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Study to Evaluate Immunogenicity, Safety and Tolerability of Adjuvanted and Non-Adjuvanted H2N3 Influenza Vaccines in Adults

Primary Purpose

Influenza, Human, Infections, Respiratory Tract Infections

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Low dose A/H2N3c + standard dose MF59
Intermediate dose A/H2N3c + standard dose MF59
High dose A/H2N3c + standard dose MF59
High dose A/H2N3c non-adjuvanted
Lowest dose A/H2N3c + high dose MF59
Low dose A/H2N3c + high dose MF59
Sponsored by
Seqirus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza, Human focused on measuring Influenza, Vaccine, MF59, Adjuvant, H2N3

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Individuals of 18 years of age and older on the day of informed consent who were not born in 1968. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. Individuals who can comply with study procedures including follow-up. Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method, at least 30 days prior to informed consent, which they intend to use for at least 2 months after the last study vaccination. Exclusion Criteria: Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to study entry and who do not plan to do so until 2 months after the last study vaccination. A body mass index (BMI) ≥35 kg/m2. Progressive, unstable, or uncontrolled clinical conditions as per investigator's assessment. Subjects must be stable and unchanged for a minimum of 3 months. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. Abnormal function of the immune system resulting from: Clinical conditions. Systemic administration of corticosteroids at a dose of ≥20 mg/day of prednisone or equivalent for more than 14 consecutive days within 90 days prior to informed consent. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. History of any medical condition considered an adverse event of special interest (AESI). Received immunoglobulins with immunomodulating effects or any blood products within 180 days prior to informed consent. Received an investigational or non-registered medicinal product within 30 days prior to informed consent. Study personnel or immediate family or household member of study personnel. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study. Individuals who received any other vaccines (with the exception of COVID-19 vaccines) within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines. Receipt of any (investigational or licensed) COVID-19 vaccine within 14 days (non-replicating vaccines) or 28 days (replicating vaccines) prior to enrollment or plan to receive any COVID-19 vaccine within 14 days from study vaccination. A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.

Sites / Locations

  • Meridian Clinical Research
  • Meridian Clinical Research
  • Meridian Clinical Research
  • De La Salle Medical and Health Sciences Institute
  • West Visayas State University Medical CenterRecruiting
  • Manila Doctors HospitalRecruiting
  • Quirino Memorial Medical CenterRecruiting
  • Silang Specialists Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Group D

Group E

Group F

Arm Description

Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of low dose A/H2N3c + standard dose MF59 adjuvant

Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of intermediate dose A/H2N3c + standard dose MF59 adjuvant

Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of high dose A/H2N3c + standard dose MF59 adjuvant

Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of high dose A/H2N3c non-adjuvanted

Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of lowest dose A/H2N3c + high dose MF59 adjuvant

Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of low dose A/H2N3c + high dose MF59 adjuvant

Outcomes

Primary Outcome Measures

Geometric mean titer (GMT) of hemagglutination inhibition (HI) antibodies against homologous H2N3 strain - Day 1
GMT (HI) prevaccination
GMT of HI antibodies against homologous H2N3 strain - Day 8
GMT (HI) 1 week postvaccination 1
GMT of HI antibodies against homologous H2N3 strain Day 22
GMT (HI) 3 weeks postvaccination 1
GMT of HI antibodies against homologous H2N3 strain - Day 29
GMT (HI) 1 week postvaccination 2
GMT of HI antibodies against homologous H2N3 strain - Day 43
GMT (HI) 3 weeks postvaccination 2
GMT of microneutralization (MN) antibodies against homologous H2N3 strain - Day 1
GMT (MN) prevaccination
GMT of MN antibodies against homologous H2N3 strain - Day 8
GMT (MN) 1 week postvaccination 1
GMT of MN antibodies against homologous H2N3 strain - Day 22
GMT (MN) 3 weeks postvaccination 1
GMT of MN antibodies against homologous H2N3 strain - Day 29
GMT (MN) 1 week postvaccination 2
GMT of MN antibodies against homologous H2N3 strain - Day 43
GMT (MN) 3 weeks postvaccination 2
Geometric mean fold increase (GMFI) of HI antibodies against homologous H2N3 strain - Day 8
GMFI (HI) 1 week postvaccination 1 compared to prevaccination
GMFI of HI antibodies against homologous H2N3 strain - Day 22
GMFI (HI) 3 weeks postvaccination 1 compared to prevaccination
GMFI of HI antibodies against homologous H2N3 strain - Day 29
GMFI (HI) 1 week postvaccination 2 compared to prevaccination
GMFI of HI antibodies against homologous H2N3 strain - Day 43
GMFI (HI) 3 weeks postvaccination 2 compared to prevaccination
GMFI of MN antibodies against homologous H2N3 strain - Day 8
GMFI (MN) 1 week postvaccination 1 compared to prevaccination
GMFI of MN antibodies against homologous H2N3 strain - Day 22
GMFI (MN) 3 weeks postvaccination 1 compared to prevaccination
GMFI of MN antibodies against homologous H2N3 strain - Day 29
GMFI (MN) 1 week postvaccination 2 compared to prevaccination
GMFI of MN antibodies against homologous H2N3 strain - Day 43
GMFI (MN) 3 weeks postvaccination 2 compared to prevaccination
Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Day 1
% ≥1:40 (HI) prevaccination
Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Day 8
% ≥1:40 (HI) 1 week postvaccination 1
Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Day 22
% ≥1:40 (HI) 3 weeks postvaccination 1
Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Day 29
% ≥1:40 (HI) 1 week postvaccination 2
Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Day 43
% ≥1:40 (HI) 3 weeks postvaccination 2
Percentages of subjects with MN titers ≥1:40 against homologous H2N3 strain - Day 1
% ≥1:40 (MN) prevaccination
Percentages of subjects with MN titers ≥1:40 against homologous H2N3 strain - Day 8
% ≥1:40 (MN) 1 week postvaccination 1
Percentages of subjects with MN titers ≥1:40 against homologous H2N3 strain - Day 22
% ≥1:40 (MN) 3 weeks postvaccination 1
Percentages of subjects with MN titers ≥1:40 against homologous H2N3 strain - Day 29
% ≥1:40 (MN) 1 week postvaccination 2
Percentages of subjects with MN titers ≥1:40 against homologous H2N3 strain - Day 43
% ≥1:40 (MN) 3 weeks postvaccination 2
Percentages of subjects with seroconversion by HI against homologous H2N3 strain - Day 8
% seroconversion (HI) 1 week postvaccination 1, defined as a ≥4-fold increase in HI titer postvaccination in those with prevaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with baseline titer <1:10
Percentages of subjects with seroconversion by HI against homologous H2N3 strain - Day 22
% seroconversion (HI) 3 weeks postvaccination 1, defined as a ≥4-fold increase in HI titer postvaccination in those with prevaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with baseline titer <1:10
Percentages of subjects with seroconversion by HI against homologous H2N3 strain - Day 29
% seroconversion (HI) 1 week postvaccination 2, defined as a ≥4-fold increase in HI titer postvaccination in those with prevaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with baseline titer <1:10
Percentages of subjects with seroconversion by HI against homologous H2N3 strain - Day 43
% seroconversion (HI) 3 weeks postvaccination 2, defined as a ≥4-fold increase in HI titer postvaccination in those with prevaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with baseline titer <1:10
Percentages of subjects with seroconversion by MN against homologous H2N3 strain - Day 8
% seroconversion (MN) 1 week postvaccination 1, defined as a ≥4-fold increase in MN titer postvaccination in those with prevaccination titer ≥lower limit of quantification (LLOQ), or a postvaccination MN titer ≥4×LLOQ for subjects with baseline titer <LLOQ
Percentages of subjects with seroconversion by MN against homologous H2N3 strain - Day 22
% seroconversion (MN) 3 weeks postvaccination 1, defined as a ≥4-fold increase in MN titer postvaccination in those with prevaccination titer ≥lower limit of quantification (LLOQ), or a postvaccination MN titer ≥4×LLOQ for subjects with baseline titer <LLOQ
Percentages of subjects with seroconversion by MN against homologous H2N3 strain - Day 29
% seroconversion (MN) 1 week postvaccination 2, defined as a ≥4-fold increase in MN titer postvaccination in those with prevaccination titer ≥lower limit of quantification (LLOQ), or a postvaccination MN titer ≥4×LLOQ for subjects with baseline titer <LLOQ
Percentages of subjects with seroconversion by MN against homologous H2N3 strain - Day 43
% seroconversion (MN) 3 weeks postvaccination 2, defined as a ≥4-fold increase in MN titer postvaccination in those with prevaccination titer ≥lower limit of quantification (LLOQ), or a postvaccination MN titer ≥4×LLOQ for subjects with baseline titer <LLOQ
Number and percentages of subjects reporting solicited local and systemic adverse events (AEs) - Day 1 through Day 10
10 consecutive days postvaccination 1
Number and percentages of subjects reporting solicited local and systemic AEs - Day 22 through Day 31
10 consecutive days postvaccination 2
Number and percentage of subjects reporting any unsolicited AEs
For 3 weeks following each vaccination
Number and percentage of subjects reporting serious AEs (SAEs), AEs leading to withdrawal, AEs of special interest (AESI) and medically attended AEs (MAAEs)
From vaccination until study completion

Secondary Outcome Measures

GMT of ELLA titers as a measure of anti-neuraminidase (NA) immunogenicity
GMT (ELLA) prevaccination, 1 and 3 weeks postvaccination
GMFI of ELLA titers as a measure of anti-NA immunogenicity
GMFI (ELLA) 1 and 3 weeks postvaccination compared to prevaccination
Percentage of subjects with ≥4-fold increase in ELLA titer as a measure of anti-NA immunogenicity
% ≥4-fold increase (ELLA) 1 and 3 weeks postvaccination compared to prevaccination
GMT of HI antibodies against homologous H2N3 strain - Persistence
GMT (HI) 6 and 12 months postvaccination 2
GMT of MN antibodies against homologous H2N3 strain - Persistence
GMT (MN) 6 and 12 months postvaccination 2
GMT of ELLA titer as a measure of anti-NA immunogenicity- Persistence
GMT (ELLA) 6 and 12 months postvaccination 2
GMFI of HI antibodies against homologous H2N3 strain - Persistence
GMFI (HI) 6 and 12 months postvaccination 2 compared to prevaccination
GMFI of MN antibodies against homologous H2N3 strain - Persistence
GMFI (MN) 6 and 12 months postvaccination 2 compared to prevaccination
GMFI of ELLA titer as a measure of anti-NA immunogenicity- Persistence
GMFI (ELLA) 6 and 12 months postvaccination 2 compared to prevaccination
Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Persistence
% ≥1:40 (HI) 6 and 12 months postvaccination 2
Percentages of subjects with MN titers ≥1:40, ≥1:80 and ≥1:160 against homologous H2N3 strain - Persistence
% ≥1:40, ≥1:80 and ≥1:160 (MN) 6 and 12 months postvaccination 2
Percentages of subjects with seroconversion by HI against homologous H2N3 strain - Persistence
% seroconversion (HI) 6 and 12 months postvaccination 2, defined as a ≥4-fold increase in HI titer postvaccination in those with prevaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with baseline titer <1:10
Percentages of subjects with seroconversion by MN against homologous H2N3 strain - Persistence
% seroconversion (MN) 6 and 12 months postvaccination 2, defined as a ≥4-fold increase in MN titer postvaccination in those with prevaccination titer ≥LLOQ, or a postvaccination MN titer ≥4×LLOQ for subjects with baseline titer <LLOQ
Percentage of subjects with ≥4-fold increase in ELLA titer as a measure of anti-NA immunogenicity - Persistence
% ≥4-fold increase (ELLA) 6 and 12 months postvaccination 2 compared to prevaccination

Full Information

First Posted
May 5, 2023
Last Updated
October 10, 2023
Sponsor
Seqirus
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT05875961
Brief Title
Study to Evaluate Immunogenicity, Safety and Tolerability of Adjuvanted and Non-Adjuvanted H2N3 Influenza Vaccines in Adults
Official Title
A Phase 1, Randomized, Observer-Blind, Multi-Center, Dose Ranging Study to Evaluate the Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted or Non-Adjuvanted Cell Culture-derived A/H2N3 Subunit Influenza Virus Vaccine in Healthy Subjects 18 Years and Above
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seqirus
Collaborators
Department of Health and Human Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This Phase 1, randomized, observer-blind, dose-ranging clinical study is evaluating 6 different formulations of MF59-adjuvanted and non-adjuvanted H2N3 influenza vaccine. Approximately 600 healthy adult subjects are to be randomized into 1 of 6 possible treatment groups with 100 subjects per group, stratified by age group (born after or before 1968). Each subject will receive an influenza vaccine injection on Day 1 and Day 22. Subjects will be followed up for approximately 12 months after the second vaccine injection. The primary immunogenicity analysis is based on the Day 1, Day 8, Day 22, Day 29, and Day 43 serology data. The primary safety analysis is based on solicited local and systemic adverse events (AEs) reported within 10 days after each vaccination, unsolicited AEs reported within 3 weeks after each vaccination, and serious AEs (SAEs), medically attended AEs (MAAEs), AEs leading to withdrawal from the study, and AEs of special interest (AESIs) reported throughout the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human, Infections, Respiratory Tract Infections, Virus Diseases, Infection Viral
Keywords
Influenza, Vaccine, MF59, Adjuvant, H2N3

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Eligible subjects are randomized in an equal ratio to one of the 6 different treatment groups (formulations) and will receive two doses of the allocated H2N3c vaccine (adjuvanted or non-adjuvanted) at 3 weeks apart, ie, at Day 1 and Day 22.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of low dose A/H2N3c + standard dose MF59 adjuvant
Arm Title
Group B
Arm Type
Experimental
Arm Description
Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of intermediate dose A/H2N3c + standard dose MF59 adjuvant
Arm Title
Group C
Arm Type
Experimental
Arm Description
Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of high dose A/H2N3c + standard dose MF59 adjuvant
Arm Title
Group D
Arm Type
Experimental
Arm Description
Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of high dose A/H2N3c non-adjuvanted
Arm Title
Group E
Arm Type
Experimental
Arm Description
Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of lowest dose A/H2N3c + high dose MF59 adjuvant
Arm Title
Group F
Arm Type
Experimental
Arm Description
Eligible subjects who have been randomized to receive two intramuscular vaccinations (3 weeks apart) of low dose A/H2N3c + high dose MF59 adjuvant
Intervention Type
Biological
Intervention Name(s)
Low dose A/H2N3c + standard dose MF59
Intervention Description
Two intramuscular injections (3 weeks apart) of cell culture-derived MF59 adjuvanted H2N3 vaccine
Intervention Type
Biological
Intervention Name(s)
Intermediate dose A/H2N3c + standard dose MF59
Intervention Description
Two intramuscular injections (3 weeks apart) of cell culture-derived MF59 adjuvanted H2N3 vaccine
Intervention Type
Biological
Intervention Name(s)
High dose A/H2N3c + standard dose MF59
Intervention Description
Two intramuscular injections (3 weeks apart) of cell culture-derived MF59 adjuvanted H2N3 vaccine
Intervention Type
Biological
Intervention Name(s)
High dose A/H2N3c non-adjuvanted
Intervention Description
Two intramuscular injections (3 weeks apart) of cell culture-derived non-adjuvanted H2N3 vaccine
Intervention Type
Biological
Intervention Name(s)
Lowest dose A/H2N3c + high dose MF59
Intervention Description
Two intramuscular injections (3 weeks apart) of cell culture-derived MF59 adjuvanted H2N3 vaccine
Intervention Type
Biological
Intervention Name(s)
Low dose A/H2N3c + high dose MF59
Intervention Description
Two intramuscular injections (3 weeks apart) of cell culture-derived MF59 adjuvanted H2N3 vaccine
Primary Outcome Measure Information:
Title
Geometric mean titer (GMT) of hemagglutination inhibition (HI) antibodies against homologous H2N3 strain - Day 1
Description
GMT (HI) prevaccination
Time Frame
Day 1
Title
GMT of HI antibodies against homologous H2N3 strain - Day 8
Description
GMT (HI) 1 week postvaccination 1
Time Frame
Day 8
Title
GMT of HI antibodies against homologous H2N3 strain Day 22
Description
GMT (HI) 3 weeks postvaccination 1
Time Frame
Day 22
Title
GMT of HI antibodies against homologous H2N3 strain - Day 29
Description
GMT (HI) 1 week postvaccination 2
Time Frame
Day 29
Title
GMT of HI antibodies against homologous H2N3 strain - Day 43
Description
GMT (HI) 3 weeks postvaccination 2
Time Frame
Day 43
Title
GMT of microneutralization (MN) antibodies against homologous H2N3 strain - Day 1
Description
GMT (MN) prevaccination
Time Frame
Day 1
Title
GMT of MN antibodies against homologous H2N3 strain - Day 8
Description
GMT (MN) 1 week postvaccination 1
Time Frame
Day 8
Title
GMT of MN antibodies against homologous H2N3 strain - Day 22
Description
GMT (MN) 3 weeks postvaccination 1
Time Frame
Day 22
Title
GMT of MN antibodies against homologous H2N3 strain - Day 29
Description
GMT (MN) 1 week postvaccination 2
Time Frame
Day 29
Title
GMT of MN antibodies against homologous H2N3 strain - Day 43
Description
GMT (MN) 3 weeks postvaccination 2
Time Frame
Day 43
Title
Geometric mean fold increase (GMFI) of HI antibodies against homologous H2N3 strain - Day 8
Description
GMFI (HI) 1 week postvaccination 1 compared to prevaccination
Time Frame
Day 8
Title
GMFI of HI antibodies against homologous H2N3 strain - Day 22
Description
GMFI (HI) 3 weeks postvaccination 1 compared to prevaccination
Time Frame
Day 22
Title
GMFI of HI antibodies against homologous H2N3 strain - Day 29
Description
GMFI (HI) 1 week postvaccination 2 compared to prevaccination
Time Frame
Day 29
Title
GMFI of HI antibodies against homologous H2N3 strain - Day 43
Description
GMFI (HI) 3 weeks postvaccination 2 compared to prevaccination
Time Frame
Day 43
Title
GMFI of MN antibodies against homologous H2N3 strain - Day 8
Description
GMFI (MN) 1 week postvaccination 1 compared to prevaccination
Time Frame
Day 8
Title
GMFI of MN antibodies against homologous H2N3 strain - Day 22
Description
GMFI (MN) 3 weeks postvaccination 1 compared to prevaccination
Time Frame
Day 22
Title
GMFI of MN antibodies against homologous H2N3 strain - Day 29
Description
GMFI (MN) 1 week postvaccination 2 compared to prevaccination
Time Frame
Day 29
Title
GMFI of MN antibodies against homologous H2N3 strain - Day 43
Description
GMFI (MN) 3 weeks postvaccination 2 compared to prevaccination
Time Frame
Day 43
Title
Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Day 1
Description
% ≥1:40 (HI) prevaccination
Time Frame
Day 1
Title
Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Day 8
Description
% ≥1:40 (HI) 1 week postvaccination 1
Time Frame
Day 8
Title
Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Day 22
Description
% ≥1:40 (HI) 3 weeks postvaccination 1
Time Frame
Day 22
Title
Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Day 29
Description
% ≥1:40 (HI) 1 week postvaccination 2
Time Frame
Day 29
Title
Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Day 43
Description
% ≥1:40 (HI) 3 weeks postvaccination 2
Time Frame
Day 43
Title
Percentages of subjects with MN titers ≥1:40 against homologous H2N3 strain - Day 1
Description
% ≥1:40 (MN) prevaccination
Time Frame
Day 1
Title
Percentages of subjects with MN titers ≥1:40 against homologous H2N3 strain - Day 8
Description
% ≥1:40 (MN) 1 week postvaccination 1
Time Frame
Day 8
Title
Percentages of subjects with MN titers ≥1:40 against homologous H2N3 strain - Day 22
Description
% ≥1:40 (MN) 3 weeks postvaccination 1
Time Frame
Day 22
Title
Percentages of subjects with MN titers ≥1:40 against homologous H2N3 strain - Day 29
Description
% ≥1:40 (MN) 1 week postvaccination 2
Time Frame
Day 29
Title
Percentages of subjects with MN titers ≥1:40 against homologous H2N3 strain - Day 43
Description
% ≥1:40 (MN) 3 weeks postvaccination 2
Time Frame
Day 43
Title
Percentages of subjects with seroconversion by HI against homologous H2N3 strain - Day 8
Description
% seroconversion (HI) 1 week postvaccination 1, defined as a ≥4-fold increase in HI titer postvaccination in those with prevaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with baseline titer <1:10
Time Frame
Day 8
Title
Percentages of subjects with seroconversion by HI against homologous H2N3 strain - Day 22
Description
% seroconversion (HI) 3 weeks postvaccination 1, defined as a ≥4-fold increase in HI titer postvaccination in those with prevaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with baseline titer <1:10
Time Frame
Day 22
Title
Percentages of subjects with seroconversion by HI against homologous H2N3 strain - Day 29
Description
% seroconversion (HI) 1 week postvaccination 2, defined as a ≥4-fold increase in HI titer postvaccination in those with prevaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with baseline titer <1:10
Time Frame
Day 29
Title
Percentages of subjects with seroconversion by HI against homologous H2N3 strain - Day 43
Description
% seroconversion (HI) 3 weeks postvaccination 2, defined as a ≥4-fold increase in HI titer postvaccination in those with prevaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with baseline titer <1:10
Time Frame
Day 43
Title
Percentages of subjects with seroconversion by MN against homologous H2N3 strain - Day 8
Description
% seroconversion (MN) 1 week postvaccination 1, defined as a ≥4-fold increase in MN titer postvaccination in those with prevaccination titer ≥lower limit of quantification (LLOQ), or a postvaccination MN titer ≥4×LLOQ for subjects with baseline titer <LLOQ
Time Frame
Day 8
Title
Percentages of subjects with seroconversion by MN against homologous H2N3 strain - Day 22
Description
% seroconversion (MN) 3 weeks postvaccination 1, defined as a ≥4-fold increase in MN titer postvaccination in those with prevaccination titer ≥lower limit of quantification (LLOQ), or a postvaccination MN titer ≥4×LLOQ for subjects with baseline titer <LLOQ
Time Frame
Day 22
Title
Percentages of subjects with seroconversion by MN against homologous H2N3 strain - Day 29
Description
% seroconversion (MN) 1 week postvaccination 2, defined as a ≥4-fold increase in MN titer postvaccination in those with prevaccination titer ≥lower limit of quantification (LLOQ), or a postvaccination MN titer ≥4×LLOQ for subjects with baseline titer <LLOQ
Time Frame
Day 29
Title
Percentages of subjects with seroconversion by MN against homologous H2N3 strain - Day 43
Description
% seroconversion (MN) 3 weeks postvaccination 2, defined as a ≥4-fold increase in MN titer postvaccination in those with prevaccination titer ≥lower limit of quantification (LLOQ), or a postvaccination MN titer ≥4×LLOQ for subjects with baseline titer <LLOQ
Time Frame
Day 43
Title
Number and percentages of subjects reporting solicited local and systemic adverse events (AEs) - Day 1 through Day 10
Description
10 consecutive days postvaccination 1
Time Frame
Day 1 through Day 10
Title
Number and percentages of subjects reporting solicited local and systemic AEs - Day 22 through Day 31
Description
10 consecutive days postvaccination 2
Time Frame
Day 22 through Day 31
Title
Number and percentage of subjects reporting any unsolicited AEs
Description
For 3 weeks following each vaccination
Time Frame
Day 1 through Day 43
Title
Number and percentage of subjects reporting serious AEs (SAEs), AEs leading to withdrawal, AEs of special interest (AESI) and medically attended AEs (MAAEs)
Description
From vaccination until study completion
Time Frame
Day 1 through Day 387
Secondary Outcome Measure Information:
Title
GMT of ELLA titers as a measure of anti-neuraminidase (NA) immunogenicity
Description
GMT (ELLA) prevaccination, 1 and 3 weeks postvaccination
Time Frame
Day 1, Day 8, Day 22, Day 29, Day 43
Title
GMFI of ELLA titers as a measure of anti-NA immunogenicity
Description
GMFI (ELLA) 1 and 3 weeks postvaccination compared to prevaccination
Time Frame
Day 8, Day 22, Day 29, Day 43
Title
Percentage of subjects with ≥4-fold increase in ELLA titer as a measure of anti-NA immunogenicity
Description
% ≥4-fold increase (ELLA) 1 and 3 weeks postvaccination compared to prevaccination
Time Frame
Day 8, Day 22, Day 29, Day 43
Title
GMT of HI antibodies against homologous H2N3 strain - Persistence
Description
GMT (HI) 6 and 12 months postvaccination 2
Time Frame
Day 202, Day 387
Title
GMT of MN antibodies against homologous H2N3 strain - Persistence
Description
GMT (MN) 6 and 12 months postvaccination 2
Time Frame
Day 202, Day 387
Title
GMT of ELLA titer as a measure of anti-NA immunogenicity- Persistence
Description
GMT (ELLA) 6 and 12 months postvaccination 2
Time Frame
Day 202, Day 387
Title
GMFI of HI antibodies against homologous H2N3 strain - Persistence
Description
GMFI (HI) 6 and 12 months postvaccination 2 compared to prevaccination
Time Frame
Day 202, Day 387
Title
GMFI of MN antibodies against homologous H2N3 strain - Persistence
Description
GMFI (MN) 6 and 12 months postvaccination 2 compared to prevaccination
Time Frame
Day 202, Day 387
Title
GMFI of ELLA titer as a measure of anti-NA immunogenicity- Persistence
Description
GMFI (ELLA) 6 and 12 months postvaccination 2 compared to prevaccination
Time Frame
Day 202, Day 387
Title
Percentages of subjects with HI titers ≥1:40 against homologous H2N3 strain - Persistence
Description
% ≥1:40 (HI) 6 and 12 months postvaccination 2
Time Frame
Day 202, Day 387
Title
Percentages of subjects with MN titers ≥1:40, ≥1:80 and ≥1:160 against homologous H2N3 strain - Persistence
Description
% ≥1:40, ≥1:80 and ≥1:160 (MN) 6 and 12 months postvaccination 2
Time Frame
Day 202, Day 387
Title
Percentages of subjects with seroconversion by HI against homologous H2N3 strain - Persistence
Description
% seroconversion (HI) 6 and 12 months postvaccination 2, defined as a ≥4-fold increase in HI titer postvaccination in those with prevaccination titer ≥1:10, or a postvaccination HI titer ≥1:40 for subjects with baseline titer <1:10
Time Frame
Day 202, Day 387
Title
Percentages of subjects with seroconversion by MN against homologous H2N3 strain - Persistence
Description
% seroconversion (MN) 6 and 12 months postvaccination 2, defined as a ≥4-fold increase in MN titer postvaccination in those with prevaccination titer ≥LLOQ, or a postvaccination MN titer ≥4×LLOQ for subjects with baseline titer <LLOQ
Time Frame
Day 202, Day 387
Title
Percentage of subjects with ≥4-fold increase in ELLA titer as a measure of anti-NA immunogenicity - Persistence
Description
% ≥4-fold increase (ELLA) 6 and 12 months postvaccination 2 compared to prevaccination
Time Frame
Day 202, Day 387

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals of 18 years of age and older on the day of informed consent who were not born in 1968. Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. Individuals who can comply with study procedures including follow-up. Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method, at least 30 days prior to informed consent, which they intend to use for at least 2 months after the last study vaccination. Exclusion Criteria: Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to study entry and who do not plan to do so until 2 months after the last study vaccination. A body mass index (BMI) ≥35 kg/m2. Progressive, unstable, or uncontrolled clinical conditions as per investigator's assessment. Subjects must be stable and unchanged for a minimum of 3 months. Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study. Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. Abnormal function of the immune system resulting from: Clinical conditions. Systemic administration of corticosteroids at a dose of ≥20 mg/day of prednisone or equivalent for more than 14 consecutive days within 90 days prior to informed consent. Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. History of any medical condition considered an adverse event of special interest (AESI). Received immunoglobulins with immunomodulating effects or any blood products within 180 days prior to informed consent. Received an investigational or non-registered medicinal product within 30 days prior to informed consent. Study personnel or immediate family or household member of study personnel. Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study. Individuals who received any other vaccines (with the exception of COVID-19 vaccines) within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines. Receipt of any (investigational or licensed) COVID-19 vaccine within 14 days (non-replicating vaccines) or 28 days (replicating vaccines) prior to enrollment or plan to receive any COVID-19 vaccine within 14 days from study vaccination. A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Disclosure Manager
Phone
use email
Email
seqirus.clinicaltrials@seqirus.com
First Name & Middle Initial & Last Name or Official Title & Degree
Medical Writing & Disclosures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Science & Strategy
Organizational Affiliation
Seqirus
Official's Role
Study Chair
Facility Information:
Facility Name
Meridian Clinical Research
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Meridian Clinical Research
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Meridian Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
58134
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
De La Salle Medical and Health Sciences Institute
City
Dasmariñas
State/Province
Cavite
ZIP/Postal Code
4114
Country
Philippines
Individual Site Status
Withdrawn
Facility Name
West Visayas State University Medical Center
City
Iloilo City
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Manila Doctors Hospital
City
Manila
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Quirino Memorial Medical Center
City
Quezon City
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Silang Specialists Medical Center
City
Silang
Country
Philippines
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Study to Evaluate Immunogenicity, Safety and Tolerability of Adjuvanted and Non-Adjuvanted H2N3 Influenza Vaccines in Adults

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