Trial · NCT02839330
A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age
NCT02839330, Phase 3, Completed, Seqirus; results first posted 2019-04-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age. Trials, record NCT02839330. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02839330
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects ≥18 Years of Age
- NCT number
- NCT02839330
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 3,196 participants, actual
- Lead sponsor
- Seqirus
- Conditions
- Avian Influenza
- Interventions
- aH5N1c, Placebo
- First posted
- 2016-07-20
- Last updated
- 2024-12-06
- Results first posted
- 2019-04-04
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot | Day 1, Day 43 | Hemagglutination Inhibition (HI) GMT was assessed at Day 1 and Day 43 for 3 consecutively produced lots. |
| Primary | Primary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 at Day 43 by Age Cohort | Day 1, Day 43 | Percentage of subjects with HI titer ≥ 1:40 at Day 43 was assessed by age cohort (18 to \<65 years of age and ≥65 years of age) for the pooled lots. Center for Biologics Evaluation and Research (CBER) criterion for subjects aged 18 to \<65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%. CBER criterion for subjects aged ≥65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 60%. |
| Primary | Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination | Day 1 to Day 7 | Percentages of subjects with solicited local, solicited systemic, and other AEs as measured for 7 days (inclusive) following each vaccination (first and second) and any (first or second) vaccination, by treatment group and calculated for several time intervals after vaccination : 30 minutes, 1 to 3 days (without 30 minutes), 4 to 7 days, and 1 to 7 days (without 30 minutes), and 1 to 3 days (including 30 minutes) and 1 to 7 days (including 30 minutes). Analysis for intervals of the first 30 minutes, days 1 to 3, and days 4 to 7 was not performed. |
| Primary | Percentages of Subjects With Any Unsolicited AEs Reported Through 21 Day After Vaccination | Day 1 to Day 43 | Percentages of subjects with any unsolicited AEs reported through 21 days after each (first and second) and any (first or second) vaccination by treatment group. |
| Primary | Percentages of Subjects Reporting SAEs, AESIs, NOCD, AEs Leading to Vaccine/Study Withdrawal, and Medically Attended AEs, and Concomitant Medications Associated With These Events as Collected From Day 1 to Day 387, by Vaccine Group. | Day 1 to Day 387 | Percentages of subjects with any adverse events (AE), adverse events of special interest (AESI), new onset of chronic disease (NOCD), and serious adverse event (SAE) through study termination by treatment group. |
| Secondary | Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age). | Day 1, Day 22, Day 43, and Day 183 | Estimates of hemagglutination inhibition (HI) GMTs, and their associated 95% CIs at Day 1, Day 22, Day 43 and Day 183 were computed using ANCOVA with factors for treatment (active treatment groups or placebo), center and a covariate for the effect defined by the log-transformed prevaccination antibody titer (Day 1). |
| Secondary | Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age). | Day 1, Day 22, Day 43 and Day 183 | The percentage of subjects with HI titer ≥1:40 data over time by vaccine group and age cohort are presented. CBER criterion for subjects aged 18 to \<65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%. CBER criterion for subjects aged ≥65 years: The lower bound of the 2-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 60%. |
| Secondary | Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age). | Day 22, and Day 43 | Percentage of subjects achieving seroconversion (defined as: HI titer ≥1:40 for subjects negative at baseline \[HI titer \<1:10\]; or a minimum 4-fold increase in HI titer for subjects positive at baseline \[HI titer ≥1:10\]) on Day 22, and Day 43 by vaccine group (aH5N1c or placebo) and by age cohort (18 to \<65 years of age and ≥65 years of age). |
| Secondary | Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and By Age Cohort (18 to <60 Years of Age and ≥60 Years of Age) | Day 1, Day 22, Day 43 and Day 183 | Hemagglutination inhibition (HI) GMTs were assessed over time for the vaccine group and age cohort. Adjusted estimates of GMTs, and their associated 95% CIs at Day 1, Day 22, Day 43 and Day 183 were computed using ANCOVA with factors for treatment (active treatment groups or placebo), center and a covariate for the effect defined by the log-transformed prevaccination antibody titer (Day 1). |
| Secondary | Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age) | Day 1, Day 22, Day 43, and Day 183 | The percentage of subjects with HI titer ≥1:40 data over time by vaccine group and age cohort. Committee for Medicinal Products for Human Use (CHMP) criterion for subjects aged 18 to \<60 years: The percentage of subjects achieving an HI titer ≥1:40 is \>70%. CHMP criterion for subjects aged ≥60 years: The percentage of subjects achieving an HI titer ≥1:40 is \>60%. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot | Day 1, Day 43 | Per Protocol Set (PPS) - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample (lot-to-lot consistency) at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons. | geometric mean titer | GEOMETRIC_MEAN |
| PRIMARY | Primary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 at Day 43 by Age Cohort | Day 1, Day 43 | The PPS consisting of all subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons was used for analysis. | percentage of subjects | NUMBER |
| PRIMARY | Percentage of Subjects With Solicited Local, Solicited Systemic, and Other Adverse Events (AEs) as Measured for 7 Days (Inclusive) Following Each Vaccination | Day 1 to Day 7 | The overall safety set consisting of all subjects who received a study vaccination who underwent any assessment of local and systemic site reaction and/or assessment of any use of analgesics/antipyretics was used for analysis. | percentage of subjects | NUMBER |
| PRIMARY | Percentages of Subjects With Any Unsolicited AEs Reported Through 21 Day After Vaccination | Day 1 to Day 43 | The unsolicited safety set consisting of all subjects who received a study vaccination and who underwent any AEs assessment (ie, a subject did not have to have any AEs) was used for analysis. | percentage of subjects | NUMBER |
| PRIMARY | Percentages of Subjects Reporting SAEs, AESIs, NOCD, AEs Leading to Vaccine/Study Withdrawal, and Medically Attended AEs, and Concomitant Medications Associated With These Events as Collected From Day 1 to Day 387, by Vaccine Group. | Day 1 to Day 387 | The unsolicited safety set consisting of all subjects who received a study vaccination and who underwent any AEs assessment (ie, a subject did not have to have any AEs) was used for analysis. | percentage of subjects | NUMBER |
| SECONDARY | Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age). | Day 1, Day 22, Day 43, and Day 183 | PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons. | titer | GEOMETRIC_MEAN |
| SECONDARY | Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age). | Day 1, Day 22, Day 43 and Day 183 | PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons. | percentage of subjects | NUMBER |
| SECONDARY | Secondary Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion on Day 22, and Day 43 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <65 Years of Age and ≥65 Years of Age). | Day 22, and Day 43 | PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons. | percentage of subjects | NUMBER |
| SECONDARY | Secondary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 1, Day 22, Day 43 and Day 183 by Vaccine Group (aH5N1c or Placebo) and By Age Cohort (18 to <60 Years of Age and ≥60 Years of Age) | Day 1, Day 22, Day 43 and Day 183 | PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons. | titer | NUMBER |
| SECONDARY | Secondary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 on Day 1, Day 22, Day 43, and Day 183 by Vaccine Group (aH5N1c or Placebo) and by Age Cohort (18 to <60 Years of Age and ≥60 Years of Age) | Day 1, Day 22, Day 43, and Day 183 | PPS - All subjects who received at least one dose of study vaccination and provided at least one evaluable serum sample at relevant timepoints and who correctly received the vaccine, had no major protocol deviations leading to exclusion, and were not excluded due to other reasons. | percentage of subjects | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group188
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot | Group A: aH5N1c Lot #1 | Day 1 | 16.1 | 95% Confidence Interval 15.1 to 17.2 | geometric mean titer |
| Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot | Group B: aH5N1c Lot #2 | Day 1 | 17.0 | 95% Confidence Interval 15.9 to 18.2 | geometric mean titer |
| Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot | Group C: aH5N1c Lot #3 | Day 1 | 17.0 | 95% Confidence Interval 15.9 to 18.2 | geometric mean titer |
| Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot | Group A: aH5N1c Lot #1 | Day 43 | 128.6 | 95% Confidence Interval 118.9 to 139.1 | geometric mean titer |
| Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot | Group B: aH5N1c Lot #2 | Day 43 | 127.4 | 95% Confidence Interval 117.6 to 138.0 | geometric mean titer |
| Primary Immunogenicity Endpoint: Geometric Mean Titer (GMT) at Day 43 by Lot | Group C: aH5N1c Lot #3 | Day 43 | 132.2 | 95% Confidence Interval 122.1 to 143.1 | geometric mean titer |
| Primary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 at Day 43 by Age Cohort | aH5N1c | Day 1, 18 to <65 years | 13.0 | 95% Confidence Interval 10.7 to 15.6 | percentage of subjects |
| Primary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 at Day 43 by Age Cohort | Placebo | Day 1, 18 to <65 years | 15.0 | 95% Confidence Interval 11.5 to 19.4 | percentage of subjects |
| Primary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 at Day 43 by Age Cohort | aH5N1c | Day 1, ≥65 Years | 27.8 | 95% Confidence Interval 24.9 to 30.9 | percentage of subjects |
| Primary Immunogenicity Endpoint: Percentage of Subjects With Haemagglutination Inhibition (HI) Titer ≥ 1:40 at Day 43 by Age Cohort | Placebo | Day 1, ≥65 Years | 24.5 | 95% Confidence Interval 20.1 to 29.6 | percentage of subjects |
1 to 10 of 188Source ClinicalTrials.gov
See all 188 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group A: aH5N1c Lot #1 | 804 | |
| Overall Study | STARTED | Group B: aH5N1c Lot #2 | 799 | |
| Overall Study | STARTED | Group C: aH5N1c Lot #3 | 795 | |
| Overall Study | STARTED | Group D: Placebo | 798 | |
| Overall Study | Exposed | Group A: aH5N1c Lot #1 | 804 | |
| Overall Study | Exposed | Group B: aH5N1c Lot #2 | 797 | |
| Overall Study | Exposed | Group C: aH5N1c Lot #3 | 793 | |
| Overall Study | Exposed | Group D: Placebo | 797 | |
| Overall Study | COMPLETED | Group A: aH5N1c Lot #1 | 746 | |
| Overall Study | COMPLETED | Group B: aH5N1c Lot #2 | 741 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events386
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 | Upper respiratory tract infection | Infections and infestations | aH5N1c | 91 | 2,395 | |
| other | Upper respiratory tract infection | Infections and infestations | Placebo | 44 | 796 | |
| serious | Anaemia | Blood and lymphatic system disorders | aH5N1c | 2 | 2,395 | |
| serious | Anaemia | Blood and lymphatic system disorders | Placebo | 0 | 796 | |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | aH5N1c | 1 | 2,395 | |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | Placebo | 0 | 796 | |
| serious | Immune thrombocytopenic purpura | Blood and lymphatic system disorders | aH5N1c | 0 | 2,395 | |
| serious | Immune thrombocytopenic purpura | Blood and lymphatic system disorders | Placebo | 1 | 796 | |
| serious | Atrial fibrillation | Cardiac disorders | aH5N1c | 8 | 2,395 | |
| serious | Atrial fibrillation | Cardiac disorders | Placebo | 8 | 796 |
1 to 10 of 386Source ClinicalTrials.gov
See all 386 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | aH5N1c | 11 | 2,395 |
| Total, all-cause mortality | Placebo | 1 | 796 |
| Total, other adverse events | aH5N1c | 91 | 2,395 |
| Total, other adverse events | Placebo | 44 | 796 |
| Total, serious adverse events | aH5N1c | 161 | 2,395 |
| Total, serious adverse events | Placebo | 74 | 796 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35455245 | 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 |
|---|---|
| aH5N1c vs Placebo: deaths from any cause | Trial comparisons |
| aH5N1c vs Placebo: 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.
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Read this trial from software.
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