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: 16.0 Level: LLT Classification code 10054187 Term: Polio immunization System Organ Class: 100000004865 MedDRA version: 16.0 Level: LLT Classification code 10069543 Term: Hemophilus influenzae type b immunization System Organ Class: 100000004865 MedDRA version: 16.0 Level: LLT Classification code 10069593 Term: Pertussis immunization System Organ Class: 100000004865
Conditions
Interventions
Product Name: PR5I
Product Code: V419
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: PERTUSSIS TOXOID
Other descriptive name: Pertussis Toxoid
Concentration unit: µg microgram(s)
C
Sponsors
Sanofi Pasteur MSD
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The two co-primary objectives for the study are: -To demonstrate that the mixed schedule induces acceptable responses for Hepatitis B (% of subjects with an anti-HBs titre =10 mIU/mL ) one month after the third dose of the mixed schedule (i.e. at Month 7) -To demonstrate that the mixed schedule induces acceptable responses for Hib (% of subjects with an anti-PRP titre =0.15 µg/mL ) one month after the third dose of the mixed schedule (i.e. at Month 7).;Secondary Objective: Immunogenicity: -To describe the antibody response to all PR5I antigens: hepatitis B, Hib, diphtheria (D) and tetanus (T) toxoids, pertussis (PT, FHA, PRN, FIM 2&3) and inactivated poliovirus antigens (IPV1, IPV2, IPV3) one month after completion of the mixed schedule (i.e. at Month 7). -To describe the antibody response to meningococcal serogroup C conjugate (MenC) vaccine one month after the second dose of MenC vaccine when used concomitantly with the mixed schedule. Safety: - To describe the safety profile after each dose of study vaccines administered.;Primary end point(s): -Proportion of subjects with an anti-HBs titre =10 mIU/mL -Proportion of subjects with an anti-PRP titre =0.15 µg/mL;Timepoint(s) of evaluation of this end point: One month after the complete mixed schedule PR5I/Pediacel/PR5I | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity: -Anti-HBs Geometric Mean Titers (GMT) -Anti-PRP GMT -Proportion of subjects with an anti-PRP titre =1 µg/mL -Proportion of subjects with an anti-diphtheria concentration =0.01 IU/mL -Proportion of subjects with an anti-diphtheria concentration =0.1 IU/mL -Anti-diphtheria Geometric Mean Concentrations (GMC) -Proportion of subjects with an anti-tetanus concentration =0.01 IU/mL -Proportion of subjects with an anti-tetanus concentration =0.1 IU/mL -Anti-tetanus GMC -Proportion of subjects with an anti-IPV1 titre =1:8 dil -Proportion of subjects with an anti-IPV2 titre =1:8 dil -Proportion of subjects with an anti-IPV3 titre =1:8 dil -Anti-IPV1, anti-IPV2 and anti-IPV3 GMTs -Anti-PT , anti-FHA, anti-PRN and anti-FIM 2&3 GMCs -Proportion of subjects with an anti-MenC titre = 1:8dil -Anti-MenC GMT Safety: Incidence of solicited injection-sites reactions and solicited systemic adverse event. Incidence of unsolicited injection-site reactions, unsolicited systemic adverse events and all serious adverse events.;Timepoint(s) of evaluation of this end point: Immunogenicity: one month after the complete mixed schedule PR5I/Pediacel/PR5I and one month after the second dose of MenC vaccine. Safety: from Visit 1 to Visit 5 | — |
Countries
Spain
Contacts
Public ContactClinical Development Director
Sanofi Pasteur MSD S.N.C.
Outcome results
None listed