Diphtheria, Haemophilus Influenzae Type B, Pertussis, Tetanus
Conditions
Keywords
Diphtheria Tetanus Pertussis Haemophilus Influenzae Type B
Brief summary
The purpose of this study is to assess the immunogenicity and safety of ACTACEL combined vaccine in support of registration of this product in China Primary Objectives: * To demonstrate that ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age is not inferior, in terms of seroprotection, to Wuhan's Diphtheria, Tetanus, acellular Pertussis (DTaP) and Haemophilus influenzae type b (Act-HIB) vaccine given concomitantly, for diphtheria, tetanus, and Polyribosyl Ribitol Phosphate (PRP) antigens, one month after the three-dose primary vaccination. * To demonstrate the superiority, in terms of seroconversion, of ACTACEL vaccine administered at 2, 3 and 4 months of age or at 3, 4 and 5 months of age for Pertussis Toxoid (PT), Fimbriae types 2 and 3 (FIM2) and (FIM3) pertussis antigens, compared with Wuhan's DTaP and Act-HIB vaccines given concomitantly, one month after the three-dose primary vaccination. Secondary Objectives: * To describe the safety after administration of the study vaccines. * To describe in each group the immunogenicity of the study vaccines one month after the primary vaccination and before and one month after the booster vaccination.
Detailed description
Participants will receive a primary vaccination consisting of three doses of ACTACEL at either 2, 3, and 4 months of age or at 3, 4, and 5 months of age; or Wuhan DTaP and Act-HIB vaccines at 3, 4, and 5 months of age. All participants will receive a single booster dose at 18-20 months of age and will be followed up for one month after the last dose of study vaccine.
Interventions
BIOLOGICALDTaP//PRP-T Combined Vaccine
0.5 mL, Intramuscular
BIOLOGICALDTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine
0.5 mL, Intramuscular (each vaccine)
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Days to 89 Days
Healthy volunteers
Yes
Inclusion criteria
: * Aged 2 months on the day of inclusion * Born at full term pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg * Informed consent form signed by the parent(s) or legal representative * Participant and parent/legal representative able to attend all scheduled visits and to comply with all trial procedures
Exclusion criteria
: * Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination * Planned participation in another clinical trial during the present trial period * Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or long-term systemic corticosteroids therapy * Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances * Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator * Receipt of blood or blood-derived products since birth that might interfere with the assessment of immune response * Receipt or planned receipt of any vaccine in the 4 weeks preceding or following any trial vaccination (except oral poliovirus (OPV), bacillus Calmette-Guérin (BCG), and Hepatitis B vaccines which cannot be given within 8 days before or after any study vaccination) * History of seizures * Known personal or maternal Human Immunodeficiency Virus (HIV), Hepatitis B (HB) surface antigen or Hepatitis C seropositivity * History of diphtheria, tetanus, pertussis or Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically) * Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae type b disease with either the trial vaccine or another vaccine * Participant at high risk for diphtheria, tetanus, pertussis or Haemophilus influenzae type b infection during the trial * Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination * History of contraindication to vaccination with pertussis-containing vaccine * Febrile illness (axillary temperature ≥37.1°C) or moderate or severe acute illness/infection on the day of inclusion, according to Investigator judgment Temporary contraindications that must be resolved before vaccination: * Acute febrile illness within the 72 hours preceding the vaccination, or temperature ≥37.1°C present at this visit * Any vaccination in the 4 weeks preceding the vaccination (except OPV, BCG, and hepatitis B vaccines which cannot be given within 8 days before or after any study vaccination) * Systemic corticosteroids therapy (prednisone or equivalent) for more than 2 consecutive weeks within the past 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity: To provide information concerning the immunogenicity of ACTACEL vaccine after primary and booster vaccination. | One month post-vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Safety: To provide information concerning the safety after primary and booster administration of ACTACEL vaccine. | 0-7 days post-vaccination and entire study duration |
Countries
China
Outcome results
None listed