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Evaluation of a 3-dose Vaccination Regimen With One of Three Ascending Dose Levels of Clostridium Difficile Vaccine With or Without Adjuvant in Healthy Adults Aged 50 to 85 Years

NCT01706367 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2014-03-06

No results posted yet for this study

Summary

This is a first-in-human study (phase 1) of a 3-dose vaccination regimen with one of three dose levels of C difficile vaccine with or without adjuvant in healthy adults aged 50 to 85 years. The main goal of the study is to determine how safe and well-tolerated the vaccine is. In addition, the study aims to assess the immune response to the C difficile vaccine.

Conditions

  • Clostridium Difficile Associated Disease

Interventions

BIOLOGICAL

C. difficile vaccine

0.5 mL IM injection

BIOLOGICAL

C. difficile vaccine +adjuvant

0.5 mL IM injection

BIOLOGICAL

C. difficile vaccine

0.5 mL IM injection

BIOLOGICAL

C. difficile vaccine +adjuvant

0.5 mL IM injection

BIOLOGICAL

C. difficile vaccine

0.5 mL IM injection

BIOLOGICAL

C. difficile vaccine +adjuvant

0.5 mL IM injection

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01706367 on ClinicalTrials.gov