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A Study to Learn About the Safety and Immune Response of 20vPnC in Adults in India.
A Study to Learn About the Safety and Immune Response of 20vPnC in Adults in India.

NCT05875727

CompletedPhase 3

Sponsor: Pfizer

Conditions: Pneumococcal Disease

Interventions: 20-valent pneumococcal conjugate vaccine

Countries: India

The purpose of this study is to learn about the safety and immune response of 20vPnC in adults in India. This study is seeking participants who: * are generally healthy adults of 18 years or older. * have not received pneumococcal vaccine. The study will have 2 groups based on age. One group will have particpants between 18 to 49 years of age. The other group will have participants of 50 years or older. Participants will take part in the study for about one month which includes two visits to the study clinic. Participants will receive a single dose of study vaccine (20vPnC) into the arm at visit 1 and will come to study site for a follow-up visit after about a month. The study team will ask questions about the participant's health and blood samples will be taken in a subset of participants during the visits.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

\- Generally healthy participants ≥18 years of age at the time of consent.

Exclusion Criteria:

* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of 20vPnC, or to any other diphtheria toxoid-containing vaccine.
* Known or suspected immune deficiency or suppression.
* 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.
* Previous vaccination with any pneumococcal vaccine, or planned receipt of any pneumococcal vaccine through study participation.
Locations (8)
  • Surat, Gujarat, India
  • Bangalore, Karnataka, India
  • Bangalore, Karnataka, India
  • Bengaluru, Karnataka, India
  • Pune, Maharashtra, India
  • New Delhi, National Capital Territory of Delhi, India
  • Ajmer, Rajasthan, India
  • Ajmer, Rajasthan, India