A Phase 4 Study to Evaluate the Safety and Immunogenicity of Trivalent Oral Polio Vaccine in Healthy Polio Vaccinated Children 1 to 5 Years of Age and in Healthy Unvaccinated Infants at 6 Weeks of Age in the Dominican Republic (T2-ABMG)

NCT02580201 Phase 4 COMPLETED Results posted

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.

Details

Lead sponsor	Fidec Corporation
Phase	Phase 4
Status	COMPLETED
Enrolment	154
Start date	2015-11
Completion	2016-08-11

Conditions

• Poliomyelitis

Interventions

• Oral Polio Vaccine

Primary outcomes

• SAEs and AEs G3 — 6 months
  Number of subjects experiencing SAEs and severe AEs grade 3 considered consistent with a causal association to study vaccine 28 days after three doses of SABIN tOPV in vaccine-naïve infants in Dominican Republic.
• Seroprotection Rate — 3 months
  Seroprotection rate of type-specific polio neutralizing antibodies at Day 84, 28 days after the third dose of SABIN tOPV in infants (Group 2).