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New vaccine strategy aims to shield spleenless adults from deadly infections

NCT ID NCT02052154

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a two-step vaccine approach in 70 adults who had their spleen removed. Participants received one shot of a conjugate vaccine followed by a second shot of a polysaccharide vaccine two months later. The goal was to see if this combination triggers a strong immune response against 9 types of pneumococcal bacteria that can cause serious infections. Results were measured by antibody levels in the blood one month after the second shot.

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

70 people

The number who actually took part.

Started

Mar 2014

Finished

Apr 2019

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 to 75 years

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: * Age ≥ 18 years and ≤ 75 years * Splenectomized since at least 2 weeks, with Howell-Jolly bodies on a blood smear and ultrasonographic confirmation * No immunosppressived conditions : mainly trauma , idiopathic thrombocytopathic purpura or autoimmune hemolytic anemia, with no active treatment * Available for 37 months of follow-up starting from the screening visit * Contraception that the investigator judges effective for the first 2 months of the trial, with a negative pregnancy test * Women not planning to become pregnant in the 6 months following inclusion (M0) * Signed informed consent Exclusion Criteria: * Pregnancy or planned pregnancy in the 2 months following inclusion (M0) * Pathology or conditions which modify immune response (excluding splenectomy) : HIV infection, immunosuppressive therapy ongoing or in 6 months before inclusion (M0), including corticosteroids \> 10 mg daily, topic inhaled or dermic corticoid treatments are allowed, hematopoietic stem cell allo / autograft, primary immune deficiency, nephrotic syndrome, sickle cell disease, evolutive neoplasia * History of anaphylactic reaction following vaccination * Known allergy to any of the ingredients of the vaccines: aluminium phosphate, phenol, Corynebacterium diphtheriae CRM-197 protein * Previous vaccination with 7-valent or 13-valent pneumococcal conjugate vaccine (in the 5 last years) * Previous vaccination with the pneumococcal polysaccharidic vaccine in the 3 years before inclusion (M0) * Other vaccination in the month before inclusion (M0) * Polyvalent immunoglobulin infusion in the 3 months before inclusion (M0) or during the planned duration of the study * Anticoagulant treatment current or stopped less than 7 days before inclusion (M0); or clotting disorder contra-indicating intramuscular injection * Participation to an other vaccine study in the 28 days before inclusion till the end of study * Not covered by national health insurance (beneficiary or assignee)

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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

  • Service des Maladies Infectieuses et Tropicales - Centre d'Infectiologie Necker-Pasteur, IHU Imagine - Hôpital Necker-Enfants

    Paris, 75015, France

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