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

Pneumococcal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05329259
• Other study ID #: B1851214
• Status: Completed
• Phase: Phase 4
• Start date: October 6, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: November 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pneumococcal Disease
• Pneumococcal Infections

Intervention

Biological:
• 13-valent pneumococcal conjugate vaccine
One dose of 13vPnC (0.5mL) will be administered intramuscularly.

Locations

Country	Name	City	State
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	Calcutta School of Tropical Medicine	Kolkata	WEST Bengal
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 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
Primary	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
Primary	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
Primary	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

External Links

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