WithdrawnPhase 2/3

Phase 3 Lot Consistency Study of Trivalent Hemagglutinin Nanoparticle Influenza Vaccine

Stopped: Decided to not move forward with the study

0Started 2024-11

Plain-language summary

Phase 3 Study Comparing Safety and Immune Response of Three Batches of Novavax Flu Vaccine in older adult participants

Who can participate

Age range60 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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
✓. 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 at least one arm.

Exclusion criteria

✕. 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 (NOTE: hypertension ≤ 170/100 is NOT exclusionary);
✕. Congestive heart failure requiring hospitalization within 3 months prior to Screening (NOTE: stable congestive heart failure is NOT exclusionary);
✕. Chronic obstructive pulmonary disease (COPD) requiring hospitalization within 3 months prior to Screening (NOTE: stable COPD is NOT exclusionary);
✕. Within 3 months prior to Screening, evidence of unstable coronary artery disease as manifested by cardiac interventions (eg, cardiac stent placement, coronary artery bypass graft surgery), new cardiac medications for control of symptoms, or unstable angina (NOTE: stable coronary heart disease is NOT exclusionary);
✕. 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

What they're measuring

Safety- Solicited AEs over 7 days post-vaccination

Timeframe: 7 days post-vaccination

Safety- Unsolicited AEs and MAAEs over 28 days post-vaccination

Timeframe: Day 0 to 28

Safety-Treatment-related MAAEs, SAEs, and AESIs (including PIMMC)

Timeframe: Day-0 to 182

Immunogenicity-HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMT

Timeframe: Day-0 to 28

Immunogenicity-HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMTR

Timeframe: Day-0 to 28

Trial details

NCT IDNCT06485752

SponsorNovavax

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-04

View on ClinicalTrials.gov More COVID-19 trials

Who can participate

Age range60 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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
✓. 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 at least one arm.

Exclusion criteria

✕. 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 (NOTE: hypertension ≤ 170/100 is NOT exclusionary);
✕. Congestive heart failure requiring hospitalization within 3 months prior to Screening (NOTE: stable congestive heart failure is NOT exclusionary);
✕. Chronic obstructive pulmonary disease (COPD) requiring hospitalization within 3 months prior to Screening (NOTE: stable COPD is NOT exclusionary);
✕. Within 3 months prior to Screening, evidence of unstable coronary artery disease as manifested by cardiac interventions (eg, cardiac stent placement, coronary artery bypass graft surgery), new cardiac medications for control of symptoms, or unstable angina (NOTE: stable coronary heart disease is NOT exclusionary);
✕. 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

What they're measuring

Safety- Solicited AEs over 7 days post-vaccination

Timeframe: 7 days post-vaccination

Safety- Unsolicited AEs and MAAEs over 28 days post-vaccination

Timeframe: Day 0 to 28

Safety-Treatment-related MAAEs, SAEs, and AESIs (including PIMMC)

Timeframe: Day-0 to 182

Immunogenicity-HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMT

Timeframe: Day-0 to 28

Immunogenicity-HAI antibody titers specific for the HA receptor binding domains of vaccine homologous A and B influenza strains Expressed as GMTR

Timeframe: Day-0 to 28