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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00453570
Other study ID # E2I42
Secondary ID
Status Completed
Phase Phase 3
First received March 28, 2007
Last updated April 13, 2012
Start date March 2007
Est. completion date January 2009

Study information

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

Clinical Trial Summary

As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety of sanofi pasteur's DTacP-IPV// PRP~T combined vaccine (PENTAXIM™) as a three-dose primary vaccination at 2, 3, and 4 months of age or 3, 4 and 5 months of age followed by a booster dose at 18-20 months of age as compared to commercially available DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines in order to meet the requirements for registration of the product in People's Republic of China.


Recruitment information / eligibility

Status Completed
Enrollment 792
Est. completion date January 2009
Est. primary completion date December 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Days to 74 Days
Eligibility Inclusion Criteria :

- Aged 2 months (60 to 74 days) inclusive on the day of inclusion

- Born at full term pregnancy (³36 weeks) 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

- Any vaccination performed or planned in the 4 weeks preceding the first trial visit (except BCG and Hepatitis B, which can not be given within 8 days before the first study visit)

- Vaccination planned in the 4 weeks following any trial vaccination (except BCG and Hepatitis B, which can not be given within 8 days before or after the study vaccine(s) administration)

- History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically)

- Clinical or serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or 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 seizures

- Febrile illness (axillary temperature = 37.1°C) or acute illness on the day of inclusion

Study Design

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


Intervention

Biological:
Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
0.5 mL, IM
Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
0.5 mL, IM
Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed
0.5 mL, IM

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine 1 Month post-dose 3 No
Secondary To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine 19 months post-dose 1 Yes
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