Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants
NCT ID: NCT00366899
Last Updated: 2013-02-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
605 participants
INTERVENTIONAL
2006-10-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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1
13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Single 0.5 mL dose of 13vPnC given at 3, 5 and 11 months of age.
2
7-valent pneumococcal conjugate vaccine
7 valent pneumococcal conjugate vaccine
Single 0.5 mL dose of 7vPnC given at 3, 5 and 11 months of age.
Interventions
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13-valent pneumococcal conjugate vaccine
Single 0.5 mL dose of 13vPnC given at 3, 5 and 11 months of age.
7 valent pneumococcal conjugate vaccine
Single 0.5 mL dose of 7vPnC given at 3, 5 and 11 months of age.
Eligibility Criteria
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Inclusion Criteria
2. Available for entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
3. Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
4. Born at greater than 32 weeks gestational age and greater than 2000 grams. Regardless of gestational age and birth weight, all subjects must have met inclusion criterion number 3.
5. Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures during study participation.
Exclusion Criteria
2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B vaccines.
3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or 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 or Hib.
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, hydrocephalus, or other significant disorders. Did not include resolving syndromes due to birth trauma such as Erb palsy.
10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis® \[MedImmune\]).
11. Participation in another investigational trial. Participation in purely observational studies was acceptable.
12. Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.
75 Days
105 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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Taranto, Apulia, Italy
Napoli, Campania, Italy
Napoli, Campania, Italy
Bologna, Emilia-Romagna, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Genoa, Liguria, Italy
Milan, Lombardy, Italy
Novara, Piedmont, Italy
Sassari, Sardinia, Italy
Palermo, Sicily, Italy
Ragusa, Sicily, Italy
Florence, Tuscany, Italy
Countries
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References
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Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.
Other Identifiers
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6096A1-500
Identifier Type: -
Identifier Source: org_study_id
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