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
Interventions
Trade Name: Hexyon
Product Name: Hexyon
Product Code: DTaP-IPV-HB-Hib
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Purified Diphtheria Toxoid
Current Sponsor code: D
Other descri
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: 1) Infants/toddlers previously included in Study A3L39 who completed the 3- dose primary series vaccination according to protocol 2) Groups 1 and 2 (Germany and the Czech Republic) aged 11 to 15 months on the day of the first study visit; Group 3 (Spain) aged 18 months on the day of the first study visit 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 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 4 weeks preceding the booster 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 out-of-study vaccines within the 2-week period prior to Visit 01 and within the 4-week period following the receipt of study vaccines or until all Visit 02 study procedures have been completed 3) Receipt of immune globulins, blood or blood-derived products in the last 3 months 4) 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) 5) History of diphtheria, tetanus, pertussis, poliomyelitis, Hep B or Haemophilus influenzae type b and pneumococcal infections, confirmed either clinically, serologically, or microbiologically 6) 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 7) Known thrombocytopenia, as reported by the parent/legally acceptable representative 8) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination 9) Subjects in an emergency setting, or hospitalized involuntarily 10) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion 11) 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. 12) Identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed study 13) If any of the following events are known to have occurred in temporal relation to the receipt of a pertussis-containing vaccine, the decision to give further doses of pertussis-containing vaccines should be carefully considered: • Encephalopathy • Temperature of = 40°C within 48 hours not due to another identifiable cause • Collapse of shock-like state (hypotonic-hyporesponsive episode [HHE]) within 48 hours of vaccination • Persistent, inconsolable crying lasting = 3 hours, occurring within 48 hours if vaccination • Convulsions with or without fever, occurring within 3 days of vaccination
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Immunogenicity Groups 1 and 2 • Assess the antibody persistence of DTaP-IPV-HB-Hib or Infanrix hexa following a 3-dose primary series at 2, 3, and 4 months of age (MoA) before the administration of a booster dose of either vaccine • Describe the immunogenicity and booster effect of the DTaP-IPV-HBHib or Infanrix hexa vaccine given as a booster dose at 11 to 15 MoA concomitantly with PCV13 (after a primary series with the same vaccine) • To describe the immunogenicity of a booster dose of PCV13 given from 11 to 15 MoA Group 3 • Assess the antibody persistence of all valences contained in the vaccines administered in a mixed schedule following a 3-dose primary series at 2, 4, and 6 MoA before the administration of a booster dose of Pentavac • Describe the immunogenicity and booster effect of Pentavac given at 18 MoA after the administration of a mixed schedule primary series combining a hexavalent and a pentavalent vaccine To describe the safety profile for group 1, 2 and 3;Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: Blood sampling All subjects will provide a pre-vaccination blood sample at D0 (V01) and a post-vaccination sample at D30 (V02). Collection of safety data Subjects' parents/legal representatives will record information about solicited reactions in a diary card (DC) from Days 0-7 post-vaccination, and will record information about unsolicited AEs from Days 0-30. Solicited reactions will be collected for DTaP-IPV-HB-Hib, Infanrix hexa, Pentavac and PCV13 vaccines. The SAEs will be recorded throughout the trial period. Staff will contact subjects' parents/legal representative by telephone at 2-3 days and 8-10 days after vaccination to discuss any safety information. Staff will review the Days 0-30 safety data with subjects' parents/legal representatives at V02.;Primary end point(s): Immunogenicity Ab Persistence The following endpoints will be used to assess the Ab persistence (for all valences except PC | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Czech Republic, Germany, Spain
Contacts
Public ContactClinical Development
Sanofi Pasteur SA
Outcome results
None listed