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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.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal (vaccine) | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | ||
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| After each vaccination, occurrence of: solicited local, general symptoms within 4 days; | After each vaccination | |
| Unsolicited adverse events within 31 days, SAEs (whole study period) | ||
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Espoo | 02100 | Finland | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19325447 | Background | 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. | |
| 19833248 |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 105553 | Clinical Study Report | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| 1m post dose3: For all vaccine pneumococcal serotypes: Opsono titres |
| Antibody (Ab) concentrations >= 0.20 µg/mL |
| Ab concentrations to protein D and seropositivity (S+) status |
| S+/seroprotection status to antigens in DTPa combo vaccine |
| Helsinki |
| 00930 |
| Finland |
| GSK Investigational Site | Jarvenpaa | 04400 | Finland |
| GSK Investigational Site | Jyväskylä | 40100 | Finland |
| GSK Investigational Site | Kokkola | 67100 | Finland |
| GSK Investigational Site | Kotka | 48100 | Finland |
| GSK Investigational Site | Kuopio | 70100 | Finland |
| GSK Investigational Site | Lahti | 15140 | Finland |
| GSK Investigational Site | Oulu | 90100 | Finland |
| GSK Investigational Site | Pori | 28120 | Finland |
| GSK Investigational Site | Seinäjoki | 60100 | Finland |
| GSK Investigational Site | Tampere | 33200 | Finland |
| GSK Investigational Site | Turku | 20520 | Finland |
| GSK Investigational Site | Vantaa | 01300 | Finland |
| GSK Investigational Site | Vantaa | 01600 | Finland |
| GSK Investigational Site | Bernay | 27300 | France |
| GSK Investigational Site | Colombes | 92701 | France |
| GSK Investigational Site | Courbevoie | 92400 | France |
| GSK Investigational Site | Créteil | 94000 | France |
| GSK Investigational Site | Dax | 40100 | France |
| GSK Investigational Site | Draguignan | 83300 | France |
| GSK Investigational Site | Essey-lès-Nancy | 54270 | France |
| GSK Investigational Site | Le Havre | 76600 | France |
| GSK Investigational Site | Maromme | 76150 | France |
| GSK Investigational Site | Nice | 06300 | France |
| GSK Investigational Site | Nogent-sur-Marne | 94130 | France |
| GSK Investigational Site | Paris | 75019 | France |
| GSK Investigational Site | Rouen | 76000 | France |
| GSK Investigational Site | Saint-Quentin | 02100 | France |
| GSK Investigational Site | Bydgoszcz | 85-021 | Poland |
| GSK Investigational Site | Dębica | 39-200 | Poland |
| GSK Investigational Site | Krakow | 31-202 | Poland |
| GSK Investigational Site | Poznan | 61-709 | Poland |
| GSK Investigational Site | Siemianowice Śląskie | 41-103 | Poland |
| GSK Investigational Site | Trzebnica | 55-100 | Poland |
| Background |
| 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. |
| 19325452 | Background | 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. |
| 21123523 | Background | 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. |
| 19666154 | Background | 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. |
| 21994351 | Background | 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. |
| 19325449 | Background | 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. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 105553 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105553 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105553 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105553 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 105553 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| ID | Term |
|---|---|
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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