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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

256 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2023-08-31

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.

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Detailed Description

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Conditions

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COVID-19 Pneumococcal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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NVX arm

NVX plus placebo

Group Type ACTIVE_COMPARATOR

NVX

Intervention Type BIOLOGICAL

Administration of NVX

PCV20 arm

PCV20 (Apexxnar®) plus placebo

Group Type ACTIVE_COMPARATOR

PCV20

Intervention Type BIOLOGICAL

Administration of PCV20

Combination arm

NVX plus PCV20

Group Type EXPERIMENTAL

NVX

Intervention Type BIOLOGICAL

Administration of NVX

PCV20

Intervention Type BIOLOGICAL

Administration of PCV20

Placebo arm

Placebo (normal saline) plus placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

No intervention

Interventions

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NVX

Administration of NVX

Intervention Type BIOLOGICAL

PCV20

Administration of PCV20

Intervention Type BIOLOGICAL

Placebo

No intervention

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes