Lot Consistency Study of DTaP-IPV-HB-PRP~T Vaccine Administered at 2-4-6 Months of Age in Healthy Infants

Sanofi

Status and phase: Completed; Phase 3

Conditions: Poliomyelitis; Diphtheria; Hepatitis B; Pertussis; Tetanus

Treatments: Biological: DTaP-IPV-HB-PRP~T vaccine; Biological: DTaP-HBV-IPV vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00404651

A3L11

Details and patient eligibility

About

The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP~T vaccine is consistent.

The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP~T vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after the three-dose primary series.

The secondary objectives are:

• To describe in each group, the immunogenicity parameters for all antigens one month after the third dose of the primary series
• To assess the overall safety in each group one month after the third dose of the primary series.

Enrollment: 1,189 patients

Sex: All

Ages: 2+ months old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• Two months old infants on the day of inclusion
• Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
• Informed consent form signed by one or both parents or by the guardian and two independent witnesses
• Able to attend all scheduled visits and to comply with all trial procedures
• Received Bacillus Calmette Guerin (BCG) vaccine between birth and one month of life in agreement with the national immunization calendar.

Exclusion Criteria :

• Participation in another clinical trial in the four weeks preceding the (first) trial vaccination
• Planned participation in another clinical trial during the present trial period
• Congenital or acquired immunodeficiency
• Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
• Chronic illness at a stage that could interfere with trial conduct or completion
• Blood or blood-derived products received since birth
• Any vaccination in the four weeks preceding the first trial visit
• Any planned vaccination (except BCG, rotavirus, and pneumococcal conjugated vaccines) during the study
• Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
• Previous vaccination against hepatitis B, pertussis, tetanus, diphtheria, poliovirus, or Haemophilus influenzae type b infection(s)
• Known personal or maternal history of HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity
• Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
• History of seizures
• Febrile (rectal equivalent temperature ≥ 38.0°C) or acute illness on the day of inclusion.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,189 participants in 4 patient groups

Group 1

Experimental group

Description:

Participants receive vaccine Batch A

Treatment:

Biological: DTaP-IPV-HB-PRP~T vaccine

Biological: DTaP-IPV-HB-PRP~T vaccine

Biological: DTaP-IPV-HB-PRP~T vaccine

Group 2

Experimental group

Description:

Participants receive vaccine Batch B

Treatment:

Biological: DTaP-IPV-HB-PRP~T vaccine

Biological: DTaP-IPV-HB-PRP~T vaccine

Biological: DTaP-IPV-HB-PRP~T vaccine

Group 3

Experimental group

Description:

Participants receive vaccine Batch C

Treatment:

Biological: DTaP-IPV-HB-PRP~T vaccine

Biological: DTaP-IPV-HB-PRP~T vaccine

Biological: DTaP-IPV-HB-PRP~T vaccine

Group 4

Active Comparator group

Description:

Participants receive Infanrix hexa™

Treatment:

Biological: DTaP-HBV-IPV vaccine