Pneumococcal Disease
Conditions
Interventions
* Biological: PG4
Multivalent Pneumococcal Vaccine
* Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)
Other Names:
Prevnar 20
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: * infants who are 2 months of age in Group 1. * infants who are 2 to 6 months of age in Groups 2 and 3. * Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
Exclusion criteria
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, or planned receipt through study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Percentage of participants reporting local reactions within 7 days after each dose [Time Frame: Day 7] oPrompted local reactions after each dose *Percentage of participants reporting systemic events within 7 days after each dose [Time Frame: Day 7] oPrompted systemic events after each dose *Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 3 [Time Frame: Dose 1 to 1 month after Dose 3] oAEs occurring from Dose 1 to 1 month after Dose 3 *Percentage of participants reporting AEs from Dose 4 to 1 month after Dose 4 [Time Frame: Dose 4 to 1 month after Dose 4] oAEs occurring from Dose 4 to 1 month after Dose 4 *Percentage of participants reporting serious adverse events (SAEs) [Time Frame: Dose 1 to 6 months after Dose 4] oSAEs occurring from Dose 1 to 6 months after Dose 4 *Differences in percentages of participants with predefined pneumococcal specific immunoglobulin G (IgG) concentrations 1 month after Dose 3 [Time Frame: 1 month after Dose 3] oDifferences in pneumococcal immunoglobulin G (IgG) concentrations 1 month after Dose 3 *Pneumococcal IgG geometric mean concentrations (GMCs) 1 month after Dose 4 [Time Frame: 1 month after Dose 4] oPneumococcal IgG GMCs 1 month after Dose 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| *Pneumococcal IgG GMCs 1 month after Dose 3 [Time Frame: 1 month after Dose 3] oPneumococcal IgG GMCs 1 month after Dose 3 *Percentage of participants with serotype 3 specific predefined pneumococcal IgG concentrations 1 month after Dose 3 [Time Frame: 1 month after Dose 3] oPneumococcal serotype 3 IgG concentrations 1 month after Dose 3 *Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4 [Time Frame: 1 month after Dose 4] oPneumococcal serotype 3 IgG GMCs 1 month after Dose 4 *Differences in percentages of participants with predefined pneumococcal serotype 6C and 15C immunoglobulin G (IgG) concentrations 1 month after Dose 3 [Time Frame: 1 month after Dose 3] oDifferences in pneumococcal serotype 6C and 15C immunoglobulin G (IgG) concentrations 1 month after Dose 3 *Pneumococcal serotype 6C and 15C IgG GMCs and GMRs 1 month after Dose 4 [Time Frame: 1 month after Dose 4] oPneumococcal serotype 6C and 15C IgG GMCs and GMRs 1 month after Dose 4 *Pneumococcal opsonophagocytic activity (OPA) titers 1 month after Dose 3 [Time Frame: 1 month after Dose 3] oPneumococcal OPA titers 1 month after Dose 3 *Pneumococcal OPA titers prior to Dose 4 [Time Frame: Prior to Dose 4] oPneumococcal OPA titers prior to Dose 4 *Pneumococcal OPA titers 1 month after Dose 4 [Time Frame: 1 month after Dose 4] oPneumococcal OPA titers 1 month after Dose 4 *Percentage of participants with predefined pneumococcal specific IgG concentrations 1 month after Dose 4 [Time Frame: 1 month after Dose 4] oPercentage of participants with predefined pneumococcal specific IgG concentrations 1 month after Dose 4 *Pneumococcal IgG concentrations 1 month after Dose 3 [Time Frame: 1 month after Dose 3] oPneumococcal IgG concentrations 1 month after Dose 3 *Pneumococcal IgG concentrations prior to Dose 4 [Time Frame: Prior to Dose 4] oPneumococcal IgG concentrations prior to Dose 4 *Pneumococcal IgG concentrations 1 month after Dose 4 [Time Frame: 1 month after Dose 4] oPneumococcal IgG concentrations 1 mon | — |
Countries
Japan, Puerto Rico, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed