Status:
COMPLETED
Spanish Mixed HEXA/PENTA/HEXA Schedule (V419-010)
Lead Sponsor:
MCM Vaccines B.V.
Collaborating Sponsors:
Sanofi Pasteur, a Sanofi Company
Merck Sharp & Dohme LLC
Conditions:
Neisseria Meningitidis
Bacterial Infections
Eligibility:
All Genders
46-76 years
Phase:
PHASE3
Brief Summary
To evaluate the immune response and the safety of a primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel at 4 months of age Primary objectives * To demonstrate tha...
Eligibility Criteria
Inclusion
- Healthy infant 46 to 74 days (both inclusive)
- Documented receipt of only one dose of monovalent hepatitis B vaccine within the 3 days after birth
- Parent(s)/legal representative able to comply with the study procedures
Exclusion
- Participation in any study with an investigational compound or device since birth
- History of congenital or acquired immunodeficiency
- Chronic illness that could interfere with study conduct or completion
- 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
- Contraindication to Pediacel®, NeisVac-C®, Prevenar 13®, and RotaTeq®
- History or maternal history of HBsAg seropositivity
- Coagulation disorder that contraindicate intramuscular injection
- 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)
- History of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, or serogroup C meningococcal infection
- Receipt of immune globulin, blood or blood-derived products since birth
- Receipt of systemic corticosteroids for more than 14 consecutive days within one month of the study start
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2014
Estimated Enrollment :
385 Patients enrolled
Trial Details
Trial ID
NCT01839188
Start Date
May 1 2013
End Date
March 19 2014
Last Update
February 25 2019
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