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

Pfizer104 enrolled

Overview

This Phase 1b will describe the safety and immunogenicity of 2 multivalent pneumococcal conjugate vaccine formulations in healthy Japanese adults in the United States.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

104

Conditions

Pneumococcal Infections

Interventions

Prevnar 13BIOLOGICAL

13 valent Pneumococcal Conjugate

multivalent pneumococcal conjugate formulation 1BIOLOGICAL

multivalent pneumococcal conjugate formulation 1

multivalent pneumococcal conjugate formulation 2BIOLOGICAL

multivalent pneumococcal conjugate formulation 2

Eligibility

Sex: ALLMin age: 18 YearsMax age: 49 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (4)

Collaborative Neuroscience Network, LLC.

Garden Grove, California, United States

Collaborative Neuroscience Network, LLC.

Long Beach, California, United States

East-West Medical Research Institute

Honolulu, Hawaii, United States

Clinilabs Drug Development Corporation

Eatontown, New Jersey, United States

Outcomes

Primary Outcomes

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 systemic events within 14 days after vaccination (fever, headache, fatigue, muscle pain, and joint pain).

Time frame: 14 days after vaccination

Subjects reporting adverse events (AEs) within 1 month after vaccination.

Time frame: 1 month after vaccination

Subjects reporting serious adverse events (SAEs) within 6 months after vaccination.

Time frame: 6 months after vaccination

Subjects reporting newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination.

Time frame: 6 months after vaccination

Secondary Outcomes

Immunogenicity

Pneumococcal serotype-specific OPA titers 1 month after vaccination.

Time frame: 1 month after vaccination

Data from ClinicalTrials.gov

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