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| Column | Value |
|---|---|
| Trial registration number | NCT05303402 |
|
Full text link
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
teresa.prat@hipra.com |
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Registration date
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
2022-03-31 |
|
Recruitment status
Last imported at : June 21, 2022, 7:30 p.m. Source : ClinicalTrials.gov |
Recruiting |
|
Study design
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Non-randomized |
|
Design
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Single group assignment |
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Masking
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
multi-center |
|
Study aim
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : May 7, 2022, 5 a.m. Source : ClinicalTrials.gov |
inclusion criteria: male, female or transgender, ≥ 18 years old at day 0. provide inform consent form participant who has: 3 doses of mrna vaccines 2 doses of mrna vaccines and previous covid-19 infection 2 doses of coronavac and 1 comirnaty, or, 1 coronavac and 2 comirnaty participant who has: hiv infection with cd4 tcells counts <400 primary antibody deficiency disorders kidney disease on dialysis kidney transplant at least >1 year auto immune disease (aid) in treatment with rituximab for a female of childbearing potential, to have a negative pregnancy test at day 0 use of any of these contraception: female: hormonal contraception, intrauterine device, vasectomized partner, sexual abstinence, condom. male: vasectomized participant, sexual abstinence, condom. |
|
Exclusion criteria
Last imported at : June 28, 2022, 10 p.m. Source : ClinicalTrials.gov |
history of anaphylaxis to any prior vaccine participants has received or plans to receive live attenuated vaccines, other not live vaccines, or vaxzevria or janssen vaccines. pregnant or breast-feeding at day 0. a confirmed covid-19 diagnose <90 days prior to vaccination day 0. a clinically significant acute illness or fever at screening or 48h before day 0. participant had a surgery requiring hospitalisation and has not received the hospital discharge. participant has an ongoing severe and non-stable psychiatric condition participant has a problematic or risky use of substances including alcohol participant has a bleeding disorder that contraindicates intramuscular injection participant suffering from post-acute covid-19 syndrome / long covid participant received any immunotherapy to prevent/treat covid-19 in the last 90 days participant is already participating in another research involving drug, biologics or device participant has donated ≥450 ml of blood products within 12 weeks before screening participant has any medical condition and/or finding that in the investigator opinion might increase participant risk, interfere with the study or impair interpretation of study data. |
|
Number of arms
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
1 |
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Funding
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Hipra Scientific, S.L.U |
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Inclusion age min
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Spain;Turkey |
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Type of patients
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Healthy volunteers |
|
Severity scale
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
400 |
|
primary outcome
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Immunogenicity against Omicron, Beta, Delta at Day 0 and Day 14 |
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Notes
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : April 1, 2022, 3:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "nan", "treatment_id": 1828, "treatment_name": "Phh-1v", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}] |