20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Healthy Japanese Infants
- Conditions
- Prevention of Pneumococcal infection
- Registration Number
- JPRN-jRCT2080225365
- Lead Sponsor
- Pfizer R&D Japan G.K.
- Brief Summary
20vPnC SC had a similar tolerability and safety profile to 13vPnC SC. The 4-dose series of 20vPnC SC elicits immune responses that are expected to expand protection against pneumococcal disease due to the 7 additional serotypes, while maintaining existing protection currently controlled by 13vPnC in Japanese infants. The 2 modes of administration had a similar safety and tolerability profile except for injection site swelling and redness, which were lower in 20vPnC IM.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 668
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method