Phase 3 N=400 Prevention

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

Pneumococcal Disease

Bottom Line

View on ClinicalTrials.gov: NCT05875727 ↗

Enrolled (actual)

400

Serious AEs

0.0%

Results posted

Oct 2024

Primary outcome: Primary: Percentage of Participants With Local Reactions Within 7 Days After Vaccination — 1.0; 1.0; 0.0; 0.5 Percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 20-valent pneumococcal conjugate vaccine (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Oct 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Vaccination	1.0; 1.0; 0.0; 0.5; 0.5; 0.5	—
PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Vaccination	3.0; 1.5; 1.5; 0.5; 0; 1.0	—
PRIMARY Percentage of Participants With Adverse Events (AEs) From Vaccination to 1 Month After Vaccination	1.5; 3.0	—
PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination to 1 Month After Vaccination	0; 0	—
SECONDARY Geometric Mean Fold Rise (GMFR) of Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination	24.3; 17.1; 8.9; 8.8; 15.2; 42.6	—

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.

Eligibility Criteria

Inclusion Criteria

Generally healthy participants ≥18 years of age at the time of consent.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05875727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.