Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants

Sanofi

Status and phase: Completed; Phase 3

Conditions: Poliomyelitis; Diphtheria; Whooping Cough; Hepatitis B; Tetanus

Treatments: Biological: DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine; Biological: DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide; Biological: DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01444781

U1111-1112-8473 (Other Identifier)

A3L27

Details and patient eligibility

About

This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722). The objectives are:

• To describe the antibody persistence to any antigen contained in the investigational DTaP-IPV-Hep B-PRP-T vaccine and Infanrix hexa™ prior to the booster dose
• To describe the safety and immunogenicity of the booster dose of either DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine.
• To describe the immunogenicity of a booster dose of Prevenar™ given at 12 to 24 months.

Full description

All participants who completed trial A3L24 (NCT01177722) will be recruited to participate in this trial. Those who received DTaP-IPV-Hep B-PRP-T combined vaccine will be randomized to receive either a booster dose of DTaP-IPV-Hep B-PRP-T or Infanrix hexa™ vaccine.

Those who received Infanrix hexa™ will receive a booster dose of DTaP-IPV-Hep B-PRP-T combined vaccine. All participants will receive a booster dose of Prevenar™ concomitantly.

Enrollment: 1,106 patients

Sex: All

Ages: 12 to 24 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 12 to 24 months on the day of inclusion.
• Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness(es) if required by local regulations).
• Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures.
• Toddlers previously included in Study A3L24 who completed the three-dose primary series vaccination of either DTaP-IPV-Hep B-PRP~T or Infanrix hexa™ at 2,4 and 6 months of age according to protocol (both concomitantly administered with Prevenar™ and Rotarix™).

Exclusion criteria

• Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the booster vaccinations.
• Planned participation in another clinical trial during the present trial period.
• Receipt of any vaccine in the 4 weeks preceding the booster vaccinations, except in case of pandemic influenza vaccination, which may be received at least two weeks before the study vaccines.
• Planned receipt of any vaccine in the 4 weeks following the trial vaccinations.
• Previous booster vaccination against pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b, hepatitis B and pneumococcal infection(s) with either the trial vaccine or another vaccine.
• Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response.
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 3 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
• Laboratory-confirmed or clinical suspicion of personal or maternal seropositivity for Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C, as reported by the parent/guardian.
• History of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b, hepatitis B and pneumococcal infection(s), confirmed either clinically, serologically, or microbiologically.
• At high risk for opportunistic infection during the trial.
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances.
• History of contraindication to receipt of pertussis-containing vaccine.
• Laboratory-confirmed or clinical suspicion of thrombocytopenia contraindicating Intramuscular vaccination.
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
• History of seizures .
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
• Receipt of oral or injected antibiotic therapy within 72 hours prior to the first blood draw
• Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,106 participants in 3 patient groups

Study Group 1

Experimental group

Description:

Participants previously primed with DTaP-IPV-Hep B-PRP\~T, will receive one dose of DTaP-IPV-Hep B-PRP\~T vaccine + one dose of Prevenar™

Treatment:

Biological: DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide

Study Group 2

Active Comparator group

Description:

Participants previously primed with DTaP-IPV-Hep B-PRP\~T, will receive one dose of Infanrix hexa™ vaccine + one dose of Prevenar™

Treatment:

Biological: DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide

Study Group 3

Experimental group

Description:

Participants previously primed with Infanrix hexa™ will receive one dose of DTaP-IPV-Hep B-PRP\~T + one dose of Prevenar™.

Treatment:

Biological: DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine