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. 10069577: Pertussis immunisation 10069543: Hemophilus influenzae type b immunization MedDRA version: 14.1 Level: PT Classification code 10054130 Term: Hepatitis B immunisation System Organ Class: 10042613 - Surgical and medical pro
Conditions
Sponsors
Sanofi Pasteur MSD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is a healthy infant and is = 46 days and = 74 days of age on the day of vaccination. 2. Subject’s parent(s)/legal representative understand the study procedures, alternate vaccinations available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent. 3. Subject’s parent(s)/legal representative are able to read, understand, and complete study questionnaires (i.e., the Vaccination Report Card). 4. Subject is able to attend all scheduled visits and to comply with the study procedures. 5. Subject’s parent(s)/legal representative has access to a telephone. 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: 1. Subject is currently participating or has participated in a study with an investigational compound or device within 4 weeks of expected first dose of PR5I/vaccine control(s). 2. Subject’s parent(s)/legal representative plans to enroll the subject in another clinical study during the present study period. 3. Subject has history of congenital immunodeficiency or acquired immunodeficiency (e.g., HIV, splenomegaly). 4. Prior to study entry, subject has received or is expected to receive immunosuppressive agents (e.g., substances or treatments known to diminish immune response such as radiation therapy, antimetabolites, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava TNF-a antagonists, monoclonal antibody therapies (including rituximab [Rituxantm] intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response). 5. Subject has received 1) systemic immunomodulatory steroids (> the equivalent of 2 mg/kg total daily dose of prednisone) since birth, or 2) any dose of systemic immunomodulatory steroids within 7 days prior to entering study or 3) is expected to require systemic immunomodulatory steroids through the course of the study. Subjects using non-systemic corticosteroids (e.g. topical, ophthalmic, inhaled) will be eligible for vaccination. 6. Subject has a history of leukemia, lymphoma, malignant melanoma, or myeloproliferative disorder. 7. Subject has known or suspected hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or concomitant study vaccines. 8. Subject has chronic illness that could interfere with study conduct or completion. 9. Subject has received any immune globulin, blood, or blood-derived products since birth. 10. Subject has received a dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry. 11. Subject has received previous vaccination with any acellular pertussis (DTaP) or whole cell pertussis (DTwP) based combination vaccines, Haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, measles, mumps, rubella, or varicella vaccine, or combination thereof. 12. *Subject has had a febrile illness within 24 hours prior to enrollment or a rectal temperature = 38.0°C at Visit 1. 13. *Subject has been vaccinated with an inactivated or conjugated vaccine (e.g., influenza vaccine) within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 14 days or more prior to enrollment. 15. Subject has coagulation disorder contraindicating intramuscular (IM) vaccination. 16. Subject has clinically significant findings on review of systems (by medical history) determined by investigator or sub-investigator to be sufficient for exclusion. 17. Subject has developmental delay or neurological disorder (by medical history at study entry). 18. Subject or his/her mother has a medical history of HBsAg seropositivity. 19. Subject has history of measles, mumps rubella, varicella, Haemophilus influenzae type B, hepatitis B, diphtheria, tetanus, pertussis, rotavirus, invasive pneumococcal, or poliomyelitis infection. 20. Subject’s parent(s)/legal representative is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study. 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the immunogenicity of PR5I when given at 2, 3, 4, and 12 months. 2. To compare the immunogenicity response elicited by PR5I to that of INFANRIX hexa when given at 2, 3, 4, and 12 months.;Secondary Objective: 1. Evaluate the immunogenicity of ProQuad when administered concomitantly with the toddler dose of PR5I. 2. Describe the safety profile associated with the administration of each dose of PR5I or INFANRIX hexa when given concomitantly with Prevenar 13, RotaTeq , and ProQuad . 3. Describe the fever profile from Day 1 through Day 5 after the administration of each dose and after all doses of PR5I or INFANRIX hexa when given concomitantly with Prevenar 13, RotaTeq , and ProQuad (Section 3.4 protocol for details). 4. Describe the percentage of subjects with solicited injection-site adverse events (i.e., pain, erythema, and swelling), and solicited systemic adverse events (i.e., vomiting, crying abnormal, drowsiness, appetite lost, and irritability) within 5 days after each and any doses of PR5I or INFANRIX hexa when coadministered with Prevenar 13, RotaTeq , and ProQuad . 5. Summarize the incidence of SAEs which will be collected as instructed in Section 3.4 protocol.;Primary end point(s): The primary endpoints for the acceptability hypothesis are vaccine-induced antibody responses to all antigens contained in PR5I at Postdose 3 and after the Toddler dose (12 months) as listed in Table 2-2 of the protocol. Further details can be found in Section 3.5 of the protocol The primary endpoints for non-inferiority hypothesis are vaccine-induced antibody responses against antigens that are contained in both PR5I and the control vaccine at Postdose 3 and after Toddler Dose (12 months) as listed in Table 2-3 of the protocol. | — |
Countries
Belgium, Finland, Germany
Outcome results
None listed