The overall aim of the study is to corroborate that a schedule consisting of 3 doses of Pentacel™ and a 4th dose of DAPTACEL® and ActHIB® or 4 doses of Pentacel™ or 4 doses of Quadracel and ActHIB® is as safe and immunogenic as a standard of care schedule based on 3 doses of the licensed-equivalent vaccines DAPTACEL®, Vero cell derived Inactivated Poliovirus vaccine (IPOL®), and ActHIB® and a 4th dose of DAPTACEL® and ActHIB®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
2,167
0.5 mL, Intramuscular
0.5 mL, Intramuscular
0.5 mL, Intramuscular
Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations.
Vaccine response was calculated as a pre-dose 1 titer ≤ Lower Limit of Quantitation (LLOQ) and post-dose 3 titer \> LLOQ; or a pre-dose 1 titer \> LLOQ and post-dose 3 titer ≥ pre-dose 1 titer.
Time frame: 30 Days post-dose 3 vaccination
Percentage of Participants With a Four-fold Rise in Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion)
Time frame: 30 Days post-dose 3 vaccination
Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations.
Time frame: 30 Days post-dose 3 vaccination.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
0.5 mL, Intramuscular
Unnamed facility
Tuscaloosa, Alabama, United States
Unnamed facility
Fayetteville, Arkansas, United States
Unnamed facility
Jonesboro, Arkansas, United States
Unnamed facility
Little Rock, Arkansas, United States
Unnamed facility
Fountain Valley, California, United States
Unnamed facility
Oakland, California, United States
Unnamed facility
Oakland, California, United States
Unnamed facility
Oakland, California, United States
Unnamed facility
Paramount, California, United States
Unnamed facility
Norwich, Connecticut, United States
...and 26 more locations