Safety and immune response of polio vaccines in healthy adults

Phase 1

• Conditions: Poliomyelitis; Infection - Other infectious diseases; Public Health - Epidemiology

• Registration Number: ACTRN12612000465853
• Lead Sponsor: World Health Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-27
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Subjects must fulfill all of the following criteria:
- University student attending the Faculty of Chemistry and Pharmacology, Camaguey University, Camaguey
- Age 18 to 24, inclusive at the time of enrollment
- In good health as determined by the outcome of medical history, physical examination screening/baseline labs, and clinical judgment of the investigator
- Must have received polio vaccinations with OPV according to the Cuban National Immunization Program as a child
- Preferred: number (and date) of polio vaccinations known
- Willingness and ability to adhere to the study regimen
- Having a signed informed consent form

Exclusion Criteria

Temporary exclusion criteria for vaccination:
- If body temperature >=38C this will lead to postponement of participation and vaccination. Screening may continue when the temperature has normalized.

The exclusion criteria for vaccination are:
- IPV or OPV booster dose after the age of 12 years
- Known or suspected allergy against any of the vaccine components
- History of unusual or severe reactions to any previous vaccination
- Known or suspected disease or use of medication that may influence the immune system
- Known or suspected immune deficiency
- Systemic treatment with corticosteroids within one month before screening
- Administration of plasma (including immunoglobulins) or blood products three months prior to the study
- Blood donation within one month before screening
- Any vaccination within three months before screening and during the study until the last visit
- History of any neurological disorder including epilepsy or febrile seizures
- Evidence of excessive alcohol use or drug use
- Any infectious disease
- Participation in another clinical trial within three months before screening
- Abnormal pre-treatment laboratory parameters which are clinically relevant according to the investigator

The exclusion criteria for blood collections are:
- Bleeding disorders or the usage of anticoagulants

Study & Design

• Study Type: Interventional
• Study Design: Not specified