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AzTrials

Infections, StreptococcalPhase 3NCT00307554

A Lot-to-lot Consistency (3 Lots of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine) & Non-inferiority Study

A Phase 3 study testing Pneumococcal (vaccine) in people with Infections, Streptococcal, run by GlaxoSmithKline at 35 sites in 3 countries.

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 lot-to-lot consistency, safety and reactogenicity of 3 doses of GSK Biologicals' 10-valent pneumococcal conjugate vaccine and non-inferiority with respect to Prevenar. Read more about this study

Who is it for?
Ages 6 to 12 weeksHealthy volunteers can take part
Conditions the study is for
Infections, Streptococcal
What is being tested?
Pneumococcal (vaccine)
Type of treatment
Vaccines
How many people
1,600 participants
Where
35 sitesin 3 countries
Study dates
Nov 2005to Jun 2006
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 to 12 weeks
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject.

Who cannot join

  • 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.
  • Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from one month before the first dose of vaccine(s) and during the entire study period.

Trial locations and contacts

35 sites in 3 countries.

35 sites in 3 countries

Finland15 sites

  • GSK Investigational Site

    Espoo, 02100

  • GSK Investigational Site

    Helsinki, 00930

  • GSK Investigational Site

    Jarvenpaa, 04400

  • GSK Investigational Site

    Jyväskylä, 40100

  • GSK Investigational Site

    Kokkola, 67100

  • GSK Investigational Site

    Kotka, 48100

  • GSK Investigational Site

    Kuopio, 70100

  • GSK Investigational Site

    Lahti, 15140

  • GSK Investigational Site

    Oulu, 90100

  • GSK Investigational Site

    Pori, 28120

  • GSK Investigational Site

    Seinäjoki, 60100

  • GSK Investigational Site

    Tampere, 33200

  • GSK Investigational Site

    Turku, 20520

  • GSK Investigational Site

    Vantaa, 01300

  • GSK Investigational Site

    Vantaa, 01600

Other trials in Finland

France14 sites

  • GSK Investigational Site

    Bernay, 27300

  • GSK Investigational Site

    Colombes, 92701

  • GSK Investigational Site

    Courbevoie, 92400

  • GSK Investigational Site

    Créteil, 94000

  • GSK Investigational Site

    Dax, 40100

  • GSK Investigational Site

    Draguignan, 83300

  • GSK Investigational Site

    Essey-lès-Nancy, 54270

  • GSK Investigational Site

    Le Havre, 76600

  • GSK Investigational Site

    Maromme, 76150

  • GSK Investigational Site

    Nice, 06300

  • GSK Investigational Site

    Nogent-sur-Marne, 94130

  • GSK Investigational Site

    Paris, 75019

  • GSK Investigational Site

    Rouen, 76000

  • GSK Investigational Site

    Saint-Quentin, 02100

Other trials in France

Poland6 sites

  • GSK Investigational Site

    Bydgoszcz, 85-021

  • GSK Investigational Site

    Dębica, 39-200

  • GSK Investigational Site

    Krakow, 31-202

  • GSK Investigational Site

    Poznan, 61-709

  • GSK Investigational Site

    Siemianowice Śląskie, 41-103

  • GSK Investigational Site

    Trzebnica, 55-100

Other trials in Poland

About this study

Official title: Assess Lot-to-lot Consistency of 3 Lots (Double Blind Design) of GlaxoSmithKline Biologicals' 10-valent Pneumococcal Vaccine and Evaluate Non-inferiority to Prevenar™ (Single Blind Design) When Administered as 3-dose Primary Immunization Course Before 6 Months of Age

Evaluate lot-to-lot consistency, safety and reactogenicity of 3 doses of GSK Biologicals' 10-valent pneumococcal conjugate vaccine and non-inferiority with respect to Prevenar.

Read the detailed description

Test groups: 4 (400 subjects/group). 3 groups receiving 10-valent pneumococcal conjugate vaccine (3 different lots) as follows: - 10-valent vaccine (lot 1, 2 or 3) + DTPa combined vaccine; Control group receiving Prevenar + DTPa combined vaccine

Being tested
Pneumococcal (vaccine)
Medical subject headings
Streptococcal Infections

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. Lot-to-lot consistency: antibody (Ab) concentrations to pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and to carrier protein PD

  2. Non-inferiority of 10-valent pneumococcal conjugate vaccine (pooled data of 3 10-Pn-PD-DiT vaccine groups) w.r.t. Prevenar: all anti-pneumococcal serotypes Ab concentrations>=0.20 µg/mL

Secondary outcomes (6)

  1. After each vaccination, occurrence of: solicited local, general symptoms within 4 days;

    Measured: After each vaccination

  2. Unsolicited adverse events within 31 days, SAEs (whole study period)

  3. 1m post dose3: For all vaccine pneumococcal serotypes: Opsono titres

  4. Antibody (Ab) concentrations >= 0.20 µg/mL

  5. Ab concentrations to protein D and seropositivity (S+) status

  6. S+/seroprotection status to antigens in DTPa combo vaccine

Timeline

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

  1. First posted28 Mar 2006 (estimated)
  2. Study startNov 2005
  3. Study completionJun 2006

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
1,600 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00307554
Sponsor's protocol ID
105553
Status last verified
Sep 2016
First submitted
8 Mar 2006
Last updated
26 Sep 2016
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

  • Chevallier B, Vesikari T, Brzostek J, Knuf M, Bermal N, Aristegui J, Borys D, Cleerbout J, Lommel P, Schuerman L. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S109-18. doi: 10.1097/INF.0b013e318199f62d.

    PubMed 19325447

  • Hausdorff WP, Dagan R, Beckers F, Schuerman L. Estimating the direct impact of new conjugate vaccines against invasive pneumococcal disease. Vaccine. 2009 Dec 9;27(52):7257-69. doi: 10.1016/j.vaccine.2009.09.111. Epub 2009 Oct 13.

    PubMed 19833248

  • Knuf M, Szenborn L, Moro M, Petit C, Bermal N, Bernard L, Dieussaert I, Schuerman L. Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S97-S108. doi: 10.1097/INF.0b013e318199f61b.

    PubMed 19325452

  • 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

  • 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

  • Schuerman L, Wysocki J, Tejedor JC, Knuf M, Kim KH, Poolman J. Prediction of pneumococcal conjugate vaccine effectiveness against invasive pneumococcal disease using opsonophagocytic activity and antibody concentrations determined by enzyme-linked immunosorbent assay with 22F adsorption. Clin Vaccine Immunol. 2011 Dec;18(12):2161-7. doi: 10.1128/CVI.05313-11. Epub 2011 Oct 12.

    PubMed 21994351

  • Vesikari T, Wysocki J, Chevallier B, Karvonen A, Czajka H, Arsene JP, Lommel P, Dieussaert I, Schuerman L. Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) compared to the licensed 7vCRM vaccine. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S66-76. doi: 10.1097/INF.0b013e318199f8ef.

    PubMed 19325449

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pneumococcal (vaccine) in people with Infections, Streptococcal, run by GlaxoSmithKline at 35 sites in 3 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 2 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: finished, as of the sponsor's last update on 26 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Finland, France, Poland. 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?

Lot-to-lot consistency: antibody (Ab) concentrations to pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and to carrier protein PD. The study lists 2 primary outcomes in all. 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 NCT00307554, 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 26 Sep 2016.

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