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

NCT05329259 | Completed Phase 4 Results

• 1 other identifier: B1851214
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

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.

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

13-valent pneumococcal conjugate vaccine

EXPERIMENTAL

Pneumococcal conjugate vaccine (13vPnC)

Biological: 13-valent pneumococcal conjugate vaccine

Interventions

13-valent pneumococcal conjugate vaccine BIOLOGICAL

One dose of 13vPnC (0.5mL) will be administered intramuscularly.

13-valent pneumococcal conjugate vaccine

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Generally healthy participants between the ages of ≥18 and \<50 years at the time of consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (5)

Nirmal Hospital Pvt Ltd.

Surat, Gujarat, 395002, India

Location

BGS Global Institute of Medical Sciences (BGSGIMS)

Bangalore, Karnataka, 560060, India

Location

Jawahar Lal Nehru Medical College

Ajmer, Rajasthan, 305001, India

Location

Calcutta School of Tropical Medicine

Kolkata, West Bengal, 700073, India

Location

Aakash Healthcare Private Limited

Delhi, 110075, India

Location

Related Links

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

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: October 6, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: April 26, 2024
• Results First Posted: April 26, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share

Locations

IN (5)