Clinical trial NCT05875727: A Study to Learn About the Safety and Immune Response of 20vPnC in Adults in India.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-05-25
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be assigned into 2 cohorts by age: 18 to 49 years of age and ≥50 years of age.
Primary purpose: PREVENTION

Brief 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.


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.

Primary outcomes:
measure: Percentage of Participants With Local Reactions Within 7 Days After Vaccination
timeFrame: Day 1 to Day 7 after vaccination
measure: Percentage of Participants With Systemic Events Within 7 Days After Vaccination
timeFrame: Day 1 to Day 7 after vaccination
measure: Percentage of Participants With Adverse Events (AEs) From Vaccination to 1 Month After Vaccination
timeFrame: From vaccination on Day 1 up to 1 Month after vaccination
measure: Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination to 1 Month After Vaccination
timeFrame: From vaccination on Day 1 up to 1 Month after vaccination
Secondary outcomes:
measure: Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination
timeFrame: From before vaccination to 1 Month after vaccination
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Aakash Healthcare Private Limited
state: Delhi
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: Bangalore
country: India
facility: RajaRajeswari Medical College and Hospital
state: Karnataka
city: Bengaluru
country: India
facility: RajaRajeswari Medical College and Hospital
state: Karnataka
city: Pune
country: India
facility: Bharati Vidyapeeth (Deemed to be University) Medical College Hospital & Research Centre
state: Maharashtra
city: Ajmer
country: India
facility: Jawahar Lal Nehru Hospital
state: Rajasthan
city: Ajmer
country: India
facility: Jawahar Lal Nehru Medical College
state: Rajasthan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: