PR5I is developed to provide active immunization against diphtheria, tetanus, pertussis, poliomyelitis (caused by poliovirus Types 1, 2 and 3), invasive disease caused by Haemophilus influenza type b and infection caused by all known subtypes of hepatitis B virus. MedDRA version: 14.1 Level: LLT Classification code 10054183 Term: Tetanus immunization System Organ Cl
Conditions
Interventions
Product Name: PR5I
Product Code: V419
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: TETANUS TOXOID
Concentration un
Sponsors
Sanofi Pasteur MSD S.N.C
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All the following criteria should be met at Visit 1 to be eligible for inclusion: 1. Healthy infant 46 to 74 days of age (both inclusive) 2. Informed consent signed by the subject's parents or legal representative 3. Subject's parents or legal representative able to comply will 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: 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: A subject meeting at least one of the following criteria will be ineligible for inclusion (Visit 1). For criteria with an asterisk, subject can return once this criterion no longer applies. 1. Subject participating in a study with an investigational compound or device since birth 2. History of congenital or acquired immunodeficiency (e.g. HIV, splenomegaly) 3. History of leukemia, lymphoma, malignant melanoma or myeloproliferative disorder 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 any of the study vaccines (MCC-TT, MCC-CRM, PCV-13, Hib-MCC and MMR) as per their Summary of Product Characteristics 7. History or mother history of HBsAg seropositivity 8. Coagulation disorder that contraindicate intramuscular injection 9. History of vaccination with a hepatitis B, Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acelullar or whole-cell), poliovirus, pneumococcal conjugate or polysaccharide, meningococcal serogroup C conjugate, measles, mumps, or rubella containing vaccine(s) 10. History of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, invasive pneumococcal, meningococcal serogroup C, measles, mumps or rubella infection 11. Receipt of immune globulin, blood or blood-derived products since birth 12. Receipt of immunosuppressive agents since birth (e.g. radiation therapy, antimetabolites, cyclophosphamide, aziathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide, TNF-?antagonists, monoclonal antibody therapies, intravenous gamma globulin, antilymphocyte sera) 13. Receipt of systemic corticosteroids at >2 mg/kg prednisone-equivalent total daily dose since birth 14. *Receipt of systemic corticosteroids at any dose in the last 7 days 15. *Vaccination with an inactivated (except influenza vaccine) or conjugated or live vaccine in the last 30 days 16. *Vaccination with an inactivated influenza vaccine in the last 14 days 17. *Antipyretic, analgesic and non-steroidal anti-inflammatory medications in the last 48 hours. Use of topical analgesics ispermitted except at the site of vaccine administrations. 18. *Febrile illness or body temperature =38.0°C in the last 24 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the concomitant administration of PR5I with two types of MCC vaccines (MCC-TT and MCC-CRM) to healthy infants at 3 and 4 months of age in term of antibody seroprotection rate (SPR) to MCC.; Secondary Objective: Immunogenicity • To evaluate the immunogenicity of PR5I in term of SPR to Haemophilus influenzae type b (Hib) when PR5I is given at 2 months of age and concomitantly with MCC vaccines at 3 and 4 months of age. • To describe the immunogenicity of PR5I when PR5I is given at 2 months of age and concomitantly with MCC vaccines at 3 and 4 months of age. • To describe the immunogenicity of MCC vaccines when MCC vaccines are given concomitantly with PR5I at 3 and 4 months of age (post-dose 1 and post-dose 2). Safety •To describe the safety of PR5I given concomitantly with PCV-13 at 2 months of age, concomitantly with MCC vaccines at 3 months of age, and concomitantly with both PCV-13 and MCC vaccines at 4 months of age. ;Primary end point(s): Proportion of subjects with an anti-MCC titre =1:8 dil post-dose 2 of MCC vaccine;Timepoint(s) of evaluation of this end point: post-dose 2 of MCC vaccine | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PART I: Post-dose 1 of MCC vaccines: • Proportion of subjects with an anti-MCC titre =1:8 dil Post-dose 1 and Post-dose 2 of MCC vaccine: • Proportion of subjects with an anti-MCC titre =1:128 dil • Anti-MCC geometric mean of titres (GMTs) Post-dose 3 of PR5I: • Proportion of subjects with an anti-PRP titre =0.15 µg/mL • Anti-PRP GMTs • Proportion of subjects with an anti-HBs titre =10 mIU/mL • Anti-HBs GMTs • Proportion of subjects with an anti-D titre =0.01 IU/mL • Proportion of subjects with an anti-D titre =0.1 IU/mL • Anti-D GMTs • Proportion of subjects with an anti-T titre =0.01 IU/mL • Proportion of subjects with an anti-T titre =0.1 IU/mL • Anti-T GMTs • 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 • Proportion of subjects with a seroresponse* to anti-PT • Proportion of subjects with a seroresponse* to anti-FHA • Proportion of subjects with a seroresponse* to anti-PRN • Proportion of subjects with a seroresponse* to anti-FIM • Anti-PT, anti-FHA, anti-PRN and anti-FIM GMTs *Pertussis seroresponse is defined as: (1) If prevaccination antibody concentration <LLOQ, then the postvaccination antibody concentration should be =LLOQ, (2) If prevaccination antibody concentration =LLOQ, then the postvaccination antibody concentration should be = preimmunization levels. PART II: | — |
Countries
United Kingdom
Contacts
Public ContactClinical Development Director
Sanofi Pasteur MSD S.N.C.
Outcome results
None listed