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Column | Value |
---|---|
Trial registration number | NCT04639375 |
Full text link
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
|
First author
Last imported at : Aug. 28, 2021, 8 p.m. Source : ClinicalTrials.gov |
|
Contact
Last imported at : Aug. 28, 2021, 8 p.m. Source : ClinicalTrials.gov |
johnclaytonandrews@gmail.com |
Registration date
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
2020-11-20 |
Recruitment status
Last imported at : Aug. 28, 2021, 8 p.m. Source : ClinicalTrials.gov |
Not recruiting |
Study design
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
nonRCT |
Allocation
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Non-randomized |
Design
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Single group assignment |
Masking
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Open label |
Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
Study aim
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Prevention |
Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: provision of signed and dated informed consent form stated willingness to comply with all study procedures and availability for the duration of the study male or female, aged 18-80 female subjects of child-bearing potential must have a negative pregnancy test (point-of-care dipstick) prior to being vaccinated and be willing to use an effective method of birth control from the time of entry into the study and for 30 days following vaccination in good general health with no active infectious disease as evidenced by medical history and directed physical examination. |
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
known allergic reactions to components of the polio vaccine febrile illness within 14 days positive for sars-cov-2 antigenemia at any time prior to screening1 positive for sars-cov-2 antibodies at any time prior to screening1 subjects with fever > 101o f at screening subjects who respond yes to any of the following question: have you experienced any of the following symptoms in the past 48 hours (14): fever or chills cough shortness of breath or difficulty breathing fatigue muscle or body aches headache new loss of taste or smell sore throat congestion or runny nose nausea or vomiting diarrhea treatment with an investigational drug or other intervention within the 90 days prior to enrollment in this study inoculation with polio vaccine within the last 12 years women who are pregnant or breast feeding |
Number of arms
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
1 |
Funding
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
E-MO Biology Inc |
Inclusion age min
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
Inclusion age max
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
80 |
Countries
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
United States |
Type of patients
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Healthy volunteers |
Severity scale
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
N/A |
Total sample size
Last imported at : Jan. 29, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
300 |
primary outcome
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
Percentage of Subjects with Antibodies to SARS-CoV-2 RdRp following IPV Vaccination |
Notes
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
None |
Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 4 |
Arms
Last imported at : Nov. 23, 2020, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "1", "treatment_id": 1007, "treatment_name": "Polio vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}] |