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OpenTrials
Completed

NCT Number: NCT02052726

A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 To 85 Years, Who Will Each Receive 3 Doses Of Vaccine.

This study will investigate a clostridium difficile vaccine in healthy adults aged 50 to 85 years, who will each receive 3 doses of vaccine. Subjects will receive their vaccine doses at either months 0, 1, and 3 or days 1, 8, and 30. Subjects will be divided into 2 age groups (50-64 and 65-85 years of age). The study will assess how safe and tolerable the vaccine is, and also look at subjects' immune response to the vaccine.

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Key information

Conditions

Clostridium Difficile

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Manna Research Inc., Toronto, Ontario, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male and female adults aged 50 to 85 years at enrollment

Exclusion criteria

  • Proven or suspected prior episode of Clostridium difficile associated diarrhea.
  • Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine.
  • Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components

Treatment and study plan

C. difficile vaccine with adjuvant

Biological

C. difficile vaccine with adjuvant administered at Month 0, 1, and 3.

Placebo

Biological

Placebo administered at Month 0, 1, and 3.

Primary outcomes

  1. Proportion of subjects reporting local reactions (pain, erythema, and induration) and their severity, as self reported on e-diaries.

    Time frame: 7 days after vaccination

  2. Proportion of subjects reporting systemic events (fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, and new or worsening joint pain) and their severity, as self reported on e-diaries.

    Time frame: 7 days after vaccination

Secondary outcomes

  1. Proportion of subjects in each vaccine group with neutralizing antibody levels (in Neut units/mL) greater than or equal to specified threshold(s).

    Time frame: Up to 12 months post-dose 3

  2. Proportion of subjects in each vaccine group with neutralizing antibody levels, expressed as geometric mean concentrations (GMCs) (in Neut units/mL).

    Time frame: Up to 12 months post-dose 3

  3. Proportion of subjects in each vaccine group with a greater than or equal to 4 and higher fold-rises in neutralizing antibody levels (in Neut units/mL).

    Time frame: Up to 12 months post-dose 3

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Placebo-controlled, Randomized, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of An Adjuvanted Clostridium Difficile Vaccine Administered As A 3-dose Regimen In Healthy Adults Aged 50 To 85 Years

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 3, 2014
Registry last updated
Dec 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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