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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

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NCT02955160

Last updated on March 22, 2018
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FOR MORE INFORMATION
Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.

NCT02955160
Pfizer
Completed
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

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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
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
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).
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Pneumococcal Infections
  • Biological: Multivalent
    Pneumococcal conjugate vaccine
  • Biological: Tdap
    Tetanus, diphtheria, and pertussis vaccine
  • Experimental: Multivalent
    Pneumococcal conjugate vaccine
    Intervention: Biological: Multivalent
  • Active Comparator: Tdap
    Tetanus, diphtheria, and pertussis vaccine
    Intervention: Biological: Tdap
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
August 1, 2017
August 1, 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 49 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02955160
B7471001
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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