Phase 3
N=1,796
Safety and Immunogenicity of 20vPnC Coadministered With SIIV in Adults ≥65 Years of Age
Pneumococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT04526574 ↗Enrolled (actual)
1,796
Serious AEs
3.7%
Results posted
Jul 2022
Primary outcome: Primary: Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC — 6.3; 7.4; 4.0; 3.3 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Experimental 20-valent pneumococcal conjugate vaccine (20vPnC) (Biological); Saline (Other); Influenza vaccine (Biological)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Local Reactions Within 10 Days After Vaccination With 20vPnC |
6.3; 7.4; 4.0; 3.3; 2.1; 3.3 | — |
| PRIMARY Percentage of Participants With Systemic Events Within 7 Days After Each Vaccination By Each Vaccine |
1.5; 0.6; 0.7; 0.5; 0.9; 0.5 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) Within 1 Month After Each Vaccination by Each Vaccine |
9.1; 8.0; 6.3; 8.7 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) From the First Vaccination up to 6 Months After Last Vaccination |
3.7; 3.7 | — |
| PRIMARY Percentage of Participants With Newly Diagnosed Chronic Medical Condition (NDCMC) up to 6 Months After Last Vaccination |
3.8; 3.1 | — |
| PRIMARY Model-Based Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination With 20vPnC |
70; 95; 38; 46; 567; 639 | — |
| PRIMARY Model-Based Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Titers (GMT) at 1 Month After Vaccination With SIIV |
51.9; 48.7; 189.8; 193.4; 68.1; 68.0 | — |
| SECONDARY Percentage of Participants With Greater Than or Equal to (≥4) Fold Rise in Serotype-Specific Opsonophagocytic Activity (OPA) Titers From Before Vaccination to 1 Month After Vaccination With 20vPnC |
32.9; 42.0; 31.1; 39.7; 45.3; 48.5 | — |
| SECONDARY Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination With 20vPnC |
3.0; 4.0; 2.5; 3.1; 6.2; 7.4 | — |
| SECONDARY Hemagglutination Inhibition (HAI) Strain Specific Geometric Mean Fold Rise (GMFR) Before Vaccination to 1 Month After Vaccination With SIIV |
1.8; 1.8; 2.0; 2.0; 1.7; 1.7 | — |
Summary
Study of the safety and immunogenicity of 20vPnC and influenza vaccine administered at the same visit or separately
Eligibility Criteria
Inclusion Criteria
- Male or female participants ≥65 years of age at the time of consent
- Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease
- Adults who have no history of ever receiving a pneumococcal vaccine, or have a history of receiving a licensed pneumococcal vaccination ≥6 months prior to first study vaccination.
Exclusion Criteria
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis)
- Previous vaccination with any investigational pneumococcal vaccine, or planned receipt of any licensed or investigational pneumococcal vaccine through study participation.
- Vaccination with any influenza or pneumococcal vaccine <6 months before investigational product administration, or planned receipt of any licensed or investigational non-study influenza vaccine during study participation.
-- Serious chronic disorder, that in the investigator's opinion would make the participant inappropriate for entry into the study
- Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results
Data sourced from ClinicalTrials.gov (NCT04526574). 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.