Optimising the Timing of Whooping Cough Immunisation in MUMs

Phase 4 Unknown 354 enrolled St George's, University of London Department of Health, United Kingdom · collab Thrasher Research Fund · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

A multicentre study to evaluate the impact of timing of whooping cough (pertussis) vaccination in pregnancy, with participants randomised to receive whooping cough vaccination at one of three time points in pregnancy.

Timeline

Start: 2019-05-07
Primary completion: 2020-12-10
Completion: 2021-05

Outcome

Mixed primary results

paper Equivalence of time periods was demonstrated for anti-pertussis toxin and anti-pertactin IgG concentrations. PMID 37080224 ↗

paper for infants in group 1 (≤23 weeks + 6 days), equivalence to group 3 (28-31 weeks + 6 days) was not shown. PMID 37080224 ↗

Publications

Calvert A, Amirthalingam G, Andrews N, Basude S, Coleman M, Cuthbertson H, England A, Greening V, Hallis B, Johnstone E, Jones CE, Karampatsas K, Khalil A, Le Doare K, Matheson M, Peregrine E, Snape MD, Vatish M, Heath PT; OpTIMUM Study Group. Optimising the timing of whooping cough immunisation in mums (OpTIMUM) through investigating pertussis vaccination in pregnancy: an open-label, equivalence, randomised controlled trial. Lancet Microbe. 2023 May;4(5):e300-e308. doi: 10.1016/S2666-5247(22)00332-9. Epub 2023 Apr 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Boostrix-inactivated poliovirus vaccine	Vaccine	—	—