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

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

• 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.

Study Overview

• Status: Completed
• Conditions: Pneumococcal Disease
• Intervention / Treatment: Biological: 13-valent pneumococcal conjugate vaccine

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Delhi, India, 110075
    • Aakash Healthcare Private Limited
  • Gujarat
    • Surat, Gujarat, India, 395002
      • Nirmal Hospital Pvt Ltd.
  • Karnataka
    • Bangalore, Karnataka, India, 560060
      • BGS Global Institute of Medical Sciences (BGSGIMS)
  • Rajasthan
    • Ajmer, Rajasthan, India, 305001
      • Jawahar Lal Nehru Medical College
  • WEST Bengal
    • Kolkata, WEST Bengal, India, 700073
      • Calcutta School of Tropical Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 13-valent pneumococcal conjugate vaccine; Pneumococcal conjugate vaccine (13vPnC)	Biological: 13-valent pneumococcal conjugate vaccine; One dose of 13vPnC (0.5mL) will be administered intramuscularly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Prompted Local Reactions Within 7 Days After Vaccination	From Day 1 through Day 7 following vaccination, where Day 1 is the day of vaccination, local reactions including redness, swelling, and pain at the injection site were assessed and recorded.	Within 7 Days After Vaccination
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination	From Day 1 through Day 7 following vaccination, where Day 1 is the day of vaccination, systemic events including fever, headache, fatigue, muscle pain, and joint pain were assessed and recorded. Fever was defined as temperature ≥38.0 °C.	Within 7 Days After Vaccination
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination	An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Local reactions (redness, swelling, and pain at the injection site) and systemic events (fever, headache, fatigue, muscle pain, and joint pain) were not collected as AEs.	Within 1 Month After Vaccination
Percentage of Participants With Serious Adverse Events (SAEs) Within 1 Month After Vaccination	An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event.	Within 1 Month After Vaccination

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: April 7, 2022
• First Submitted That Met QC Criteria: April 7, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Pneumococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: B1851214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No