Phase 1
N=394
Safety and Immunogenicity of Pneumococcal Conjugate Formulations in Healthy Adults 18 Through 49 Years of Age
Pneumococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT05489328 ↗Enrolled (actual)
394
Serious AEs
0.3%
Results posted
Apr 2024
Primary outcome: Primary: Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention — 0.0; 0.0; 0.0; 2.3 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Candidate-1 (Other); Candidate-2 (Other); Candidate-3 (Other); Candidate-4 (Other); Candidate-5 (Other); Candidate-6 (Other); Candidate Control (Other); 13vPnC (Biological); PCV15 (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Local Reactions Within 7 Days After Administration of Study Intervention |
0.0; 0.0; 0.0; 2.3; 2.2; 4.3 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Administration of Study Intervention |
0.0; 0.0; 0.0; 0.0; 2.2; 4.3 | — |
| PRIMARY Percentage of Participants With Adverse Events (AE) Within 1 Month After Administration of Study Intervention |
2.4; 4.8; 5.1; 0.0; 8.9; 4.3 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (SAE) Within 1 Month After Administration of Study Intervention |
0.0; 0.0; 0.0; 0.0; 2.2; 0.0 | — |
| SECONDARY Serotype Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Administration of Study Intervention From Each Candidate and Candidate Control Group |
231; 428; 350; 354; 324; 536 | — |
Summary
The purpose of the study is to describe the safety and immunogenicity of Pneumococcal Conjugate Formulations in healthy adults 18 through 49 years of age.
Eligibility Criteria
Inclusion Criteria
- Male or female participants ≥18 and ≤49 years of age at the time of consent
- Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks before receipt of study intervention
- Participants willing to use acceptable contraception for at least 28 days after study intervention; female participants not of childbearing potential; male participants unable to father children
Exclusion Criteria
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component in pneumococcal conjugate vaccines and any other diphtheria toxoid-containing vaccine
- Serious chronic disorder that in the investigator's opinion would make the participant inappropriate for entry into the study
- Medical or psychiatric condition (recent or active suicidal ideation/behavior or laboratory abnormality) that may increase risk of study participation or make participant inappropriate for the study
- Known or suspected immunodeficiency or other conditions associated with immunosuppression
- Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation
- Receipt of any inactivated or otherwise nonlive vaccine within 14 days or any live vaccine within 28 days before administration of study intervention
Data sourced from ClinicalTrials.gov (NCT05489328). 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.