AzTrials
AzTrials

Prophylaxis Pneumococcal VaccinePhase 3NCT00169507

Study of Immunological Memory Induced in Children by a Full 4 Dose Vaccination Schedule of 11 Valent Pneumococcal Conjugate Vaccine by Giving 1 Dose of Aventis Pasteur's 23-valent Pneumococcal Polysaccharide Vaccine (Pneumo 23)

A Phase 3 study testing Pneumococcal (vaccine) in people with Prophylaxis Pneumococcal Vaccine, run by GlaxoSmithKline at 4 sites in Slovakia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Evaluate the immunological memory induced by 4 doses of GSK Biologicals' 11valent pneumococcal vaccine; study antibody persistence 30 months after the 4 dose vaccination with GSK Biologicals' 11-valent pneumococcal vaccine in Undeca-Pn-010 study. Read more about this study

Who is it for?
Ages 31 to 57 monthsHealthy volunteers can take part
Conditions the study is for
Prophylaxis Pneumococcal Vaccine
What is being tested?
Pneumococcal (vaccine)
Type of treatment
Vaccines
How many people
100 participants
Where
4 sitesSlovakia
Study dates
Mar 2005to Apr 2005
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 31 to 57 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Inclusion criteria: Male or female who participated in Undeca-Pn-010 study, were part of the blood subset and received 4 doses of GSK Biologicals' 11Pn-PD vaccine, or Havrix vaccine. Exclusion criteria: Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding the first dose of study vaccine, or planned use during the study period. Administration of any additional pneumococcal vaccine since study end of Undeca-Pn-010 (347414/010)

Trial locations and contacts

4 sites in 1 country.

Slovakia4 sites

  • GSK Investigational Site

    Dubnica nad Váhom, 018 41

  • GSK Investigational Site

    Nová Dubnica, 018 51

  • GSK Investigational Site

    Považská Bystrica, 017 01

  • GSK Investigational Site

    Púchov, 020 01

Other trials in Slovakia

About this study

Official title: Phase III Multicentric Open Study to Evaluate Immunological Memory Induced by 3-dose Primary Vaccination Followed by Booster Dose of GSK Biologicals' 11-valent Conjugate Pneumococcal Vaccine Compared to Unprimed Subjects by Giving 1 Dose of Aventis Pasteur's Pneumo 23

Evaluate the immunological memory induced by 4 doses of GSK Biologicals' 11valent pneumococcal vaccine; study antibody persistence 30 months after the 4 dose vaccination with GSK Biologicals' 11-valent pneumococcal vaccine in Undeca-Pn-010 study.

Read the detailed description

Primed group: 50 subjects who previously received 4 doses of GSK Biologicals' 11Pn-PD vaccine will receive 1 dose of Pneumo 23 Unprimed group (Control): 50 subjects who received GSK Biologicals' Havrix™ vaccine will receive 1 dose of Pneumo 23

Being tested
Pneumococcal (vaccine)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pneumococcal (vaccine)Biological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Antibody concentrations (ELISA) to pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F 10-15 days after the single dose of Aventis Pasteur's 23-valent pneumococcal polysaccharide vaccine (Pneumo 23).

Secondary outcomes (3)

  1. Before Pneumo 23 administration: Antibody concentrations (ELISA) to pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F & seropositivity (S+) status* (>= 0.05 µg/mL) * also measured 10-15 days after dose of Pneumo 23

  2. Before and 10-15 days after dose of Pneumo 23: Antibody titers (opsono) to selected pneumococcal serotypes and S+ status (>= 8)

  3. Occurrence of SAEs during study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2005 (estimated)
  2. Study startMar 2005
  3. Primary completionApr 2005
  4. Study completionApr 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00169507
Sponsor's protocol ID
104083
Status last verified
May 2017
First submitted
12 Sep 2005
Last updated
30 May 2017
Results posted
No

Publications

  • Schuerman L, Prymula R, Chrobok V, Dieussaert I, Poolman J. Kinetics of the immune response following pneumococcal PD conjugate vaccination. Vaccine. 2007 Mar 1;25(11):1953-61. doi: 10.1016/j.vaccine.2006.12.007. Epub 2006 Dec 26.

    PubMed 17258358

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pneumococcal (vaccine) in people with Prophylaxis Pneumococcal Vaccine, run by GlaxoSmithKline at 4 sites in Slovakia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Antibody concentrations (ELISA) to pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F 10-15 days after the single dose of Aventis Pasteur's 23-valent pneumococcal polysaccharide vaccine (Pneumo 23).. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00169507, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.

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