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

Phase 1

Completed

• Conditions: Pneumococcal Infections
• Interventions: Biological: multivalent pneumococcal conjugate formulation 1; Biological: Prevnar 13; Biological: multivalent pneumococcal conjugate formulation 2

• Registration Number: NCT03642847
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-08-20
• Study First Posted: 2018-08-22
• Study Start: 2018-08-29
• Primary Completion: 2019-03-29
• Study Completion: 2019-03-29
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-11
• Last Update Posted: 2019-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
multivalent pneumococcal conjugate formulation 1	multivalent pneumococcal conjugate formulation 1	multivalent pneumococcal conjugate formulation 1
Prevnar 13	Prevnar 13	13 valent Pneumococcal Conjugate
multivalent pneumococcal conjugate formulation 2	multivalent pneumococcal conjugate formulation 2	multivalent pneumococcal conjugate formulation 2

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Immunogenicity	1 month after vaccination	Pneumococcal serotype-specific OPA titers 1 month after vaccination.

Trial Locations

Locations (3)

East-West Medical Research Institute; 🇺🇸 Honolulu, Hawaii, United States

Collaborative Neuroscience Network, LLC.; 🇺🇸 Long Beach, California, United States

Clinilabs Drug Development Corporation; 🇺🇸 Eatontown, New Jersey, United States