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Status unknownNCT01846923Updated May 6, 2013

B Memory Cell Response to Vaccination With the 13-valent Pneumococcal Conjugate Vaccine in Asplenic Individuals

A Phase 4 interventional study of PCV13 in Asplenia and β-thalassemia Major, sponsored by Aghia Sophia Children's Hospital of Athens. Status unknown at 1 site in Greece. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-05-06.

Sponsored by Aghia Sophia Children's Hospital of Athens · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified May 2013), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 26 studies in beta-Thalassemia with a site in Greece — 3 open to participants now, 7 under way, 3 of them phase 3. beta-Thalassemia · Greece.

Enrollment
14th of 22
37 · median 62
Started
2010
with 1 other
Phase 4
2 of 26
none open now
Registered
8th of 26
by date
Lead sponsor
1 of 26
Aghia Sophia Children's Hospital of Athens

Among the 26 studies in beta-Thalassemia with a site in Greece, this one is the 14th largest by enrollment of the 22 interventional ones that give a count, is one of 2 that started in 2010, is one of 2 in phase 4, and was the 8th registered.

beta-Thalassemia

294 studies on the registry are indexed under beta-Thalassemia; 69 are open to participants now.

Browse beta-Thalassemia studies →

Open to participants now

3 of the 26 studies in beta-Thalassemia with a site in Greece are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Greece have not opened yet or have stopped. Only those recruiting at a site in Greece →

Who these studies take

Of the 43 beta-Thalassemia studies recruiting now, 10 (23%) set no upper age limit and 31 (72%) stop at 75 or younger; 34 take children under 18; 6 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · no healthy volunteers.

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02

Study summary

The purpose of this study is to determine whether one dose of the 13-valent pneumococcal conjugate vaccine (PCV13) induces immunological memory in asplenic adults and whether previously administered immunizations with the 23-valent polysaccharide pneumococcal vaccine influence the cellular immune response to PCV13 in this group.

03

Conditions studied

  • Asplenia
  • β-thalassemia Major

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04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Asplenia
  • β-thalassemia major
  • older than 18 years

Exclusion criteria

Exclusion Criteria:

  • no previously recorded allergy to PCV
  • no intravenous immunoglobulin (IVIG) given within the previous 6 months
  • no other vaccine given within the previous 6 months
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    PCV13

    Biological: PCV13

Interventions

06

What researchers measure

Primary outcomes

  1. immunoglobulin G (IgG) B memory cell response one month post vaccination (measured by ELISpot)

    Time frame: One month post-PCV13

  2. immunoglobulin M (IgM) B memory cell response one month post vaccination (measured by ELISpot)

    Time frame: one month post PCV13

Secondary outcomes

  1. Maintenance of B memory cells three years after PCV13 vaccination

    Time frame: three years after study vaccination

07

Study locations

1 site
  • 'Aghia Sophia' Children's Hospital
    Athens, Attiki 11527, Greece
08

References and documents

Publications

  • Papadatou I, Lagousi T, Kattamis A, Spoulou V. Antibody persistence 5 years after a 13-valent pneumococcal conjugate vaccine in asplenic patients with beta-thalassemia: assessing the need for booster. Ann Hematol. 2019 Mar;98(3):775-779. doi: 10.1007/s00277-019-03615-z. Epub 2019 Jan 25. PubMed 30683996 ↗
  • Papadatou I, Piperi C, Alexandraki K, Kattamis A, Theodoridou M, Spoulou V. Antigen-specific B-cell response to 13-valent pneumococcal conjugate vaccine in asplenic individuals with beta-thalassemia previously immunized with 23-valent pneumococcal polysaccharide vaccine. Clin Infect Dis. 2014 Sep 15;59(6):862-5. doi: 10.1093/cid/ciu409. Epub 2014 May 30. PubMed 24879786 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2010 and a primary completion of Feb 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 29, 2013
First posted
May 6, 2013
Start
Oct 2010
Primary completionActual
Feb 2012
Last update
May 6, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 6, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01846923
Lead sponsor
Aghia Sophia Children's Hospital of Athens
Responsible party
Vana Spoulou (Assistant Professor of Paediatrics, Aghia Sophia Children's Hospital of Athens) — Principal investigator
First posted
May 6, 2013
Start date
Oct 2010
Primary completion
Feb 2012
Last update
May 6, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: 13-valent pneumococcal vaccine

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