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NCT05875727 Clinical Trial

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

Pneumococcal Disease Clinical Trial

Official title:
A PHASE 3, SINGLE-ARM, MULTICENTER TRIAL TO DESCRIBE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN PNEUMOCOCCAL VACCINE-NAÏVE ADULTS ≥18 YEARS OF AGE IN INDIA

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05875727
Other study ID # B7471010
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date August 16, 2023
Est. completion date October 2, 2023

Study information
Verified date January 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 400
Est. completion date October 2, 2023
Est. primary completion date October 2, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• 20-valent pneumococcal conjugate vaccine
One dose of 20vPnC will be administered intramuscularly.

Locations
Country Name City State
India Jawahar Lal Nehru Hospital Ajmer Rajasthan
India Jawahar Lal Nehru Medical College Ajmer Rajasthan
India BGS Global Institute of Medical Sciences (BGSGIMS) Bangalore Karnataka
India RajaRajeswari Medical College and Hospital Bangalore Karnataka
India RajaRajeswari Medical College and Hospital Bengaluru Karnataka
India Aakash Healthcare Private Limited New Delhi Delhi
India Bharati Vidyapeeth (Deemed to be University) Medical College Hospital & Research Centre Pune Maharashtra
India Nirmal Hospital Pvt Ltd. Surat Gujarat

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of participants reporting prompted local reactions within 7 days after vaccination Prompted local reactions (redness, swelling, and pain at the injection site) after vaccination 7 days
Primary Percentage of participants reporting prompted systemic events within 7 days after vaccination Prompted systemic events (fever, headache, fatigue, muscle pain, joint pain) after vaccination 7 days
Primary Percentage of participants reporting Adverse Events (AEs) within 1 month after vaccination AEs occurring within 1 month after vaccination 1 month
Primary Percentage of participants reporting Serious Adverse Events (SAEs) within 1 month after vaccination SAEs occurring within 1 month after vaccination 1 month
Secondary Pneumococcal opsonophagocytic activity (OPA) geometric mean fold rise (GMFR) GMFR in OPA titers from before vaccination to 1 month after vaccination 1 month
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Completed NCT04887948 - Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2 Phase 3
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Not yet recruiting NCT00843895 - Multicenter Prospective Evaluation of the Incidence and Serotyes of Invasive Pneumoccocal Disease (IPD) Among Children Below 5 Years N/A
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