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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Pneumococcal Infections

Treatments: Biological: multivalent pneumococcal conjugate formulation 1; Biological: Prevnar 13; Biological: multivalent pneumococcal conjugate formulation 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT03642847

B7471005

Details and patient eligibility

About

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

Enrollment: 104 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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104 participants in 3 patient groups

Prevnar 13

Active Comparator group

Description:

13 valent Pneumococcal Conjugate

Treatment:

Biological: Prevnar 13

multivalent pneumococcal conjugate formulation 1

Experimental group

Description:

multivalent pneumococcal conjugate formulation 1

Treatment:

Biological: multivalent pneumococcal conjugate formulation 1

multivalent pneumococcal conjugate formulation 2

Experimental group

Description:

multivalent pneumococcal conjugate formulation 2

Treatment:

Biological: multivalent pneumococcal conjugate formulation 2