Trial · NCT03880474
Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults
NCT03880474, Phase 2, Terminated, Barinthus Biotherapeutics; results first posted 2021-04-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults. Trials, record NCT03880474. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03880474
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults
- NCT number
- NCT03880474
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 2,364 participants, actual
- Lead sponsor
- Barinthus Biotherapeutics
- Conditions
- Influenza
- Interventions
- MVA-NP+M1, Saline
- First posted
- 2019-03-19
- Last updated
- 2021-04-26
- Results first posted
- 2021-04-26
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number and Percentage of Participants With Laboratory Confirmed Influenza Using Reverse Transcription Polymerase Chain Reaction (RT-PCR). | 210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019) in line with official Australian influenza season. | The measure used reverse transcription polymerase chain reaction (RT-PCR) on deep nasal/mid-turbinate swab samples to record confirmed cases of influenza. If influenza symptoms are experienced at any time during the Follow Up period, after the vaccination, participants will attend the clinic on two occasions, the first as soon as possible and at least within 72 hours of the onset of symptoms for deep nasal swabs to be taken. Both swabs must be taken within 96 hours of symptom onset. The incidence rate of laboratory confirmed influenza using RT-PCR will be estimated for each vaccine group. The 95% CI for the incidence rate will be estimated by mid-p exact method. The difference in incidence rate between vaccine groups will be compared by Fisher's exact method. |
| Secondary | Number and Percentage of Participants With Influenza-like Illness (ILI) as Derived From Daily ILI eDiary | 210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019) | ILI is defined as feeling feverish or having a fever (feeling feverish or having a fever (≥37.8Celsius)) and at least one of the following symptoms: cough, sore throat. The incidence rate of ILI by the participant completing of eDiaries will be estimated for each vaccine group. The 95% CI for the incidence will be estimated by mid-p exact method. The difference in incidence between groups will be compared by Fisher's exact method. |
| Secondary | Number and Percentage of Participants With Solicited Local and Systemic Reactogenicity Signs and Symptoms for 7 Days Following Vaccination (and Occurrence of Serious Adverse Events SAEs) | 7 days to a total of 210 days for SAEs (over the duration of the influenza season, between 01 May and 15 October) | The solicited adverse events are commonly observed soon after receipt of vaccines and relate to local and systemic signs and symptoms. The solicited local injection site reactions (ISR) include pain, induration, warmth, and erythema (redness). The solicited systemic reactions include feverishness, chills, myalgia, fatigue, headache, nausea, arthralgia, and malaise. Participants completed eDiaries post vaccination to record ISR and systemic reactogenicity over the first 7 days post-vaccination (and the ongoing (S)AEs throughout the study). The participant reporting of all ISR categories and solicited systemic reactions was compared between the MVA-NP+M1 treated group and the Placebo treated group. Diary reported ISRs and solicited systemic reactions were summarized, by vaccination group, using descriptive statistics. |
| Secondary | Number of Participants With Immunogenic Response (Immunogenicity of MVA-NP+M1 in Adjunction With Licensed QIV as Assessed Via Titres of Influenza-specific Neutralizing Antibodies) | Day 28 and Week 26 | The numbers of Immunogenic Participants (participants with positive immune response as assessed at Day 28 and week 26 in relation to the baseline day 0 Immunogenicity) were summarized and listed. The immunogenicity here was assessed as the geometric mean titers of influenza-specific neutralizing antibodies at different timepoints in relation to the baseline, against the antigens included in the licensed QIV(Influenza A/H3N2 (HI), Influenza A/H3N2 (MN), Influenza A/H3N2 (H1N1pdm), Influenza B/Victoria, and Influenza B/Yamagata). The neutralizing antibody assays included microneutralisation and hemagglutination inhibition titers using standard methodologies for the four strains that were in the licensed vaccine. The immunogenicity analyses were conducted only on the Immunology Analysis Set of Participants. |
| Secondary | Duration of Influenza-like Illness (ILI) as Derived From Daily ILI eDiary | 210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019) | The duration of ILI is defined as the duration (days) from the first day ILI criteria met (as defined at the Secondary Outcome Measure 2) until the first day afterwards ILI criteria not met (event, ILI recovery). ILI positive participants with ILI criteria met throughout the entire influenza season were censored at the last day recorded with the ILI dairy. Survival analysis was used for the analysis of duration of ILI. The survival function for the duration of ILI was estimated by the Kaplan-Meier method. |
| Secondary | Severity of Influenza-like Illness (ILI) Derived From Daily ILI eDiary as Time Weighted AUC | 210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019) | The severity of ILI was assessed by each participant completing of electronic Diaries for symptom severity daily for the following symptoms: Feeling hot, Temperature, Cough, Sore throat, Blocked nose, Chest pain, Muscle aches, Shortness of breath with their severities (scores) recorded as: Not Present (0), Mild (1), Moderate (2), Severe (3). For each symptom, the severity score was used to calculate the area under the curve (AUC), along with the calendar day, for the entire influenza season using trapezoidal rule. Participants could be followed for varying days in the influenza season, therefore the AUC will be time weighted to 168 days: Time weighted AUC=((raw AUC \[time in days\])/(number of days used for analysis)) \* 168 |
| Secondary | Number of Participants With Immunogenic Response to MVA-NP+M1 (as Assessed Via the Frequency of Influenza-specific T-cells) | Day 28 and Week 26 | The numbers of immunogenic Participants (with positive immune response as assessed at Day 28 and week 26 in relation to the baseline day 0 Immunogenicity) were listed. The immunogenicity here was determined via the frequency of influenza-specific T-cells measured by IFN-γ/granzyme B ELISpot assay (enzyme linked immunospot) where the adjusted Spot Forming Units (SFU) per million PBMCs (peripheral blood mononuclear cells) after background subtraction (dimethyl sulfoxide, DMSO) were counted. The immunogenicity analyses were conducted only in the Immunology Analysis Set of Participants. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number and Percentage of Participants With Laboratory Confirmed Influenza Using Reverse Transcription Polymerase Chain Reaction (RT-PCR). | 210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019) in line with official Australian influenza season. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number and Percentage of Participants With Influenza-like Illness (ILI) as Derived From Daily ILI eDiary | 210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number and Percentage of Participants With Solicited Local and Systemic Reactogenicity Signs and Symptoms for 7 Days Following Vaccination (and Occurrence of Serious Adverse Events SAEs) | 7 days to a total of 210 days for SAEs (over the duration of the influenza season, between 01 May and 15 October) | Safety Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Immunogenic Response (Immunogenicity of MVA-NP+M1 in Adjunction With Licensed QIV as Assessed Via Titres of Influenza-specific Neutralizing Antibodies) | Day 28 and Week 26 | The samples for immunogenicity analysis were taken only from participants in the 2 Immunogenicity cohorts included in the MVA-NP+M1 Group vs the Placebo Group.~The immunogenicity analysis for Day 28 used a number of 24 participant results from the MVA-NP+M1 Cohort and a number of 24 participant results from the Placebo Cohort.~The immunogenicity analysis for Week26 used a number of 23 participant results from the MVA-NP+M1 Cohort and a number of 25 participant results from the Placebo Cohort. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Influenza-like Illness (ILI) as Derived From Daily ILI eDiary | 210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019) | ILI duration analysis is only applicable for ILI positive participants. In the MVA-NP+M1 Group there were 273 ILI positive participants assessed: 247 with event and 26 censored; In the Placebo Group there were 273 ILI positive participants assessed: 248 with event and 25 censored. | days | MEDIAN |
| SECONDARY | Severity of Influenza-like Illness (ILI) Derived From Daily ILI eDiary as Time Weighted AUC | 210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019) | weighted days | MEAN | |
| SECONDARY | Number of Participants With Immunogenic Response to MVA-NP+M1 (as Assessed Via the Frequency of Influenza-specific T-cells) | Day 28 and Week 26 | The samples for this immunogenicity analysis were taken only from participants in the 2 Immunogenicity cohorts included in the MVA-NP+M1 Group vs the Placebo Group.~The immunogenicity analysis for Day 28 used 24 participant results from the MVA-NP+M1 Cohort and 24 participant results from the Placebo Cohort, as available.~The immunogenicity analysis for Week26 used 23 participant results from the MVA-NP+M1 Cohort and 25 participant results from the Placebo Cohort, as available. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number and Percentage of Participants With Laboratory Confirmed Influenza Using Reverse Transcription Polymerase Chain Reaction (RT-PCR). | MVA-NP+M1 Group | Participants with laboratory confirmed influenza using RT-PCR | 35 | Participants | |
| Number and Percentage of Participants With Laboratory Confirmed Influenza Using Reverse Transcription Polymerase Chain Reaction (RT-PCR). | Saline Placebo Group | Participants with laboratory confirmed influenza using RT-PCR | 23 | Participants | |
| Number and Percentage of Participants With Laboratory Confirmed Influenza Using Reverse Transcription Polymerase Chain Reaction (RT-PCR). | MVA-NP+M1 Group | Participants without laboratory confirmed influenza using RT-PCR | 1042 | Participants | |
| Number and Percentage of Participants With Laboratory Confirmed Influenza Using Reverse Transcription Polymerase Chain Reaction (RT-PCR). | Saline Placebo Group | Participants without laboratory confirmed influenza using RT-PCR | 1052 | Participants | |
| Number and Percentage of Participants With Influenza-like Illness (ILI) as Derived From Daily ILI eDiary | MVA-NP+M1 Group | Positive ILI Cases | 273 | Participants | |
| Number and Percentage of Participants With Influenza-like Illness (ILI) as Derived From Daily ILI eDiary | Saline Placebo Group | Positive ILI Cases | 273 | Participants | |
| Number and Percentage of Participants With Influenza-like Illness (ILI) as Derived From Daily ILI eDiary | MVA-NP+M1 Group | Negative ILI Cases | 804 | Participants | |
| Number and Percentage of Participants With Influenza-like Illness (ILI) as Derived From Daily ILI eDiary | Saline Placebo Group | Negative ILI Cases | 802 | Participants | |
| Number and Percentage of Participants With Solicited Local and Systemic Reactogenicity Signs and Symptoms for 7 Days Following Vaccination (and Occurrence of Serious Adverse Events SAEs) | MVA-NP+M1 Group | Participants with Solicited Local Injection Site Reaction (IRS) - Pain | 292 | Participants | |
| Number and Percentage of Participants With Solicited Local and Systemic Reactogenicity Signs and Symptoms for 7 Days Following Vaccination (and Occurrence of Serious Adverse Events SAEs) | Saline Placebo Group | Participants with Solicited Local Injection Site Reaction (IRS) - Pain | 19 | Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MVA-NP+M1 Group (Main Cohort + Immunogenicity Cohort) | 1,077 | |
| Overall Study | STARTED | Saline Placebo Group (Main Cohort+ Immunogenicity Cohort) | 1,075 | |
| Overall Study | COMPLETED | MVA-NP+M1 Group (Main Cohort + Immunogenicity Cohort) | 1,054 | |
| Overall Study | COMPLETED | Saline Placebo Group (Main Cohort+ Immunogenicity Cohort) | 1,055 | |
| Overall Study | NOT COMPLETED | MVA-NP+M1 Group (Main Cohort + Immunogenicity Cohort) | 23 | |
| Overall Study | NOT COMPLETED | Saline Placebo Group (Main Cohort+ Immunogenicity Cohort) | 20 |
Source ClinicalTrials.gov
Adverse events132
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MVA-NP+M1 Group | 115 | 1,077 | 122 |
| other | Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Saline Placebo Group | 119 | 1,075 | 127 |
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MVA-NP+M1 Group | 89 | 1,077 | 97 |
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Saline Placebo Group | 93 | 1,075 | 102 |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | MVA-NP+M1 Group | 90 | 1,077 | 95 |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Saline Placebo Group | 84 | 1,075 | 93 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | MVA-NP+M1 Group | 73 | 1,077 | 76 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Saline Placebo Group | 86 | 1,075 | 91 |
| other | Sneezing | Respiratory, thoracic and mediastinal disorders | MVA-NP+M1 Group | 25 | 1,077 | 28 |
| other | Sneezing | Respiratory, thoracic and mediastinal disorders | Saline Placebo Group | 12 | 1,075 | 13 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MVA-NP+M1 Group | 0 | 1,077 |
| Total, all-cause mortality | Saline Placebo Group | 1 | 1,075 |
| Total, other adverse events | MVA-NP+M1 Group | 524 | 1,077 |
| Total, other adverse events | Saline Placebo Group | 435 | 1,075 |
| Total, serious adverse events | MVA-NP+M1 Group | 18 | 1,077 |
| Total, serious adverse events | Saline Placebo Group | 22 | 1,075 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35305317 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| MVA-NP+M1 Group vs Saline Placebo Group: deaths from any cause | Trial comparisons |
| MVA-NP+M1 Group vs Saline Placebo Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03880474
GET https://conductscience.org/api/trials/v1/NCT03880474/results?page=2