A Phase 1, Randomized, Controlled, Observer-blinded Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults Aged 18 to 49 Years

NCT02955160

Last updated date
Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-49 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Male or female adults 18 to 49 years of age.

2. Healthy adults determined by medical history, physical examination, laboratory screening, and clinical judgment to be eligible for the study.

3. Negative serum pregnancy test for all female subjects who are of childbearing potential.

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


1. Baseline laboratory test results outside of the normal reference range considered
clinically significant.


2. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis)
associated with a vaccine.


3. History of culture-proven invasive disease caused by S pneumoniae.


4. Previous vaccination with any licensed or investigational pneumococcal vaccine, or
planned receipt through study participation.


5. Vaccination with diphtheria-, pertussis-, or tetanus-containing vaccine(s) from 12
months before investigational product administration, or planned receipt through study
participation.


6. Male subjects and female subjects of childbearing potential who are unwilling or
unable to use a highly effective method of contraception as outlined in this protocol
for the duration of the study participation and for at least 6 months after the last
dose of investigational product.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 1, Randomized, Controlled, Observer-blinded Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults Aged 18 to 49 Years
Official Title  ICMJE A Phase 1, Randomized, Controlled, Observer-blinded Trial To Evaluate The Safety And Immunogenicity Of A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults Aged 18 To 49 Years
Brief Summary This is a Phase 1 first-in-human, randomized, controlled, observer-blinded study with a 2-arm parallel design. Healthy adults aged 18 to 49 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infections
Intervention  ICMJE
  • Biological: Multivalent
    Pneumococcal conjugate vaccine
  • Biological: Tdap
    Tetanus, diphtheria, and pertussis vaccine
Study Arms  ICMJE
  • Experimental: Multivalent
    Pneumococcal conjugate vaccine
    Intervention: Biological: Multivalent
  • Active Comparator: Tdap
    Tetanus, diphtheria, and pertussis vaccine
    Intervention: Biological: Tdap
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 2, 2016)
66
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 1, 2017
Actual Primary Completion Date August 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female adults 18 to 49 years of age.
  2. Healthy adults determined by medical history, physical examination, laboratory screening, and clinical judgment to be eligible for the study.
  3. Negative serum pregnancy test for all female subjects who are of childbearing potential.

Exclusion Criteria:

  1. Baseline laboratory test results outside of the normal reference range considered clinically significant.
  2. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) associated with a vaccine.
  3. History of culture-proven invasive disease caused by S pneumoniae.
  4. Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.
  5. Vaccination with diphtheria-, pertussis-, or tetanus-containing vaccine(s) from 12 months before investigational product administration, or planned receipt through study participation.
  6. Male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study participation and for at least 6 months after the last dose of investigational product.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02955160
Other Study ID Numbers  ICMJE B7471001
Has Data Monitoring Committee Yes
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 September 2018

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