Proper Name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed
Manufacturer: Sanofi Pasteur, Ltd.
- Indicated for active immunization against diphtheria, tetanus and pertussis as a five dose series in infants and children 6 weeks through 6 years of age (prior to 7th birthday).
- September 14, 2016 Final Clinical Review - DAPTACEL
- September 16, 2016 Summary Basis of Regulatory Action - DAPTACEL
- September 16, 2016 Approval Letter - DAPTACEL
To include immunogenicity and safety data to support the co-administration of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra) with a fifth dose of DAPTACEL in children 4 through 6 years of age.
- Supporting Documents older than three years - Daptacel