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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05960097
Registration number
NCT05960097
Ethics application status
Date submitted
24/07/2023
Date registered
25/07/2023
Date last updated
15/03/2024
Titles & IDs
Public title
A Study on the Safety and Immune Response of Investigational COVID-19 mRNA Vaccines in Healthy Adults
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Scientific title
A Phase 2 Randomized, Active-controlled, Observer-blind Study to Assess the Safety, Reactogenicity, and Immunogenicity of a Booster Dose of Investigational COVID-19 mRNA Vaccines in Healthy Adults Who Previously Received a Complete Primary Vaccination Series With or Without Booster Dose(s)
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Secondary ID [1]
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2023-504596-25-00
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Secondary ID [2]
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219075
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - CV0701 Bivalent High dose
Other interventions - CV0701 Bivalent Medium dose
Other interventions - CV0701 Bivalent Low dose
Other interventions - CV0601 Monovalent High dose
Other interventions - Control vaccine
Other interventions - CV0801 Monovalent
Experimental: Part A, Group A: CV0701 High dose - Participants receive high dose of CV0701.
Experimental: Part A, Group B: CV0701 Medium dose - Participants receive medium dose of CV0701.
Experimental: Part A, Group C: CV0701 Low dose - Participants receive low dose of CV0701.
Experimental: Part A, Group D: CV0601 High dose - Participants receive high dose of CV0601.
Active Comparator: Part A, Group E: Control vaccine - Participants receive control vaccine.
Experimental: Part B, Condition 1: Baseline-control - Participants receive one dose of CV0801.
Experimental: Part B, Condition 2: Intermediate storage - Participants receive one dose of CV0801.
Experimental: Part B, Condition 3: Maximum storage conditions - Participants receive one dose of CV0801.
Other interventions: CV0701 Bivalent High dose
Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.
Other interventions: CV0701 Bivalent Medium dose
Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.
Other interventions: CV0701 Bivalent Low dose
Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.
Other interventions: CV0601 Monovalent High dose
Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.
Other interventions: Control vaccine
Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.
Other interventions: CV0801 Monovalent
Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein
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Assessment method [1]
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Timepoint [1]
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Day 29
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Primary outcome [2]
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Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein
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Assessment method [2]
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Timepoint [2]
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Day 29
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Primary outcome [3]
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Part A: Percentage of participants with solicited administration site adverse events (AEs)
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Assessment method [3]
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Timepoint [3]
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Day 1 to Day 7
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Primary outcome [4]
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Part A: Percentage of participants with solicited administration systemic AEs
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Assessment method [4]
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Timepoint [4]
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Day 1 to Day 7
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Primary outcome [5]
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Part A: Percentage of participants with unsolicited AEs
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Assessment method [5]
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Timepoint [5]
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Day 1 to Day 28
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Primary outcome [6]
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Part A: Percentage of participants with medically attended adverse events (MAAEs)
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Assessment method [6]
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Timepoint [6]
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Day 1 through End of Study (approximately 180 days after the study intervention administration)
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Primary outcome [7]
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Part A: Percentage of participants with serious adverse events (SAEs)
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Assessment method [7]
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Timepoint [7]
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Day 1 through End of Study (approximately 180 days after the study intervention administration)
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Primary outcome [8]
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Part A: Percentage of participants with adverse events of special interest (AESIs)
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Assessment method [8]
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Timepoint [8]
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Day 1 through End of Study (approximately 180 days after the study intervention administration)
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Primary outcome [9]
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Part B: Percentage of participants with solicited administration site adverse events (AEs)
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Assessment method [9]
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Timepoint [9]
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Day 1 to Day 7
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Primary outcome [10]
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Part B: Percentage of participants with solicited administration systemic AEs
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Assessment method [10]
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Timepoint [10]
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Day 1 to Day 7
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Primary outcome [11]
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Part B: Percentage of participants with unsolicited AEs
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Assessment method [11]
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Timepoint [11]
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Day 1 to Day 28
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Primary outcome [12]
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Part B: Percentage of participants with medically attended adverse events (MAAEs)
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Assessment method [12]
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Timepoint [12]
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Day 1 through End of Study (approximately 180 days after the study intervention administration)
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Primary outcome [13]
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Part B: Percentage of participants with serious adverse events (SAEs)
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Assessment method [13]
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Timepoint [13]
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Day 1 through End of Study (approximately 180 days after the study intervention administration)
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Primary outcome [14]
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Part B: Percentage of participants with adverse events of special interest (AESIs) Part B: Percentage of participants with adverse events of special interest (AESIs)
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Assessment method [14]
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Timepoint [14]
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Day 1 through End of Study (approximately 180 days after the study intervention administration)
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Primary outcome [15]
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Part B: Geometric mean titer of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein
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Assessment method [15]
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Timepoint [15]
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Day 29
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Secondary outcome [1]
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Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein
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Assessment method [1]
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Timepoint [1]
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Day 91 and Day 181
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Secondary outcome [2]
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Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein
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Assessment method [2]
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Timepoint [2]
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Day 91 and Day 181
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Secondary outcome [3]
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Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing Omicron subvariant XZ spike protein
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Assessment method [3]
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Timepoint [3]
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Days 29, 91 and 181
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Secondary outcome [4]
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Part A: Percentage of participants with seroresponse from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein
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Assessment method [4]
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Seroresponse is defined as post-booster titer greater than or equal to (=) 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer = 4 times the pre-booster titer when pre-vaccination titer is = LLOQ.
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Timepoint [4]
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Day 29
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Secondary outcome [5]
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Part A: Percentage of participants with seroresponse from baseline of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein
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Assessment method [5]
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Seroresponse is defined as post-booster titer = 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer = 4 times the pre-booster titer when pre-vaccination titer is = LLOQ.
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Timepoint [5]
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Day 29
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Secondary outcome [6]
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Part A: Percentage of participants with seroresponse from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XZ spike protein
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Assessment method [6]
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Seroresponse is defined as post-booster titer = 4 times the LLOQ when pre-vaccination titer is below LLOQ or a post-booster titer = 4 times the pre-booster titer when pre-vaccination titer is = LLOQ.
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Timepoint [6]
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Day 29
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Secondary outcome [7]
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Part A: Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein
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Assessment method [7]
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Timepoint [7]
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Days 29, 91 and 181
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Secondary outcome [8]
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Part A: Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein
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Assessment method [8]
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Timepoint [8]
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Days 29, 91 and 181
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Secondary outcome [9]
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Part A: Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XZ spike protein
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Assessment method [9]
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Timepoint [9]
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Days 29, 91 and 181
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Eligibility
Key inclusion criteria
Participants are eligible to be included in the study only if all of the following criteria
apply:
1. Is at least 18 years old and has achieved legal age according to local regulations in
each participating country.
2. Must provide documented informed consent prior to any study procedures being
performed.
3. Can and will comply with the requirements of the protocol, in the opinion of the
investigator.
4. Is healthy or medically stable as determined by the investigator's judgment based on
medical history, vital sign measurements, and physical examination findings.
Participants with pre-existing stable disease, defined as disease not requiring
significant change in therapy or hospitalization for worsening disease during the 6
weeks before enrollment, can be included.
5. Prior receipt of an mRNA COVID-19 vaccine. This may be from a completed primary
vaccination series or booster dose(s) of an approved or authorized mRNA COVID-19
vaccine. The last vaccination must be an mRNA COVID-19 vaccination received at least 3
months prior to randomization.
6. If the participant is a woman of childbearing potential, the participant may be
enrolled in the study, if they:
- have practiced adequate contraception for 30 days prior to study intervention
administration; and
- have a negative pregnancy test result on the day of study intervention
administration; and
- have agreed to continue adequate contraception for 2 months after study
intervention administration.
Female participants of non-childbearing potential may be enrolled in the study.
Nonchildbearing potential is defined as current salpingectomy, hysterectomy, ovariectomy,
or postmenopausal.
Participants are excluded from the study if any of the following criteria apply:
1. Is pregnant or has a positive pregnancy test result at Visit 1.
2. Is breastfeeding or will (re)start breastfeeding from the study intervention
administration to 3 months after study intervention administration.
3. Has any medical disease or psychiatric condition that, in the opinion of the
investigator, precludes study participation because it would place the participant at
an unacceptable risk of injury, would render them unable to meet the requirements of
the protocol or may interfere with successful completion of the study.
4. Has any history of an immunosuppressive or immunodeficient condition resulting from
disease.
5. Has used immunosuppressants or other immune-modifying drugs for 14 consecutive days or
more within 3 months prior to the study intervention administration. Non-systemic
corticosteroids are allowed. If systemic corticosteroids have been administered short
term (<14 days) for treatment of an acute illness, participants should not be enrolled
into the study until corticosteroid therapy has been discontinued for at least 28 days
before study intervention administration.
6. Has an acute medical illness or acute febrile illness with oral temperature =38.0°C or
=100.4°F within 72 hours prior to study intervention administration.
7. Has participated in another study involving any investigational product, vaccine, or
device within 28 days before the study intervention administration and/or planned
participation through end of study (EoS).
8. Has participated in Part A of this study.
9. Has a history of hypersensitivity or severe allergic reaction including anaphylaxis,
generalized urticaria, angioedema, and other significant reactions to any previous
mRNA vaccine or any component of the study intervention(s).
10. Has received or plans to receive immunoglobulins or any blood or blood products within
3 months before study intervention administration through EoS.
11. Has a bleeding disorder, or prior history of significant bleeding or bruising
following intramuscular injections.
12. Has a history of chronic alcohol consumption and/or drug abuse as deemed by the
investigator to render the potential participant unable/unlikely to provide accurate
safety reports or comply with study procedures.
13. Has a history of myocarditis, pericarditis, or idiopathic cardiomyopathy, or presence
of any medical condition that increases risk of myocarditis or pericarditis, including
cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome,
hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and
persistent myocardial infection.
14. Has received a live vaccine 30 days before the study intervention administration or
has a planned administration within 30 days after the study intervention
administration.
15. Has received a non-replicating vaccine 8 days before the study intervention
administration or has a planned administration within 14 days after the study
intervention administration.
16. Has a documented history of confirmed SARS-CoV-2 infection within 3 months before
study intervention administration.
17. Has had known close contact with anyone who had a confirmed SARS-CoV-2 infection
within 2 weeks before study intervention administration.
18. Is an employee or family member of the investigator or study site staff.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/08/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
675
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Paratus Clinical Research - Canberra - PPDS - Bruce
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Recruitment hospital [2]
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Paratus Clinical Research - Western Sydney - PPDS - Blacktown
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Recruitment hospital [3]
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Emeritus Research - Sydney - PPDS - Botany
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Recruitment hospital [4]
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Northern Beaches Clinical Research - Brookvale
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Recruitment hospital [5]
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Northside Health - Coffs Harbour
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Recruitment hospital [6]
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East Sydney Doctors - Darlinghurst
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Recruitment hospital [7]
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Paratus Clinical Research - Central Coast - PPDS - Kanwal
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Recruitment hospital [8]
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Australian Clinical Research Network - Maroubra
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Recruitment hospital [9]
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Paratus Clinical Research - Brisbane Clinic - PPDS - Herston
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Recruitment hospital [10]
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Austrials Pty Ltd - Taringa - Taringa
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Recruitment hospital [11]
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AusTrials Wellers Hill - Tarragindi
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Recruitment hospital [12]
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Cmax - Ppds - Norwood
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Recruitment hospital [13]
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Emeritus Research- Melbourne PPDS - Camberwell
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Recruitment hospital [14]
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Hunter Diabetes Center - Merewether
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Recruitment postcode(s) [1]
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2617 - Bruce
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Recruitment postcode(s) [2]
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2259 - Blacktown
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Recruitment postcode(s) [3]
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2019 - Botany
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Recruitment postcode(s) [4]
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2100 - Brookvale
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Recruitment postcode(s) [5]
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2450 - Coffs Harbour
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Recruitment postcode(s) [6]
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2010 - Darlinghurst
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Recruitment postcode(s) [7]
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2259 - Kanwal
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Recruitment postcode(s) [8]
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2035 - Maroubra
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Recruitment postcode(s) [9]
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4006 - Herston
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Recruitment postcode(s) [10]
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4068 - Taringa
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Recruitment postcode(s) [11]
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4075 - Tarragindi
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Recruitment postcode(s) [12]
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5000 - Norwood
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Recruitment postcode(s) [13]
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3124 - Camberwell
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Recruitment postcode(s) [14]
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2291 - Merewether
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Illinois
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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CureVac
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of Part A of this study is to assess the immune response and safety of a booster
dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the
investigational vaccines to control vaccine.
The purpose of Part B of this study is to assess the immune response and safety of a booster
dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the
investigational vaccine under three different storage conditions.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05960097
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05960097
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