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: 17.0 Level: LLT Classification code 10036897 Term: Prophylactic vaccination System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 17.0 Level: HLGT Classification code 10043413 Term: Therapeutic procedur
Conditions
Sponsors
Sanofi Pasteur SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: An individual must fulfill all of the following criteria in order to be eligible for trial enrollment: All Groups 1) Aged 55 to 75 days on the day of the first study visit 2) Born at full term of pregnancy (= 37 weeks) and/or with a birth weight = 2.5 kg 3) Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations) 4) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures 5) Covered by health insurance, if applicable Group 3 only 6) Previously vaccinated with one dose of hepatitis B vaccine Are the trial subjects under 18? yes Number of subjects for this age range: 795 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: An individual fulfilling any of the following criteria is to be excluded from trial enrollment: 1) Participation at the time of study enrollment (or 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 2) Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination, except in case of routine vaccines to be administered as per the National Immunization schedule and for influenza vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines 3) Groups 1 and 2 only: Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b, pneumococcal infections, and rotavirus with another vaccine(s) 4) Group 3 only: Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, pneumococcal and meningococcal infections, and rotavirus with another vaccine(s) 5) Receipt of immune globulins, blood or blood-derived products since birth 6) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth) 7) Known personal or maternal history of hepatitis B (HBsAg) or hepatitis C seropositivity 8) History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b and pneumococcal infections, confirmed either clinically, serologically, or microbiologically 9) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances 10) Known thrombocytopenia, as reported by the parent/legally acceptable representative 11) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination 12) History of seizures 13) Subjects in an emergency setting, or hospitalized involuntarily 14) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion 15) Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided. 16) Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Groups 1 and 2 only To demonstrate the non-inferiority of the DTaP-IPV-HB-Hib vaccine to the control Infanrix hexa vaccine, both co-administered with Prevenar 13, in terms of seroprotection or vaccine response rates to PT, FHA, Hep B, and PRP antigens, 1 month after a 3-dose primary series.;Secondary Objective: Immunogenicity Groups 1 and 2 • To describe in each group the immunogenicity parameters before the first vaccination for PT and FHA antigens and 1 month after the third dose of the primary series for all antigens contained in the investigational and control vaccines • To describe in each group the immune response to Prevenar 13 serotypes 1 month after the 3rd dose of the primary series • To describe the immune response to RotaTeq vaccine before the first vaccination and 1 month after the 3rd dose Group 3 • To describe the immunogenicity parameters before the first vaccination and 1 month after the 3rd dose of the primary series for all antigens contained in the investigational and Pentavac vaccines • To describe the immune response to RotaTeq vaccine before the first vaccination and 1 month after the 3rd dose Safety (all Groups) To describe the safety profile after each and any injection for each of the study groups. ;Primary end point(s): Groups 1 and 2 only The following serological endpoints will be assessed 1 month after the third dose of the primary series (i.e., at V04 = 5 MoA) with seroprotection and vaccine response being respectively defined as: Seroprotection for Hep B and PRP: • Anti-Hep B antibody (Ab) concentrations = 10 mIU/mL • Anti-PRP Ab concentrations = 0.15 µg/mL Vaccine response for PT and FHA: • Post-Dose 3 Ab concentrations = 4 x lower level of quantitation (LLOQ), if pre-Dose 1 Ab concentrations < 4 x LLOQ • Post-Dose 3 Ab concentrations = pre-Dose 1 Ab concentrations, if pre-Dose 1 Ab concentrations = 4 x LLOQ;Timepoint(s) of evaluation of this end point: Vaccination Groups 1 and 2: subjects will receive 3 doses of e | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunogenicity Groups 1 and 2 Endpoints for the immune response (descriptive) will include: V01 at 2 MoA: • Ab concentrations for PT and FHA antigens • Ab concentrations above a cut-off: • Anti-PT Ab concentrations = LLOQ • Anti-FHA Ab concentrations = LLOQ • Anti-RV IgA = 20 U/mL V04 at 5 MoA: • Ab concentrations/titers for each valence • Ab concentrations /titers above a cut-off: • Anti-D Ab concentrations = 0.01 IU/mL, = 0.1 IU/mL and = 1.0 IU/mL • Anti-T Ab concentrations = 0.01 IU/mL, = 0.1 IU/mL and = 1.0 IU/mL • Anti-PT Ab concentrations = 4 EU/mL • Anti-FHA Ab concentrations = 4 EU/mL • Anti-poliovirus 1, 2, and 3 Ab titers = 8 (1/dil) • Anti-Hep B Ab concentrations = 100 mIU/mL • Anti-PRP Ab concentrations = 1.0 µg/mL • Anti-pneumococcal serotype 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F concentrations = 0.35 µg/mL • Anti-RV IgA = 20 U/mL • Ab individual concentrations ratios for anti-PT and FHA (V04 at 5MoA/V01 at 2MoA) • Seroconversion for anti PT and anti FHA, defined as anti PT and anti FHA = 4 fold Ab concentrations increase from V01 (at 2 MoA) to V04 (at 5 MoA) • Seroconversion for anti-RV IgA defined as anti-RV IgA = 20 U/mL, in subject seronegative at pre-Dose 1) Group 3 V01 at 2 MoA: • Ab concentrations /titers for each valence (except Prevenar 13) • Ab concentrations /titers above a cut-off: • Anti-D Ab concentrations = 0.01 IU/mL and = 0.1 IU/mL • Anti-T Ab concentrations = 0.01 IU/mL and = 0.1 IU/mL • Anti-PT Ab concentrations = LLOQ • Anti-FHA Ab concentrations = LLOQ • Anti-poliovirus 1, 2, and 3 Ab titers = 8 (1/dil) • Anti-Hep B Ab concentrations = 10 mIU/mL • Anti- PRP Ab concentrations = 0.15 µg/mL • Anti-RV IgA = 20 U/mL V04 at 7 MoA: • Ab concentrations /titers for each valence (except Prevenar 13) • Ab concentrations /titers above a cut-off: • Anti-D | — |
Countries
Czech Republic, Germany, Spain
Contacts
Public ContactClinical Development
Sanofi Pasteur SA
Outcome results
None listed