DAPTACEL®. (DTaP), IPOL®., and ActHIB®.
Biological0.5 mL, Intramuscular
Other names: DAPTACEL®, IPOL®, ActHIB®
NCT Number: NCT00255047
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®.
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Notify Me42 day–89 day
All sexes
Interventional
Phase 3
Tuscaloosa, Alabama, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
0.5 mL, Intramuscular
Other names: DAPTACEL®, IPOL®, ActHIB®
0.5 mL, Intramuscular
Other names: Pentacel®
0.5 mL, Intramuscular
Other names: ActHIB®
Time frame: 30 Days post-dose 3 vaccination
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
Time frame: 30 Days post-dose 3 vaccination.
Time frame: 7 days post-vaccination 3
Solicited injection site reactions: Tenderness, Redness, and Swelling. Solicited systemic reactions: Fever (body temperature), Vomiting, Abnormal crying, Lethargy, Appetite decreased, Irritability, and Rash.
Sanofi Pasteur, a Sanofi Company
Industry
Comparative Immunogenicity of Different Multivalent Component Pertussis Vaccine Formulations Based on a 5 Component Acellular Pertussis Vaccine in Infants and Toddlers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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