A Study to Learn About the Safety and Immune Response of 20vPnC in Adults in India.

NCT05875727 | Completed Phase 3 Results FDA Drug

• 1 other identifier: B7471010
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this study is to learn about the safety and immune response of 20vPnC in adults in India. This study is seeking participants who:

• are generally healthy adults of 18 years or older.
• have not received pneumococcal vaccine. The study will have 2 groups based on age. One group will have particpants between 18 to 49 years of age. The other group will have participants of 50 years or older. Participants will take part in the study for about one month which includes two visits to the study clinic. Participants will receive a single dose of study vaccine (20vPnC) into the arm at visit 1 and will come to study site for a follow-up visit after about a month. The study team will ask questions about the participant's health and blood samples will be taken in a subset of participants during the visits.

Conditions

Pneumococcal Disease

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With Local Reactions Within 7 Days After Vaccination

  Local reactions (redness, swelling, and injection site pain) at the site of investigational product administration were recorded in electronic diary (e-diary). Redness and swelling were measured and recorded in caliper units where 1 caliper unit = 0.5 centimeter (cm). Redness and swelling were graded as mild (more than \[\>\]2.0 to 5.0 cm), moderate (\>5.0 to 10.0cm) and severe (\>10.0cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity). Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.

  Day 1 to Day 7 after vaccination

• Percentage of Participants With Systemic Events Within 7 Days After Vaccination

  Systemic events included: fever, fatigue, headache, joint pain and muscle pain. Fever was defined as an oral temperature of more than or equal to (\>=)38.0 degree Celsius (C) and was classified as \>=38.0 degree C, \>=38.0 to 38.4 degree C, \>38.4 to 38.9 degree C, \>38.9 to 40.0 degree C and \>40.0 degree C. Fatigue, headache, joint pain and muscle pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.

  Day 1 to Day 7 after vaccination

• Percentage of Participants With Adverse Events (AEs) From Vaccination to 1 Month After Vaccination

  An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. Exact 2-sided 95% confidence interval was based on the Clopper and Pearson method.

  From vaccination on Day 1 up to 1 Month after vaccination

• Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination to 1 Month After Vaccination

  An SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect or was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic or that was considered to be an important medical event.

  From vaccination on Day 1 up to 1 Month after vaccination

Secondary Outcomes (1)

• Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination

  From before vaccination to 1 Month after vaccination

Study Arms (1)

20-valent pneumococcal conjugate vaccine

EXPERIMENTAL

Pneumococcal conjugate vaccine (20vPnC)

Biological: 20-valent pneumococcal conjugate vaccine

Interventions

20-valent pneumococcal conjugate vaccine BIOLOGICAL

One dose of 20vPnC will be administered intramuscularly.

20-valent pneumococcal conjugate vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Generally healthy participants ≥18 years of age 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 20vPnC, or to any other diphtheria toxoid-containing vaccine.
• Known or suspected immune deficiency or suppression.
• 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 (8)

Nirmal Hospital Pvt Ltd.

Surat, Gujarat, 395002, India

Location

BGS Global Institute of Medical Sciences (BGSGIMS)

Bangalore, Karnataka, 560060, India

Location

RajaRajeswari Medical College and Hospital

Bangalore, Karnataka, 560074, India

Location

RajaRajeswari Medical College and Hospital

Bengaluru, Karnataka, 560074, India

Location

Bharati Vidyapeeth (Deemed to be University) Medical College Hospital & Research Centre

Pune, Maharashtra, 411043, India

Location

Aakash Healthcare Private Limited

New Delhi, National Capital Territory of Delhi, 110075, India

Location

Jawahar Lal Nehru Hospital

Ajmer, Rajasthan, 305001, India

Location

Jawahar Lal Nehru Medical College

Ajmer, Rajasthan, 305001, India

Location

Related Publications (1)

• Giriappa B, Choraria N, Ponce P, Drozd J, Su X, Lei L, Portka M, Pai S, Anderson A, Bickham K, Watson W, McElwee K. Immunogenicity and safety of 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naive adults >/=18 years of age in India: A phase 3 single-arm trial. Hum Vaccin Immunother. 2026 Dec;22(1):2605847. doi: 10.1080/21645515.2025.2605847. Epub 2026 Jan 7.

  PMID: 41504209 DERIVED

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 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be assigned into 2 cohorts by age: 18 to 49 years of age and ≥50 years of age.

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: August 16, 2023
• Primary Completion: October 2, 2023
• Study Completion: October 2, 2023
• Last Updated: October 24, 2024
• Results First Posted: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

IN (8)