Clinical trial NCT03642847: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pneumococcal Infections
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2018-08-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Subjects reporting prompted local reactions within 14 days after vaccination (redness, swelling, and pain at the injection site).
timeFrame: 14 days after vaccination
measure: Subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain).
timeFrame: 14 days after vaccination
measure: Subjects reporting adverse events (AEs) within 1 month after vaccination.
timeFrame: 1 month after vaccination
measure: Subjects reporting serious adverse events (SAEs) within 6 months after vaccination.
timeFrame: 6 months after vaccination
measure: Subjects reporting newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.
timeFrame: 6 months after vaccination
Secondary outcomes:
measure: Immunogenicity
timeFrame: 1 month after vaccination
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, LLC.
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, LLC.
state: California
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Eatontown
country: United States
facility: Clinilabs Drug Development Corporation
state: New Jersey
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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 Jul 3;17(7):2249-2256. doi: 10.1080/21645515.2020.1863177. Epub 2021 Feb 5.