Persistence of antibody against diphtheria, tetanus and poliomyelitis in 11 to 13-year-old children who received either REVAXIS or DT Polio at 6 year of age, and immune response to TETRAVAC-ACELLULAIRE MedDRA version: 14.0 Level: PT Classification code 10054175 Term: Polio immunisation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 14.0 Level: PT Classification code 10054129 Term: Diphtheria immunisation System Organ Class: 10042613 - Surgical and medical proced
Conditions
Interventions
Trade Name: TETRAVAC-ACELLULAIRE
Product Name: TETRAVAC-ACELLULAIRE
Product Code: 094
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMP
Sponsors
Sanofi Pasteur MSD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy child of either gender 11 to 13 years of age and vaccinated in Study F05-TdI-301 with either REVAXIS or DT Polio at approximately 6 years of age, Consent form signed by both parents, or by the legal guardian, properly informed about the study, Assent form signed by the child, Affiliated to a health social security system. Are the trial subjects under 18? yes Number of subjects for this age range: 476 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: Immunization against diphtheria, tetanus, pertussis and/or poliomyelitis beyond Study F05-TdI-301, Previous clinical or bacteriological diagnosis of diphtheria, tetanus, pertussis or poliomyelitis, Immune impairment or humoral/cellular deficiency, neoplasic disease or depressed immunity, Receipt of any chemotherapy agents to treat cancer received within 6 months prior to vaccination Receipt of serum immune globulin or any other blood-derived product within 3 months prior to vaccination Receipt of immunomodulator therapy within 6 weeks prior to vaccination Receipt of daily -or on alternate days- systemic corticosteroids at a dose =20 mg/day of prednisone (or equivalent) for =14 days within 4 weeks prior to vaccination Receipt of any live non-study vaccine within 28 days or of any inactivated non-study vaccine within 14 days prior to vaccination or with a vaccination planned during the whole study period, Known true hypersensitivity to at least one of the components of TETRAVAC-ACELLULAIRE, to glutaraldehyde, neomycin, streptomycin and polymyxin B, to pertussis, vaccines (acellular or whole cell pertussis), or to a vaccine containing the same substances, Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition, Known history of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection, Any medical condition that, in the opinion of the investigator, could interfere with the evaluation of the study objectives, Child who participated in another clinical study within 28 days prior to vaccination or would participate in another clinical study during the whole study period, Acute severe febrile illness and/or body temperature >=38.0°C within 72 hours prior to vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To describe in 11 to 13-year-old children who received one dose of either REVAXIS or DT Polio at 6 years of age the antibody persistence in terms of proportions of subjects with antibody concentrations =0.01 IU/mL against diphtheria and tetanus, and antibody titres =8 (1/dilution) against poliovirus types 1, 2 and 3, To describe one month after a booster dose of TETRAVAC-ACELLULAIRE when given to 11 to 13-year-old children who received one dose of either REVAXIS or DT Polio at 6 years of age the immune responses in terms of proportions of subjects with antibody concentrations =0.1 IU/mL against diphtheria and tetanus, and antibody titres =8 (1/dilution) against poliovirus types 1, 2 and 3. ;Secondary Objective: Secondary immunogenicity objectives: To describe other parameters of the antibody persistence against diphtheria, tetanus and poliomyelitis antigens in 11 to 13-year-old children who received one dose of either REVAXIS or DT Polio at 6 years of age. To describe other parameters of the immune responses to diphtheria, tetanus, pertussis and poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE when given to 11 to 13-year-old children who received one dose of either REVAXIS or DT Polio at 6 years of age. Secondary safety objective: To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE when given to 11 to 13-year-old children who received one dose of either REVAXIS or DT Polio at 6 years of age. ;Primary end point(s): Antibody persistence Proportion of subjects with an anti-diphtheria concentration =0.01 IU/mL, Proportion of subjects with an anti-tetanus concentration =0.01 IU/mL, Proportion of subjects with an anti-poliovirus type 1 (IPV1) titre =8 (1/dilution), Proportion of subjects with an anti-poliovirus type 2 (IPV2) titre =8 (1/dilution), Proportion of subjects with an anti-poliovirus type 3 (IPV3) titre =8 (1/dilution). Post-booster immune response Proportion of subjects with an anti-diphtheria | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Antibody persistence Proportion of subjects with an anti-diphtheria concentration =0.1 IU/mL, Anti-diphtheria Geometric Mean Concentration (GMC), Proportion of subjects with an anti-tetanus concentration =0.1 IU/mL, Anti-tetanus GMC, Anti-IPV1, anti-IPV2 and anti-IPV3 Geometric Mean Titres (GMT). Post-booster immune response Proportion of subjects with an anti-diphtheria concentration =1.0 IU/mL, Anti-diphtheria GMC, Anti-diphtheria Geometric Mean of individual Concentrations Ratio (GMCR), Proportion of subjects with an anti-tetanus concentration =1.0 IU/mL, Anti-tetanus GMC, Anti-tetanus GMCR, Anti-IPV1, anti-IPV2 and anti-IPV3 GMT, Anti-IPV1, anti-IPV2 and anti-IPV3 Geometric Mean of individual Titres Ratio (GMTR). ;Timepoint(s) of evaluation of this end point: 28-35 days after vaccination (V2) | — |
Countries
France
Contacts
Public ContactClinical trial information
Sanofi Pasteur MSD
Outcome results
None listed