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 Objectives: 1. To assess the lot-comparability of immunogenicity of DAPTACEL by when co-administered with other recommended vaccines. 2. To compare the immune response to DTaP-IPV/Hib (Pentacel) with those of three lots of DAPTACEL when co-administered with other recommended vaccines. 3. To compare the immune response of PRP-T antigen in Pentacel with that of ActHIB concurrently administered in a different injection site with DAPTACEL when these vaccines are co-administered with other recommended vaccines. Stage II Primary Objectives: 1. To compare the immune response of DAPTACEL when the 4th dose is co-administered with Hib or other infant vaccines. 2. To compare the the immune response of Pentacel with those elicited by DAPTACEL when co-administered with ActHIB in toddlers.
This is a two-stage, randomized, multi-center study to assess the safety, immunogenicity and lot comparability of DAPTACEL
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,941
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Unnamed facility
Fayetteville, AR 72703, Arkansas, United States
Unnamed facility
Jonesboro, AR 72401, Arkansas, United States
Unnamed facility
Little Rock, AR 72211, Arkansas, United States
Unnamed facility
Fountain Valley, CA 92708, California, United States
Unnamed facility
Englewood, CO 80112, Colorado, United States
Unnamed facility
Norwich, CT 06360, Connecticut, United States
Unnamed facility
Orlando, FL 32856, Florida, United States
Unnamed facility
Marietta, GA 30062, Georgia, United States
Unnamed facility
Chicago, IL 60614, Illinois, United States
Unnamed facility
Bardstown, KY 40004, Kentucky, United States
...and 16 more locations
Immunogenicity: To provide information concerning the immune response of DAPTACEL after vaccination.
Time frame: 30 days post-vaccination 3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.