Immunogenicity and Safety Study of a Hexavalent DTaP-IPV-Hep B-PRP-T Combined Vaccine or Infanrix hexa™ Concomitantly Administered With 13-Valent Pneumococcal Conjugate Vaccine (PCV13), at 3, 5, 11 to 12 Months of Age in Healthy Infants in Europe

• Conditions: Prevention of infections caused by Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis, poliovirus type 1, 2 and 3, prevention against invasive infections caused by Haemophilus influenzae type b and infection caused by hepatitis B virus; MedDRA version: 16.1Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 16.1Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 16.1Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 16.1Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-001054-26-FI
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-27
• Last Update Posted: 14 April 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 554

Inclusion Criteria

An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
1) Aged 85 to 95 days on the day of the first study visit
2) Born at full term of pregnancy (= 37 weeks) and/or with a birth weight = 2.5 kg
3) Healthy subjects as established by medical history and clinical examination before entering into the study
4) Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
5) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
6) Covered by health insurance
Are the trial subjects under 18? yes
Number of subjects for this age range: 554
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
1) Participation at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
2) Receipt of any vaccine in the 4 weeks preceding each trial vaccination or planned receipt of any vaccine in the 4 weeks following each trial vaccination (except rotavirus vaccination)
3) Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b or pneumococcal infections with another vaccine(s)
4) Receipt of immune globulins, blood or blood-derived products since birth
5) Known or suspected congenital, hereditary or acquired immunodeficiency or other immunosuppressive or immunodeficient condition
6) Receipt of immunosuppressive therapy or other immune-modifying drugs, such as anti-cancer chemotherapy or radiation therapy, since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth).
7) Known personal or maternal history of hepatitis B (HBsAg) or hepatitis C seropositivity
8) History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b, or pneumococcal infection(s), confirmed either clinically, serologically, or microbiologically
9) 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
10) History of seizures or encephalopathy
11) Known thrombocytopenia, as reported by the parent/legally acceptable representative
12) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
13) Subjects in an emergency setting, or hospitalized involuntarily
14) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
15) Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature = 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
16) Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified