Status:
COMPLETED
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Vaccines, Pneumococcal
Eligibility:
All Genders
42-98 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneum...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Aged 2 months (42 through 98 days) at the time of enrollment.
- Available for the entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
- In good health as determined by medical history, physical examination, and judgment of the investigator.
- Parent(s)/legal guardian(s) were able to complete all relevant study procedures during study participation.
- Exclusion criteria:
- Previous vaccination with licensed or investigational pneumococcal vaccine.
- Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, or pneumococcal vaccines.
- Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
- Known or suspected immune deficiency or suppression.
- History of culture-proven invasive disease caused by S pneumoniae.
- Major known congenital malformation or serious chronic disorder.
- 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.
- Receipt of blood products or γ-globulin (including hepatitis B immunoglobulin and monoclonal antibodies \[eg, Synagis\]).
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00366548
Start Date
November 1 2006
End Date
June 1 2008
Last Update
August 15 2012
Active Locations (14)
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1
Bydgoszcz, Poland, 85-168
2
Dębica, Poland, 39-200
3
Krakow, Poland, 30-663
4
Krakow, Poland, 31-202