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Clinical Trials/EUCTR2015-005182-23-Outside-EU/EEA
EUCTR2015-005182-23-Outside-EU/EEAActive, not recruitingNot Applicable

Immunogenicity and Safety of the Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) Administered at 2, 3, and 4 Months of Age and Followed by a Booster Dose at 18 Months of age in Healthy Infants in China, versus Commercially Available Oral Poliomyelitis Vaccine

Sanofi Pasteur SA0 sites600 target enrollmentStarted: November 17, 2015Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
600
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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

Investigators

Sponsor
Sanofi Pasteur SA

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