20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
NCT ID: NCT04530838
Last Updated: 2023-04-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
668 participants
INTERVENTIONAL
2020-09-16
2022-04-02
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Safety And Immunogenicity Study Of A 13-valent Pneumococcal Conjugate Vaccine In Japanese Subjects Aged 6 To 64 Years.
NCT03571607
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Infants
NCT00574795
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults Aged >= 50 Years
NCT00562354
20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan
NCT04875533
A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older
NCT01646398
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
20-valent pneumococcal conjugate vaccine (subcutaneous)
20-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)
20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine (subcutaneous)
13-valent pneumococcal conjugate vaccine administered by subcutaneous injection (SC)
13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine (intramuscular)
20-valent pneumococcal conjugate vaccine administered by intramuscular injection (IM)
20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
20-valent pneumococcal conjugate vaccine
20-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
13-valent pneumococcal conjugate vaccine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Exclusion Criteria
* 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.
2 Months
6 Months
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
NHO Nagoya Medical Center
Nagoya, Aichi-ken, Japan
TOYOTA Memorial Hospital
Toyota-shi, Aichi-ken, Japan
Tsubaki Children's Clinic
Chiba, Chiba, Japan
Sunrise Children's Clinic
Funabashi, Chiba, Japan
medical corporation Shigyo-no-kai Sotobo Children's Clinic
Isumi, Chiba, Japan
Sou Clinic
Yotsukaido-shi, Chiba, Japan
NHO Shimoshizu National Hospital
Yotsukaido-shi, Chiba, Japan
Fukui Aiiku Hospital
Fukui-shi, Fukui, Japan
Fukazawa Clinic
Fukuoka, Fukuoka, Japan
Shindo children's clinic
Fukuoka, Fukuoka, Japan
Shimomura Pediatrics Clinic
Fukuoka, Fukuoka, Japan
Inamitsu Children's Clinic
Fukuoka, Fukuoka, Japan
Iizuka Hospital
Iizuka, Fukuoka, Japan
Yokoyama Children'S Clinic
Kasuga, Fukuoka, Japan
Yajima Children's Clinic
Gifu, Gifu, Japan
Azuma kodomo katei clinic
Ebetsu Shi, Hokkaido, Japan
Nakata pediatric clinic
Sapporo, Hokkaido, Japan
Nishi Sapporo Pediatrics
Sapporo, Hokkaido, Japan
Yoshimura Child Clinic
Akashi, Hyōgo, Japan
Morino Kodomo Clinic
Kawasaki-shi, Kanagawa, Japan
Sakuranbo Kodomo Clinic
Kumamoto, Kumamoto, Japan
MIURA Children's Clinic
Kumamoto, Kumamoto, Japan
Matsuda Pediatric Clinic
Kuwana, Mie-ken, Japan
Arakawa Family Clinic
Nagano, Nagano, Japan
NHO Osaka Minami Medical Center
Kawachi-Nagano, Osaka, Japan
Aizenbashi Hospital
Osaka, Osaka, Japan
NHO Ureshino Medical center
Ureshino-shi, Saga-ken, Japan
Hanyu General Hospital
Hanyu-shi, Saitama, Japan
Enomoto Clinic
Kumagaya-shi, Saitama, Japan
Saiseikai Shiga Hospital
Ritto-Shi, Shiga, Japan
Sakiyama Pediatric Clinic
Fuchū, Tokyo, Japan
Saitoh-Clinic
Nishi-Tokyo-shi, Tokyo, Japan
Inami Pediatrics
Setagaya-ku, Tokyo, Japan
Sasamoto Children's Clinic
Setagaya-ku, Tokyo, Japan
Futaba Clinic
Shinjuku-ku, Tokyo, Japan
Tamura Clinic
Suginami-ku, Tokyo, Japan
Childrens clinic of Kose
Kofu, Yamanashi, Japan
Takei Clinic
Tsuru-shi, Yamanashi, Japan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ishihara Y, Fukazawa M, Enomoto S, de Solom R, Yamaji M, Kline M, Aizawa M, Peng Y, Kogawara O, Giardina PC, Tamimi N, Gruber WC, Watson W. A phase 3 randomized study to evaluate safety and immunogenicity of 20-valent pneumococcal conjugate vaccine in healthy Japanese infants. Int J Infect Dis. 2024 Apr;141:106942. doi: 10.1016/j.ijid.2024.01.009. Epub 2024 Jan 17.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-001146-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B7471016
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.