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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-29

Study Completion Date

2019-03-29

Brief Summary

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

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Detailed Description

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Conditions

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Pneumococcal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Prevnar 13

13 valent Pneumococcal Conjugate

Group Type ACTIVE_COMPARATOR

Prevnar 13

Intervention Type BIOLOGICAL

13 valent Pneumococcal Conjugate

multivalent pneumococcal conjugate formulation 1

Group Type EXPERIMENTAL

multivalent pneumococcal conjugate formulation 1

Intervention Type BIOLOGICAL

multivalent pneumococcal conjugate formulation 1

multivalent pneumococcal conjugate formulation 2

Group Type EXPERIMENTAL

multivalent pneumococcal conjugate formulation 2

Intervention Type BIOLOGICAL

multivalent pneumococcal conjugate formulation 2

Interventions

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Prevnar 13

13 valent Pneumococcal Conjugate

Intervention Type BIOLOGICAL

multivalent pneumococcal conjugate formulation 1

Intervention Type BIOLOGICAL

multivalent pneumococcal conjugate formulation 2

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes