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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-06

Study Completion Date

2022-11-30

Brief Summary

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* 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.

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Detailed Description

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Conditions

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Pneumococcal Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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13-valent pneumococcal conjugate vaccine

Pneumococcal conjugate vaccine (13vPnC)

Group Type EXPERIMENTAL

13-valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

One dose of 13vPnC (0.5mL) will be administered intramuscularly.

Interventions

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13-valent pneumococcal conjugate vaccine

One dose of 13vPnC (0.5mL) will be administered intramuscularly.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes