DTaP-IPV-Hep B-PRP~T Combined Vaccine versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed Infants

Phase 1

• Conditions: Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b infection, Poliomyelitis, and Hepatitis B; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-002873-36-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-08
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
1) Aged 30 to 40 days on the day of the first study visit
2) Born at full term of pregnancy (=37 weeks) and with a birth weight =2.5 kg
3) Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
4) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
5) Born to known hepatitis B surface antigen (HBsAg) seronegative mother: documented HBsAg negative status during the last trimester of pregnancy (or post-birth) or documented HBsAg negative and HBsAb positive status before last trimester of pregnancy
6) Have received one documented dose of Hep B vaccine at birth according to the national recommendations
Are the trial subjects under 18? yes
Number of subjects for this age range: 310
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 in the 4 weeks preceding the trial inclusion 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 any trial vaccination (except Bacille Calmette Guerin [BCG] vaccine) or planned receipt of any vaccine in the 8 days following any trial vaccination
3) Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (except the dose of Hep B vaccine given at birth) diseases or Haemophilus influenzae type b infection with either the trial vaccine or another vaccine
4) Past or current receipt of immune globulins, blood or blood-derived products or planned administration during the trial
5) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, 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)
6) Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity
7) History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Haemophilus influenzae type b infection, confirmed either clinically,
serologically, or microbiologically
8) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances
9) Known thrombocytopenia, as reported by the parent/legally acceptable representative
10) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
11) In an emergency setting, or hospitalized involuntarily
12) Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
13) 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.
14) Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
15) History of seizures

Study & Design

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