AzTrials
AzTrials

Hepatitis APhase 3NCT00119743

A Efficacy Against Otitis Media in Children With 11 Valent Pneumococcal Vaccine

A Phase 3 study testing undecavalent pneumococcal-protein D conjugate vaccine in people with Hepatitis A, run by GlaxoSmithKline at 41 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the efficacy in young children in preventing acute otitis media due to vaccine serotype pneumococcal or non typable Hemophilus influenza, following immunization with an 11-valent pneumococcal vaccine according to a 3 dose primary vaccination in the first year of life, with… Read more about this study

Who is it for?
Ages 6 weeks to 27 monthsHealthy volunteers can take part
Conditions the study is for
Hepatitis A
What is being tested?
undecavalent pneumococcal-protein D conjugate vaccine
Type of treatment
Vaccines
How many people
5,000 participants
Where
41 sitesin 2 countries
Study dates
Oct 2000to Jun 2004
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 6 weeks to 27 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Male or female between 6 weeks and 5 months (42-152 days) of age at the time of first vaccination.

Who cannot join

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

Trial locations and contacts

41 sites in 2 countries.

41 sites in 2 countries

Czechia22 sites

  • GSK Investigational Site

    Brno, 628 00

  • GSK Investigational Site

    České Budějovice, 370 71

  • GSK Investigational Site

    Děčín, 405 01

  • GSK Investigational Site

    Frýdek-Místek, 738 02

  • GSK Investigational Site

    Fryštát, 734 01

  • GSK Investigational Site

    Havlíčkův Brod, 580 22

  • GSK Investigational Site

    Hlinsko, 539 01

  • GSK Investigational Site

    Jičín, 506 01

  • GSK Investigational Site

    Jindřichův Hradec, 377 01

  • GSK Investigational Site

    Litoměřice, 412 01

  • GSK Investigational Site

    Náchod, 547 01

  • GSK Investigational Site

    Ostrava, 728 92

  • GSK Investigational Site

    Pardubice, 532 03

  • GSK Investigational Site

    Prague, 120 00

  • GSK Investigational Site

    Prague, 140 00

  • GSK Investigational Site

    Prague, 150 06

  • GSK Investigational Site

    Prague, 160 00

  • GSK Investigational Site

    Prague, 180 00

  • GSK Investigational Site

    Prague, 190 00

  • GSK Investigational Site

    Ústí nad Labem, 400 01

  • GSK Investigational Site

    Ústí nad Labem, 400 78

  • GSK Investigational Site

    Znojmo, 669 00

Other trials in Czechia

Slovakia19 sites

  • GSK Investigational Site

    Dolný Kubín, 026 01

  • GSK Investigational Site

    Dubnica nad Váhom, 018 41

  • GSK Investigational Site

    Košťany nad Turcom, 038 41

  • GSK Investigational Site

    Liptovský Hrádok, 033 01

  • GSK Investigational Site

    Liptovský Mikuláš, 031 01

  • GSK Investigational Site

    Martin, 036 01

  • GSK Investigational Site

    Námestovo, 029 01

  • GSK Investigational Site

    Nitra, 949 11

  • GSK Investigational Site

    Nová Dubnica, 018 51

  • GSK Investigational Site

    Nové Mesto nad Váhom, 915 01

  • GSK Investigational Site

    Nové Zámky, 940 01

  • GSK Investigational Site

    Považská Bystrica, 017 01

  • GSK Investigational Site

    Púchov, 020 01

  • GSK Investigational Site

    Ružomberok, 034 01

  • GSK Investigational Site

    Štúrovo, 943 01

  • GSK Investigational Site

    Sučany, 038 42

  • GSK Investigational Site

    Šurany, 942 18

  • GSK Investigational Site

    Trenčín, 911 01

  • GSK Investigational Site

    Zlaté Moravce, 953 01

Other trials in Slovakia

About this study

Official title: Assess, in Young Children, the Efficacy in Preventing Acute Otitis Media (AOM) of GSK Biologicals Undecavalent Pneumococcal-protein D Conjugate Vaccine, When Administered as a Three Dose Primary Vaccination Course During the First Year of Life With a Booster Dose in the Second Year of Life.

The purpose of this study is to assess the efficacy in young children in preventing acute otitis media due to vaccine serotype pneumococcal or non typable Hemophilus influenza, following immunization with an 11-valent pneumococcal vaccine according to a 3 dose primary vaccination in the first year of life, with booster dose in the second year of life. Prophylactic immunization with pneumococcal conjugate vaccine is compared to placebo (hepatitis A vaccine).

Conditions
Hepatitis A
Being tested
undecavalent pneumococcal-protein D conjugate vaccine
Keywords
Prophylaxis pneumococcal vaccine
Medical subject headings
Hepatitis A

What participants receive

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

  • undecavalent pneumococcal-protein D conjugate vaccineBiological

What is being measured

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

  1. To demonstrate the efficacy of the 11 Pn-PD vaccine in preventing AOM caused by vaccine-type pneumococcus in fully vaccinated children less than 2 years of age.

Secondary outcomes (1)

  1. To assess the efficacy of the 11 Pn-PD vaccine in preventing AOM caused by NTHI in fully vaccinated children less than 2 years of age.

Timeline

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

  1. First posted14 Jul 2005 (estimated)
  2. Study startOct 2000
  3. Primary completionJun 2004
  4. Study completionJun 2004

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
5,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00119743
Sponsor's protocol ID
347414/010
Status last verified
Mar 2017
First submitted
6 Jul 2005
Last updated
23 Mar 2017
Results posted
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Poolman J, Kriz P, Feron C, Di-Paolo E, Henckaerts I, Miseur A, Wauters D, Prymula R, Schuerman L. Pneumococcal serotype 3 otitis media, limited effect of polysaccharide conjugate immunisation and strain characteristics. Vaccine. 2009 May 21;27(24):3213-22. doi: 10.1016/j.vaccine.2009.03.017. Epub 2009 Mar 26.

    PubMed 19446194

  • Poolman J, Frasch C, Nurkka A, Kayhty H, Biemans R, Schuerman L. Impact of the conjugation method on the immunogenicity of Streptococcus pneumoniae serotype 19F polysaccharide in conjugate vaccines. Clin Vaccine Immunol. 2011 Feb;18(2):327-36. doi: 10.1128/CVI.00402-10. Epub 2010 Dec 1.

    PubMed 21123523

  • Prymula R, Peeters P, Chrobok V, Kriz P, Novakova E, Kaliskova E, Kohl I, Lommel P, Poolman J, Prieels JP, Schuerman L. Pneumococcal capsular polysaccharides conjugated to protein D for prevention of acute otitis media caused by both Streptococcus pneumoniae and non-typable Haemophilus influenzae: a randomised double-blind efficacy study. Lancet. 2006 Mar 4;367(9512):740-8. doi: 10.1016/S0140-6736(06)68304-9.

    PubMed 16517274

  • Prymula R, Chlibek R, Splino M, Kaliskova E, Kohl I, Lommel P, Schuerman L. Safety of the 11-valent pneumococcal vaccine conjugated to non-typeable Haemophilus influenzae-derived protein D in the first 2 years of life and immunogenicity of the co-administered hexavalent diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated polio virus, Haemophilus influenzae type b and control hepatitis A vaccines. Vaccine. 2008 Aug 18;26(35):4563-70. doi: 10.1016/j.vaccine.2008.05.080. Epub 2008 Jun 17.

    PubMed 18602724

  • Schuerman L, Prymula R, Henckaerts I, Poolman J. ELISA IgG concentrations and opsonophagocytic activity following pneumococcal protein D conjugate vaccination and relationship to efficacy against acute otitis media. Vaccine. 2007 Mar 1;25(11):1962-8. doi: 10.1016/j.vaccine.2006.12.008. Epub 2006 Dec 26.

    PubMed 17258357

  • 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

  • Schuerman L, Borys D, Hoet B, Forsgren A, Prymula R. Prevention of otitis media: now a reality? Vaccine. 2009 Sep 25;27(42):5748-54. doi: 10.1016/j.vaccine.2009.07.070. Epub 2009 Aug 8.

    PubMed 19666154

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing undecavalent pneumococcal-protein D conjugate vaccine in people with Hepatitis A, run by GlaxoSmithKline at 41 sites in 2 countries.

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

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. 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: stopped early, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Czechia, 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 was stopped early. Results are not available in the source record.

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?

To demonstrate the efficacy of the 11 Pn-PD vaccine in preventing AOM caused by vaccine-type pneumococcus in fully vaccinated children less than 2 years of age.. 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 NCT00119743, which also lists 7 linked publications.

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 23 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in