccine helps prevent pneumococcal infection

The vaccine will be given as part of the National Immunization Program in 2025

2 First blood sample and mucosal test

A blood sample will be taken before the vaccination to measure antibody levels

A sample of the fluid from the lining of your nose will also be collected

3 One-month follow-up

One month after vaccination, you will need to provide another blood sample

A second sample of nose fluid will be collected

These samples help measure how your body responded to the vaccine

4 Eleven-month follow-up

Eleven months after vaccination, you will need to provide a final blood sample

A final nose fluid sample will be collected

These samples help measure the long-term effects of the vaccine

5 Study completion

The study will end after the collection of the final samples

Total participation time will be approximately one year

The overall study is expected to conclude by December 31, 2026

Who Can Join the Study?

  • Be born between the years 1941 and 1947
  • Have previously participated in the VIVO study during 2020
  • Have received the PPSV23 vaccine (a pneumococcal vaccine that helps protect against bacterial infections) in 2020
  • Be willing to receive the PCV20 vaccine (a new type of pneumococcal vaccine) as part of the National Immunization Program in 2025
  • Sign and provide informed consent form, which shows you agree to participate in the study
  • Be able to understand the purpose and requirements of the study, as determined by the research team
  • Can be either male or female
  • Must be capable of making independent decisions (not from vulnerable populations)

Who Cannot Join the Study?

  • History of severe allergic reactions to any pneumococcal vaccine or its components
  • Currently participating in another clinical trial or received another vaccine within 30 days
  • Pregnant or breastfeeding women
  • Active infection or fever above 38°C (100.4°F) at time of vaccination
  • Taking medications that suppress the immune system (immunosuppressive drugs)
  • History of serious chronic medical conditions affecting the immune system
  • Received blood products or immunoglobulins (antibody treatments) within the last 3 months
  • Previous vaccination with any pneumococcal vaccine within the past 5 years
  • Known bleeding disorders or current use of blood-thinning medications
  • History of Guillain-Barré syndrome (a rare disorder where the immune system attacks the nerves)
  • Any condition that, in the opinion of the study doctor, could interfere with the study evaluation

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Rijksinstituut voor Volksgezondheid en Milieu (RIVM) Bilthoven The Netherlands

Other Sites

No sites found in this category

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
01.08.2025

Trial locations

Investigated drugs:

PCV20 (Pneumococcal 20-valent Conjugate Vaccine) is a vaccine that helps protect against 20 different types of pneumococcal bacteria. This vaccine works by stimulating the immune system to produce antibodies that can fight against pneumococcal infections. It is specifically designed to provide protection against pneumonia and other serious infections caused by Streptococcus pneumoniae bacteria. The vaccine is particularly important for older adults who may be more vulnerable to pneumococcal infections due to their age.

Pneumococcal Infection – A bacterial infection caused by Streptococcus pneumoniae that can affect various parts of the body. The bacteria can spread through close contact with infected people, particularly through respiratory droplets. Pneumococcal infection can develop in different forms, including pneumonia (infection of the lungs), sinusitis (infection of the sinuses), or otitis media (middle ear infection). The bacteria can also enter the bloodstream or affect the protective membranes covering the brain and spinal cord. In healthy adults, the immune system usually provides some natural defense against these bacteria, though the level of protection varies among individuals.

Trial ID:
2025-521616-19-00
Protocol code:
IIV-720
Trial Phase:
Therapeutic confirmatory (Phase III)

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