A new vaccine for babies which adds protection against hepatitis B

Phase 1

• 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: 14.1 Level: LLT Classification code 10054183 Term: Tetanus immunization System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1 Level: LLT Classification code 10019743 Term: Hepatitis B virus (HBV) System Organ Class: 10022891 - Investigations; MedDRA version: 14.1 Level: LLT Classification code 10054181 Term: Hepatitis B immunization System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1 Level: LLT Classification code 10069593 Term: Pertussis immunization System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1 Level: LLT Classification code 10054180 Term: Diphtheria immunization System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1 Level: LLT Classification code 10053386 Term: Poliomyelitis vaccine System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.1 Level: LLT Classification code 10069543 Term: Hemophilus influenzae type b immunizatio; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2011-002413-11-GB
• Lead Sponsor: Sanofi Pasteur MSD S.N.C

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-21
• Study Completion: 2013-09-27
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 284

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

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

Study & Design

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