A phase 4 safety study of pneumococcal conjugate vaccine in adults 18 to 49 years

Phase 4

Completed

• Registration Number: CTRI/2022/04/041856
• Lead Sponsor: Pfizer Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Generally healthy participants between the ages of =18 and <50 years, at Visit 1. Participants who are willing and able to comply with all scheduled visits, treatment plan, lifestyle considerations, and other study procedures. Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.

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

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 ( <14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified