A Study to Evaluate the Safety and Immunogenicity of COVID-19 and Influenza Combination Vaccine

NCT05519839 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 2019nCoV-CIC-E-201
• Study Type: interventional
• Target: 1,579
• Locations: 2 countries
• Sites: 35

Brief Summary

This is a randomized, observer-blinded, Phase 2 study evaluating the safety and immunogenicity of a severe acute respiratory syndrome coronavirus 2 (SARSCoV2) recombinant spike (rS) (SARS-CoV-2 rS) nanoparticle and quadrivalent hemagglutinin (HA) nanoparticle influenza vaccine (qNIV) combination vaccine with Matrix-M™ adjuvant; this combination vaccine.

Conditions

COVID-19; Influenza

Keywords

Coronavirus; Influenza

Outcome Measures

Primary Outcomes (3)

• Part 1 and Part 2 : Number of participants with solicited local and systemic Adverse Events (AEs)

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

  Day 0 to Day 7

• Part 1 and Part 2 : Percentage of participants with all AEs

  Proportions of participants reporting all AEs, solicited and unsolicited, over 21 days post-vaccination.

  Day 0 to Day 21

• Part 1 and Part 2 : Percentage of participants with Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs) and Serious Adverse Events (SAEs)

  Proportions of participants with MAAEs, AESIs (including PIMMCs and myocarditis and/or pericarditis), SAEs, will be collected for 6 months (approximately 182 days) post-vaccination

  Day 0 to Day 182

Secondary Outcomes (17)

• Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Geometric Mean Titer (GMT)

  Day 0 to Day 84

• Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Geometric Mean Fold Rise (GMFR)

  Day 0 to Day 84

• Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Seroconversion Rate (SCR)

  Day 0 to Day 84

• Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Seroprotection Rate (SPR)

  Day 0 to Day 84

• Part 1 and Part 2 : Hemagglutination Inhibition (HAI) Titers Specific for Vaccine Homologous A and B Influenza Strain(s) and Antigenically Drifted Influenza Strains Expressed as Geometric Mean Titer Ratio (GMTR)

  Day 0 to Day 84

Study Arms (22)

Group A (Part 1)

EXPERIMENTAL

CIC Vaccine Formulation1. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70

Drug: CIC Vaccine with Matrix-M Adjuvant

Group B (Part 1)

EXPERIMENTAL

CIC Vaccine Formulation 2. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70

Drug: CIC Vaccine with Matrix-M Adjuvant

Group C (Part 1)

EXPERIMENTAL

CIC Vaccine Formulation 3. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70

Drug: CIC Vaccine with Matrix-M Adjuvant

Group D (Part 1)

EXPERIMENTAL

CIC Vaccine Formulation 3. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70

Drug: CIC Vaccine with Matrix-M Adjuvant

Group E (Part 1)

EXPERIMENTAL

CIC Vaccine Formulation 1. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70

Drug: CIC Vaccine with Matrix-M Adjuvant

Group F (Part 1)

EXPERIMENTAL

CIC Vaccine Formulation 2. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70

Drug: CIC Vaccine with Matrix-M Adjuvant

Group G (Part 1)

EXPERIMENTAL

CIC Vaccine Formulation 3. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70

Drug: CIC Vaccine with Matrix-M Adjuvant

Group H (Part 1)

EXPERIMENTAL

CIC Vaccine Formulation 4. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70

Drug: CIC Vaccine with Matrix-M Adjuvant

Group I (Part 1)

EXPERIMENTAL

CIC Vaccine Formulation 5. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70

Drug: CIC Vaccine with Matrix-M Adjuvant

Group J (Part 1)

EXPERIMENTAL

CIC Vaccine Formulation 6. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70

Drug: CIC Vaccine with Matrix-M Adjuvant

Group K (Part 1)

EXPERIMENTAL

CIC Vaccine Formulation 7. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70

Drug: CIC Vaccine with Matrix-M Adjuvant

Group L (Part 1)

EXPERIMENTAL

qNIV Vaccine Formulation 1. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70

Drug: qNIV Vaccine with Matrix-M Adjuvant

Group M (Part 1)

EXPERIMENTAL

qNIV Vaccine Formulation 2. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70

Drug: qNIV Vaccine with Matrix-M Adjuvant

Group N (Part 1)

EXPERIMENTAL

qNIV Vaccine Formulation 3 . 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70

Drug: qNIV Vaccine with Matrix-M Adjuvant

Group O (Part 1)

EXPERIMENTAL

SARS-CoV-2 rS Vaccine Formulation 1. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70

Drug: SARS-CoV-2 rS Vaccine with Matrix-M Adjuvant

Group P (Part 1)

EXPERIMENTAL

SARS-CoV-2 rS Vaccine Formulation 2. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70

Drug: SARS-CoV-2 rS Vaccine with Matrix-M Adjuvant

Group Q (Part 1)

EXPERIMENTAL

SARS-CoV-2 rS Vaccine Formulation 3. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70

Drug: SARS-CoV-2 rS Vaccine with Matrix-M Adjuvant

Group R (Part 1)

EXPERIMENTAL

SARS-CoV-2 rS Vaccine Formulation 4. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70

Drug: SARS-CoV-2 rS Vaccine with Matrix-M Adjuvant

Group S (Part 1)

EXPERIMENTAL

Influenza Vaccine Formulation 1. 1 intramuscular (IM) doses of vaccine, on Day 0.

Drug: Influenza Vaccine

Group T (Part 2)

EXPERIMENTAL

CIC Vaccine Formulation 8. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 (if applicable).

Drug: CIC Vaccine with Matrix-M Adjuvant

Group U (Part 2)

EXPERIMENTAL

CIC Vaccine Formulation 9. 2 intramuscular (IM) doses of vaccine, the first on Day 0 and the second on Day 70 (if applicable).

Drug: CIC Vaccine with Matrix-M Adjuvant

Group S (Part 1)-Placebo

PLACEBO COMPARATOR

1 intramuscular (IM) doses of placebo, on Day 70.

Other: Placebo Comparator

Interventions

qNIV Vaccine with Matrix-M Adjuvant DRUG

Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV vaccine given on Day 0 and Day 70 .

Group L (Part 1); Group M (Part 1); Group N (Part 1)

Influenza Vaccine DRUG

Intramuscular (deltoid) injections of Comparator influenza vaccine given on Day 0 and Day 70 (if applicable).

Group S (Part 1)

CIC Vaccine with Matrix-M Adjuvant DRUG

Intramuscular (deltoid) injections of co-formulated mix of various doses and formulations of CIC Vaccine given on Day 0 and Day 70

Group A (Part 1); Group B (Part 1); Group C (Part 1); Group D (Part 1); Group E (Part 1); Group F (Part 1); Group G (Part 1); Group H (Part 1); Group I (Part 1); Group J (Part 1); Group K (Part 1); Group T (Part 2); Group U (Part 2)

Placebo Comparator OTHER

Intramuscular (deltoid) injection of placebo given on Day 70.

Group S (Part 1)-Placebo

SARS-CoV-2 rS Vaccine with Matrix-M Adjuvant DRUG

Intramuscular (deltoid) injections of in-clinic mix of various doses of SARS-CoV-2 rS vaccine given on Day 0 and Day 70 .

Group O (Part 1); Group P (Part 1); Group Q (Part 1); Group R (Part 1)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be included in this study, each individual must satisfy all the following criteria:
• Medically stable adult male or females ≥ 50 to ≤ 80 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.
• Willing and able to give informed consent prior to study enrollment.
• 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 against SARS-CoV-2 with an authorized COVID 19 vaccine (and fulfill national recommendations for his/her age and morbidity category) with receipt of second/last dose of authorized vaccine (with or without boosters\[s\]) ≥ 8 weeks prior to enrollment (first study vaccination).
• Women of childbearing potential (defined as any female participant who is NOT surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea at least 12 consecutive months\]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study
• Condoms (male or female) with spermicide (if acceptable in country)
• Diaphragm with spermicide
• Cervical cap with spermicide
• Intrauterine device

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 ≤ 8 weeks prior to enrollment.
• Any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness that required changes in medication in the past 2 months 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:
• Congestive heart failure with a history of an acute exacerbation of any severity in the prior 2 years (NOTE:
• Chronic kidney disease/renal insufficiency;
• Chronic gastrointestinal and hepatic diseases; or
• 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 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 8 weeks preceding the study vaccination. Note: Routine vaccinations will not be allowed until after study Day 21 and COVID and influenza vaccination will not be allowed until after Day 84.
• 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.

Sponsors & Collaborators

• Novavax: lead

Study Sites (35)

Paratus Clinical Research - Canberra

Bruce, Australian Capital Territory, Australia

Location

Paratus Clinical Research - Western Sydney

Blacktown, New South Wales, 2148, Australia

Location

Emeritus Research - Sydney

Botany, New South Wales, Australia

Location

Genesis Central Coast

Broadmeadow, New South Wales, Australia

Location

Northern Beaches Clinical Research

Brookvale, New South Wales, Australia

Location

East Sydney Doctors

Darlinghurst, New South Wales, Australia

Location

Holdsworth House Medical Brisbane

Darlinghurst, New South Wales, Australia

Location

Oztrials Clinical Research

Drummoyne, New South Wales, Australia

Location

Paratus Clinical Research - Central Coast

Kanwal, New South Wales, Australia

Location

Australian Clinical Research Network

Maroubra, New South Wales, Australia

Location

Hunter Diabetes Centre

Merewether, New South Wales, Australia

Location

Sutherland Clinical Trials

Miranda, New South Wales, Australia

Location

Illawarra Health and Medical Research Institute

Wollongong, New South Wales, Australia

Location

Northside Health

Coffs Harbour, New South Whales, 2450, Australia

Location

Novatrials

Kotara, New South Whales, 2289, Australia

Location

Menzies Darwin

Tiwi, Norther Territory, Australia

Location

Paratus Clinical Research - Brisbane Clinic

Albion, Queensland, Australia

Location

Mater Adult Hospital

Brisbane, Queensland, Australia

Location

Nucleus Network Pty Ltd

Herston, Queensland, Australia

Location

Core Research Group

Milton, Queensland, Australia

Location

Austrials Pty Ltd - Taringa

Taringa, Queensland, Australia

Location

AusTrials (Wellers Hill)

Tarragindi, Queensland, Australia

Location

CMAX

Adelaide, South Australia, Australia

Location

Emeritus Research

Camberwell, Victoria, Australia

Location

Nucleus Network Limited

Melbourne, Victoria, Australia

Location

P3 Reseach - Hawkes Bay

Havelock North, Hawkes Bay, New Zealand

Location

P3 Research - Palmerston North

Palmerston North, Manawatu-Wanganui, 4414, New Zealand

Location

P3 Research - Lower Hutt

Palmerston, Wellington Region, New Zealand

Location

P3 Research Kapiti

Paraparaumu, Wellington Region, New Zealand

Location

Middlemore Clinical Trials

Auckland, New Zealand

Location

Optimal Clinical Trials Ltd

Auckland, New Zealand

Location

New Zealand Clinical Research - Christchurch

Christchurch, New Zealand

Location

P3 Research - Dunedin

Dunedin, New Zealand

Location

P3 Research - Tauranga

Tauranga, New Zealand

Location

P3 Research - Wellington

Wellington, New Zealand

Location

MeSH Terms

Conditions

COVID-19; Influenza, Human; Coronavirus Infections

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Clinical Development

  Novavax, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 29, 2022
• Study Start: December 30, 2022
• Primary Completion: July 25, 2023
• Study Completion: December 24, 2023
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

AU (25); NZ (10)