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20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants

NCT04530838

CompletedPhase 3

Sponsor: Pfizer

Conditions: Pneumococcal Disease

Interventions: 20-valent pneumococcal conjugate vaccine, 13-valent pneumococcal conjugate vaccine

Countries: Japan

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants

Eligibility overview

Sex: ALL

Age: 2 Months to 6 Months

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Japanese male or female infants ≥2 months to ≤6 months at the time of consent.
* Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion Criteria:

* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
* Major known congenital malformation or serious chronic disorder.
* History of microbiologically proven invasive disease caused by S pneumoniae.
* Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

Locations (38)

Nagoya, Aichi-ken, Japan
Toyota-shi, Aichi-ken, Japan
Chiba, Chiba, Japan
Funabashi, Chiba, Japan
Isumi, Chiba, Japan
Yotsukaido-shi, Chiba, Japan
Yotsukaido-shi, Chiba, Japan
Fukui-shi, Fukui, Japan
Fukuoka, Fukuoka, Japan
Fukuoka, Fukuoka, Japan
Fukuoka, Fukuoka, Japan
Fukuoka, Fukuoka, Japan
Iizuka, Fukuoka, Japan
Kasuga, Fukuoka, Japan
Gifu, Gifu, Japan
Ebetsu Shi, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Sapporo, Hokkaido, Japan
Akashi, Hyōgo, Japan
Kawasaki-shi, Kanagawa, Japan
Kumamoto, Kumamoto, Japan
Kumamoto, Kumamoto, Japan
Kuwana, Mie-ken, Japan
Nagano, Nagano, Japan
Kawachi-Nagano, Osaka, Japan
Osaka, Osaka, Japan
Ureshino-shi, Saga-ken, Japan
Hanyu-shi, Saitama, Japan
Kumagaya-shi, Saitama, Japan
Ritto-Shi, Shiga, Japan
+ 8 more on CT.gov