Trial Outcomes & Findings for OPV as Potential Protection Against COVID-19 (NCT NCT04445428)

Results Overview

Composite outcome of the first of death, hospitalisation for infection and/or consultation for infection at the health centre

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

3729 participants

Primary outcome timeframe

6 months

Results posted on

2026-04-07

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19	Control Information regarding prevention of COVID-19
Overall Study STARTED	1580	2149
Overall Study COMPLETED	1580	2146
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=1580 Participants Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19	Control n=2149 Participants Information regarding prevention of COVID-19	Total n=3729 Participants Total of all reporting groups
Age, Continuous	59 Years n=1580 Participants	60 Years n=2149 Participants	60 Years n=3729 Participants
Sex: Female, Male Female	937 Participants n=1580 Participants	1286 Participants n=2149 Participants	2223 Participants n=3729 Participants
Sex: Female, Male Male	643 Participants n=1580 Participants	863 Participants n=2149 Participants	1506 Participants n=3729 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 6 months

Composite outcome of the first of death, hospitalisation for infection and/or consultation for infection at the health centre

Outcome measures

Outcome measures
Measure	Intervention n=1580 Participants Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19	Control n=2146 Participants Information regarding prevention of COVID-19
Mortality or Infectious Disease Causing Consultation or Admission (Composite Outcome)	169 Participants	239 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Repeated eventes

Episodes with self-reported infectious disease morbidity.

Outcome measures

Outcome measures
Measure	Intervention n=1580 Participants Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19	Control n=2146 Participants Information regarding prevention of COVID-19
Self-reported Morbidity	2724 events	3326 events

SECONDARY outcome

Timeframe: 6 months

Episodes with self-reported infectious disease morbidity suspected to be caused by COVID (three or more of the following: fever, cough, sore thought, extreme fatigue, loss of smell/taste).

Outcome measures

Outcome measures
Measure	Intervention n=1580 Participants Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19	Control n=2146 Participants Information regarding prevention of COVID-19
Suspected COVID-19 Infection	162 Number of events	187 Number of events

SECONDARY outcome

Timeframe: 6 months

Either of the components of the composite outcome.

Outcome measures

Outcome measures
Measure	Intervention n=1580 Participants Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19	Control n=2146 Participants Information regarding prevention of COVID-19
Mortality	28 Participants	38 Participants

SECONDARY outcome

Timeframe: 6 months

Either of the components of the composite outcome included repeated events.

Outcome measures

Outcome measures
Measure	Intervention n=1580 Participants Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19	Control n=2146 Participants Information regarding prevention of COVID-19
Hospital Admission for Infectious Disease	35 Number of events	62 Number of events

SECONDARY outcome

Timeframe: 6 months

Either of the components of the composite outcome included repeated events.

Outcome measures

Outcome measures
Measure	Intervention n=1580 Participants Standard dose bivalent oral polio vaccine, 0.1ml, and information regarding prevention of COVID-19	Control n=2146 Participants Information regarding prevention of COVID-19
Consultations for Infectious Disease	442 Number of events	528 Number of events

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 28 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 38 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ane Fisker

Bandim Health Project, University of Southern Denmark

Phone: +45 65 50 37 40

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place