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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Poliomyelitis

Polio

Treatments

Biological: Poliomyelitis Vaccine in Dragee Candy (Human Diploid Cell)

Biological: Poliomyelitis Vaccine inactivated

Study type

Interventional

Funder types

Industry

Identifiers

NCT00348387

IPV13

Details and patient eligibility

About

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.

Enrollment

600 patients

Sex

All

Ages

60 to 70 days old

Volunteers

Accepts Healthy Volunteers

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