Status:
COMPLETED
Study of the Safety, Immunogenicity and Lot Comparability of DAPTACEL When Administered With Other Recommended Vaccine
Lead Sponsor:
Sanofi
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
42-84 years
Phase:
PHASE3
Brief Summary
This study was designed to assess the lot comparability of DAPTACEL, as well as the safety and immunogenicity of DAPTACEL when co-administered with other recommended infant vaccines. Stage I Primary ...
Detailed Description
This is a two-stage, randomized, multi-center study to assess the safety, immunogenicity and lot comparability of DAPTACEL
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Healthy infants 2 months of age.
- Infants with at least 37 weeks of gestation at delivery.
- Signed informed consent from parent or guardian.
- Able to attend the scheduled visits and to comply with the study procedure.
- Subjects must have received the first dose of hepatitis B vaccine from birth to 28 days prior to the first dose of DAPTACEL or Pentacel.
- Exclusion Criteria :
- Clinically significant findings on review of systems or physical examination (determined by investigator or sub-investigator to be sufficient for exclusion).
- Known or suspected hypersensitivity to any component of the study vaccine to be administered.
- Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
- Known HIV-positive mother.
- Personal or immediate family history of congenital immune deficiency.
- Developmental delay or neurologic disorders.
- Chronic medical, congenital, developmental or surgical disease.
- Participation in any other experimental vaccine trial.
- Any condition which, in the opinion of the investigator or sub-investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
- Prior history of having received more than one dose of hepatitis B vaccine, any diphtheria, tetanus and acellular pertussis combination vaccine (DTaP), diphtheria, tetanus and whole-cell pertussis combination vaccine (DTwP), Haemophilus influenzae type b (Hib)-conjugate vaccine, poliovirus vaccine or pneumococcal conjugate vaccine
Exclusion
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2004
Estimated Enrollment :
1941 Patients enrolled
Trial Details
Trial ID
NCT00662870
Start Date
May 1 2001
End Date
January 1 2004
Last Update
January 31 2012
Active Locations (26)
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1
Fayetteville, AR 72703, Arkansas, United States, 72703
2
Jonesboro, AR 72401, Arkansas, United States, 7240
3
Little Rock, AR 72211, Arkansas, United States, 72211
4
Fountain Valley, CA 92708, California, United States, 92708