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Completed Phase 1 Interventional Accepts healthy volunteers

Safety and Immunogenicity of Peru-15-pCTB in Healthy Adult Subjects

ClinicalTrials.gov ID: NCT00654108

Public ClinicalTrials.gov record NCT00654108. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 7:33 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled Dose Escalation, Inpatient Phase I Study to Determine the Safety and Immunogenicity of a Single Oral Dose of a Combined Live, Attenuated, Enterotoxigenic Escherichia Coli (ETEC)-Cholera Vaccine (Peru-15 pCTB) in Healthy Adult Subjects

Study identification

NCT ID
NCT00654108
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Enrollment
62 participants

Conditions and interventions

Interventions

  • Ciprofloxacin Drug
  • Peru-15-pCTB Biological
  • Sodium bicarbonate/Ascorbic Acid/Aspartame Buffer Other

Drug · Biological · Other

Eligibility (public fields only)

Age range
18 Years to 45 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 1, 2008
Primary completion
May 29, 2010
Completion
Dec 30, 2010
Last update posted
Jul 28, 2021

2008 – 2010

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Cincinnati Children's Hospital Medical Center - Infectious Diseases Cincinnati Ohio 45229-3039

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00654108, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 28, 2021 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00654108 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →