Clinical trial NCT05329259: A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India
Official title: A PHASE 4, OPEN-LABEL, SINGLE-ARM, MULTICENTER STUDY TO DESCRIBE THE SAFETY OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS 18 TO 49 YEARS OF AGE IN INDIA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-04-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: * 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 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.

Primary outcomes:
measure: Percentage of Participants With Prompted Local Reactions Within 7 Days After Vaccination
timeFrame: Within 7 Days After Vaccination
measure: Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination
timeFrame: Within 7 Days After Vaccination
measure: Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
timeFrame: Within 1 Month After Vaccination
measure: Percentage of Participants With Serious Adverse Events (SAEs) Within 1 Month After Vaccination
timeFrame: Within 1 Month After Vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Surat
country: India
facility: Nirmal Hospital Pvt Ltd.
state: Gujarat
city: Bangalore
country: India
facility: BGS Global Institute of Medical Sciences (BGSGIMS)
state: Karnataka
city: Ajmer
country: India
facility: Jawahar Lal Nehru Medical College
state: Rajasthan
city: Kolkata
country: India
facility: Calcutta School of Tropical Medicine
state: WEST Bengal
city: Delhi
country: India
facility: Aakash Healthcare Private Limited
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: