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CompletedNCT01402245PncHRUpdated Jul 26, 2011

Targeting of Immune Response After Pneumococcal Vaccination

A Phase 4 interventional study of Pneumococcal polysaccharide vaccine and pneumococcal conjugate vaccine in Pneumococcal Pneumonia, sponsored by Helsinki University Central Hospital. Completed at 4 sites in Finland. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-26.

Sponsored by Helsinki University Central Hospital · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
42
Allocation
Non-randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

Pneumococcal polysaccharide vaccine does not confer protection against noninvasive pneumonia. The study aims to compare lymphocyte homing in pneumonia and in those receiving Pnc polysaccharide vaccine (PPV) or Pnc conjugate vaccine (PCV)

Read the detailed description

Pneumococcal polysaccharide vaccine does not confer protection against noninvasive pneumonia. The study compares the homing profiles of Pnc-specific plasmablasts in 15 patients with pneumonia and in 15 volunteers receiving Pnc polysaccharide vaccine (PPV) and 12 volunteers receiving Pnc conjugate vaccine (PCV)

02

Conditions studied

  • Pneumococcal Pneumonia

Keywords

  • pneumonia
  • pneumococcal polysaccharide vaccine
  • pneumococcal conjugate vaccine
03

In context

Pneumonia, Pneumococcal

122 studies on the registry are indexed under Pneumonia, Pneumococcal; 7 are open to participants now.

This study's enrollment of 42 is below the median of 304 across 80 interventional studies indexed under Pneumonia, Pneumococcal.

Browse Pneumonia, Pneumococcal studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

  • Males and females ≥ 18 and \<65 years of age.
  • General good health.
  • Written informed consent.
  • No previous vaccination against Pnc
  • No previous history of Pnc pneumonia
  • In pneumonia: Diagnosis of Pnc pneumonia within a week

Exclusion criteria

Exclusion Criteria:

  • \< 18 years, ≥65 of age.
  • In vaccinees: Acute disease at the time of enrollment.
  • Pregnancy or lactation.
  • Known immunodeficiency or immune suppressive treatment.
  • Any chronic illness that might interfere with the immune response
  • Alcohol or drug abuse
  • Any clinically significant history of known or suspected anaphylaxis or hypersensitivity (based on the investigator's judgement).
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • No intervention
    Pneumonia group

    Patients with Pnc pneumonia

  • Active comparator
    PPV Group

    Volunteers immunized with Pnc polysaccharide vaccine

    Biological: Pneumococcal polysaccharide vaccine

  • Active comparator
    PCV Group

    Volunteers immunized with Pnc conjugate vaccine

    Biological: pneumococcal conjugate vaccine

Interventions

  • BiologicalPneumococcal polysaccharide vaccine

    Pneumococcal polysaccharide vaccine 0.5 ml i.m.

    Also known as: Pneumovax

  • pneumococcal conjugate vaccine 0.5 ml i.m.

    Also known as: Prevenar

06

What researchers measure

Primary outcomes

  1. Expression of homing receptors on circulating plasmablasts in Pnc pneumonia and after vaccination

    HR on circulating Pnc-specific plasmablasts are determined in patients with pneumonia on day 7-10, in vaccinees on days 0 and 7

    Time frame: Day 0 and Day 7-10

07

Study locations

4 sites
  • University of Helsinki, Haartman institute, Dept. of Bacteriology and Immunology
    Helsinki, 00014, Finland
  • Division of Infectious Diseases, HUCH
    Helsinki, 00029, Finland
  • Division of Microbiology, HUSLAB, Helsinki University Central Hospital
    Helsinki, 00029, Finland
  • University of Turku
    Turku, 20520, Finland
08

Timeline

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

The record gives a start of Jan 2005, a primary completion of Jun 2010 and a completion of Jun 2010. 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
Jul 25, 2011
First posted
Jul 26, 2011
Start
Jan 2005
Primary completionActual
Jun 2010
CompletionActual
Jun 2010
Last update
Jul 26, 2011
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.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
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 Jul 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01402245
First posted
Jul 26, 2011
Start date
Jan 2005
Primary completion
Jun 2010
Completion
Jun 2010
Last update
Jul 26, 2011

Study contacts

Anu Kantele, MD PhD
principal investigator · Helsinki University Central Hospital

Oversight

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

Not currently enrolling

This study is completed, as verified in Jan 2007. 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: Pneumococcal Conjugate Vaccine

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