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

• ClinicalTrials.gov Identifier: NCT03642847
• Recruitment Status: Completed
• First Posted: August 22, 2018
• Last Update Posted: June 12, 2019
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: August 20, 2018
• First Posted Date: August 22, 2018
• Last Update Posted Date: June 12, 2019
• Actual Study Start Date: August 29, 2018
• Actual Primary Completion Date: March 29, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 20, 2018)

• Subjects reporting prompted local reactions within 14 days after vaccination (redness, swelling, and pain at the injection site). [ Time Frame: 14 days after vaccination ]
  Subjects reporting prompted local reactions within 14 days after vaccination (redness, swelling, and pain at the injection site).
• Subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain). [ Time Frame: 14 days after vaccination ]
  Subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain).
• Subjects reporting adverse events (AEs) within 1 month after vaccination. [ Time Frame: 1 month after vaccination ]
  Subjects reporting adverse events (AEs) within 1 month after vaccination.
• Subjects reporting serious adverse events (SAEs) within 6 months after vaccination. [ Time Frame: 6 months after vaccination ]
  Subjects reporting serious adverse events (SAEs) within 6 months after vaccination.
• Subjects reporting newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination. [ Time Frame: 6 months after vaccination ]
  Subjects reporting newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 20, 2018)

Immunogenicity [ Time Frame: 1 month after vaccination ]

Pneumococcal serotype-specific OPA titers 1 month after vaccination.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age
• Official Title: 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
• Brief Summary: This Phase 1b will describe the safety and immunogenicity of 2 multivalent pneumococcal conjugate vaccine formulations in healthy Japanese adults in the United States.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Prevention
• Condition: Pneumococcal Infections

Intervention

• 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

Study Arms

• 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

• Publications *: Fitz-Patrick D, Young M Jr, Scott DA, Scully IL, Baugher G, Peng Y, Jansen KU, Gruber W, Watson W. A randomized phase 1 study of the safety and immunogenicity of 2 novel pneumococcal conjugate vaccines in healthy Japanese adults in the United States. Hum Vaccin Immunother. 2021 Feb 5:1-8. doi: 10.1080/21645515.2020.1863177. [Epub ahead of print]

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 23, 2019): 104
• Original Estimated Enrollment (submitted: August 20, 2018): 99
• Actual Study Completion Date: March 29, 2019
• Actual Primary Completion Date: March 29, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 49 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03642847
• Other Study ID Numbers: B7471005
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: June 2019