CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
Sabin mOPV2biological
Likely dose
Sabin mOPV2 0.1 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02582255
NCT02582255Phase 4Completed
CompareCT.gov

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

Fidec Corporation·interventional·Posted Oct 21, 2015·Updated Jan 14, 2020

In Brief

A Phase 4 clinical trial evaluating Sabin mOPV2 for Poliomyelitis. Completed, enrolled 100 participants.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPoliomyelitis
Countries--
CollaboratorsBill and Melinda Gates Foundation

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedOct 21, 2015
Enrollment StartNov 1, 2015
Primary CompletionJul 1, 2016
Study CompletionDec 22, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.7 years ago

Interventions

Sabin mOPV2biological

Polio Sabin™ Mono Two (oral) is a licensed, monovalent, live attenuated poliomyelitis virus vaccine of the Sabin strain Type 2 (P 712, Ch, 2ab), propagated in MRC5 human diploid cells. Each two-drop dose (0.1 mL) contains not less than 105.0 CCID50 of Type 2. Magnesium chloride is used as a stabilizer. Polio Sabin™ Mono Two (Oral) contains trace amounts of neomycin sulphate and polymyxin B sulphate. One dose of vaccine (0.1 mL) is contained in two drops which are delivered from the polyethylene dropper supplied with vaccine.