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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03642847
Enrollment
104
Registered
2018-08-22
Start date
2018-08-29
Completion date
2019-03-29
Last updated
2019-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumococcal Infections

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.

Interventions

BIOLOGICALPrevnar 13

13 valent Pneumococcal Conjugate

BIOLOGICALmultivalent pneumococcal conjugate formulation 1

multivalent pneumococcal conjugate formulation 1

BIOLOGICALmultivalent pneumococcal conjugate formulation 2

multivalent pneumococcal conjugate formulation 2

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Immunogenicity1 month after vaccinationPneumococcal serotype-specific OPA titers 1 month after vaccination.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026