Study to Evaluate Safety and Immunogenicity of nOPV2 at Different Intervals in Infants

Phase 3 Completed 905 enrolled Fidec Corporation Bill and Melinda Gates Foundation · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

Study to determine immunogenicity and safety following administration of 2 doses of novel oral poliovirus vaccine type 2 (nOPV2) given at different intervals of 1 week or 2 weeks or the standard 4-week interval in infants

Timeline

Start: 2021-12-16
Primary completion: 2022-05-24
Completion: 2022-10-25

Outcome

Mixed primary results

paper Non-inferiority was shown for group B compared with group C (difference in rates -3·7; 95% CI -7·9 to 0·3) PMID 38109921 ↗

paper not for group A compared with group C (-8·0; -12·7 to -3·6) PMID 38109921 ↗

Publications

Rivera Mejia L, Pena Mendez L, Bandyopadhyay AS, Gast C, Mazara S, Rodriguez K, Rosario N, Zhang Y, Mainou BA, Jimeno J, Aguirre G, Ruttimann R. Safety and immunogenicity of shorter interval schedules of the novel oral poliovirus vaccine type 2 in infants: a phase 3, randomised, controlled, non-inferiority study in the Dominican Republic. Lancet Infect Dis. 2024 Mar;24(3):275-284. doi: 10.1016/S1473-3099(23)00519-4. Epub 2023 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	nOPV2	Vaccine	0.1 ml	Oral