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
56-112 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 compared to 7-valent pneumococcal conjugate (Prevenar/Prevenar...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Aged 2 months (56 to 112 days) at time of enrollment.
- Available for entire study period and whose parent(s) or legal guardian(s) could be reached by telephone.
- Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
- Parent(s) or legal guardian(s) had to be 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, polio, or hepatitis B vaccines.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or 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 or H influenzae type b.
- 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, hydrocephalus, or other significant disorders. Did 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 trial. Participation in purely observational studies was acceptable.
- Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
604 Patients enrolled
Trial Details
Trial ID
NCT00366340
Start Date
October 1 2006
End Date
August 1 2008
Last Update
August 8 2012
Active Locations (51)
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1
Bad Kreuznach, Germany, 55543
2
Bad Saulgau, Germany, 88348
3
Bad Sobernheim, Germany, 55566
4
Berlin, Germany, 10551