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A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India
A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India

NCT05329259

CompletedPhase 4

Sponsor: Pfizer

Conditions: Pneumococcal Disease

Interventions: 13-valent pneumococcal conjugate vaccine

Countries: India

* The purpose of this study is to describe the safety of the study vaccine (called 13vPnC) in people who are 18-49 years of age in India. * This study is seeking participants who are generally healthy adults ≥18 and \<50 years of age, with no prior history of pneumococcal vaccination. * Participants will take part in the study for approximately one month which includes two visits to the study clinic. * Participants will receive a single dose of study vaccine (13vPnC) into the arm at visit 1 and will come to study site for a follow-up visit after about a month.

Eligibility overview

Sex: ALL

Age: 18 Years to 49 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Generally healthy participants between the ages of ≥18 and \<50 years at the time of consent.
* 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.

Exclusion Criteria:

* 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.
* Congenital, functional, or surgical asplenia.
* 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 (5)
  • Surat, Gujarat, India
  • Bangalore, Karnataka, India
  • Ajmer, Rajasthan, India
  • Kolkata, West Bengal, India
  • Delhi, India