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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVX arm | Active Comparator | NVX plus placebo |
|
| PCV20 arm | Active Comparator | PCV20 (Apexxnar®) plus placebo |
|
| Combination arm | Experimental | NVX plus PCV20 |
|
| Placebo arm | Placebo Comparator | Placebo (normal saline) plus placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVX | Biological | Administration of NVX |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Antibody levels | Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39756693 | Derived | Jorda A, Prager M, Pracher L, Haselwanter P, Jackwerth M, Al Jalali V, Yildiz E, Leutzendorff A, Weber M, Yourieva S, Kammerer P, Pecho T, Decaminada A, Ederer L, Wiedermann U, Weseslindtner L, Redlberger-Fritz M, Bergmann F, Zeitlinger M. Immunogenicity, safety, and reactogenicity of concomitant administration of the novavax vaccine against Omicron XBB.1.5 (NVX-CoV2601) and a 20-valent pneumococcal conjugate vaccine in adults aged >/=60 years: A randomised, double-blind, placebo-controlled, non-inferiority trial. J Infect. 2025 Feb;90(2):106405. doi: 10.1016/j.jinf.2024.106405. Epub 2025 Jan 3. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| PCV20 |
| Biological |
Administration of PCV20 |
|
| Placebo | Biological | No intervention |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |