A phase 3 open-label study to evaluate the immunogenicity and safety of a mixed (HEXA/PENTA/HEXA) primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel® at 4 months of age. - Spanish mixed HEXA/PENTA/HEXA schedule

Sanofi Pasteur MSD0 sites385 target enrollmentJanuary 14, 2013

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy infants greater than or equal to 46 days and less than or equal to 74 days of age on the day of inclusion
Sponsor: Sanofi Pasteur MSD
Enrollment: 385
Status: Active, not recruiting
Last Updated: 11 years ago

No summary available.

Registry

who.int

Start Date

January 14, 2013

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Sanofi Pasteur MSD

•1\.Subject is a healthy infant greater than or equal to 46 days and less than or equal to 74 days of age on the day of inclusion.
•2\.Subject has received only one dose of monovalent hepatitis B vaccine, within the 3 days after birth, outside of the study context and it is documented in subject´s medical history.
•3\.Informed consent has been signed by the subject's parent(s) or legal representative.
•4\.Subject's parent(s) or legal representative able to comply with the study procedures such as adherence to study visits and completion of the Vaccination Report Cards.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 385
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•1\.Participation in any study with an investigational compound or device since birth
•2\.Subject´s parent(s)/legal representative plans to enrol the subject in another clinical study during the present study period
•3\.History of congenital or acquired immunodeficiency (e.g. HIV)
•4\.Chronic illness that could interfere with study conduct or completion, or significant findings on review of systems (by medical history) such as development delay or neurological disorder
•5\.Known or suspected hypersensitivity to any of the study vaccines' components or history of a life\-threatening reaction to a vaccine containing the same substances as the study vaccines
•6\.Contraindication to Pediacel®, NeisVac\-C®, Prevenar 13®, and RotaTeq® as per their Summary of Product Characteristics
•7\.History or maternal history of HBsAg seropositivity
•8\.Coagulation disorder that contraindicate intramuscular injection
•9\.History of vaccination with a Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acelullar or whole\-cell), poliovirus, meningococcal serogroup C conjugate, pneumococcal conjugate containing vaccine(s)
•10\.History of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, or serogroup C meningococcal infection