Trial · NCT03165617
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of QIVc in Subjects ≥2 to <18 Years of Age
NCT03165617, Phase 3, Completed, Seqirus; results first posted 2020-10-22
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of QIVc in Subjects ≥2 to <18 Years of Age. Trials, record NCT03165617. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03165617
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of QIVc in Subjects ≥2 to <18 Years of Age
- NCT number
- NCT03165617
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,514 participants, actual
- Lead sponsor
- Seqirus
- Conditions
- Influenza, Human
- Interventions
- QIVc, Non-influenza Comparator Vaccine
- First posted
- 2017-05-24
- Last updated
- 2020-10-22
- Other registries' IDs
- eudract:2016-002883-15
- Results first posted
- 2020-10-22
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Efficacy: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza (Time-to-event Analyses) Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine in Subjects ≥2 to <18 Years | Day 14 to Day 180 or until the end of the influenza season, whichever is longer | The primary efficacy endpoint was defined as the time from the last study vaccination to the onset of the first occurrence of either RT-PCR- or culture-confirmed influenza (time-to-event analyses) due to any influenza Type A or B strain regardless of antigenic match to the strains selected for the seasonal vaccine, that occurred more than 14 days after the last vaccination until the end of the influenza season. Dataset Used: FAS-Efficacy = All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination. The success criterion used for this primary objective was as follows: The efficacy of the QIVc was demonstrated if the lower limit (LL) of the 2-sided 95% confidence interval (CI) for VE was above 20%. |
| Primary | Co-Primary: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza (Time-to-event Analyses) Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine in Subjects ≥3 to <18 Years | Day 14 to Day 180 or until the end of the influenza season, whichever is longer | The co-primary efficacy endpoint: was defined as the time from the last study vaccination to the onset of the first occurrence of either RT-PCR- or culture-confirmed influenza (time-to-event analyses) due to any influenza Type A or B strain regardless of antigenic match to the strains selected for the seasonal vaccine, that occurred more than 14 days after the last vaccination until the end of the influenza season.Absolute vaccine efficacy of QIVc by first occurrence RT-PCR or culture confirmed influenza, due to any influenza Type A and B strain in subjects ≥3 years to \<18 years of age |
| Secondary | Secondary Efficacy #1: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine | Day 14 to Day 180 or until the end of the influenza season, whichever is longer. | The endpoint was defined as the time from the last study vaccination to the onset of the first occurrence of either RT-PCR- or culture-confirmed influenza due to any influenza Type A or B strain regardless of antigenic match to the strains selected for the seasonal vaccine, that occurred more than 14 days after the last vaccination until the end of the influenza season in subjects 2 to \<18 years, 2 to \<9 years, 4 to \<18 years, and 9 to \<18 years. Dataset used: FAS Efficacy = All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination. |
| Secondary | Secondary Efficacy #2: First Occurrence of RT-PCR-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine | Day 14 to Day 180 or until the end of the influenza season, whichever is longer. | The endpoint was defined as the time from the last study vaccination to the onset of the first occurrence of RT-PCR-confirmed influenza due to any influenza Type A or B strain regardless of antigenic match to the strains selected for the seasonal vaccine, that occurred more than 14 days after the last vaccination until the end of the influenza season in subjects 2 to \<18 years, 2 to \<9 years, 4 to \<18 years, and 9 to \<18 years Dataset used: FAS Efficacy - All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination. |
| Secondary | Secondary Efficacy #3: First Occurrence of Culture-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine | Day 14 to Day 180 or until the end of the influenza season, whichever is longer. | The secondary endpoint was defined as the time from the last study vaccination to the onset of the first occurrence of culture-confirmed influenza due to any influenza Type A or B strain regardless of antigenic match to the strains selected for the seasonal vaccine, that occurred more than 14 days after the last vaccination until the end of the influenza season in subjects 2 to \<18 years, 2 to \<9 years, 4 to \<18 years, and 9 to \<18 years. Dataset used: FAS Efficacy |
| Secondary | Secondary Efficacy #4: First Occurrence of Culture-confirmed Influenza Due to Influenza Type A or B Strain Antigenically Matched to the Strains Selected for the Seasonal Vaccine | Day 14 to Day 180 or until the end of the influenza season, whichever is longer. | The endpoint was defined as the time from the last study vaccination to the onset of the first occurrence of culture-confirmed influenza due to influenza Type A or B strain antigenically matched to the strains selected for the seasonal vaccine, that occurred more than 14 days after the last vaccination until the end of the influenza season in subjects 2 to \<18 years, 2 to \<9 years, 4 to \<18 years, and 9 to \<18 years. |
| Secondary | Secondary Immunogenicity: Geometric Mean Titers for 4 Influenza Strains (HI Assay) | Day 1 (all subjects), Day 22 (all previously vaccinated subjects) or Day 29 and Day 50 (all not previously vaccinated subjects receiving 2 doses) | Immunogenicity was characterized by HI assay 3 weeks after the last vaccination in a subset of subjects 2 to \<9 years of age enrolled in Season 2 (n=432) and Season 3 (n=319) who were immunized and had immunogenicity data at the assessed timepoints (FAS Immunogenicity). Immunogenicity was assessed at baseline (Day 1; all subjects in immunogenicity subset), at Day 22 (all "previously vaccinated" subjects receiving a single dose of the study vaccine), and at Days 29 and 50 (all "not previously vaccinated" subjects receiving 2 doses) for all 4 influenza strains using the HI assay. |
| Secondary | ISecondary Immunogenicity: Percentage of Subjects Achieving Seroconversion for 4 Influenza Strains (HI Assay) | Day 22 (all previously vaccinated subjects) or Day 29 and Day 50 (all not previously vaccinated subjects) | Immunogenicity was characterized by HI assay 3 weeks after the last vaccination in a subset of subjects 2 to \<9 years of age enrolled in Season 2 (n=432) and Season 3 (n=319) who were immunized and had immunogenicity data at the assessed timepoints (FAS Immunogenicity). Immunogenicity was assessed at baseline (Day 1; all subjects in immunogenicity subset), at Day 22 (all "previously vaccinated" subjects receiving a single dose of the study vaccine), and at Days 29 and 50 (all "not previously vaccinated" subjects receiving 2 doses) for all 4 influenza strains using the HI assay. Seroconversion was defined as: either a prevaccination HI titer \<1:10 and a postvaccination HI titer ≥1:40 or a prevaccination HI titer ≥1:10 and a ≥4 fold increase in postvaccination HI titer) Dataset used: FAS Immunogenicity = All subjects in the All Enrolled Set who received at least one dose of study vaccine and provided evaluable serum samples at both baseline and after the last vaccination. |
| Secondary | Secondary Immunogenicity: Geometric Mean Ratio for 4 Influenza Strains (HI Assay) | Day 22/Day 1 (all previously vaccinated subjects) or Day 29/Day 1 and Day 50/Day 1 (all not previously vaccinated subjects receiving 2 doses) | Immunogenicity was characterized by HI assay 3 weeks after the last vaccination in a subset of subjects 2 to \<9 years of age enrolled in Season 2 (n=432) and Season 3 (n=319) who were immunized and had immunogenicity data at the assessed timepoints (FAS Immunogenicity). Immunogenicity was assessed at baseline (Day 1; all subjects in immunogenicity subset), at Day 22 (all "previously vaccinated" subjects receiving a single dose of the study vaccine), and at Days 29 and 50 (all "not previously vaccinated" subjects receiving 2 doses) for all 4 influenza strains using the HI assay. Geometric mean ratios (GMRs) measure the ratio in immunogenicity titers within subject\\ Dataset used: FAS Immunogenicity = All subjects in the All Enrolled Set who received at least one dose of study vaccine and provided evaluable serum samples at both baseline and after the last vaccination. |
| Secondary | Secondary Immunogenicity: Percentage of Subjects With HI Titer ≥1:40 for All 4 Influenza Strains (HI Assay) | Day 1 (all subjects), Day 22 (all "previously vaccinated" subjects receiving a single vaccine dose) or Days 29 and 50 (all "not previously vaccinated"subjects receiving 2 doses) | Immunogenicity was characterized by HI assay 3 weeks after the last vaccination in a subset of subjects 2 to \<9 years of age enrolled in Season 2 (n=432) and Season 3 (n=319) who were immunized and had immunogenicity data at the assessed timepoints (FAS Immunogenicity). Immunogenicity was assessed at baseline (Day 1; all subjects in immunogenicity subset), at Day 22 (all "previously vaccinated" subjects receiving a single dose of the study vaccine), and at Days 29 and 50 (all "not previously vaccinated" subjects receiving 2 doses) for all 4 influenza strains using the HI assay. The measures for assessing immunogenicity as determined by HI were as follows: Percentage of subjects with an HI titer ≥1:40 on Day 22 (all "previously vaccinated" subjects receiving a single vaccine dose) or Days 29 and 50 (all "not previously vaccinated" subjects receiving 2 doses) for all 4 influenza strains |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Primary Efficacy: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza (Time-to-event Analyses) Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine in Subjects ≥2 to <18 Years | Day 14 to Day 180 or until the end of the influenza season, whichever is longer | FAS Efficacy - All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination. | Number of cases | NUMBER |
| PRIMARY | Co-Primary: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza (Time-to-event Analyses) Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine in Subjects ≥3 to <18 Years | Day 14 to Day 180 or until the end of the influenza season, whichever is longer | FAS Efficacy - All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination. | Number of cases | NUMBER |
| SECONDARY | Secondary Efficacy #1: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine | Day 14 to Day 180 or until the end of the influenza season, whichever is longer. | FAS Efficacy = All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination. | Number of cases | NUMBER |
| SECONDARY | Secondary Efficacy #2: First Occurrence of RT-PCR-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine | Day 14 to Day 180 or until the end of the influenza season, whichever is longer. | FAS-Efficacy = All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination. | Number of cases | NUMBER |
| SECONDARY | Secondary Efficacy #3: First Occurrence of Culture-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine | Day 14 to Day 180 or until the end of the influenza season, whichever is longer. | FAS-Efficacy = All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination. | Number of cases | NUMBER |
| SECONDARY | Secondary Efficacy #4: First Occurrence of Culture-confirmed Influenza Due to Influenza Type A or B Strain Antigenically Matched to the Strains Selected for the Seasonal Vaccine | Day 14 to Day 180 or until the end of the influenza season, whichever is longer. | FAS-Efficacy = All subjects in the All Enrolled Set who received at least one dose of study vaccine and were evaluated for efficacy from 14 days after the last vaccination. | Number of cases | NUMBER |
| SECONDARY | Secondary Immunogenicity: Geometric Mean Titers for 4 Influenza Strains (HI Assay) | Day 1 (all subjects), Day 22 (all previously vaccinated subjects) or Day 29 and Day 50 (all not previously vaccinated subjects receiving 2 doses) | FAS Immunogenicity - All Subjects in the All Enrolled Set who received at least one dose of study vaccine and provided evaluable serum samples at both baseline at after the last vaccination | Geometric mean titers (GMTs) | NUMBER |
| SECONDARY | ISecondary Immunogenicity: Percentage of Subjects Achieving Seroconversion for 4 Influenza Strains (HI Assay) | Day 22 (all previously vaccinated subjects) or Day 29 and Day 50 (all not previously vaccinated subjects) | FAS Immunogenicity: all subjects in the All Enrolled Set who received at least one dose of study vaccine and provided evaluable serum samples at both baseline and after the last vaccination. | Percentage of participants | NUMBER |
| SECONDARY | Secondary Immunogenicity: Geometric Mean Ratio for 4 Influenza Strains (HI Assay) | Day 22/Day 1 (all previously vaccinated subjects) or Day 29/Day 1 and Day 50/Day 1 (all not previously vaccinated subjects receiving 2 doses) | FAS Immunogenicity: all subjects in the All Enrolled Set who received at least one dose of study vaccine and provided evaluable serum samples at both baseline and after the last vaccination. | Geometric mean ratio (GMR) | NUMBER |
| SECONDARY | Secondary Immunogenicity: Percentage of Subjects With HI Titer ≥1:40 for All 4 Influenza Strains (HI Assay) | Day 1 (all subjects), Day 22 (all previously vaccinated subjects receiving a single vaccine dose) or Days 29 and 50 (all not previously vaccinatedsubjects receiving 2 doses) | Dataset used: FAS Immunogenicity = all subjects in the All Enrolled Set who received at least one dose of study vaccine and provided evaluable serum samples at both baseline and after the last vaccination. | Percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group146
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Primary Efficacy: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza (Time-to-event Analyses) Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine in Subjects ≥2 to <18 Years | QIVc (≥2 Years to <18 Years of Age) | 175 | Number of cases | ||
Primary Efficacy: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza (Time-to-event Analyses) Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine in Subjects ≥2 to <18 Years | Non-Influenza Comparator Vaccine | 364 | Number of cases | ||
Co-Primary: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza (Time-to-event Analyses) Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine in Subjects ≥3 to <18 Years | QIVc (≥3 Years to <18 Years of Age) | 171 | Number of cases | ||
Co-Primary: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza (Time-to-event Analyses) Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine in Subjects ≥3 to <18 Years | Non-Influenza Comparator Vaccine | 351 | Number of cases | ||
Secondary Efficacy #1: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine | QIVc (≥2 Years to <18 Years of Age) | 175 | Number of cases | ||
Secondary Efficacy #1: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine | Non-Influenza Comparator Vaccine | 364 | Number of cases | ||
Secondary Efficacy #1: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine | QIVc (≥2 Years to <9 Years of Age) | 123 | Number of cases | ||
Secondary Efficacy #1: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine | Comparator (≥2 Years to <9 Years of Age) | 234 | Number of cases | ||
Secondary Efficacy #1: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine | QIVc (≥4 Years to <18 Years of Age) | 154 | Number of cases | ||
Secondary Efficacy #1: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine | Comparator (≥4 Years to <18 Years of Age) | 310 | Number of cases |
1 to 10 of 146Source ClinicalTrials.gov
See all 146 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | QIVc (≥2 Years to <18 Years of Age) | 2,258 | |
| Overall Study | STARTED | Non-Influenza Comparator Vaccine | 2,256 | |
| Overall Study | COMPLETED | QIVc (≥2 Years to <18 Years of Age) | 2,249 | |
| Overall Study | COMPLETED | Non-Influenza Comparator Vaccine | 2,247 | |
| Overall Study | NOT COMPLETED | QIVc (≥2 Years to <18 Years of Age) | 9 | |
| Overall Study | NOT COMPLETED | Non-Influenza Comparator Vaccine | 9 |
Source ClinicalTrials.gov
Adverse events90
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 | Influenza like illness | General disorders | QIVc (≥2 Years to <18 Years of Age) | 791 | 2,258 | 791 |
| other | Influenza like illness | General disorders | Non-Influenza Comparator Vaccine | 894 | 2,255 | 894 |
| other | Nasopharyngitis | Infections and infestations | QIVc (≥2 Years to <18 Years of Age) | 111 | 2,258 | 111 |
| other | Nasopharyngitis | Infections and infestations | Non-Influenza Comparator Vaccine | 135 | 2,255 | 135 |
| other | Upper respiratory tract infection | Infections and infestations | QIVc (≥2 Years to <18 Years of Age) | 298 | 2,258 | 298 |
| other | Upper respiratory tract infection | Infections and infestations | Non-Influenza Comparator Vaccine | 270 | 2,255 | 270 |
| serious | Clavicle fracture | Injury, poisoning and procedural complications | QIVc (≥2 Years to <18 Years of Age) | 1 | 2,258 | 1 |
| serious | Clavicle fracture | Injury, poisoning and procedural complications | Non-Influenza Comparator Vaccine | 0 | 2,255 | 0 |
| serious | Hand fracture | Injury, poisoning and procedural complications | QIVc (≥2 Years to <18 Years of Age) | 1 | 2,258 | 1 |
| serious | Hand fracture | Injury, poisoning and procedural complications | Non-Influenza Comparator Vaccine | 0 | 2,255 | 0 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | QIVc (≥2 Years to <18 Years of Age) | 0 | 2,258 |
| Total, all-cause mortality | Non-Influenza Comparator Vaccine | 1 | 2,255 |
| Total, other adverse events | QIVc (≥2 Years to <18 Years of Age) | 871 | 2,258 |
| Total, other adverse events | Non-Influenza Comparator Vaccine | 963 | 2,255 |
| Total, serious adverse events | QIVc (≥2 Years to <18 Years of Age) | 25 | 2,258 |
| Total, serious adverse events | Non-Influenza Comparator Vaccine | 30 | 2,255 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34644472 | 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 |
|---|---|
| QIVc (≥2 Years to <18 Years of Age) vs Non-Influenza Comparator Vaccine: deaths from any cause | Trial comparisons |
| QIVc (≥2 Years to <18 Years of Age) vs Non-Influenza Comparator Vaccine: 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/NCT03165617
GET https://conductscience.org/api/trials/v1/NCT03165617/results?page=2