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: 18.0 Level: LLT Classification code 10036897 Term: Prophylactic vaccination System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 18.0 Level: HLGT Classification code 10043413 Term: Therapeutic procedur
Conditions
Sponsors
Sanofi Pasteur SA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe the safety and reactogenicity after each and all doses of the study vaccine administered as a 3-dose primary series.;Secondary Objective: NA;Primary end point(s): 1. Occurrence of any unsolicited systemic AEs reported in the 30 minutes after each and all dose(s) 2. Occurrence of solicited (prelisted in the subject’s diary card [DC] and electronic Case Report Form [CRF]) injection site and systemic reactions occurring through 7 days (D0-D7) following each and all dose(s) 3. Occurrence of unsolicited AEs through 30 days following each and all dose(s) 4. Occurrence of SAEs throughout the trial 5. Other endpoints recorded or derived as described in the statistical analysis plan. Depending on the item, these could include: nature (Medical Dictionary for Regulatory Activities [MedDRA] preferred term), time of onset, duration, number of days of occurrence, Grade of severity, relationship to vaccine, action taken, whether the AE led to early termination from the study, seriousness, or outcome;Timepoint(s) of evaluation of this end point: 1. in the 30 minutes after each and all dose(s) 2. through 7 days (D0-D7) following each and all dose(s) 3. through 30 days following each and all dose(s) 4. throughout the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Poland, Russian Federation
Contacts
Public ContactGlobal Medical Affairs
Sanofi Pasteur SA
Outcome results
None listed