Haemophilus influenzae type b immunisation MedDRA version: 21.1 Level: LLT Classification code 10054181 Term: Hepatitis B immunization System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.1 Level: PT Classification code 10069533 Term: Haemophilus influenzae type b immunisation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Hexyon sospensione iniettabile - vaccino coniugato (adsorbito) contro difterite, tetano, pertosse (componente acellulare), epatite B (rDNA), poliomielite (inattivato) ed Haemophilus influe
Sponsors
SANOFI PASTEUR
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Aged 76 to 110 days on the day of the first study visit (depending on local practices as per National Immunization Program (NIP)) - Born to an adult mother (>= 18 years of age) (including mothers vaccinated and not vaccinated with Tdap during pregnancy) - Born at full term of pregnancy (>= 37 weeks) and with a birth weight >= 2.5 kg or born after a gestation period of 32 through 37 weeks with a birth weight >= 2.0 kg and under stable condition defined as: infant who does not require significant medical support or ongoing management for debilitating disease and who have demonstrated a sustained recovery growth curve by the time he/she receives the first dose of the vaccination series - Participant and parent(s)/legally acceptable representative(s) 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: 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. 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 NIP and for influenza vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines 3. Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (Hep B), pneumococcal, meningococcal, or Hib infections or diseases with the study vaccine or another vaccine 4. Receipt of immunoglobulins, blood or blood-derived products since birth 5. 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) 6. Known personal or maternal history of Hep B (HBsAg) or Hep C seropositivity 7. History of diphtheria, tetanus, pertussis, poliomyelitis, Hep B, Hib infection, meningococcal infection, or pneumococcal infection, confirmed either clinically, serologically or microbiologically 8. Known systemic hypersensitivity to latex or 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 9. Known thrombocytopenia, as reported by the parent(s)/legally acceptable representative(s) contraindicating intramuscular (IM) vaccination as assessed by the investigator 10. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination 11. History of seizures 12. Participants in an emergency setting or hospitalized involuntarily 13. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion 14. Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature >= 38.0°C [>= 100.4°F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided 15. 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: To demonstrate the non-inferiority of the co-administration of DTaP-IPV-HB- PRP~T combined vaccine with 4CMenB vaccine in terms of seroprotection rates for anti-hepatitis B surface antigen (HBsAg) and anti-Haemophilus influenzae type b (Hib) polyribosyl ribitol phosphate (PRP) antibodies (Abs), compared to the sequential administration of the same vaccines.;Secondary Objective: - To describe the immune responses against all antigens of the DTaP-IPV-HB-PRP~T combined vaccine and to the 4CMenB vaccine before the first and after the third dose of each vaccine for each of the study groups. - To describe the immune responses against all antigens of the PCV13 vaccine (with the different anti-polysaccharide responses described following a pre-defined priority list and driven by the amount of sera available) after the third dose for each of the study groups. - To describe the safety profile after each and any injection of DTaP-IPVHB-PRP~T combined vaccine and the other co-administered vaccines (4CMenB and PCV13 vaccines) for each of the study groups.;Primary end point(s): 1. Number of participants with anti-HBsAg antibody (Ab) above predefined threshold. The Ab against HBsAg will be measured, threshold values will be considered. 2. Number of participants with anti-PRP Ab above predefined threshold. The Ab against PRP will be measured, threshold values will be considered.;Timepoint(s) of evaluation of this end point: 1. 1 month post third dose of DTaP-IPV-HB-PRP~T combined vaccine (Month 10) 2. 1 month post third dose of DTaP-IPV-HB-PRP~T combined vaccine (Month 10) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Geometric Mean Concentrations (GMCs)/Geometric Mean Titers (GMTs) of Ab against all antigens of the DTaP-IPV-HB-PRP~T combined vaccine. The Ab against the antigens: diphtheria (D), tetanus (T), poliovirus types 1, 2, and 3, pertussis toxoid (PT), filamentous hemagglutinin (FHA), PRP, and HBsAg will be measured. 2. Geometric Mean Concentrations Ratio/ Titers Ratio (GMCR/GMTR) of Ab against all antigens of the DTaP-IPV-HB-PRP~T combined vaccine. The Ab against the antigens: D, T, poliovirus types 1, 2, and 3, PT, FHA, PRP, and HBsAg will be measured. The ratio calculated will be: (post dose 3/pre-dose 1). 3. Number of participants with Ab against all antigens of the DTaP-IPVHB-PRP~T combined vaccine above predefined thresholds. The Ab against the antigens: D, T, poliovirus types 1, 2, and 3, PT, FHA, PRP, and HBsAg will be measured. Threshold values will be considered for each Ab: anti-D and anti-T Ab; anti-poliovirus 1, 2, and 3 Ab; anti-PT and anti-FHA Ab; anti-PRP Ab; anti-HBsAg Ab. 4. Seroconversion for anti-PT and anti-FHA. The Ab against PT and FHA will be measured. 5. Number of participants with a vaccine response to PT and FHA. The Ab against PT and FHA will be measured. Vaccine response to PT and FHA, threshold values will be considered. 6. GMCs/GMTs of Ab against antigens of the 4CMenB vaccine. The Ab against antigens of the 4CMenB vaccine will be measured. 7. GMCR/GMTR of Ab against antigens of the 4CMenB vaccine. The Ab against antigens of the 4CMenB vaccine will be measured. The ratio calculated will be: (post dose 3/pre-dose 1). 8. Number of participants with Ab against antigens of the 4CMenB vaccine above predefined thresholds. The Ab against antigens of the 4CMenB vaccine will be measured. Threshold values will be considered. 9. GMCs of Ab against pneumococcal capsular polysaccharide (PnPS) antigens of the PCV13 vaccine. The Ab against PnPS antigens will be measured. 10. Number of participants with a vaccine response to PnPS | — |
Countries
Finland, Italy
Contacts
Public ContactContact Point
SANOFI S.p.A.
Outcome results
None listed