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: 16.0 Level: LLT Classification code 10019743 Term: Hepatitis B virus (HBV) System Organ Class: 100000004848 MedDRA version: 16.0 Level: LLT Classification code 10069543 Term: Hemophilus influenzae type b immunization
Conditions
Sponsors
Sanofi Pasteur MSD S.N.C.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be randomized and receive the first study vaccinations, subjects must meet all inclusion criteria. 1. Subject is a healthy infant and is greater than or equal to 46 days and less than or equal to 89 days of age on the day of vaccination. 2. Subject’s parent(s)/legal representative understand the study procedures, alternate treatments 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 [VRC]). 4. Subject is able to attend all scheduled visits and to comply with the study procedures. 5. Subject’s parent(s)/legal representative have access to a telephone. Are the trial subjects under 18? yes Number of subjects for this age range: 1315 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: To be randomized and receive the first study vaccinations, subjects must not meet any exclusion criteria. If a subject meets any of the exclusion criteria marked with an asterisk (*), the Day 1 visit may be rescheduled for a time when these criteria are no longer met. 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 plan 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, cyclosporine, leflunomide [Arava™], TNF-a antagonists, monoclonal antibody therapies [including rituximab (Rituxan™)], intravenous gamma globulin [IVIG], antilymphocyte sera, or other therapy known to interfere with the immune response). 5. Subject has received (a) systemic immunomodulatory steroids (> the equivalent of 2 mg/kg total daily dose of prednisone) since birth, or (b) any dose of systemic immunomodulatory steroids within 7 days prior to entering study, or (c) 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 a 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, prior to enrollment, 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 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 any non-study vaccine (e.g. inactivated, conjugated or live virus vaccine) within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 14 days or more prior to enrollment. 14. Subject has a coagulation disorder contraindicating intramuscular (IM) vaccination. 15. Subject has clinically significant findings on review of systems (by medical history) determined by the investigator or sub-investigator to be sufficient for exclusion. 16. Subject has developmental delay or neurological disorder (by medical history at study entry). 17. Subject or his/her mother has a medical history of HBsAg seropositivity. 18. Subject has a history of Haemophilus influenzae type b, hepatitis B, diphtheria, tetanus, pertussis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1) To compare the post-infant series anti-PRP response elicited by PR5I to that of INFANRIX™ hexa. 2) To compare the immunogenicity response elicited by PR5I to that of INFANRIX™ hexa when given at 2, 4, and 11 to 12 months. 3) To evaluate the immunogenicity of Rotarix™ when administered concomitantly with PR5I 4) To describe the safety profile associated with the administration of each dose of PR5I or INFANRIX™ hexa when given concomitantly with Prevenar 13™ and Rotarix™. 5) To describe fever occurring within 5 days after the administration of each dose and after all doses of PR5I or INFANRIX™ hexa when given concomitantly with Prevenar 13™ and Rotarix™ or RotaTeq™. 6) To describe the percentage of subjects with solicited injection-site adverse events and solicited systemic adverse events within 5 days after each dose and after all doses of PR5I or INFANRIX™ hexa when co-administered with other recommended vaccines. 7) To summarize the incidence of serious adverse events (SAEs).;Main Objective: To evaluate the immunogenicity of PR5I when given at 2, 4, and 11 to 12 months of age.;Timepoint(s) of evaluation of this end point: After the toddler dose (12 months);Primary end point(s): The primary endpoints for the acceptability hypothesis are vaccine-induced antibody responses to all antigens contained in PR5I following the Toddler dose (~12 months). The primary endpoints for the non-inferiority hypothesis are vaccine-induced antibody responses against antigens that are contained in both PR5I and the control vaccine after the Toddler dose (~12 months) as listed in Table 2-3 of the protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The endpoint for the secondary hypothesis testing of non-inferiority and superiority regarding PRP response is the proportion of subjects with anti-PRP level =1.0 µg/ml at Postdose 2. The endpoint for the secondary hypothesis testing of non-inferiority regarding antirotavirus IgA is the GMT at Postdose 2 in subjects receiving Rotarix;Timepoint(s) of evaluation of this end point: After the toddler dose (12 months) | — |
Countries
Finland, Italy, Sweden
Contacts
Public ContactClinical Development Director
Sanofi Pasteur MSD S.N.C.
Outcome results
None listed