A Phase 4 Study to Evaluate the Safety and Immunogenicity of Monovalent Oral Polio Vaccine Type 2 in Healthy IPV-vaccinated Children Aged 1 to 5 Years in Lithuania (M3-ABMG)

NCT02582255 Phase 4 COMPLETED Results posted

A Phase 4 study to evaluate the safety and immunogenicity of monovalent oral polio vaccine type 2 in healthy IPV-vaccinated children aged 1 to 5 years in Lithuania.

Details

Lead sponsor	Fidec Corporation
Phase	Phase 4
Status	COMPLETED
Enrolment	100
Start date	2015-11
Completion	2016-12-22

Conditions

• Poliomyelitis

Interventions

• Sabin mOPV2

Primary outcomes

• SAEs and Severe AEs — 3 months
  Incidence of SAEs and severe AEs grade 3 considered consistent with a causal association to study vaccine throughout the study period in children 1 to 5 years.
• Seroprotection Rate of Type 2 Polio Neutralizing Antibodies. — 1 month
  Seroprotection rate at type 2 polio neutralizing antibodies measured at D28 after the first dose of mOPV2.