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

Phase 4

Completed

• Conditions: Pneumococcal Disease
• Interventions: Biological: 13-valent pneumococcal conjugate vaccine

• Registration Number: NCT05329259
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-14
• Study Start: 2022-10-06
• Primary Completion: 2022-11-30
• Study Completion: 2022-11-30
• Status Verified: 2023-11
• Results First Submitted: 2023-11-21
• Results First Submitted QC: 2023-11-21
• Last Update Submitted: 2023-11-21
• Results First Posted: 2024-04-26
• Last Update Posted: 2024-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
13-valent pneumococcal conjugate vaccine	13-valent pneumococcal conjugate vaccine	Pneumococcal conjugate vaccine (13vPnC)

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Prompted Local Reactions Within 7 Days After Vaccination	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.
Percentage of Participants With Serious Adverse Events (SAEs) Within 1 Month After Vaccination	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.
Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination	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.
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination	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.

Trial Locations

Locations (5)

Calcutta School of Tropical Medicine; 🇮🇳 Kolkata, WEST Bengal, India

Nirmal Hospital Pvt Ltd.; 🇮🇳 Surat, Gujarat, India

Jawahar Lal Nehru Medical College; 🇮🇳 Ajmer, Rajasthan, India

BGS Global Institute of Medical Sciences (BGSGIMS); 🇮🇳 Bangalore, Karnataka, India

Aakash Healthcare Private Limited; 🇮🇳 Delhi, India