A phase 3 open-label study to evaluate the immune response and the safety of a primary series schedule that includes V419 (PR5I: hexavalent vaccine) at 2 and 6 months of age and Pediacel® (pentavalent vaccine) at 4 months of age

• 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; MedDRA version: 16.0Level: LLTClassification code 10054187Term: Polio immunizationSystem Organ Class: 100000004865; MedDRA version: 16.0Level: LLTClassification code 10069543Term: Hemophilus influenzae type b immunizationSystem Organ Class: 100000004865; MedDRA version: 16.0Level: LLTClassification code 10069593Term: Pertussis immunizationSystem Organ Class: 100000004865; MedDRA version: 16.0Level: LLTClassification code 10054181Term: Hepatitis B immunizationSystem Organ Class: 100000004865; MedDRA version: 16.0Level: LLTClassification code 10054180Term: Diphtheria immunizationSystem Organ Class: 100000004865; MedDRA version: 16.0Level: LLTClassification code 10054183Term: Tetanus immunizationSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2012-004221-25-ES
• Lead Sponsor: Sanofi Pasteur MSD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-14
• Last Update Posted: 10 November 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 385

Inclusion Criteria

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

Exclusion Criteria

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
11.Receipt of immune globulin, blood or blood-derived products since birth
12.Receipt of systemic corticosteroids (greater than the equivalent of 2 mg/kg total daily dose of prednisone) for more than 14 consecutive days within one month of the study start
13.Subjects expected to require systemic corticosteroids (greater than the equivalent of 2 mg/kg total daily dose of prednisone) for more than 14 consecutive days from the time of study start through the end of the safety follow-up period following the last dose. Subjects using non-systemic corticosteroids (e.g. topical, ophthalmic, and inhaled) will be eligible for vaccination.
14.Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified