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

Pfizer405 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

405

Conditions

Pneumococcal Disease

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (8)

Nirmal Hospital Pvt Ltd.

Surat, Gujarat, 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

Bharati Vidyapeeth (Deemed to be University) Medical College Hospital & Research Centre

Pune, Maharashtra, India

Aakash Healthcare Private Limited

New Delhi, National Capital Territory of Delhi, India

Jawahar Lal Nehru Hospital

Ajmer, Rajasthan, India

Jawahar Lal Nehru Medical College

Ajmer, Rajasthan, India

Outcomes

Primary Outcomes

Percentage of Participants With Local Reactions Within 7 Days After Vaccination

Local reactions (redness, swelling, and injection site pain) at the site of investigational product administration were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units where 1 caliper unit = 0.5 centimeter (cm). Redness and swelling were graded as mild (more than \[\>\]2.0 to 5.0 cm), moderate (\>5.0 to 10.0cm) and severe (\>10.0cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.

Time frame: Day 1 to Day 7 after vaccination

Percentage of Participants With Systemic Events Within 7 Days After Vaccination

Systemic events included: fever, fatigue, headache, joint pain and muscle pain. Fever was defined as an oral temperature of more than or equal to (\>=)38.0 degree Celsius (C) and was classified as \>=38.0 degree C, \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, joint pain and muscle pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.

Time frame: Day 1 to Day 7 after vaccination

Percentage of Participants With Adverse Events (AEs) From Vaccination to 1 Month After Vaccination

An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.

Time frame: From vaccination on Day 1 up to 1 Month after vaccination

Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination to 1 Month After Vaccination

An SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or that was considered to be an important medical event.

Time frame: From vaccination on Day 1 up to 1 Month after vaccination

Secondary Outcomes

Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination

GMFRs and 2-sided 95% confidence interval (CIs) were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantification (LLOQ) were set to 0.5\*LLOQ in the analysis. Evaluable immunogenicity population: Eligible participants in the immunogenicity subset who received 1 dose of the intervention with at least 1 valid immunogenicity result from the blood sample collection within 27 to 49 days after vaccination, had no other major protocol deviations as determined by the clinician.

Time frame: From before vaccination to 1 Month after vaccination