Pneumococcal Disease
Conditions
Interventions
Product Name: PF-07872412
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE
Other descripti
Sponsors
Pfizer, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? yes Number of subjects for this age range: 225 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 |
|---|---|
| Main Objective: To evaluate the safety and tolerability profile of a fourth-generation multivalent pneumococcal conjugate vaccine (PG4) administered to toddlers =12 to =15 months of age;Secondary Objective: To describe the immune responses elicited by PG4;Primary end point(s): -Percentage of participants reporting prespecified local reactions within 7 days after each dose -Percentage of participants reporting prespecified systemic events within 7 days after each dose -Percentage of participants reporting Adverse Events (AEs) within 1 month after the last assigned vaccination -Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination;Timepoint(s) of evaluation of this end point: 7 days after each dose 1 month after the last assigned vaccination 6 months after vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Pneumococcal serotype specific IgG concentrations 1 month after last assigned vaccination;Timepoint(s) of evaluation of this end point: 1 month after last assigned vaccination | — |
Countries
United States
Contacts
Public ContactClinical Trials.gov Call Center
Pfizer, Inc
Outcome results
None listed