None listed
Conditions
Interventions
Intervention1: 13vPnC: 13vPnC contains saccharides from pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14,
18C, 19A, 19F, and 23F individually conjugated to nontoxic diphtheria toxin CRM197. The
v
Sponsors
Pfizer Inc
Eligibility
Inclusion criteria
Inclusion criteria: Generally healthy participants between the ages of =18 and Note: Participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 12 weeks before enrollment, can be included. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: Medical Conditions: 1. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 13vPnC, or to any other diphtheria toxoid–containing vaccine. 2. History of microbiologically-proven invasive disease caused by S pneumoniae. 3. Known or suspected immune deficiency or suppression. 4. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. 5. Congenital, functional, or surgical asplenia. 6. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study. Prior/Concomitant Therapy: 7. Previous vaccination with any pneumococcal vaccine, or planned receipt of any pneumococcal vaccine through study participation. 8. Currently receives treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, or planned receipt during the study. If systemic corticosteroids have been administered short term ( administration. Inhaled/nebulized, intraarticular, intrabursal, or topical (skin, eyes, or ears) corticosteroids are permitted. 9. Receipt of blood/plasma products or immunoglobulin within the 60 days before study intervention administration, or planned receipt during the study. Prior/Concurrent Clinical Study Experience: 10. Participation in other studies involving investigational drugs, investigational vaccines (with the exception of vaccines authorized by the DCGI for pandemic use), or investigational devices within 28 days prior to study entry and/or during study participation. Participation in purely observational studies is acceptable. Diagnostic Assessments: Not applicable. Other Exclusions: 11. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To describe the safety profile of 13vPnC when administered to adults 18 to 49 years of ageTimepoint: Adults 18 to 49 years of age will receive 1 intramuscular dose of 13vPnC. Participants will take part in the study for approximately 1 month. | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Seema Pai
Pfizer Limited
Outcome results
None listed