COVID-19Phase 4NVX_PCV20NCT05767606
Concomitant Administration of the Novavax Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Adults Aged ≥60 Years
A Phase 4 study testing NVX and PCV20 in people with COVID-19 and Pneumococcal Infections, run by Medical University of Vienna.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Pneumococcal Infections
- What is being tested?
- NVX and PCV20
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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
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
- Being tested
- NVX, PCV20, Placebo
- Medical subject headings
- COVID-19, Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVXBiological
Administration of NVX
PCV20Biological
Administration of PCV20
PlaceboBiological
No intervention
| Study group | Role | What they receive |
|---|---|---|
| NVX arm | Active comparator | NVX plus placebo Receives: Biological: NVX |
| PCV20 arm | Active comparator | PCV20 (Apexxnar®) plus placebo Receives: Biological: PCV20 |
| Combination arm | Experimental | NVX plus PCV20 Receives: Biological: NVX; Biological: PCV20 |
| Placebo arm | Placebo comparator | Placebo (normal saline) plus placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity
Antibody levels
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study startMar 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus Zeitlinger, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767606
- Sponsor's protocol ID
- NVX_PCV20_V2.1
- Acronym
- NVX_PCV20
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39756693
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05767606
- Acronym / sponsor ID
- NVX_PCV20 / NVX_PCV20_V2.1
- Conditions
- COVID-19, Pneumococcal Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NVX arm | Active comparator | Biological: NVXNVX plus placebo |
| PCV20 arm | Active comparator | Biological: PCV20PCV20 (Apexxnar®) plus placebo |
| Combination arm | Experimental | Biological: NVX, Biological: PCV20NVX plus PCV20 |
| Placebo arm | Placebo comparator | Biological: PlaceboPlacebo (normal saline) plus placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NVXAdministration of NVX | Biological | Combination arm, NVX arm |
| PCV20Administration of PCV20 | Biological | Combination arm, PCV20 arm |
| PlaceboNo intervention | Biological | Placebo arm |
Primary outcome
Immunogenicity
Time frame: Day 28
Antibody levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Derived from this study: PubMed 39756693Jorda 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NVX and PCV20 in people with COVID-19 and Pneumococcal Infections, run by Medical University of Vienna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05767606, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.