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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01214889
Other study ID # E2I49
Secondary ID U1111-1115-6381
Status Completed
Phase Phase 3
First received October 1, 2010
Last updated April 13, 2012
Start date September 2010
Est. completion date December 2011

Study information

Verified date April 2012
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 370
Est. completion date December 2011
Est. primary completion date November 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 56 Days to 70 Days
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Biological:
PENTAXIM™: DTacP IPV//PRP~T combined vaccine
0.5 mL, intramuscular
TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine
0.5 mL of each vaccine; intramuscular

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 month post-dose 3 vaccination No
Secondary Information regarding the safety (in terms of solicited injection site and systemic reactions) of PENTAXIM™ vaccine. Day 0 up to Day 157 No
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