Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) iā¦ (NCT05844423) | Clinical Trial Compass
CompletedPhase 2
Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants
United States802 participantsStarted 2023-03-29
Plain-language summary
The objective of the study is to evaluate the safety and tolerability of 4 injections of VAX-24 (at 3 dose levels) compared to PCV15 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll the remainder of the sample size.
Who can participate
Age range42 Days ā 89 Days
SexALL
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Inclusion criteria
ā. Healthy male or female infant ā„42 days to ā¤89 days (inclusive).
ā. Full-term infant at least 37 weeks gestational age at birth.
ā. Afebrile for ā„72 hours with a rectal temperature \<38.0Ā°C (\<100.4Ā°F) or axillary temperature \<37.8Ā°C (\<100.0Ā°F) before receipt of study vaccine.\*
ā. Able to attend all scheduled visits and comply with the study procedures.
ā. Subject's parent/legal guardian is able to read and understands the study procedures, alternate treatments, risks and benefits, and provides written informed consent.
ā. Subject's parent/legal guardian is able to fill out an ediary of solicited AE and take daily axillary temperature and measurements of local injection site reactions for the 7 days after each study vaccination.
ā. Subject's parent/legal guardian has an e-mail address and access to a computer or smartphone with internet to complete the ediary.
Exclusion criteria
ā. History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
ā. Previous receipt of a licensed or investigational vaccine (excluding 1 dose hepatitis B vaccine).
ā. Known hypersensitivity to any vaccine.
ā. Known or suspected impairment of immunological function (e.g., asplenia, HIV, primary immunodeficiency).
What they're measuring
1
Percentage of participants with any solicited local injection site Adverse Events (AE) within 7 days after each vaccination
Timeframe: 7 days after each vaccination
2
Percentage of participants with any solicited systemic AE within 7 days after each vaccination
Timeframe: 7 days after each vaccination
3
Percentage of participants with any related Serious Adverse Events (SAE) within 6 months after last vaccination