Immunogenicity and Safety of Imovax Polio in Chinese Infants Compared to Local Oral Poliomyelitis Vaccine

• Conditions: Poliomyelitis; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-005182-23-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11-17
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 600

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
Are the trial subjects under 18? yes
Number of subjects for this age range: 600
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Immunogenicity:<br> - To assess and describe the immunogenicity of the study vaccines one month after the third dose of the primary vaccination in both groups.<br> - To assess and describe the immunogenicity of polio types 1, 2, 3 in terms of antibody persistence approximately 14-16 months after the third dose of the primary vaccination in both groups.<br> - To assess and describe the immunogenicity of the study vaccine after the IPV booster dose in Group A.<br><br>Safety:<br> - To describe the safety after each dose of the study vaccines.;Timepoint(s) of evaluation of this end point: 1 month post-vaccination 3 (V04);Main Objective: - To demonstrate the non-inferiority in terms of seroprotection rates (polio types 1, 2 and 3) of IMOVAX Polio™ versus commercially available OPV one month after the 3-dose primary vaccination.;Primary end point(s): 1) Seroprotection rates defined as anti-Polio 1, 2, and 3 antibody titers = 8 (1/dil)1 month after the third dose of study vaccines (V04).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Individual anti-Polio 1, 2 and 3 antibody titers <br>2) Individual antibody titers ratio, defined post-primary vaccination/pre-primary vaccination and post-booster dose/pre-booster dose<br>3) Anti-Polio 1, 2 and 3 titers = 8 (1/dil);Timepoint(s) of evaluation of this end point: 1) 14-16 months after the 3-dose primary vaccination in both groups (at V05) and 1 month after the third dose in both groups (at V04) <br>2) 1 month after the third dose in both groups (at V04) <br>3) 14-16 months after the 3-dose primary vaccination in both groups (at V05) and 1 month after the IPV booster dose in the Group A (at V06):