A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older

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NCT01646398

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Study Location
Seishinkai Inoue Hospital
Itoshima, Fukuoka, , Japan
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Vaccines, Pneumococcal Conjugate Vaccine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Healthy Japanese male and female adults aged 65 years old and older at time of enrollment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of the study vaccine, are eligible.

2. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study or for at least 28 days after the last dose of the study vaccine whichever is longer.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. History of severe adverse reaction including hypersensitivity such as anaphylaxis
associated with a vaccine or vaccine component.


2. Previous vaccination with any licensed or experimental pneumococcal vaccine.


3. Documented Streptococcus pneumoniae infection within the past 5 years.


4. Residence in a nursing home, long-term care facility, or other institution or
requirement of semiskilled nursing care.

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Pneumococcal Vaccines, Pneumococcal Conjugate VaccineA Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older NCT01646398
  1. Itoshima, Fukuoka
  2. Yokohama, Kanagawa
  3. Shinjuku-ku, Tokyo
  4. Shinjuku-ku, Tokyo
  5. Sumida-ku, Tokyo
  6. Fukuoka,
  7. Kyoto,
  8. Osaka,
ALL GENDERS
65 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older
Official Title  ICMJE A Phase 3, Randomized, Modified Double-Blind, Active-Controlled Trial Evaluating The Safety, Tolerability, And Immunogenicity Of A 13-Valent Pneumococcal Conjugate Vaccine In Japanese Elderly Adults Aged 65 Years Old And Older Who Are Naive To Pneumococcal Vaccine
Brief Summary The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of 23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Pneumococcal Vaccines
  • Pneumococcal Conjugate Vaccine
Intervention  ICMJE
  • Biological: 13-valent pneumococcal conjugate vaccine
    A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
    Other Name: 13vPnC
  • Biological: 23-valent pneumococcal polysaccharide vaccine
    A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
    Other Name: 23VPS
Study Arms  ICMJE
  • Experimental: >= 65-year age group-13vPnC
    Intervention: Biological: 13-valent pneumococcal conjugate vaccine
  • Active Comparator: >= 65-year age group-23vPS
    Intervention: Biological: 23-valent pneumococcal polysaccharide vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 28, 2012)		764
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2012)		734
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy Japanese male and female adults aged 65 years old and older at time of enrollment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of the study vaccine, are eligible.
  2. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study or for at least 28 days after the last dose of the study vaccine whichever is longer.

Exclusion Criteria:

  1. History of severe adverse reaction including hypersensitivity such as anaphylaxis associated with a vaccine or vaccine component.
  2. Previous vaccination with any licensed or experimental pneumococcal vaccine.
  3. Documented Streptococcus pneumoniae infection within the past 5 years.
  4. Residence in a nursing home, long-term care facility, or other institution or requirement of semiskilled nursing care.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01646398
Other Study ID Numbers  ICMJE B1851088
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP