Lot Consistency Study of COVID-19 and Influenza Combination Vaccine

NCT06482359 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: CIC-E-303
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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+

Conditions

COVID-19; Influenza

Keywords

COVID-19; Influenza

Outcome Measures

Primary Outcomes (3)

• Numbers of participants with solicited local and systemic AEs.

  Numbers of participants with solicited local and systemic AEs over the 7 days post-vaccination.

  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.

  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).

  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)

  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)

  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)

  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)

  Day 0 to Day 28

• Neutralizing Antibody (NAb)specific to vaccine homologous wild-type influenza strains A and B Expressed as GMT.

  Day- 0 to 28

Study Arms (4)

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

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

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

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

Biological: Fluzone HD trivalent

Interventions

coformulated CIC Vaccine BIOLOGICAL

SARS-CoV-2 rS (35 µg) + trivalent hemagglutinin nanoparticle influenza (tNIV) antigen (180 µg; 60 µg per strain) + Matrix-M adjuvant (75 µg)

Also known as: SARS-CoV-2 rS, tNIV, Matrix-M adjuvant

Lot 1 (Group 1); Lot 2 (Group 2); Lot 3 (Group 3)

Fluzone HD trivalent BIOLOGICAL

60 µg per strain of 3 strains (sodium phosphate buffered isotonic sodium chloride solution + formaldehyde and octyl phenol ethoxylate)

Fluzone HD

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Novavax: lead

MeSH Terms

Conditions

COVID-19; Influenza, Human

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; Orthomyxoviridae Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 1, 2024
• Study Start: February 1, 2025
• Primary Completion: November 16, 2025
• Study Completion (Estimated): May 17, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03