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

Pneumococcal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03642847
• Other study ID #: B7471005
• Status: Completed
• Phase: Phase 1
• Start date: August 29, 2018
• Est. completion date: March 29, 2019

Study information

• Verified date: June 2019
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: March 29, 2019
• Est. primary completion date: March 29, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

Biological:
• Prevnar 13
13 valent Pneumococcal Conjugate
• multivalent pneumococcal conjugate formulation 1
multivalent pneumococcal conjugate formulation 1
• multivalent pneumococcal conjugate formulation 2
multivalent pneumococcal conjugate formulation 2

Locations

Country	Name	City	State
United States	Clinilabs Drug Development Corporation	Eatontown	New Jersey
United States	Collaborative Neuroscience Network, LLC.	Garden Grove	California
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Collaborative Neuroscience Network, LLC.	Long Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjects reporting prompted local reactions within 14 days after vaccination (redness, swelling, and pain at the injection site).	Subjects reporting prompted local reactions within 14 days after vaccination (redness, swelling, and pain at the injection site).	14 days after vaccination
Primary	Subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain).	Subjects reporting prompted systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain).	14 days after vaccination
Primary	Subjects reporting adverse events (AEs) within 1 month after vaccination.	Subjects reporting adverse events (AEs) within 1 month after vaccination.	1 month after vaccination
Primary	Subjects reporting serious adverse events (SAEs) within 6 months after vaccination.	Subjects reporting serious adverse events (SAEs) within 6 months after vaccination.	6 months after vaccination
Primary	Subjects reporting newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.	Subjects reporting newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.	6 months after vaccination
Secondary	Immunogenicity	Pneumococcal serotype-specific OPA titers 1 month after vaccination.	1 month after vaccination

External Links

•   To obtain contact information for a study center near you, click here.