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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00348387
Other study ID # IPV13
Secondary ID
Status Completed
Phase Phase 3
First received July 3, 2006
Last updated January 20, 2014
Start date June 2006
Est. completion date December 2008

Study information

Verified date January 2014
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This study is intended to support the registration of IMOVAX Polio in China.

The primary objective of this Pase III trial is to compare IMOVAX Polio to the current Chinese standard of care (OPV) that is administered following a schedule of 2-3-4 months. The objective is to demonstrate that after the 3 doses primary series, in terms of seroprotection rates, IMOVAX Polio is not inferior to OPV. The safety of IPV will be assessed after each IPV dose.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date December 2008
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 60 Days to 70 Days
Eligibility Inclusion Criteria:

- Aged 2 months (60-70 days) on the day of inclusion into the study

- Born at full term pregnancy ( over 36 weeks) with a birth weight = 2.5 kg 2Ibs) or more

- Parent(s) or legal representative able to understand and give authorization and sign informed consent for participation

- Able to attend all planned clinic appointment and obey and follow all study instructions

Exclusion Criteria:

- Taking part in another clinical trial during the 4 weeks before the first trial vaccination

- Have plans to take part in another clinical trial d during this trial period

- Inborn or acquired decreased body natural defense, undertaking treatment that can reduce body's natural defense such as cancer drugs, radiation in the past six months or long term corticosteroid treatment

- Systemic reaction to any vaccine component or history of life-threatening reaction to study vaccine or any vaccine with the same ingredient(s)

- Prolonged or long time illness that could interfere with study or full participation

- Received blood or blood-derived products since birth

- Received any vaccine in the 4 weeks before the first trial vaccination is given (except BCG and hepatitis B)

- Have plans to receive any vaccine in the 4 weeks after the (or any) study vaccination is given (except DTacP)

- Previous vaccination against the poliomyelitis infection with the trial vaccine or another vaccine

- History of poliomyelitis infection (confirmed either by symptoms, blood or other laboratory test)

- Clinical or serological evidence of systemic illness including hepatitis B, hepatitis C or Human immunodeficiency virus (HIV)

- Bleeding disorder or a low platelet which do not allow vaccination into the muscle

- Had seizures in the past

- 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


Related Conditions & MeSH terms


Intervention

Biological:
Poliomyelitis Vaccine inactivated
0.5 mL, Intramuscular
Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)
1g dragee, oral

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary To provide information concerning the immunogenicity of IMOVAX Polio™ vaccine 1 month post-vaccination 3 No
Secondary To provide information concerning the safety of IMOVAX Polio™ vaccine Entire study period Yes
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Completed NCT02985320 - Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine Phase 1/Phase 2
Completed NCT02274285 - DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants Phase 3
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