PG4
BiologicalMultivalent pneumococcal conjugate vaccine.
NCT Number: NCT06531538
The purpose of this study is to learn about the safety, tolerability and immune effects of a pneumococcal vaccine in toddlers.
Participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to. During this time participants will have 2 clinic visits and 1 phone visit for the 1-Dose group, or 3 clinic visits and 1 phone visit for the 2-Dose group.
At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during some clinic visits.
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Notify Me12 month–15 month
All sexes
Interventional
Phase 2
BRCR Medical Center - Ponce, Ponce, Puerto Rico
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Multivalent pneumococcal conjugate vaccine.
20-valent pneumococcal conjugate vaccine (20vPnC)
Other names: Prevnar 20
Time frame: 7 days after each dose
Prespecified local reactions (redness, swelling, and pain at the injection site) after each dose
Time frame: 7 days after each dose
Prespecified systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability) after each dose
Time frame: From signing of ICD to 1 month after last assigned vaccination
Adverse events occurring within 1 month after the last assigned vaccination
Time frame: From signing of ICD to 6 months after last assigned vaccination
SAEs occurring from Dose 1 through 6 months after the last assigned vaccination
Time frame: 1 month after last assigned vaccination
Pneumococcal IgG GMCs 1 month after the last assigned vaccination
Pfizer
Industry
A PHASE 2, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE ADMINISTERED IN HEALTHY TODDLERS 12 THROUGH 15 MONTHS OF AGE
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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