Pneumococcal Disease
Conditions
Brief summary
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.
Interventions
BIOLOGICALPG4
Multivalent pneumococcal conjugate vaccine.
20-valent pneumococcal conjugate vaccine (20vPnC)
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Study is partially blinded as 2 of the 3 groups are blinded and 1 is unblinded.
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
12 Months to 15 Months
Healthy volunteers
Yes
Inclusion criteria
* Male or female toddlers ≥12 to ≤15 months of age at the time of consent. * Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study. * Have received 3 infant doses of 20vPnC with the last dose administered \>56 days before enrollment into the study. Documented confirmation of receipt will be collected prior to randomization.
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. * 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. * Previous vaccination with any licensed or investigational pneumococcal vaccine (other than 20vPnC) or planned receipt during study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants reporting Adverse Events (AEs) within 1 month after the last assigned vaccination | From signing of ICD to 1 month after last assigned vaccination | Adverse events occurring within 1 month after the last assigned vaccination |
| Percentage of participants reporting prespecified systemic events within 7 days after each dose | 7 days after each dose | Prespecified systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability) after each dose |
| Percentage of participants reporting prespecified local reactions within 7 days after each dose | 7 days after each dose | Prespecified local reactions (redness, swelling, and pain at the injection site) after each dose |
| Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination | From signing of ICD to 6 months after last assigned vaccination | SAEs occurring from Dose 1 through 6 months after the last assigned vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pneumococcal serotype specific IgG concentrations | 1 month after last assigned vaccination | Pneumococcal IgG GMCs 1 month after the last assigned vaccination |
Countries
Puerto Rico, United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed