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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2006-06-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Infections, Streptococcal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Pneumococcal (vaccine)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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.

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.
* 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.

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Espoo, , Finland

Site Status

GSK Investigational Site

Helsinki, , Finland

Site Status

GSK Investigational Site

Järvenpää, , Finland

Site Status

GSK Investigational Site

Jyväskylä, , Finland

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GSK Investigational Site

Kokkola, , Finland

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GSK Investigational Site

Kotka, , Finland

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GSK Investigational Site

Kuopio, , Finland

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GSK Investigational Site

Lahti, , Finland

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GSK Investigational Site

Oulu, , Finland

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GSK Investigational Site

Pori, , Finland

Site Status

GSK Investigational Site

Seinäjoki, , Finland

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GSK Investigational Site

Tampere, , Finland

Site Status

GSK Investigational Site

Turku, , Finland

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GSK Investigational Site

Vantaa, , Finland

Site Status

GSK Investigational Site

Vantaa, , Finland

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GSK Investigational Site

Bernay, , France

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GSK Investigational Site

Colombes, , France

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GSK Investigational Site

Courbevoie, , France

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GSK Investigational Site

Créteil, , France

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GSK Investigational Site

Dax, , France

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GSK Investigational Site

Draguignan, , France

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GSK Investigational Site

Essey-lès-Nancy, , France

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GSK Investigational Site

Le Havre, , France

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GSK Investigational Site

Maromme, , France

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GSK Investigational Site

Nice, , France

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GSK Investigational Site

Nogent-sur-Marne, , France

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GSK Investigational Site

Paris, , France

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GSK Investigational Site

Rouen, , France

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GSK Investigational Site

Saint-Quentin, , France

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GSK Investigational Site

Bydgoszcz, , Poland

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GSK Investigational Site

Dębica, , Poland

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GSK Investigational Site

Krakow, , Poland

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GSK Investigational Site

Poznan, , Poland

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GSK Investigational Site

Siemianowice Śląskie, , Poland

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GSK Investigational Site

Trzebnica, , Poland

Site Status

Countries

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Finland France Poland

References

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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.

Reference Type BACKGROUND

PMID: 19325447 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 19833248 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 19325452 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 21123523 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 19666154 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 21994351 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 19325449 (View on PubMed)

Study Documents

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