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Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age

Last updated on August 29, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
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

- Male or female Japanese subjects 18 to 49 years of age, defined as Japanese born in
Japan, with both parents and 4 grandparents who wer born in Japan (family tree by
history), and who have not lived outside of Japan for more than 5 years total
(confirmed by passport or interview)

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

- Participation in other studies involving investigational drug(s), investigational
vaccines, or investigational medical devised within 28 days prior to study entry
and/or during study participation. Participation in purely observational studies is
acceptable.

NCT03642847
Pfizer
Not yet recruiting
Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age

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Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age.
A Phase 1b, Randomized, Controlled, Double-blind Trial To Evaluate The Safety And Immunogenicity Of Multivalent Pneumococcal Conjugate Vaccines In Healthy Japanese Adults 18 To 49 Years Of Age
This Phase 1b will describe the safety and immunogenicity of 2 multivalent pneumococcal conjugate vaccine formulations in healthy Japanese adults in the United States.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Pneumococcal Infections
  • Biological: Prevnar 13
    13 valent Pneumococcal Conjugate
  • Biological: multivalent pneumococcal conjugate formulation 1
    multivalent pneumococcal conjugate formulation 1
  • Biological: multivalent pneumococcal conjugate formulation 2
    multivalent pneumococcal conjugate formulation 2
  • Active Comparator: Prevnar 13
    13 valent Pneumococcal Conjugate
    Intervention: Biological: Prevnar 13
  • Experimental: multivalent pneumococcal conjugate formulation 1
    multivalent pneumococcal conjugate formulation 1
    Intervention: Biological: multivalent pneumococcal conjugate formulation 1
  • Experimental: multivalent pneumococcal conjugate formulation 2
    multivalent pneumococcal conjugate formulation 2
    Intervention: Biological: multivalent pneumococcal conjugate formulation 2
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
99
Same as current
April 24, 2019
April 24, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female Japanese subjects 18 to 49 years of age, defined as Japanese born in Japan, with both parents and 4 grandparents who wer born in Japan (family tree by history), and who have not lived outside of Japan for more than 5 years total (confirmed by passport or interview)

Exclusion Criteria:

  • Participation in other studies involving investigational drug(s), investigational vaccines, or investigational medical devised within 28 days prior to study entry and/or during study participation. Participation in purely observational studies is acceptable.
Sexes Eligible for Study: All
18 Years to 49 Years   (Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03642847
B7471005
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2018

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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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]



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