WithdrawnPhase 2/3

Lot Consistency Study of COVID-19 and Influenza Combination Vaccine

Stopped: It was decided to not move forward with the study.

0Started 2025-02-01

Plain-language 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+

Age range65 Years – 85 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.

✓. 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 either arm.

✕. 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;
✕. 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

Numbers of participants with solicited local and systemic AEs.

Timeframe: 7 days post-vaccination]

Numbers of participants reporting Unsolicited AEs and medically attended adverse events (MAAEs).

Timeframe: 28 days post-vaccination.

Number of participants with MAAEs, SAEs, AESIs (including [PIMMCs] and myocarditis and/or pericarditis).

Timeframe: 6 months (approximately 182 days) post-vaccination.

NCT IDNCT06482359

SponsorNovavax

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-16

Who can participate