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Trial #NCT01214889
Diphtheria Clinical Trials

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


Immunogenicity and Safety of the Sanofi Pasteur's DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Versus Sanofi Pasteur's DTacP-IPV Combined Vaccine (TETRAXIM™) Given Simultaneously at Separate Sites With PRP~T Conjugate Vaccine (ACTHIB™) as a Three-dose Primary Vaccination at 2, 4 and 6 Months of Age in South Korean Infants
Study ID: E2I49; Secondary ID: U1111-1115-6381; Source: Sanofi
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Completed
Country Korea, Republic of
Study type Interventional
Enrollment 370
Start date September 2010
Completion date December 2011
Phase Phase 3
Sponsor Sanofi
Summary:
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.
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.
Eligibility:
Gender: Both
Age: 56 Days - 70 Days
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.
Outcome:
Primary outcome
  • Non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3, Polyribosyl Ribitol Phosphate conjugated to Tetanus protein) of PENTAXIM™ Vaccine to the Tetraxim™ and PRP~T conjugate (Act-HIB™) vaccines.
    Time frame: 1 month post-dose 3 vaccination
Secondary outcome
  • Information regarding the safety (in terms of solicited injection site and systemic reactions) of PENTAXIM™ vaccine.
    Time frame: Day 0 up to Day 157
Contacts:
  • Medical Director; Sanofi Pasteur SA (Study Director)
Location Country Status
Daejeon, Korea, Republic of
Gyeionggi do, Korea, Republic of
Gyeonggi-do, Korea, Republic of
Gyeonggi-do, Korea, Republic of
Incheon, Korea, Republic of
Incheon, Korea, Republic of
Incheon, Korea, Republic of
Seoul, Korea, Republic of
Seoul, Korea, Republic of
Seoul, Korea, Republic of
Seoul, Korea, Republic of
Seoul, Korea, Republic of
Seoul, Korea, Republic of
Seoul, Korea, Republic of
Sponsors:
  • Sanofi - (Lead Sponsor)

Related trials: Terms
  • Haemophilus influenzae type B
  • PENTAXIM™
  • TETRAXIM™
  • Poliomyelitis
  • Tetanus
  • Pertussis
  • Diphtheria
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