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

Phase 4

Not yet recruiting

• Conditions: COVID-19; Pneumococcal Infections
• Interventions: Biological: NVX; Biological: Placebo; Biological: PCV20

• Registration Number: NCT05767606
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study Start: 2023-03
• Study First Submitted: 2023-03-02
• Study First Submitted QC: 2023-03-02
• Last Update Submitted: 2023-03-13
• Study First Posted: 2023-03-14
• Last Update Posted: 2023-03-15
• Primary Completion: 2023-07
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 256

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination arm	PCV20	NVX plus PCV20
NVX arm	NVX	NVX plus placebo
PCV20 arm	PCV20	PCV20 (Apexxnar®) plus placebo
Placebo arm	Placebo	Placebo (normal saline) plus placebo
Combination arm	NVX	NVX plus PCV20

Primary Outcome Measures

Name	Time	Method
Immunogenicity	Day 28	Antibody levels