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Completed

NCT Number: NCT02725437

Clostridium Difficile Vaccine Safety, Tolerability, and Immunogenicity Study in Japanese Adults

The first-in-Japanese study B5091010 has been designed to evaluate the safety, tolerability, and immunogenicity of 2 antigen dose levels of C difficile vaccine when administered as one of two 3-dose regimens to healthy Japanese adults aged 65 to 85 years.

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Key information

Conditions

Clostridium Difficile Associated Disease

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SOUSEIKAI Sumida Hospital (formerly Medical Co. LTA Sumida Hospital), Sumida-ku, Tokyo, Japan

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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 65 to 85 years

Exclusion criteria

  • Proven or suspected prior episode of Clostridium difficile associated diarrhea
  • Unstable chronic medical condition
  • Disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine
  • Serious chronic medical disorders
  • Bleeding diathesis or condition associated with prolonged bleeding time that may contraindicate intramuscular injection
  • Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components
  • Subjects with congenital or acquired immunodeficiency disorders
  • Subjects with rheumatologic disorders or other illnesses requiring chronic treatment with known immunosuppressant medications
  • Active or treated leukemia or lymphoma or bone marrow disorder
  • Residence in a nursing home or other long-term care facility, or requirement for semiskilled nursing care or assisted living
  • Abnormality in screening hematology and/or blood chemistry laboratory values

Treatment and study plan

Clostridium difficile vaccine

Biological

0.5 mL intramuscular injection

Placebo

Biological

0.5 mL intramuscular injection

Primary outcomes

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

    Time frame: Up to 14 days after each vaccination

  2. Proportions 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: Up to 14 days after each vaccination

  3. Proportions of subjects reporting AEs (categorized according to the Medical Dictionary for Regulatory Activities [MedDRA])

    Time frame: From the first vaccination up to 28 days after the last vaccination

  4. Proportions of subjects reporting SAEs (categorized according to the Medical Dictionary for Regulatory Activities [MedDRA])

    Time frame: From the first vaccination until 6 months after the last vaccination

  5. Proportions of subjects with abnormal hematology and blood chemistry laboratory assessments

    Time frame: 7 days or 14 days after each vaccination

Secondary outcomes

  1. Toxin A- and toxin B-specific neutralizing antibody levels, expressed as geometric mean concentrations

    Time frame: Up to 6 months after dose 3

  2. Geometric mean fold rises in toxin A- and toxin B-specific neutralizing antibody levels

    Time frame: Up to 6 months after dose 3

  3. Proportions of subjects in each vaccine group with toxin A-specific neutralizing antibody level ≥ the specified threshold for toxin A

    Time frame: Up to 6 months after dose 3

  4. Proportions of subjects in each vaccine group with toxin B-specific neutralizing antibody level ≥ the specified threshold for toxin B

    Time frame: Up to 6 months after dose 3

  5. Proportions of subjects in each vaccine group with both toxin A- and toxin B-specific neutralizing antibody levels ≥ the specified threshold for toxin A and the specified threshold for toxin B, respectively

    Time frame: Up to 6 months after dose 3

  6. Proportions of subjects in each vaccine group with fold rises in toxin A-specific neutralizing antibody levels

    Time frame: Up to 6 months after dose 3

  7. Proportions of subjects in each vaccine group with fold rises in toxin B-specific neutralizing antibody levels

    Time frame: Up to 6 months after dose 3

  8. Proportions of subjects in each vaccine group with fold rises in both toxin A- and toxin B-specific neutralizing antibody levels

    Time frame: Up to 6 months after dose 3

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Placebo-controlled, Randomized, Observer-blinded Study To Evaluate The Safety, Tolerability, And Immunogenicity Of Two 3-dose Regimens Of Clostridium Difficile Vaccine Administered In Healthy Japanese Adults Aged 65 To 85 Years.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 1, 2016
Registry last updated
Jul 13, 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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