Clinical Trials Logo

Clinical Trial Summary

The purpose of this clinical trial is to assess the safety and tolerability (primary objective), immunogenicity (primary and secondary objectives), fecal shedding of vaccine viruses (secondary objective) and the potential for neurovirulence of shed virus (secondary objective) of a novel oral polio type 3 vaccine, nOPV3, as compared to Sabin monovalent type 3 vaccine controls (mOPV3), in healthy young children (192 subjects), infants (860 subjects), and neonates (480 subjects).


Clinical Trial Description

This multicentered, 12-arm phase 2 study will be the first pediatric evaluation of nOPV3 in healthy young children, infants, and newborns. This trial will be initiated once results in the adult phase 1 study of nOPV3 indicate that there are no safety concerns, and that the vaccine elicits demonstrable immunogenicity. Additionally, prior to enrolling into cohort 2, the adult phase 1 data must show no concerning signals of reversion of attenuating sites from a subset of Next Generation Sequencing. This study is intended to provide critical data on safety, immunogenicity, and genetic stability, as well as to demonstrate the vaccine's ability to reduce fecal shedding following a challenge with the Sabin type 3 strain. Enrollment in this pediatric study will be staggered into three age-descending cohorts of 6 treatment groups of escalated target dose levels for the nOPV3 vaccine: cohort 1 composed of 192 healthy young children 1 to <5 years of age who have completed their full routine polio immunization series; cohort 2 composed of 860 healthy infants 6 weeks of age not previously vaccinated (OPV/IPV) who will be primed with a dose of inactivated poliomyelitis vaccine (IPV) prior to OPV3 vaccination [a subset, of the infants (n=360) will also receive the challenge virus]; and cohort 3, composed of 480 healthy poliomyelitis unvaccinated neonates (day of birth +3 days). Progression into the next cohort and groups within cohorts will depend on safety evaluations of the prior Phase 1 adult trial and Day 8 safety evaluation of the previous groups in prior cohorts in the study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05654467
Study type Interventional
Source PATH
Contact Xavier Saez-Llorens, MD
Phone +507 203-9760
Email xavier.saez-llorens@cevaxin.com
Status Recruiting
Phase Phase 2
Start date December 5, 2023
Completion date November 20, 2025

See also
  Status Clinical Trial Phase
Completed NCT04989231 - An Immunity Persistence Study of Sabin Inactivated Poliovirus Vaccine(Vero Cell) After Four Doses
Completed NCT00352963 - Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age). Phase 3
Recruiting NCT03890497 - Assessment of Poliovirus Type 2 Immunogenicity of One and Two Dose Schedule With IPV and fIPV When Administered at 9-13 Months of Age in Bangladesh Phase 4
Completed NCT00753649 - Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants Phase 4
Completed NCT04693286 - Clinical Trial of Novel OPV2 Vaccine Phase 2
Completed NCT02847026 - Fractional Inactivated Poliovirus Vaccine Booster and Rotavirus Study Phase 4
Completed NCT02189811 - Polio End-game Strategies - Poliovirus Type 2 Challenge Study Phase 4
Completed NCT01444781 - Study of the Booster Effect of DTaP-IPV-Hep B-PRP~T Combined Vaccine or Infanrix Hexa™ and Prevenar™ in Healthy Infants Phase 3
Completed NCT01214889 - Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants. Phase 3
Completed NCT00137696 - Comparison of Immune Response Using 2 Vaccination Schedules Using Inactivated Polio Vaccine N/A
Completed NCT00879827 - Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants Phase 3
Completed NCT01457495 - Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly Phase 2
Completed NCT02853929 - Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery Phase 4
Completed NCT03614702 - Clinic Trial to Evaluate the Safety and Immunogenicity by Different Sequential Schedules of bOPV and IPV Phase 3
Terminated NCT04063150 - Immunogenicity of Intramuscular and Intradermal IPV Phase 4
Completed NCT04614597 - A Study on Immunity Duration Against Polio Over 18 Months Infants After 2 or 3 Primary Doses Sabin IPV in China
Completed NCT03239496 - A Study to Evaluate Immunogenicity of Intramuscular Full-Dose and Intradermal Fractional Dose of IPV Phase 3
Completed NCT04544787 - A Phase 2 Study to Evaluate the Safety and Immunogenicity of Two Oral Poliovirus Vaccine Candidates Phase 2
Completed NCT02985320 - Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine Phase 1/Phase 2
Completed NCT02291263 - Immunogenicity of Intramuscular Inactivated Poliovirus Vaccine Phase 3