Healthy infants 46 to 74 days of age (both inclusive) MedDRA version: 17.0 Level: LLT Classification code 10054187 Term: Polio immunization System Organ Class: 100000004865 MedDRA version: 17.0 Level: LLT Classification code 10069543 Term: Hemophilus influenzae type b immunization System Organ Class: 100000004865 MedDRA version: 17.0 Level: LLT Classification code 10069593 Term: Pertussis immunization System Organ Class: 100000004865 MedDRA version: 17.0 Level: LLT Classification code 100541
Conditions
Interventions
Trade Name: Hexyon
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: DIPHTHERIA TOXOID
Current Sponsor code: D
Other descriptive name: DIPHTHERIA TOXOID
Concentration unit: IU interna
Sponsors
Sanofi Pasteur MSD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: PRIMARY SERIES: 1. Healthy infant 46 to 74 days of age (both inclusive) 2. Born at full term of pregnancy (=37 weeks) and/or with a birth weight=2.5 kg 3. Informed consent signed by the subject's parent(s) or legal representative 4. Subject's parent(s) or legal representative able to comply with the study procedures such as adherence to study visits and completion of the diary cards 5. Covered by health insurance BOOSTER: 1. Infant who received 3 doses of the hexavalent vaccine in the Primary series 2. Healthy infant from 12 months of age 3. Informed consent signed by the subject's parent(s) or legal representative Are the trial subjects under 18? yes Number of subjects for this age range: 350 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: PRIMARY SERIES: 1. Participation at the time of study enrolment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure 2. Receipt of any vaccine in the 4 weeks preceding each study vaccination or planned receipt of a vaccine in the 4 weeks following each study vaccine administration 3. Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, meningococcal, pneumococcal, rotavirus infection 4. Know or suspected congenital, hereditary or acquired immunodeficiency or other immunosuppressive or immunodeficiency condition 5. History of seizures or encephalopathy 6. Known thrombocytopenia, as reported by the subject's parent or legal representative 7. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection 8. Chronic illness that, in the opinion of the investigators, is at a stage where it might interfere with trial conduct or completion 9. Known or suspected hypersensitivity to any of the study vaccines' active substance or excipients or history of a life-threatening reaction to a vaccine(s) containing the same substances as the study vaccines 10. Contraindication to any of the study vaccines as per their Summary of Product Characteristics 11. Known personal or maternal history of hepatitis B (HBs Ag) or hepatitis C seropositivity 12. History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b or meningococcal serogroup C infection 13. Receipt of immune globulin, blood or blood-derived products since birth 14. Receipt of immunosuppressive therapy or other immune-modifying drugs, such as anticancer chemotherapy or radiation therapy since birth 15. Receipt of systemic corticosteroid therapy for more than 14 consecutive days since birth 16. Identified as a natural or adopted child of the investigator or employee with direct involvement in the current study. BOOSTER: 1. Prior (in the last 4 weeks), current or planned participation in another clinical study investigating a vaccine, drug, medical device, or medical procedure during the entire duration of the Booster vaccination 2. Receipt of a flu vaccine in the 2 weeks preceding vaccination at Visit 5 or receipt of any vaccine in the 4 weeks preceding vaccination at Visit 5 or planned receipt of a vaccine in the 4 weeks following vaccination at Visit 5 3. Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, meningococcal, pneumococcal infections with either the trial vaccine or another vaccine 4. History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b or meningococcal serogroup A, C, W or Y infection(s) confirmed either clinically, serologically, or microbiologically 5. Known or suspected hypersensitivity to any of the active substance or excipients or trace residuals of the hexavalent vaccine or the meningococcal group ACWY conjugate vaccine, to any pertussis vaccine, history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines 6. Contraindication to the hexavalent vaccine or the meningococcal group ACWY conjugate vaccine, as per their Summary of Product Characteristics 7. Receipt of imm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: PRIMARY SERIES: - To demonstrate that the concomitant administration of the hexavalent vaccine given at 2, 3 and 4 months of age with a meningococcal serogroup C conjugate (MenC) vaccine given at 2 and 4 months of age is non inferior to the administration of the hexavalent vaccine without a MenC vaccine concomitantly in term of seroprotection rate for hepatitis B one month after the third dose of the hexavalent vaccine. - To demonstrate that the concomitant administration of a MenC vaccine given at 2 and 4 months of age with the hexavalent vaccine given at 2, 3 and 4 months of age induces an acceptable response for MenC in term of seroprotection rate (SPR) one month after the second dose of MenC. BOOSTER: To describe the immunogenicity of a booster dose of the hexavalent vaccine and of a meningococcal group ACWY conjugate vaccine either co-administered at 12 months of age or given separately.;Timepoint(s) of evaluation of this end point: PRIMARY SERIES: One month after dose 3 of the hexavalent vaccine and dose 2 of MenC vaccine. BOOSTER: One month after administration of hexavalent and/or MenACWY (at 13 months of age);Secondary Objective: PRIMARY SERIES: Immunogenicity: -To describe the antibody response to all the hexavalent vaccine antigens one month after the third dose of the hexavalent vaccine when given concomitantly or not to MenC vaccine. -To describe the antibody response to MenC vaccine when a MenC vaccine is given concomitantly with the hexavalent vaccine, one month after the first and the second dose of MenC vaccine. Safety: -To describe the safety profile of the hexavalent vaccine after each and any injection when given concomitantly or not with a MenC vaccine. BOOSTER: Immunogenicity: To describe the antibody (Ab) persistence at 12 months of age for the hexavalent valences following a 3-dose primary vaccination at 2, 3 and 4 months of age (prior to administration of a booster dose) Safety: To describe the safety of a booster dose of | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PRIMARY SERIES: Immunogenicity: - Anti-HBs geometric mean concentrations (GMC) - Proportion of subjects with an anti-PRP concentration =0.15 µg/mL - Anti-PRP GMC - Proportion of subjects with an anti-diphtheria (D) concentration =0.1 IU/mL - Proportion of subjects with an anti-D concentration =0.01 IU/mL - Anti-D geometric mean concentration (GMC) - Proportion of subjects with an anti-tetanus (T) concentration =0.1 IU/mL - Proportion of subjects with an anti-T concentration =0.01 IU/mL - Anti-T GMC - Proportion of subjects with an anti-inactivated poliovirus (IPV)1 titre =1:8 dil - Proportion of subjects with an anti-IPV2 titre =1:8 dil - Proportion of subjects with an anti-IPV3 titre =1:8 dil - Anti-IPV1, anti-IPV2 and anti-IPV3 GMTs - Proportion of subjects with an anti-PT vaccine response - Proportion of subjects with anti-FHA vaccine response - Anti-PT and anti-FHA GMCs - Anti-PT and anti-FHA GMCRs - Anti-PT and anti-FHA 4-fold increase - Proportion of subjects with an anti-MenC titre =1:8 dil - Proportion of subjects with an anti-MenC titre =1:128 dil - Anti-MenC GMT Safety: - Incidence of solicited injection-sites reactions and solicited systemic adverse event. - Incidence of unsolicited injection-site reactions, unsolicited systemic adverse events and all serious adverse events. BOOSTER: Immunogenicity, hexavalent vaccine: -Proportion of subjects with an anti-D concentration =0.01 IU/mL -Proportion of subjects with an anti-D concentration =0.1 IU/mL -Proportion of subjects with an anti-T concentration =0.01 IU/mL -Proportion of subjects with an anti-T concentration =0.1 IU/mL -Proportion of subjects with an anti-IPV1 titre =1:8 dil -Proportion of subjects with an anti-IPV2 titre =1:8 dil -Proportion of subjects with an anti-IPV3 titre =1:8 dil -Proportion of subjects with an anti-HBs concentration =10 mIU/mL -Proportion of subjects with an anti-HBs concentration =100 mIU/mL -Proportion of subjec | — |
Countries
Finland
Contacts
Public ContactClinical Development Director
Sanofi Pasteur MSD S.N.C.
Outcome results
None listed