COVID-19Phase 2/3CICNCT06482359
Lot Consistency Study of COVID-19 and Influenza Combination Vaccine
A Phase 2/3 study testing coformulated CIC Vaccine and Fluzone HD trivalent in people with COVID-19 and Influenza, run by Novavax.
Trial summary
The goal of Phase 3 Study is Comparing the Safety and Immune Response of Three Batches of a COVID-19 and Flu Combination Vaccine in Seniors Aged 65+ Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- What is being tested?
- coformulated CIC Vaccine and Fluzone HD trivalent
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 17 May 2026
- Phase
- Phase 2/3
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- To be included in this study, each individual must satisfy all the following criteria:
- Willing and able to give informed consent prior to study enrollment.
- Medically stable adult male or female ≥ 60 years of age at Screening.
- Participants may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by:
- Absence of changes in medical therapy in the past 2 months due to treatment failure or toxicity.
- Absence of medical events qualifying as SAEs within 3 months; and
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- Absence of known, current, and life-limiting diagnoses which render survival to completion of the protocol unlikely in the opinion of the Investigator.
- The participant has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at Screening.
- Participant must be able to receive an injection in the deltoid of either arm.
- Able to attend study visits, comply with study requirements, and provide reliable and complete reports of AEs.
- Participants must have completed a primary vaccination series/booster against SARS-CoV-2 with an authorized/approved COVID-19 vaccine, with receipt of last dose of authorized/approved vaccine (with or without boosters[s]) ≥ 8 weeks prior to vaccination.
- Participants must agree to not participate in any other SARS-CoV-2 or influenza prevention or treatment studies for the duration of the study.
Who cannot join
- If an individual meets any of the following criteria, he or she is ineligible for this study:
- History of laboratory-confirmed (by polymerase chain reaction [PCR] or rapid antigen test) COVID-19 or asymptomatic SARS-CoV-2 infection; either occurring ≤ 8 weeks prior to Screening.
- Any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness that required substantive changes in medication in the past 2 months prior to Screening indicating that chronic illness/disease is not stable (at the discretion of the Investigator). This includes any current workup of undiagnosed illness that could lead to a new condition.
- Serious chronic diseases inclusive of:
- Uncontrolled hypertension;
- Congestive heart failure requiring hospitalization within 3 months prior to Screening;
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- Chronic obstructive pulmonary disease (COPD) requiring hospitalization within 3 months prior to Screening;
- Within 3 months prior to Screening, evidence of unstable coronary artery disease as manifested by cardiac interventions (e.g., cardiac stent placement, coronary artery bypass graft surgery), new cardiac medications for control of symptoms, or unstable angina.
- Hospitalization for diabetic ketoacidosis within 6 months prior to Screening
- Chronic kidney disease/renal requiring institution of substantive new therapy within 3 months prior to Screening
- Chronic clinically significant gastrointestinal and hepatic diseases requiring hospitalization or institution of substantive new therapy within 3 months prior to Screening.
- Chronic neurological diseases or neurological compromise preventing access to the study clinic, compliance with protocol, or accurate reporting of safety.
- Participation in research involving an investigational product (drug/biologic/device) within 90 days before planned date of vaccination.
- Use of COVID-19 prophylactic or treatment monoclonal antibodies or antibody cocktails within 90 days prior to planned date of vaccination.
- History of a serious reaction to a prior influenza vaccination or known allergy to constituents of influenza vaccines - including egg proteins - or polysorbate 80; or any known allergies to products contained in the investigational product.
- Any history of anaphylaxis to any prior vaccine.
- History of Guillain-Barré Syndrome within 6 weeks following a previous influenza vaccine.
- Receipt of any vaccine in the 4 weeks preceding the study vaccination and any influenza vaccine within 2 months preceding the study vaccination. Note: Routine vaccinations will not be allowed until after study Day 28 and COVID-19 and influenza vaccination will not be allowed until after Day 28.
- Any known or suspected autoimmune or immunosuppressive illness, congenital or acquired, based on medical history and/or physical examination.
- Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccines. An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids is permitted.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
- Active cancer (malignancy) therapy within 1 year prior to study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo malign and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the Investigator).
- Women of childbearing potential (defined as any female participant who is NOT surgically sterile [i.e., hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months].
- Suspected or known history of alcohol abuse or drug addiction within 2 years prior to study vaccination, which in the opinion of the Investigator, might interfere with protocol compliance.
- Acute disease at the time of enrollment (defined as the presence of a moderate or severe illness with or without fever, or an oral temperature ≥ 38.0°C, on the planned day of vaccine administration).
- History of myocarditis or pericarditis.
- Any condition that in the opinion of the Investigator would pose a health risk to the participant if enrolled or could interfere with evaluation of the vaccine or interpretation of study results (including neurologic or psychiatric conditions deemed likely to impair the quality of safety reporting).
- Study team member or immediate family member of any study team member (inclusive of Sponsor, contract research organization [CRO], and study site personnel involved in the conduct or planning of the study).
About this study
Official title: A Phase 3, Randomized, Observer-Blinded, Study to Compare the Safety and Immunogenicity of 3 Lots of SARS-CoV-2 rS Nanoparticle and Trivalent Hemagglutinin Nanoparticle Influenza Combination Vaccine With Matrix M™ Adjuvant in Participants ≥ 65 Years of Age
The goal of Phase 3 Study is Comparing the Safety and Immune Response of Three Batches of a COVID-19 and Flu Combination Vaccine in Seniors Aged 65+
Read the detailed description
This is a randomized, Phase 3 study comparing the safety and immunogenicity of 3 different lots of Novavax coronavirus disease 2019 (COVID-19) and influenza combination (CIC) vaccine in terms of wild-type influenza hemagglutinin inhibition (HAI) antibody responses to 3 vaccine-homologous influenza strains (i.e., 2 influenza A strains and an influenza B-Victoria lineage strain) and 1 IM dose of Fluzone HD in terms of the neutralizing antibody (NAb) responses to the homologous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strain.
- Being tested
- coformulated CIC Vaccine, Fluzone HD trivalent
- Keywords
- COVID-19, Influenza
- Medical subject headings
- COVID-19, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coformulated CIC VaccineBiological
Also called SARS-CoV-2 rS, tNIV, Matrix-M adjuvant
SARS-CoV-2 rS (35 µg) + trivalent hemagglutinin nanoparticle influenza (tNIV) antigen (180 µg; 60 µg per strain) + Matrix-M adjuvant (75 µg)
Fluzone HD trivalentBiological
60 µg per strain of 3 strains (sodium phosphate buffered isotonic sodium chloride solution + formaldehyde and octyl phenol ethoxylate)
| Study group | Role | What they receive |
|---|---|---|
| Lot 1 (Group 1) | Active comparator | CIC vaccine will be administered as a single 0.5 mL IM injection in the deltoid on Day 0 Receives: Biological: coformulated CIC Vaccine |
| Lot 2 (Group 2) | Active comparator | CIC vaccine will be administered as a single 0.5 mL IM injection in the deltoid on Day 0 Receives: Biological: coformulated CIC Vaccine |
| Lot 3 (Group 3) | Active comparator | CIC vaccine will be administered as a single 0.5 mL IM injection in the deltoid on Day 0 Receives: Biological: coformulated CIC Vaccine |
| Fluzone HD | Active comparator | Fluzone HD trivalent will be administered as a suspension 1M Injection at 0.5mL on Day 0 Receives: Biological: Fluzone HD trivalent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of participants with solicited local and systemic AEs.
Numbers of participants with solicited local and systemic AEs over the 7 days post-vaccination.
Measured: 7 days post-vaccination]
Numbers of participants reporting Unsolicited AEs and medically attended adverse events (MAAEs).
Numbers of participants reporting unsolicited AEs and medically attended adverse events (MAAEs) over 28 days post-vaccination.
Measured: 28 days post-vaccination.
Number of participants with MAAEs, SAEs, AESIs (including [PIMMCs] and myocarditis and/or pericarditis).
Numbers of participants with Medical Attended Adverse Events (MAAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) (including potential immune-mediated medical conditions [PIMMCs] and myocarditis and/or pericarditis).
Measured: 6 months (approximately 182 days) post-vaccination.
Secondary outcomes (8)
Hemagglutination-inhibition (HAI) antibody titers specific for the Hemagglutinin (HA) receptor binding domains of vaccine homologous Influenza A and B strains expressed as Geometric Mean Titer (GMT)
HAI antibody titers specific for the Hemagglutinin (HA) receptor binding domains of vaccine response to immunization of 3 lots of CIC vaccine to 3 vaccine-homologous influenza strains at Days 0 and 28 Expressed as GMT
Measured: Day 0 to Day 28
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A and B strains expressed as Geometric Mean Fold Rise (GMFR)
HAI antibody titers specific for the HA receptor binding domains of vaccine response to immunization of 3 lots of CIC vaccine to 3 vaccine-homologous influenza strains at Days 0 and 28 Expressed as GMFR.
Measured: Day 0 to Day 28
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A and B strains expressed as Geometric Mean Titer Ratio (GMTR)
HAI antibody titers specific for the HA receptor binding domains of vaccine response to immunization of 3 lots of CIC vaccine to 3 vaccine-homologous influenza strains at Days 0 and 28 Expressed as GMTR
Measured: Day 0 to Day 28
HAI antibody Titers specific for the Hemagglutinin (HA) receptor binding domains of vaccine- homologous influenza strains A and B Expressed as Seroconversion Rate (SCR)
HAI antibody titers specific for the HA receptor binding domains of vaccine response to immunization of 3 lots of CIC vaccine to 3 vaccine-homologous influenza strains at Days 0 and 28 Expressed as SCR.
Measured: Day 0 to Day 28
Neutralizing Antibody (NAb)specific to vaccine homologous wild-type influenza strains A and B Expressed as GMT.
Neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, as measured by a neutralization assay CIC vaccine Expressed as GMT
Measured: Day- 0 to 28
Neutralizing Antibody (NAb)specific to vaccine homologous wild-type influenza strains A and B Expressed as GMFR.
Neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, as measured by a neutralization assay CIC vaccine Expressed as GMFR.
Measured: Day- 0 to 28
Number of participants of Neutralizing antibody titers specific to vaccine-matched wild-type A and B influenza strains expressed as GMTR.
Neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, as measured by a neutralization assay CIC vaccine Expressed as GMTR
Measured: Day- 0 to 28
Percentage of Participants with a Neutralizing Antibody (NAb)specific to vaccine homologous wild-type influenza strains A and B expressed as SCR.
Neutralizing antibody titers specific to vaccine homologous wild-type A and B influenza strains, as measured by a neutralization assay CIC vaccine Expressed as SCR
Measured: Day- 0 to 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Feb 2025
- Primary completion16 Nov 2025 (estimated)
- Study completion17 May 2026 (estimated)
Why it stopped: It was decided to not move forward with the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novavax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482359
- Sponsor's protocol ID
- CIC-E-303
- Acronym
- CIC
- Status last verified
- Mar 2025
- First submitted
- 27 Jun 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Observer-Blinded, Study to Compare the Safety and Immunogenicity of 3 Lots of SARS-CoV-2 rS Nanoparticle and Trivalent Hemagglutinin Nanoparticle Influenza Combination Vaccine With Matrix M™ Adjuvant in Participants ≥ 65 Years of Age
- ClinicalTrials.gov ID
- NCT06482359
- Acronym / sponsor ID
- CIC / CIC-E-303
- Keywords
- COVID-19, Influenza
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was decided to not move forward with the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NovavaxIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 16 Nov 2025 (estimated)
- Study completion
- 17 May 2026 (estimated)
- First posted
- 1 Jul 2024 (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.
The goal of Phase 3 Study is Comparing the Safety and Immune Response of Three Batches of a COVID-19 and Flu Combination Vaccine in Seniors Aged 65+
Detailed description
This is a randomized, Phase 3 study comparing the safety and immunogenicity of 3 different lots of Novavax coronavirus disease 2019 (COVID-19) and influenza combination (CIC) vaccine in terms of wild-type influenza hemagglutinin inhibition (HAI) antibody responses to 3 vaccine-homologous influenza strains (i.e., 2 influenza A strains and an influenza B-Victoria lineage strain) and 1 IM dose of Fluzone HD in terms of the neutralizing antibody (NAb) responses to the homologous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lot 1 (Group 1) | Active comparator | Biological: coformulated CIC VaccineCIC vaccine will be administered as a single 0.5 mL IM injection in the deltoid on Day 0 |
| Lot 2 (Group 2) | Active comparator | Biological: coformulated CIC VaccineCIC vaccine will be administered as a single 0.5 mL IM injection in the deltoid on Day 0 |
| Lot 3 (Group 3) | Active comparator | Biological: coformulated CIC VaccineCIC vaccine will be administered as a single 0.5 mL IM injection in the deltoid on Day 0 |
| Fluzone HD | Active comparator | Biological: Fluzone HD trivalentFluzone HD trivalent will be administered as a suspension 1M Injection at 0.5mL on Day 0 |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- Willing and able to give informed consent prior to study enrollment.
- Medically stable adult male or female ≥ 60 years of age at Screening.
- Participants may have 1 or more chronic medical diagnoses, but should be clinically stable as assessed by:
- The participant has a body mass index (BMI) of 17 to 40 kg/m2, inclusive, at Screening.
- Participant must be able to receive an injection in the deltoid of either arm.
Key exclusion criteria (28 listed)
- If an individual meets any of the following criteria, he or she is ineligible for this study:
- History of laboratory-confirmed (by polymerase chain reaction [PCR] or rapid antigen test) COVID-19 or asymptomatic SARS-CoV-2 infection; either occurring ≤ 8 weeks prior to Screening.
- Any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness that required substantive changes in medication in the past 2 months prior to Screening indicating that chronic illness/disease is not stable (at the discretion of the Investigator). This includes any current workup of undiagnosed illness that could lead to a new condition.
- Serious chronic diseases inclusive of:
- Participation in research involving an investigational product (drug/biologic/device) within 90 days before planned date of 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 |
|---|---|---|
| coformulated CIC VaccineAlso: SARS-CoV-2 rS, tNIV, Matrix-M adjuvantSARS-CoV-2 rS (35 µg) + trivalent hemagglutinin nanoparticle influenza (tNIV) antigen (180 µg; 60 µg per strain) + Matrix-M adjuvant (75 µg) | Biological | Lot 1 (Group 1), Lot 2 (Group 2), Lot 3 (Group 3) |
| Fluzone HD trivalent60 µg per strain of 3 strains (sodium phosphate buffered isotonic sodium chloride solution + formaldehyde and octyl phenol ethoxylate) | Biological | Fluzone HD |
Primary outcome
Numbers of participants with solicited local and systemic AEs.
Time frame: 7 days post-vaccination]
Numbers of participants with solicited local and systemic AEs over the 7 days post-vaccination.
Numbers of participants reporting Unsolicited AEs and medically attended adverse events (MAAEs).
Time frame: 28 days post-vaccination.
Numbers of participants reporting unsolicited AEs and medically attended adverse events (MAAEs) over 28 days post-vaccination.
Number of participants with MAAEs, SAEs, AESIs (including [PIMMCs] and myocarditis and/or pericarditis).
Time frame: 6 months (approximately 182 days) post-vaccination.
Numbers of participants with Medical Attended Adverse Events (MAAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) (including potential immune-mediated medical conditions [PIMMCs] and myocarditis and/or pericarditis).
8 secondary outcomes
Hemagglutination-inhibition (HAI) antibody titers specific for the Hemagglutinin (HA) receptor binding domains of vaccine homologous Influenza A and B strains expressed as Geometric Mean Titer (GMT)
Time frame: Day 0 to Day 28
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A and B strains expressed as Geometric Mean Fold Rise (GMFR)
Time frame: Day 0 to Day 28
HAI antibody titers specific for the HA receptor binding domains of vaccine homologous Influenza A and B strains expressed as Geometric Mean Titer Ratio (GMTR)
Time frame: Day 0 to Day 28
HAI antibody Titers specific for the Hemagglutinin (HA) receptor binding domains of vaccine- homologous influenza strains A and B Expressed as Seroconversion Rate (SCR)
Time frame: Day 0 to Day 28
Neutralizing Antibody (NAb)specific to vaccine homologous wild-type influenza strains A and B Expressed as GMT.
Time frame: Day- 0 to 28
Neutralizing Antibody (NAb)specific to vaccine homologous wild-type influenza strains A and B Expressed as GMFR.
Time frame: Day- 0 to 28
Number of participants of Neutralizing antibody titers specific to vaccine-matched wild-type A and B influenza strains expressed as GMTR.
Time frame: Day- 0 to 28
Percentage of Participants with a Neutralizing Antibody (NAb)specific to vaccine homologous wild-type influenza strains A and B expressed as SCR.
Time frame: Day- 0 to 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
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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 2/3 study testing coformulated CIC Vaccine and Fluzone HD trivalent in people with COVID-19 and Influenza, run by Novavax.
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 12 inclusion and 28 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: withdrawn, as of the sponsor's last update on 11 Mar 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Numbers of participants with solicited local and systemic AEs. (time frame: 7 days post-vaccination]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2025.