A Phase 2 Bridging Study to Assess the New Formulation of ETVAX (NCT05178134) | Clinical Trial Compass
CompletedPhase 2
A Phase 2 Bridging Study to Assess the New Formulation of ETVAX
Sweden280 participantsStarted 2021-11-08
Plain-language summary
This is a phase 2,prospective double-blind, randomized, parallel-group study with the aim to demonstrate non-inferiority, in terms of immunogenicity, between the wet formulation and a newly developed partially dried formulation of selected components of ETVAX.
Who can participate
Age range18 Years – 50 Years
SexALL
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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 in the protocol):
* 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, as defined in Section 9.3.6
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.…