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Completed

NCT Number: NCT05329259

A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 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.

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Key information

Conditions

Pneumococcal Disease Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pneumococcal Infections Streptococcal Infections

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Nirmal Hospital Pvt Ltd., Surat, Gujarat, India

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

13-valent Pneumococcal Conjugate Vaccine

Biological

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

Primary outcomes

  1. Percentage of Participants With Prompted Local Reactions Within 7 Days After Vaccination

    Time frame: 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.

  2. Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination

    Time frame: 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.

  3. Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination

    Time frame: 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.

  4. Percentage of Participants With Serious Adverse Events (SAEs) Within 1 Month After Vaccination

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2022
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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