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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diphtheria Tetanus Whooping Cough Hepatitis B Poliomyelitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Study Group 1

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™

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular each into the right and left deltoid muscle

Study Group 2

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular each into the right and left deltoid muscle

Study Group 3

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

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

0.5 mL (each), Intramuscular each into the right and left deltoid muscle

Interventions

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

0.5 mL, Intramuscular each into the right and left deltoid muscle

Intervention Type BIOLOGICAL

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

0.5 mL, Intramuscular each into the right and left deltoid muscle

Intervention Type BIOLOGICAL

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

0.5 mL (each), Intramuscular each into the right and left deltoid muscle

Intervention Type BIOLOGICAL

Other Intervention Names

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DTaP-IPV-Hep B-PRP~T vaccine Prevenar™ Infanrix hexa™ Prevenar™ DTaP-IPV-Hep B-PRP~T combined vaccine Prevenar™

Eligibility Criteria

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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.

Minimum Eligible Age

12 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes