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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05767606
Acronym
NVX_PCV20
Enrollment
256
Registered
2023-03-14
Start date
2023-03-31
Completion date
2023-08-31
Last updated
2023-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19, Pneumococcal Infections

Brief summary

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.

Interventions

BIOLOGICALNVX

Administration of NVX

BIOLOGICALPCV20

Administration of PCV20

BIOLOGICALPlacebo

No intervention

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
ImmunogenicityDay 28Antibody levels

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026