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Completed

NCT Number: NCT03642847

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

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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Key information

Conditions

Pneumococcal Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Streptococcal Infections

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Collaborative Neuroscience Network, LLC., Garden Grove, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prevnar 13

Biological

13 valent Pneumococcal Conjugate

multivalent pneumococcal conjugate formulation 1

Biological

multivalent pneumococcal conjugate formulation 1

multivalent pneumococcal conjugate formulation 2

Biological

multivalent pneumococcal conjugate formulation 2

Primary outcomes

  1. 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 local reactions within 14 days after vaccination (redness, swelling, and pain at the injection site).

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

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

    Time frame: 1 month after vaccination

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

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

    Time frame: 6 months after vaccination

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

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

    Time frame: 6 months after vaccination

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

Secondary outcomes

  1. Immunogenicity

    Time frame: 1 month after vaccination

    Pneumococcal serotype-specific OPA titers 1 month after vaccination.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 22, 2018
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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