CompletedPhase 3

To Evaluate the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children

Philippines3,632 participantsStarted 2014-05

Plain-language summary

The purpose of this study is to evaluate the efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children.

Age range1 Year – 40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Written informed consent to study participation voluntarily provided by an individual or his/her legally acceptable representative.
✓. Age of 1 \~ 40 years
✓. An individual who can be followed up during the study period and is capable of complying with the study requirements.

✕. History of hypersensitivity reactions to other preventative vaccinations.
✕. Immune function disorders including immunodeficiency diseases.
✕. An individual thought to have difficulty participating in the study due to severe chronic diseases, based on the judgment of the investigator.
✕. 38℃ or higher body temperature measured prior to investigational product dosing.
✕. Abdominal pain, nausea, vomiting, or decreased appetite within 24 hours prior to study initiation.
✕. Diarrhea or administration of antidiarrheal drugs or antibiotics to treat diarrhea within 1 week prior to study initiation.
✕. Other vaccination within 1 week prior to study initiation or planned vaccination during the study.
✕. Diarrhea or abdominal pain lasting 2 weeks or longer within 6 months prior to study initiation.

Efficacy

Timeframe: 14 days after second doses

Safety

Timeframe: From first shot to 14 days after second dose

NCT IDNCT02164110

SponsorEuBiologics Co.,Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-09