A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX200 in Healthy Adults

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Brief Title

A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults

Official Title

Phase 3 Randomized, Double-blind, Placebo-Controlled 3-Lot Study in Healthy Volunteers to Assess Immunogenicity, & Acceptability of a Single-dose of Live Oral Cholera Vaccine, Vibrio Cholerae O1 Serotype Inaba Vaccine Strain CVD 103-HgR

Brief Summary

      The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.

Detailed Description

      The primary goal of this Phase III study is to compare three lots for consistency of
      manufacture.

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Geometric Mean Ratio (GMR) at Day 11 for Vaccine Lots A and B

Secondary Outcome

 SVA Seroconversion at Day 11

Condition

Cholera

Intervention

PXVX0200 Lot A

Study Arms / Comparison Groups

 PXVX0200 Lot A
Description:  PXVX0200 (Lot P700-1CA03) Single dose; liquid suspension after reconstitution with buffer; > 2x10^8 CFU in a liquid suspension

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Biological

Estimated Enrollment

3146

Start Date

May 2014

Completion Date

June 2015

Primary Completion Date

February 2015

Eligibility Criteria

        Inclusion Criteria:

          -  healthy men or women,

          -  age 18 to 45 years inclusive;

          -  normal medical history and physical examination

          -  Women must have a negative pregnancy test.

        Exclusion Criteria:

          -  travel to a cholera endemic area in the previous 5 years;

          -  abnormal stool pattern or regular use of laxatives;

          -  Currently active unstable or undiagnosed medical conditions

          -  current or recent antibiotic use;

          -  pregnancy or nursing;

          -  Previously received a licensed or investigational cholera vaccine

          -  History of cholera or enterotoxigenic E. coli infection

          -  History of Guillain-Barré Syndrome

          -  Received or plans to receive any other licensed vaccines, except for seasonal
             influenza

          -  Recipient of bone marrow or solid organ transplant

          -  Malignancy (excluding non-melanotic skin cancers) or lymphoproliferative disorders
             diagnosed or treated during the past 5 years

          -  Use of systemic chemotherapy in the previous 5 years prior to the study

          -  any immunosuppressive medical condition

Gender

All

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

James McCarty, MD, ,

Location Countries

Australia

Location Countries

Australia

Administrative Informations

NCT ID

NCT02094586

Organization ID

PXVX-VC-200-004

Responsible Party

Sponsor

Study Sponsor

Emergent BioSolutions

Study Sponsor

James McCarty, MD, Study Director, Emergent Travel Health Inc.

Verification Date

June 2021