Concomitant administration of the Novavax vaccine and a 20-valent pneumococcal conjugate vaccine in adults aged =60 years
- 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.Therapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2022-004118-12-AT
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 256
• 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
F.1.3.1 Number of subjects for this age range 176
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate whether the combined administration of NVX XBB.1.5 with a PCV20 is non-inferior to the administration of the NVX vaccine alone in<br>terms of immunogenicity, as determined by anti-RBD antibody levels at day 28.;Secondary Objective: I. To investigate whether the combined administration of new Novavax with a 20-valent pneumococcal vaccine is non-inferior to the administration of the pneumococcal vaccine alone in terms of immunogenicity, as determined by serotype-specific opsonophagocytic antibody titers (OPA titers).<br>II. To compare the local and systemic reactogenicity following combined or separated administration of the two vaccines<br>;Primary end point(s): •Anti-RBD antibody levels (BAU/mL) at Day 28 ;Timepoint(s) of evaluation of this end point: The primary outcome of this study will be the comparison of anti-RBD antibody titers (BAU/ml) at 28 days after vaccination between the NVX arm and the Combination arm.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): •Opsonophagocytic antibody titers (OPA titers) at Day 28<br>•Relative increase of Anti-RBD antibody levels (GMR)<br>•Relative increase in OPA titers (GMR)<br>•Proportion (%) of participants with serotype-specific OPA response (increase in OPA by =4-times)<br>•Relative increase of serotype-specific opsonophagocytic antibody titers (OPA titers) (GMR)<br>•PCR-confirmed SARS-CoV-2 infection<br>•Microbiologically confirmed Pneumococcal infection<br>;Timepoint(s) of evaluation of this end point: Day 28<br>