ot Applicable

• Conditions: 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: 14.1Level: PTClassification code 10054130Term: Hepatitis B immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: PTClassification code 10054129Term: Diphtheria immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: LLTClassification code 10053386Term: Poliomyelitis vaccineSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: LLTClassification code 10069543Term: Hemophilus influenzae type b immunizationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: PTClassification code 10069577Term: Pertussis immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1Level: PTClassification code 10019731Term: Hepatitis BSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: PTClassification code 10054131Term: Tetanus immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2011-004095-10-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-20
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 1472

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 inclusion.
2. Subject has received only one dose of monovalent hepatitis B vaccine, outside of the study context prior to or at one month of age and it is documented in subject’s medical history.
3. Subject’s parent/legal guardian understands the study procedures, alternate treatments available, risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
4. Subject’s parent/legal guardian is able to read, understand, and complete study questionnaires (i.e., the Vaccination Report Card [VRC]).
5. Subject is able to attend all scheduled visits and to comply with the study procedures.
6. Subject’s parent/legal guardian has access to a telephone.
Are the trial subjects under 18? yes
Number of subjects for this age range: 1472
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. 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/component vaccine control(s).
2. Subject’s parent/legal guardian 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 enrollment, 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-alpha 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 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 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 more than one dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry.
11. Subject has received vaccination prior to study entry 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, or combination thereof.
12. *Subject has had a febrile illness within 24 hours prior to enrollment or a rectal temperature =38.0°C [=100.4°F] 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 will be permitted 15 days or more prior to enrollment.
14. Subject has coagulation disorder contraindicating intramuscular (IM) vaccination.
15. Subject has clinically significant findings on review of systems (medical history) determined by investigator or sub-investigator to be sufficient for exclusion.
16. Subject has developmental delay or neurological disorder at the time of enrollment (by medical history).
17. Subject or his/her mother has a medical history of HBsAg seropositivity.
18. Subject has history of Haemophilus influenzae type B, hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus, or pneumococcal infection.
19. Subject’s parent/legal guardian is unlikely to adhere to study procedures, keep appointments, or is planning to relocate during the study.
20. Any contraindica

Study & Design

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