EUCTR2021-001541-13-SE
Active, not recruiting
Phase 1
A Phase 2 immunological bridging study assessing the non-inferiority of a new formulation of ETVAX®. A prospective double-blind, randomized study in healthy volunteers
ConditionsHealthy volunteers (prevention of diarrheal disease due to infection with enterotoxigenic E. coli [ETEC])MedDRA version: 21.1Level: LLTClassification code 10054983Term: Prophylaxis against traveller's diarrheaSystem Organ Class: 100000004865MedDRA version: 20.1Level: LLTClassification code 10022665Term: Intestinal infection due to enterotoxigenic E. coliSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Healthy volunteers (prevention of diarrheal disease due to infection with enterotoxigenic E. coli [ETEC])
- Sponsor
- Scandinavian Biopharma Holding AB
- Enrollment
- 280
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female aged 18\-50 years, inclusive at the time of signing the informed consent.
- •Healthy constitution as established by medical history and physical examination.
- •Willing and able to give written informed consent for participation in the study
- •Able to comply with study activities, as judged by the Investigator.
- •Female Participants: Women of child\-bearing potential (for definition see Section 9\.3\.6\):
- •\- Have to agree to use an acceptable birth control method during participation in the investigation (see Section 9\.3\.6\).
- •\- A negative pregnancy test (beta human chorionic gonadotropin dipstick test in urine) at Visit 2/Day 1 will be required.
- •Male Participants:
- •\- Have to agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.
- •Are the trial subjects under 18? no
Exclusion Criteria
- •An acute or chronic medical condition that, in the opinion of the investigator/physician, would render ingestion of the investigational products unsafe or would interfere with the evaluation of responses. This includes, but is not limited to gastrointestinal diseases, and autoimmune diseases.
- •Current malignancy or history of malignancy during the last five years, based on anamnesis.
- •Gastroenteritis within two weeks prior to vaccination.
- •Regular use of laxatives, antacids or other agents that lower stomach acidity.
- •Any planned major surgery during the duration of the study.
- •After 10 minutes supine rest, any vital signs outside the following ranges:
- •\-Systolic BP \> 160 mm Hg
- •\-Diastolic BP \> 100 mm Hg
- •\-Heart rate \< 40 or \>85 beats per minute
- •Antibiotic therapy within two weeks prior to the vaccination.
Outcomes
Primary Outcomes
Not specified
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