Phase 4
N=200
A Study to Describe the Safety of a Vaccine (Called 13vPnC) in Healthy People 18 to 49 Years of Age in India
Pneumococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT05329259 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Percentage of Participants With Prompted Local Reactions Within 7 Days After Vaccination — 1.5; 6.5; 63.0 Percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 13-valent pneumococcal conjugate vaccine (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Prompted Local Reactions Within 7 Days After Vaccination |
1.5; 6.5; 63.0 | — |
| PRIMARY Percentage of Participants With Prompted Systemic Events Within 7 Days After Vaccination |
3.0; 25.0; 23.0; 7.5; 32.0 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination |
0.5 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) Within 1 Month After Vaccination |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05329259). 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.