Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
NCT ID: NCT00366678
Last Updated: 2012-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
613 participants
INTERVENTIONAL
2006-10-31
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.
Pentavac
The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).
7-valent pneumococcal conjugate vaccine
7-valent pneumococcal conjugate vaccine
7-valent pneumococcal conjugate vaccine
Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.
Pentavac
The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).
Interventions
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13-valent pneumococcal conjugate vaccine
Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.
7-valent pneumococcal conjugate vaccine
Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.
Pentavac
The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).
Eligibility Criteria
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Inclusion Criteria
* Available for the entire study period.
Exclusion Criteria
42 Days
98 Days
ALL
Yes
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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Albi, , France
Amiens, , France
Ancenis, , France
Blanquefort, , France
Bondues, , France
Bordeaux, , France
Brest, , France
Châlons-en-Champagne, , France
Créteil, , France
Dijon, , France
Draguignan, , France
Essey-lès-Nancy, , France
Écully, , France
Floirac, , France
Fréjus, , France
Garges-lès-Gonesse, , France
Illkirch-Graffenstaden, , France
Joué-lès-Tours, , France
Le Havre, , France
Le Plessis-Trévise, , France
Le Pontet, , France
Les Lilas, , France
Les Sables-d'Olonne, , France
Libourne, , France
Lingolsheim, , France
Lyon, , France
Lyon, , France
Marcq-en-Barœul, , France
Maromme, , France
Moûtiers, , France
Nancy, , France
Nice, , France
Nogent-sur-Marne, , France
Oullins, , France
Paris, , France
Rouen, , France
Strasbourg, , France
Strasbourg, , France
Thionville, , France
Tours, , France
Tresses Melac, , France
Vandœuvre-lès-Nancy, , France
Vaulx-en-Velin, , France
Villeneuve-d'Ascq, , France
Vitry-sur-Seine, , France
Countries
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Other Identifiers
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6096A1-008
Identifier Type: -
Identifier Source: org_study_id