EUCTR2022-004118-12-AT
Active, not recruiting
Phase 1
Safety and immunogenicity of concomitant administration of the Novavax vaccine and a 20-valent pneumococcal conjugate vaccine in adults aged =60 years: a four-arm, double-blind, non-inferiority trial - NVX_PCV20
ConditionsVaccination is a key strategy for preventing respiratory illnesses. Pneumococcal vaccination is recommended for all adults (age >60 years). Given their wide application, co-administration of pneumococcal and Covid-19 vaccines may support broad population-wide coverage. However, it is unclear whether the co-administration of the new, Omicron-adapted Novavax (NVX XBB.1.5) vaccine and a 20-valent pneumococcal conjugate vaccine results in lower immunogenicity than the administration of either alone.Therapeutic area: Body processes [G] - Immune system processes [G12]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Vaccination is a key strategy for preventing respiratory illnesses. Pneumococcal vaccination is recommended for all adults (age >60 years). Given their wide application, co-administration of pneumococcal and Covid-19 vaccines may support broad population-wide coverage. However, it is unclear whether the co-administration of the new, Omicron-adapted Novavax (NVX XBB.1.5) vaccine and a 20-valent pneumococcal conjugate vaccine results in lower immunogenicity than the administration of either alone.
- Sponsor
- Medical University of Vienna
- Enrollment
- 256
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: 60 years or older
- •Males and females
- •Able and willing (in the investigator's opinion) to comply with all study requirements.
- •Participants, who already received at least two Covid\-19 vaccines, of which the last was an mRNA vaccine (BNT162b2 or mRNA\-1273\) and at least 12 weeks ago
- •Only applicable for women: last menstrual bleeding more than one year ago
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 80
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •Use of immunosuppressants
- •Congenital or acquired immunodeficiency (eg, history of HIV infection, hematological disease, current malignancy, or others)
- •Chronic condition that may significantly interfere with the immune response in the opinion of the investigator
- •Any unstable medical condition, as assessed by the investigator
- •History of Covid\-19 within 16 weeks before study vaccination
- •Pneumococcal vaccination within the past 6 months
- •Contraindication against any ingredient of the NVX XBB.1\.5 or the PCV20 vaccine
Outcomes
Primary Outcomes
Not specified
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