Concomitant Administration of the Novavax Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Adults Aged ≥60 Years

Study Overview
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Brief Summary
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Vaccination is a key strategy for preventing respiratory illnesses. Pneumococcal vaccination is recommended for all adults aged over 60 or 65 years (depending local guidelines) who have never received a pneumococcal vaccine or whose previous vaccination history is unknown. 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 Novavax (NVX) vaccine and a 20-valent pneumococcal conjugate vaccine (PCV20) results in lower immunogenicity than the administration of either alone. The investigators will thus conduct a 4-four arm study with the following treatments: NVX plus placebo (NVX arm), PCV20 plus placebo group (PCV20 arm), NVX plus PCV20 (Combination arm), and placebo plus placebo group (Placebo arm). Vaccines and/or placebo will be administered as single doses, given as intramuscular injections on Day 1 (one in each shoulder). Subjects will be randomly assigned to one of the four arms. The outcome will be the antibody levels after 28 days.

Official Title
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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

Conditions
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COVID-19, Pneumococcal Infections

Intervention / Treatment
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* Biological: NVX
* Biological: PCV20
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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 three Covid-19 vaccines, of which the third was a mRNA vaccine (BNT162b2 or mRNA-1273) and at least 16 weeks ago Only applicable for women: last menstrual bleeding more than one year ago 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 History of Covid-19 within 16 weeks before study vaccination Previous pneumococcal vaccination Contraindication against any ingredient of the NVX or the PCV20 vaccine

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NVX arm<br>NVX plus placebo | Biological: NVX<br>* Administration of NVX<br>|
| Active Comparator: PCV20 arm<br>PCV20 (Apexxnar®) plus placebo | Biological: PCV20<br>* Administration of PCV20<br>|
| Experimental: Combination arm<br>NVX plus PCV20 | Biological: NVX<br>* Administration of NVX<br>Biological: PCV20<br>* Administration of PCV20<br>|
| Placebo Comparator: Placebo arm<br>Placebo (normal saline) plus placebo | Biological: Placebo<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity | Antibody levels | Day 28 |