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Could a Two-Vaccine strategy better shield spleenless patients from pneumonia?

NCT ID NCT03873727

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This trial investigates whether giving two different pneumonia vaccines—one followed by another a year later—boosts immune protection more than a single vaccine alone in adults who have had their spleen removed. People without a spleen are at higher risk for serious pneumococcal infections. The study compares a combined vaccine approach against the standard single vaccine, measuring antibody responses in blood samples.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Prevenar13 (PCV13) and Pneumovax (PPS23) vaccines
What this could lead to
If successful, this could establish a more effective revaccination schedule to better protect splenectomised patients from serious pneumococcal infections.
What could go wrong
This is a Phase 2 trial with only 39 participants, so results may not apply to all patients. The immune response measured may not translate to real-world infection prevention.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

39 people

The number who actually took part.

Started

Aug 2019

Finished

May 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years 2. Splenectomised patients. 3. For patients not enrolled in SPLENEVAC clinical trial: presence of Jolly Body at blood smear and spelenectomy confirmation by abdominal ultrasound. 4. Vaccinated according to the schedule of SPLENEVAC clinical trial (PCV13 / PPS23 two months later (until +4 months)), enrolled or not from this study. Vaccination of PPS23 must have been administered 5 years - 6 months/+ 1 year before inclusion. 5. Patients will be followed during the 24 months from the inclusion visit. 6. Patients must give written informed consent prior to any trial procedure. 7. Women of childbearing age must have an effective contraception during the first 13 months of the study. 8. Patients must be covered by social security regimen or equivalent. Exclusion Criteria: 1. History of pneumococcal revaccination in the last five years. 2. Having received any another vaccines within 4 weeks prior to enrolment or who is planning to receive any vaccine (for example: ZOSTAVAX®) within the first 13 months of the study (excepted seasonal influenza vaccine which is permitted 4 weeks before and after each vaccination visit of the study and then allowed at any time during the study follow up. Furthermore, the vaccination against Sars-CoV-2 is allowed during the study with a minimum interval of 14 days between pneumococcal vaccine and Sars-Cov-2 vaccine injection) 3. History of known allergies to any component of both study vaccines (active substances, excipients or diphtheria toxoid). 4. History of anaphylactic reaction following vaccination. 5. Infusion of immunoglobulins within the three months preceding the inclusion. 6. Any pathology or condition that may impair the immune response, apart from splenectomy: immunosuppressive therapy in progress or in the 6 months prior to inclusion, hematopoietic stem cells allo / autograft, primary immunodeficiency, nephrotic syndrome, progressive neoplasia, evolutive cancer, cirrhosis, known infection to HIV and / or hepatitis B virus (HBV) (HBs Ag +) and / or hepatitis C virus (HCV), taking corticosteroids \> 10mg for more than 14 days within the month preceding the inclusion , inhaled corticosteroid and cutaneous topical being allowed. 7. Coagulation disorder contra-indicating intramuscularly injections. 8. Acute respiratory tract infection or severe acute febrile illness or systemic reaction which could represent a significant risk in case of vaccination within the month before inclusion. 9. Pregnancy, breastfeeding or positive pregnancy test up to 13 months after inclusion. 10. History of suspected or documented invasive pneumococcal infection within the year before inclusion. 11. Immunosuppressive factors associated. 12. Enrolment in any other clinical trial during the whole trial period except observational study. 13. Adults under protection

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CIC 1417 Cochin-Pasteur - GH Broca-Cochin-Hôtel-Dieu

    Paris, 75014, France