A Phase I, Open-label, Randomized, Active-Controlled, to Evaluate the Safety and Immunogenicity of the DuoChol Oral Cholera Vaccine in 18 to 45 years old Healthy Participants in Sweden.

Status Authorised, recruitment pending · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans

Status Authorised, recruitment pending

Participants planned 60

Countries 1

Sites 1

Prevention of Cholera disease

Key facts

Sponsor: International Vaccine Institute
Participant type: Healthy volunteers
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Decision date (initial): 2025-10-06
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Prevention of Cholera disease

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

International Vaccine Institute

Sponsor organisation: International Vaccine Institute
Address: 1 Gwanak-Ro Gwanak-Gu, SNU Research Park SNU Research Park
City: Seoul
Postcode: 08826
Country: Korea, Republic of

Scientific contact point

Organisation: International Vaccine Institute
Contact name: Jessica Cowden

Public contact point

Organisation: International Vaccine Institute
Contact name: Jessica Cowden

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Sweden	Authorised, recruitment pending	60	1
Rest of world	—	0	—

Investigational sites

Sweden

1 site · Authorised, recruitment pending

Studieenheten Akademiskt

Studieenheten Akademiskt Specialistcentrum, Olivecronas väg 15, 113 61, Stockholm

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-07-17	Sweden	Acceptable 2025-10-02	2025-10-06