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

Sanofi

Status and phase: Completed; Phase 3

Conditions: Diphtheria; Haemophilus Influenzae Type B; Pertussis; Tetanus

Treatments: Biological: DTaP//PRP-T Combined Vaccine; Biological: DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01062477

C5A06

UTN: U1111-1112-2509 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,056 patients

Sex: All

Ages: 60 to 89 days old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,056 participants in 3 patient groups

Study Group 1

Experimental group

Description:

Participants will receive ACTACEL vaccine at 2, 3, and 4 months of age.

Treatment:

Biological: DTaP//PRP-T Combined Vaccine

Biological: DTaP//PRP-T Combined Vaccine

Study Group 2

Experimental group

Description:

Participants will receive ACTACEL vaccine at 3, 4, and 5 months of age.

Treatment:

Biological: DTaP//PRP-T Combined Vaccine

Biological: DTaP//PRP-T Combined Vaccine

Study Group 3

Active Comparator group

Description:

Participants will receive Wuhan DTaP and Act-HIB vaccines concomitantly at 3, 4 and 5 months of age.

Treatment:

Biological: DTaP Combined Vaccine and PRP-Tetanus Conjugate Vaccine