CompletedPhase 4

A Study to Evaluate Safety and Immunogenicity of tOPV in 1 to 5 Years and at 6 Weeks of Age

154 participantsStarted 2015-11

Plain-language summary

The purpose of this study is to assess the safety (serious adverse events \[SAEs\]), and severe adverse events \[AEs\] (grade 3 according to CTCAE 4.03) after one dose of SABIN tOPV in 1-5 year-old children and three doses of SABIN tOPV in 6 week-old infants, and immunogenicity (seroprotection rates for all 3 serotypes) 28 days after three doses of SABIN tOPV in vaccine-naïve infants.

Who can participate

Age range5 Weeks – 5 Years

SexALL

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Inclusion criteria

✓. Age:
✓. Healthy without obvious medical conditions that preclude the subject to be in the study as established by the medical history and physical examination.
✓. Written informed consent obtained from 1 or 2 parents or legal guardians as per Dominican Republic regulations.

Exclusion criteria

✕. Previous Vaccinations:
✕. Group 2: Infants with birth weight (BW) \< 2,500 gm.
✕. Any confirmed or suspected immunosuppressive or known immunodeficient condition including human immunodeficiency virus (HIV) infection.
✕. Family history of congenital or hereditary immunodeficiency.
✕. Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
✕. Known allergy to any component of the study vaccines or to any antibiotics.
✕. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections.
✕. Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

What they're measuring

SAEs and AEs G3

Timeframe: 6 months

Seroprotection Rate

Timeframe: 3 months

Trial details

NCT IDNCT02580201

SponsorFidec Corporation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-07

Results submitted2020-08-16

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