Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants.

Sanofi

Status and phase

Completed

Phase 3

Conditions

Poliomyelitis

Diphtheria

Haemophilus Influenzae Type B

Pertussis

Tetanus

Treatments

Biological: PENTAXIM™: DTacP IPV//PRP~T combined vaccine

Biological: TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01214889

U1111-1115-6381 (Other Identifier)

E2I49

Details and patient eligibility

About

This study is designed to assess the immunogenicity and safety of PENTAXIM™ combined vaccine versus TETRAXIM™ vaccine to support registration of PENTAXIM™ in South Korea.

Primary Objective:

To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3, Polyribosyl Ribitol Phosphate [PRP]) and vaccine response rates to acellular Pertussis antigens of sanofi pasteur's PENTAXIM™ vaccine versus sanofi pasteur's TETRAXIM™ and Act (Haemophilus influenzae type b) HIB™ vaccines, one month after the three-dose primary vaccination.

Full description

All participants will receive three primary doses of their assigned study the vaccine, on Days 0, 60, and 120. They will be assessed for immunogenicity on Day 0 before vaccination and Day 150 post-vaccination. Safety will be assessed for all participants throughout the study, up to Day 157.

Enrollment

370 patients

Sex

All

Ages

56 to 70 days old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Aged 2 months (56 to 70 days) inclusive on the day of inclusion
Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
Informed consent form signed by the parent(s) or other legal representative
Able to attend all scheduled visits and to comply with all trial procedures

Exclusion criteria

Participation in another clinical trial in the 4 weeks preceding the trial inclusion
Planned participation in another clinical trial during the present trial period
Congenital or acquired immunodeficiency, immunosuppressive therapy such as long term systemic corticosteroids therapy
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 in the past or current or planned administration during the trial (including immunoglobulins).
Any vaccination in the 3 weeks preceding the first trial vaccination.
History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically).
Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus (HIV) infection
Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection with the trial vaccine or another vaccine.
Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
History of/current major neurological diseases or seizures.
Febrile illness (axillary temperature ≥ 38ºC) or acute illness on the day of inclusion.
Known family history of congenital or genetic immuno-deficiency.