Status:
COMPLETED
Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Pneumococcal Vaccines
Eligibility:
All Genders
41-99 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale 13vPnC in healthy in...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Aged 2 months (42 to 98 days) at time of enrollment.
- Available for entire study period and whose parent/legal guardian can be reached by telephone.
- Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
- Parent/legal guardian must be able to complete all relevant study procedures during study participation.
- Exclusion criteria:
- Previous vaccination with licensed or investigational pneumococcal, 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, measles, mumps, rubella, 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 disorders.
- 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. Does not include resolving syndromes due to birth trauma such as Erb palsy.
- Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
- Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
- Infant who is a direct descendant (child or grandchild) of a member of the study site personnel.
Exclusion
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
269 Patients enrolled
Trial Details
Trial ID
NCT00464945
Start Date
June 1 2007
End Date
September 1 2008
Last Update
August 15 2012
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Torun, Bydgoszcz, Poland, 87-100
2
Krakow, Krakow, Poland, 30-663
3
Krakow, Krakow, Poland, 31-442
4
Siemianowice Śląskie, Krakow, Poland, 41-103