Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local OPV

Poliomyelitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00348387
• Other study ID #: IPV13
• 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

• Polio
• Poliomyelitis

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

External Links

•   Link
•   Link