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Trial record 1 of 1 for:    FLU009
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Efficacy of Candidate Influenza Vaccine MVA-NP+M1 in Adults

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ClinicalTrials.gov Identifier: NCT03880474
Recruitment Status : Terminated (The trial is being stopped for futility. Season 2 cancelled.)
First Posted : March 19, 2019
Results First Posted : April 26, 2021
Last Update Posted : April 26, 2021
Sponsor:
Collaborator:
Clinical Network Services (CNS) Pty Ltd
Information provided by (Responsible Party):
Vaccitech (UK) Limited

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: MVA-NP+M1
Drug: Saline
Enrollment 2364
Recruitment Details The single-blind study was conducted at 9 sites across Australia, over one Influenza season.
Pre-assignment Details 2364 were screened and 2152 participants started randomized in a 1:1 ratio and received (along with a licensed adult dose of QIV), either active drug (MVA-NP+M1) or Placebo, via IM injection. Overall, 1077 participants received active drug and 1075 Placebo. A total of 2109 participants completed the study. The Immunogenicity Cohort was a subset of 50 participants: 25 participants were administered active drug and 25 participants were administered Placebo. All 50 participants completed the study.
Arm/Group Title MVA-NP+M1 Group (Main Cohort + Immunogenicity Cohort) Saline Placebo Group (Main Cohort+ Immunogenicity Cohort)
Hide Arm/Group Description

Vaccination administered: 1 dose of MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu per dose) MVA-NP+M1: Trial Vaccine Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.

Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.

The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.

The Immunogenicity Cohort of the MVA-NP+M1 group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.

In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).

At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected.

Vaccination administered: 1 dose of Sodium Chloride (IM injection, 0.5 ml, 0.9% per dose) Saline: Sodium Chloride Placebo Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.

Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.

The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.

The Immunogenicity Cohort of the Placebo group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.

In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).

At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected.

Period Title: Overall Study
Started 1077 1075
Completed 1054 1055
Not Completed 23 20
Arm/Group Title MVA-NP+M1 Group Saline Placebo Group Total
Hide Arm/Group Description

Vaccination administered: 1 dose of MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu per dose) MVA-NP+M1: Trial Vaccine Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.

Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.

The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.

The Immunogenicity Cohort of the MVA-NP+M1 group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.

In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).

At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected.

Vaccination administered: 1 dose of Sodium Chloride (IM injection, 0.5 ml, 0.9% per dose) Saline: Sodium Chloride Placebo Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.

Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.

The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.

The Immunogenicity Cohort of the Placebo group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.

In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).

At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected.

Total of all reporting groups
Overall Number of Baseline Participants 1077 1075 2152
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1077 participants 1075 participants 2152 participants
43.6  (18.93) 43.8  (18.40) 43.7  (18.66)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1077 participants 1075 participants 2152 participants
Female
631
  58.6%
631
  58.7%
1262
  58.6%
Male
445
  41.3%
443
  41.2%
888
  41.3%
Unknown
1
   0.1%
1
   0.1%
2
   0.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1077 participants 1075 participants 2152 participants
Hispanic or Latino
10
   0.9%
11
   1.0%
21
   1.0%
Not Hispanic or Latino
1061
  98.5%
1052
  97.9%
2113
  98.2%
Unknown or Not Reported
6
   0.6%
12
   1.1%
18
   0.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1077 participants 1075 participants 2152 participants
American Indian or Alaska Native
1
   0.1%
0
   0.0%
1
   0.0%
Asian
143
  13.3%
118
  11.0%
261
  12.1%
Native Hawaiian or Other Pacific Islander
8
   0.7%
13
   1.2%
21
   1.0%
Black or African American
9
   0.8%
7
   0.7%
16
   0.7%
White
882
  81.9%
892
  83.0%
1774
  82.4%
More than one race
5
   0.5%
3
   0.3%
8
   0.4%
Unknown or Not Reported
29
   2.7%
42
   3.9%
71
   3.3%
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 1077 participants 1075 participants 2152 participants
28.36  (6.727) 28.26  (6.143) 28.31  (6.435)
Body Temperature  
Mean (Standard Deviation)
Unit of measure:  Degree Celsius
Number Analyzed 1077 participants 1075 participants 2152 participants
36.44  (0.420) 36.44  (0.401) 36.44  (0.410)
1.Primary Outcome
Title Number and Percentage of Participants With Laboratory Confirmed Influenza Using Reverse Transcription Polymerase Chain Reaction (RT-PCR).
Hide Description

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.

Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MVA-NP+M1 Group Saline Placebo Group
Hide Arm/Group Description:

Vaccination administered: 1 dose of MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu per dose) MVA-NP+M1: Trial Vaccine Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.

Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.

The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.

The Immunogenicity Cohort of the MVA-NP+M1 group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.

In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).

At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected.

Vaccination administered: 1 dose of Sodium Chloride (IM injection, 0.5 ml, 0.9% per dose) Saline: Sodium Chloride Placebo Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.

Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.

The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.

The Immunogenicity Cohort of the Placebo group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.

In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).

At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected.

Overall Number of Participants Analyzed 1077 1075
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with laboratory confirmed influenza using RT-PCR
35
   3.2%
23
   2.1%
Participants without laboratory confirmed influenza using RT-PCR
1042
  96.8%
1052
  97.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1146
Comments [Not Specified]
Method Log Binominal Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 1.52
Confidence Interval (2-Sided) 95%
0.90 to 2.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1146
Comments [Not Specified]
Method Poisson Model with Robust Variance
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 1.52
Confidence Interval (2-Sided) 95%
0.90 to 2.55
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number and Percentage of Participants With Influenza-like Illness (ILI) as Derived From Daily ILI eDiary
Hide Description

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.

Time Frame 210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MVA-NP+M1 Group Saline Placebo Group
Hide Arm/Group Description:

Vaccination administered: 1 dose of MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu per dose) MVA-NP+M1: Trial Vaccine Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.

Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.

The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.

The Immunogenicity Cohort of the MVA-NP+M1 group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.

In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).

At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected.

Vaccination administered: 1 dose of Sodium Chloride (IM injection, 0.5 ml, 0.9% per dose) Saline: Sodium Chloride Placebo Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.

Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.

The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.

The Immunogenicity Cohort of the Placebo group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.

In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).

At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected.

Overall Number of Participants Analyzed 1077 1075
Measure Type: Count of Participants
Unit of Measure: Participants
Positive ILI Cases
273
  25.3%
273
  25.4%
Negative ILI Cases
804
  74.7%
802
  74.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments The Analysis concerns the Incidence of Influenza-like Illness (ILI)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method Log Binomial Model
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 1
Confidence Interval (2-Sided) 95%
0.86 to 1.15
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments The Analysis concerns the Incidence of Influenza-like Illness (ILI)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9799
Comments [Not Specified]
Method Poisson Model with Robust Variance
Comments [Not Specified]
Method of Estimation Estimation Parameter Relative Risk
Estimated Value 1
Confidence Interval (2-Sided) 95%
0.86 to 1.15
Estimation Comments [Not Specified]
3.Secondary Outcome
Title 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)
Hide Description

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.

Time Frame 7 days to a total of 210 days for SAEs (over the duration of the influenza season, between 01 May and 15 October)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title MVA-NP+M1 Group Saline Placebo Group
Hide Arm/Group Description:

Vaccination administered: 1 dose of MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu per dose) MVA-NP+M1: Trial Vaccine Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.

Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.

The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.

The Immunogenicity Cohort of the MVA-NP+M1 group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.

In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).

At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected.

Vaccination administered: 1 dose of Sodium Chloride (IM injection, 0.5 ml, 0.9% per dose) Saline: Sodium Chloride Placebo Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.

Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.

The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.

The Immunogenicity Cohort of the Placebo group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.

In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).

At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected.

Overall Number of Participants Analyzed 1077 1075
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with Solicited Local Injection Site Reaction (IRS) - Pain
292
  27.1%
19
   1.8%
Participants with Solicited Local Injection Site Reaction (IRS) - Induration
113
  10.5%
4
   0.4%
Participants with Solicited Local Injection Site Reaction (IRS) - Warmth
205
  19.0%
18
   1.7%
Participants with Solicited Local Injection Site Reaction (IRS) - Erythema
198
  18.4%
15
   1.4%
Participants with Severe, Solicited Local Injection Site Reaction
12
   1.1%
1
   0.1%
Participants with Solicited Systemic Reactions - Chills
61
   5.7%
18
   1.7%
Participants with Solicited Systemic Reactions - Myalgia
256
  23.8%
85
   7.9%
Participants with Solicited Systemic Reactions - Fatigue
248
  23.0%
117
  10.9%
Participants with Solicited Systemic Reactions - Headache
238
  22.1%
106
   9.9%
Participants with Solicited Systemic Reactions - Nausea
88
   8.2%
31
   2.9%
Participants with Solicited Systemic Reactions - Arthralgia
156
  14.5%
57
   5.3%
Participants with Solicited Systemic Reactions - Malaise
273
  25.3%
139
  12.9%
Participants with Solicited Systemic Reactions - Feverishness
214
  19.9%
93
   8.7%
Participants with Severe, Solicited Systemic Reaction
45
   4.2%
14
   1.3%
4.Secondary Outcome
Title 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)
Hide Description

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.

Time Frame Day 28 and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title MVA-NP+M1 Group Saline Placebo Group
Hide Arm/Group Description:

Vaccination administered: 1 dose of MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu per dose) MVA-NP+M1: Trial Vaccine Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.

Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.

The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.

The Immunogenicity Cohort of the MVA-NP+M1 group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.

In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).

At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected.

Vaccination administered: 1 dose of Sodium Chloride (IM injection, 0.5 ml, 0.9% per dose) Saline: Sodium Chloride Placebo Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.

Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.

The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.

The Immunogenicity Cohort of the Placebo group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.

In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).

At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected.

Overall Number of Participants Analyzed 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with Influenza Antibody Titer: ANCOVA Analysis Immunology, at Day 28 Number Analyzed 24 participants 24 participants
23
  95.8%
24
 100.0%
Participants with Influenza Antibody Titer: ANCOVA Analysis Immunology, at Week 26 Number Analyzed 23 participants 25 participants
23
 100.0%
25
 100.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (HI) at Day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3284
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -287.1
Confidence Interval (2-Sided) 95%
-872.75 to 298.59
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (HI) at Week26
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8468
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -13.39
Confidence Interval (2-Sided) 95%
-152.26 to 125.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (MN) at Day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5087
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -465.7
Confidence Interval (2-Sided) 95%
-1875.21 to 943.75
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments Titers of influenza-specific neutralizing antibodies against Influenza A/H3N2 (MN) at Week 26
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7509
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -83.68
Confidence Interval (2-Sided) 95%
-611.67 to 444.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments Titers of influenza-specific neutralizing antibodies against Influenza A/H1N1pdm at Day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3398
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -81.17
Confidence Interval (2-Sided) 95%
-250.72 to 88.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments Titers of influenza-specific neutralizing antibodies against Influenza A/H1N1pdm at Week 26
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4154
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 26.15
Confidence Interval (2-Sided) 95%
-37.95 to 90.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments Titers of neutralizing antibodies against Influenza B/ Victoria at Day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7193
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 22.84
Confidence Interval (2-Sided) 95%
-104.50 to 150.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments Titers of influenza-specific neutralizing antibodies against Influenza B/ Victoria at Week 26
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1496
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 52.38
Confidence Interval (2-Sided) 95%
-19.59 to 124.35
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments Titers of influenza-specific neutralizing antibodies against Influenza B/Yamagata at Day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9044
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -16.76
Confidence Interval (2-Sided) 95%
-296.57 to 263.06
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments Titers of influenza-specific neutralizing antibodies against Influenza B/Yamagata at Week 26
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4198
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 38.64
Confidence Interval (2-Sided) 95%
-56.97 to 134.24
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Duration of Influenza-like Illness (ILI) as Derived From Daily ILI eDiary
Hide Description

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.

Time Frame 210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title MVA-NP+M1 Group Saline Placebo Group
Hide Arm/Group Description:

Vaccination administered: 1 dose of MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu per dose) MVA-NP+M1: Trial Vaccine Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.

Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.

The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.

The Immunogenicity Cohort of the MVA-NP+M1 group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.

In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).

At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected.

Vaccination administered: 1 dose of Sodium Chloride (IM injection, 0.5 ml, 0.9% per dose) Saline: Sodium Chloride Placebo Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.

Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.

The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.

The Immunogenicity Cohort of the Placebo group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.

In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).

At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected.

Overall Number of Participants Analyzed 273 273
Median (95% Confidence Interval)
Unit of Measure: days
3
(3 to 4)
3
(3 to 4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4159
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.90 to 1.28
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Severity of Influenza-like Illness (ILI) Derived From Daily ILI eDiary as Time Weighted AUC
Hide Description 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
Time Frame 210 days (during the influenza season, starting on 01 May 2019 and ending on or before 15 October 2019)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MVA-NP+M1 Group Saline Placebo Group
Hide Arm/Group Description:

Vaccination administered: 1 dose of MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu per dose) MVA-NP+M1: Trial Vaccine Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.

Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.

The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.

The Immunogenicity Cohort of the MVA-NP+M1 group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.

In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).

At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected.

Vaccination administered: 1 dose of Sodium Chloride (IM injection, 0.5 ml, 0.9% per dose) Saline: Sodium Chloride Placebo Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.

Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.

The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.

The Immunogenicity Cohort of the Placebo group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.

In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).

At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected.

Overall Number of Participants Analyzed 1077 1075
Mean (Standard Deviation)
Unit of Measure: weighted days
5490  (23.4944) 5297  (21.3996)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Feeling Hot (AUC)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9550
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio (Active vs Placebo)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.83 to 1.19
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Temperature (AUC)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8933
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio (Active vs Placebo)
Estimated Value 1
Confidence Interval (2-Sided) 95%
1 to 1
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Cough (AUC)
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2156
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio (Active vs Placebo)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.7 to 1.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Sore Throat AUC
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2216
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio (Active vs Placebo)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.71 to 1.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Blocked Nose AUC
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2306
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio (Active vs Placebo)
Estimated Value 0.87
Confidence Interval (2-Sided) 95%
0.69 to 1.09
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Chest Pain AUC
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8038
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio (Active vs Placebo)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.97 to 1.13
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Muscle Pain AUC
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9319
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio (Active vs Placebo)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.84 to 1.21
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments Time Weight Area Under the Curve (AUC) for Symptoms of Influenza - Symptom: Shortness of Breath AUC
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8399
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric Mean Ratio (Active vs Placebo)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.86 to 1.19
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Participants With Immunogenic Response to MVA-NP+M1 (as Assessed Via the Frequency of Influenza-specific T-cells)
Hide Description

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.

Time Frame Day 28 and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title MVA-NP+M1 Group Saline Placebo Group
Hide Arm/Group Description:

Vaccination administered: 1 dose of MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu per dose) MVA-NP+M1: Trial Vaccine Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.

Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.

The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.

The Immunogenicity Cohort of the MVA-NP+M1 group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.

In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).

At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected.

Vaccination administered: 1 dose of Sodium Chloride (IM injection, 0.5 ml, 0.9% per dose) Saline: Sodium Chloride Placebo Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.

Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.

The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.

The Immunogenicity Cohort of the Placebo group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.

In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).

At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected.

Overall Number of Participants Analyzed 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
Participants with immunogenic response (as the frequency of influenza-specific T-cells) at Day 28 Number Analyzed 24 participants 24 participants
20
  83.3%
21
  87.5%
Participants with Immunogenic response (via the frequency of influenza-specific T-cells) at Week 26 Number Analyzed 23 participants 25 participants
16
  69.6%
13
  52.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments Statistical analysis was performed for Total(NP+M) (SFU/10^6 PBMC) at Day 28 Nucleoprotein = NP, matrix1 = M1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 743.78
Confidence Interval (2-Sided) 95%
443.71 to 1043.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MVA-NP+M1 Group, Saline Placebo Group
Comments Statistical analysis was performed for Total(NP+M) (SFU/10^6 PBMC) at Week 26 Nucleoprotein = NP, matrix1 = M1
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0673
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 177.10
Confidence Interval (2-Sided) 95%
-13.14 to 367.33
Estimation Comments [Not Specified]
Time Frame Unsolicited non-serious adverse events will be collected for 28 days post-vaccination. Hospitalisations, other serious adverse events and or adverse events of special interest will be collected for the duration of the influenza season. Solicited adverse events, including solicited local injection site reactions (ISR) and solicited systemic reactions, will be collected for 7 days post-vaccination. These will be recorded daily in the eDiary for all participants.
Adverse Event Reporting Description

Adverse events were coded using MedDRA(most recent version). AEs are grouped by system organ class (SOC) and preferred term and summarized by vaccination group (MVA-NP+M1 Group vs Saline Placebo Group) at the time of AE onset. All AEs are reported for each group and the Immunogenicity cohorts (as parts of each group) did not influence the adverse events reporting style.

In the summary tables, adverse events are presented/summarized by decreasing frequency of Total Events overall within each SOC

 
Arm/Group Title MVA-NP+M1 Group Saline Placebo Group
Hide Arm/Group Description

Vaccination administered: 1 dose of MVA-NP+M1 (IM injection, 0.5 ml, 1.5 x10^8 pfu per dose) MVA-NP+M1: Trial Vaccine Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.

Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.

The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.

The Immunogenicity Cohort of the MVA-NP+M1 group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.

In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).

At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected.

Vaccination administered: 1 dose of Sodium Chloride (IM injection, 0.5 ml, 0.9% per dose) Saline: Sodium Chloride Placebo Vaccinations were administered by intramuscular injection on Day 0. The participants were provided with an oral thermometer, tape measure and electronic diary card (eDiary) and instructed how to complete the eDiary at home.

Participants recorded their oral temperature and any solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination.

The study team contacted participants by telephone on Day 1 (+2 days) post-vaccination and Day 7 (+3 days) post-vaccination for safety follow-up. If the participant had persistent, vaccine-related Grade 3 AEs during the first 4 weeks post-vaccination they could be asked to attend a further clinical assessment.

The Immunogenicity Cohort of the Placebo group (25 participants), had pre vaccination safety laboratory and immunogenicity blood samples taken.

In addition to the visits and procedures outlined above these participants attended an additional three clinic visits on Days 7 (+3 days), 28 (±7 days) and Week 26 (±1 week) (approximate end of the influenza season).

At the end of the influenza season, all participants were contacted by telephone to inform them of the end of the follow-up period and confirm all information had been collected.

All-Cause Mortality
MVA-NP+M1 Group Saline Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1077 (0.00%)      1/1075 (0.09%)    
Hide Serious Adverse Events
MVA-NP+M1 Group Saline Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/1077 (1.67%)      22/1075 (2.05%)    
Cardiac disorders     
Acute myocardial infarction  1  1/1077 (0.09%)  1 0/1075 (0.00%)  0
Atrial fibrillation  1  1/1077 (0.09%)  1 0/1075 (0.00%)  0
Cardiac failure  1  1/1077 (0.09%)  1 0/1075 (0.00%)  0
Cardiomyopathy  1  0/1077 (0.00%)  0 1/1075 (0.09%)  1
Endocrine disorders     
Hyperthyroidism  1  1/1077 (0.09%)  1 0/1075 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/1077 (0.09%)  1 0/1075 (0.00%)  0
Diarrhoea  1  1/1077 (0.09%)  1 0/1075 (0.00%)  0
General disorders     
Chest pain  1  0/1077 (0.00%)  0 1/1075 (0.09%)  1
Non-cardiac chest pain  1  1/1077 (0.09%)  1 0/1075 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1  1/1077 (0.09%)  1 0/1075 (0.00%)  0
Immune system disorders     
Medical device site joint infection  1  1/1077 (0.09%)  1 0/1075 (0.00%)  0
Infections and infestations     
Pneumonia  1  2/1077 (0.19%)  3 3/1075 (0.28%)  3
Diverticulitis  1  1/1077 (0.09%)  1 1/1075 (0.09%) 
Appendicitis  1  0/1077 (0.00%)  0 1/1075 (0.09%)  1
Infective exacerbation of chronic obstructive airways disease  1  0/1077 (0.00%)  0 1/1075 (0.09%)  1
Lower respiratory tract infection viral  1  1/1077 (0.09%)  1 0/1075 (0.00%)  0
Pneumonia mycoplasmal  1  0/1077 (0.00%)  0 1/1075 (0.09%)  1
Pyelonephritis acute  1  0/1077 (0.00%)  0 1/1075 (0.09%)  1
Tonsillitis  1  0/1077 (0.00%)  0 1/1075 (0.09%)  1
Injury, poisoning and procedural complications     
Ankle fracture  1  0/1077 (0.00%)  0 1/1075 (0.09%)  1
Fall  1  0/1077 (0.00%)  0 1/1075 (0.09%)  1
Skin laceration  1  1/1077 (0.09%)  1 0/1075 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis reactive  1  1/1077 (0.09%)  1 0/1075 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate cancer  1  0/1077 (0.00%)  0 1/1075 (0.09%)  1
Nervous system disorders     
Migraine  1  0/1077 (0.00%)  0 1/1075 (0.09%)  1
Psychiatric disorders     
Bipolar disorder  1  0/1077 (0.00%)  0 1/1075 (0.09%)  1
Delirium  1  0/1077 (0.00%)  0 1/1075 (0.09%)  1
Reproductive system and breast disorders     
Adnexal torsion  1  1/1077 (0.09%)  1 0/1075 (0.00%)  0
Ovarian cyst  1  1/1077 (0.09%)  1 0/1075 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/1077 (0.00%)  0 2/1075 (0.19%)  2
COPD  1  1/1077 (0.09%)  1 1/1075 (0.09%)  1
Bronchial hyperreactivity  1  0/1077 (0.00%)  0 1/1075 (0.09%)  1
Bronchiectasis  1  0/1077 (0.00%)  0 1/1075 (0.09%)  1
Pulmonary embolism  1  0/1077 (0.00%)  0 1/1075 (0.09%)  1
Surgical and medical procedures     
Cholecystectomy  1  1/1077 (0.09%)  1 0/1075 (0.00%)  0
Endometriosis ablation  1  1/1077 (0.09%)  1 0/1075 (0.00%)  0
Hysterectomy  1  0/1077 (0.00%)  0 1/1075 (0.09%)  1
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MVA-NP+M1 Group Saline Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   524/1077 (48.65%)      435/1075 (40.47%)    
Ear and labyrinth disorders     
EAR AND LABYRINTH DISORDERS  1  14/1077 (1.30%)  15 12/1075 (1.12%)  12
Eye disorders     
EYE DISORDERS  1  0/1077 (0.00%)  0 14/1075 (1.30%)  16
Gastrointestinal disorders     
Nausea  1  26/1077 (2.41%)  28 24/1075 (2.23%)  26
Diarrhoea  1  12/1077 (1.11%)  12 15/1075 (1.40%)  16
General disorders     
Injection site pain  1  73/1077 (6.78%)  74 0/1075 (0.00%)  0
Fatigue  1  43/1077 (3.99%)  46 24/1075 (2.23%)  25
Pyrexia  1  30/1077 (2.79%)  32 0/1075 (0.00%)  0
Malaise  1  16/1077 (1.49%)  18 19/1075 (1.77%)  21
Influenza like illness  1  23/1077 (2.14%)  23 15/1075 (1.40%)  15
Feeling hot  1  11/1077 (1.02%)  11 0/1075 (0.00%)  0
Immune system disorders     
Seasonal allergy  1  14/1077 (1.30%)  15 12/1075 (1.12%)  14
Infections and infestations     
Upper respiratory tract infection  1  20/1077 (1.86%)  22 31/1075 (2.88%)  34
Nasopharyngitis  1  12/1077 (1.11%)  12 15/1075 (1.40%)  16
Influenza  1  11/1077 (1.02%)  11 0/1075 (0.00%)  0
Injury, poisoning and procedural complications     
INJURY, POISONING AND PROCEDURAL COMPLICATIONS  1  25/1077 (2.32%)  30 24/1075 (2.23%)  27
Musculoskeletal and connective tissue disorders     
Myalgia  1  59/1077 (5.48%)  61 36/1075 (3.35%)  39
Arthralgia  1  12/1077 (1.11%)  12 13/1075 (1.21%)  15
Back pain  1  0/1077 (0.00%)  0 11/1075 (1.02%)  11
Musculoskeletal pain  1  11/1077 (1.02%)  11 0/1075 (0.00%)  0
Pain in extremity  1  11/1077 (1.02%)  11 0/1075 (0.00%)  0
Nervous system disorders     
Headache  1  145/1077 (13.46%)  170 122/1075 (11.35%)  135
Dizziness  1  12/1077 (1.11%)  12 0/1075 (0.00%)  0
Migraine  1  0/1077 (0.00%)  0 12/1075 (1.12%)  15
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal pain  1  115/1077 (10.68%)  122 119/1075 (11.07%)  127
Rhinorrhoea  1  89/1077 (8.26%)  97 93/1075 (8.65%)  102
Nasal congestion  1  90/1077 (8.36%)  95 84/1075 (7.81%)  93
Cough  1  73/1077 (6.78%)  76 86/1075 (8.00%)  91
Sneezing  1  25/1077 (2.32%)  28 12/1075 (1.12%)  13
Skin and subcutaneous tissue disorders     
SKIN AND SUBCUTANEOUS TISSUE DISORDERS  1  19/1077 (1.76%)  22 18/1075 (1.67%)  19
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tom Evans, MD
Organization: Vaccitech Ltd.
Phone: +44 01865 591 445
EMail: enquiries@vaccitech.co.uk
Layout table for additonal information
Responsible Party: Vaccitech (UK) Limited
ClinicalTrials.gov Identifier: NCT03880474    
Other Study ID Numbers: FLU009
First Submitted: February 21, 2019
First Posted: March 19, 2019
Results First Submitted: January 29, 2021
Results First Posted: April 26, 2021
Last Update Posted: April 26, 2021