Safety and Immunogenicity of Sanofi Pasteur’s DTaP-IPV-Hep B-PRP-T Combined Vaccine Given as a Primary Series of Vaccination in Infants

Phase 1

• Conditions: Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus type 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infection caused by hepatitis B virus; MedDRA version: 18.0Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.0Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.0Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.0Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2013-003267-55-PL
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-28
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1) Male and female aged 42 to 56 days (between 6 and 8 weeks of age) on the day of inclusion
2) Have received one dose of Hep B vaccine at birth (documented according to national recommendations)
3) Born at full term of pregnancy (= 37 weeks) and with a birth weight = 2.5 kg
4) Born to known Hep B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample during pregnancy is available)
5) Informed consent form signed and dated by the parent(s) or any other legally acceptable representative (if applicable*)
6) Subject and parent/legally acceptable representative (if applicable) are able to attend all scheduled visits and to comply with all trial procedures
Are the trial subjects under 18? yes
Number of subjects for this age range: 150
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) Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B diseases (accept Hep B given at birth), or Haemophilus Influenzae type B infection with the trial vaccine or another vaccine
2) Acute illness of any severity on the day of inclusion or febrile illness (rectal temperature = 38°C) on the day of inclusion (a prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
3) Participation in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
4) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (except Bacille Calmette Guerin [BCG] vaccine) or planned receipt of any other vaccine within the period from 8 days before to 8 days after each subsequent trial vaccination
5) Past or current receipt of immune globulins, blood or blood-derived products or planned administration during the trial
6) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 3 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
7) History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infections (confirmed either clinically, serologically or microbiologically)
8) Known personal or maternal history of HIV or hepatitis C seropositivity
9) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances (the list of vaccine components is included in the Investigator’s Brochure/Summary of Product Characteristics)
10) Known thrombocytopenia in medical history, contraindicating intramuscular vaccination
11) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
12) In an emergency setting, or hospitalized involuntarily
13) Chronic illness in medical history that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion (may include, but is not limited to, cardiac, renal or auto-immune disorders, diabetes, psychomotor diseases, and known congenital or genetic diseases)
14) Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study
15) Known history of seizures
16) Known uncontrolled neurologic disorder (including epilepsy)

Study & Design

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