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

NCT05767606 | Unknown Phase 4 FDA Drug

• 1 other identifier: NVX_PCV20_V2.1
• Study Type: interventional
• Target: 256
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19; Pneumococcal Infections

Outcome Measures

Primary Outcomes (1)

• Immunogenicity

  Antibody levels

  Day 28

Study Arms (4)

NVX arm

ACTIVE COMPARATOR

NVX plus placebo

Biological: NVX

PCV20 arm

ACTIVE COMPARATOR

PCV20 (Apexxnar®) plus placebo

Biological: PCV20

Combination arm

EXPERIMENTAL

NVX plus PCV20

Biological: NVX; Biological: PCV20

Placebo arm

PLACEBO COMPARATOR

Placebo (normal saline) plus placebo

Biological: Placebo

Interventions

NVX BIOLOGICAL

Administration of NVX

Combination arm; NVX arm

PCV20 BIOLOGICAL

Administration of PCV20

Combination arm; PCV20 arm

Placebo BIOLOGICAL

No intervention

Placebo arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Related Publications (1)

• 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.

  PMID: 39756693 DERIVED

MeSH Terms

Conditions

COVID-19; Pneumococcal Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 14, 2023
• Study Start: March 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: August 1, 2023
• Last Updated: March 15, 2023

Record last verified: 2023-03