Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
NCT ID: NCT00366548
Last Updated: 2012-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
500 participants
INTERVENTIONAL
2006-11-30
2008-06-30
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
DOUBLE
Study Groups
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1
13 valent pneumococcal conjugate vaccine with Polysorbate 80
2
13 valent pneumococcal conjugate vaccine without Polysorbate 80
Interventions
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13 valent pneumococcal conjugate vaccine with Polysorbate 80
13 valent pneumococcal conjugate vaccine without Polysorbate 80
Eligibility Criteria
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Inclusion Criteria
2. Available for the entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
3. In good health as determined by medical history, physical examination, and judgment of the investigator.
4. Parent(s)/legal guardian(s) were able to complete all relevant study procedures during study participation.
Exclusion Criteria
2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, or pneumococcal vaccines.
5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
6. Known or suspected immune deficiency or suppression.
7. History of culture-proven invasive disease caused by S pneumoniae.
8. Major known congenital malformation or serious chronic disorder.
9. Significant neurological disorder or history of seizure (including febrile seizure), or significant stable or evolving disorders (such as cerebral palsy, encephalopathy, or hydrocephalus), or other significant disorders. This did not include resolving syndromes because of birth trauma such as Erb palsy.
10. Receipt of blood products or γ-globulin (including hepatitis B immunoglobulin and monoclonal antibodies \[eg, Synagis\]).
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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Bydgoszcz, , Poland
Dębica, , Poland
Krakow, , Poland
Krakow, , Poland
Krakow, , Poland
Lodz, , Poland
Lubartów, , Poland
Lublin, , Poland
Oborniki Śląskie, , Poland
Poznan, , Poland
Poznan, , Poland
Siemianowice Śląskie, , Poland
Torun, , Poland
Trzebnica, , Poland
Countries
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References
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Gadzinowski J, Tansey SP, Wysocki J, Kopinska E, Majda-Stanislawska E, Czajka H, Korbal P, Pietrzyk JJ, Baker SA, Giardina PC, Gruber WC, Emini EA, Scott DA. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine manufactured with and without polysorbate 80 given to healthy infants at 2, 3, 4 and 12 months of age. Pediatr Infect Dis J. 2015 Feb;34(2):180-5. doi: 10.1097/INF.0000000000000511.
Other Identifiers
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6096A1-009
Identifier Type: -
Identifier Source: org_study_id