A Study of DTaP//PRP-T Combined Vaccine (ACTACEL) Versus Local DTaP and Act-HIB Monovalent Vaccine in Healthy Infants

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.

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