Trial · NCT02914275
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.
NCT02914275, Phase 3, Completed, Seqirus; results first posted 2019-01-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age. Trials, record NCT02914275. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02914275
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.
- NCT number
- NCT02914275
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,250 participants, actual
- Lead sponsor
- Seqirus
- Conditions
- Influenza, Human
- Interventions
- Seqirus Quadrivalent Inactivated Influenza Vaccine, Comparator Quadrivalent Inactivated Influenza Vaccine
- First posted
- 2016-09-26
- Last updated
- 2019-01-23
- Results first posted
- 2019-01-23
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. | Postvaccination (28 days after last vaccination) | Noninferiority of Seqirus QIV compared to comparator QIV was assessed by hemagglutination inhibition (HI) antibody geometric mean titer (GMT) for each viral strain included in the vaccines. The GMT ratio is defined as the geometric mean of the postvaccination HI titer for the US-licensed comparator QIV over the geometric mean of the postvaccination HI titer for Seqirus QIV. B/VIC = B/Victoria B/YAM = B/Yamagata |
| Primary | The Difference in Seroconversion Rate (SCR) for Each Virus Strain. | Postvaccination (28 days after last vaccination) | Noninferiority of Seqirus QIV compared to comparator QIV will be assessed by seroconversion rate (SCR) for each viral strain. SCR is defined as the percentage of subjects with 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. For the SCR comparison, the difference between the SCR for each vaccine (for each strain) will be determined. |
| Secondary | Number of Participants With Solicited Local Adverse Reactions and Solicited Systemic Adverse Events (AE) | Postvaccination (up to 7 days after vaccination) | Frequency and severity of solicited local adverse reactions and systemic AEs for 7 days after each vaccination dose |
| Secondary | Number of Participants With Cellulitis-like Reactions | Postvaccination (up to 28 days after each vaccination) | Frequency of cellulitis-like reactions for at least 28 days after each vaccination dose |
| Secondary | Number of Participants With Unsolicited AEs | Postvaccination (up to 28 days after vaccination) | Frequency and severity of unsolicited AEs for at least 28 days after each vaccination dose |
| Secondary | Number of Participants With Serious Adverse Events (SAE) | 180 days after the last vaccination dose. | Frequency of SAEs for 180 days after the last vaccination dose. SAE = serious adverse events, AESI = adverse event of special interest |
| Secondary | Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain | 28 days after last vaccination. | The humoral immune response will be assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate geometric mean of HI titers prevaccination \& postvaccination. |
| Secondary | Seroconversion Rates (SCRs) of Each Virus Strain | 28 days after last vaccination | The humoral immune response will be assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate SCRs defined as the % of subjects with either a prevaccination HI titer \< 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in postvaccination titer. |
| Secondary | Seroprotection Rates of Each Virus Strain | 28 days after last vaccination. | The humoral immune response will be assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate the percentage of subjects with a titer ≥40 (seroprotection rates) at Day 1 and at Study Exit Visit. |
| Secondary | Geometric Mean Fold Increase (GMFI) of Each Virus Strain | Prevaccination (Day 1) and Postvaccination (28 days after last vaccination) | The humoral immune response will be assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains will be used to calculate GMFIs, defined as the geometric mean fold titer change (rise) from Day 1 to Study Exit Visit. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. | Postvaccination (28 days after last vaccination) | The Per-Protocol Population (PPS) comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results. | Geometric Mean Titer | GEOMETRIC_MEAN |
| PRIMARY | The Difference in Seroconversion Rate (SCR) for Each Virus Strain. | Postvaccination (28 days after last vaccination) | The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Solicited Local Adverse Reactions and Solicited Systemic Adverse Events (AE) | Postvaccination (up to 7 days after vaccination) | The Solicited Safety Population comprises all subjects in the Full Analysis Set (FAS) who received at least one dose or partial dose of Study Vaccine and had provided any evaluable data on solicited events. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Cellulitis-like Reactions | Postvaccination (up to 28 days after each vaccination) | The Solicited Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and had provided any evaluable data on solicited events. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Unsolicited AEs | Postvaccination (up to 28 days after vaccination) | The Overall Safety Population was used for the analysis of overall and unsolicited adverse event safety and comprised all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and have provided any evaluable follow-up safety data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Adverse Events (SAE) | 180 days after the last vaccination dose. | The Overall Safety Population was used for the analysis of overall and unsolicited adverse event safety and comprised all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and have provided any evaluable follow-up safety data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain | 28 days after last vaccination. | The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results. | Titers | GEOMETRIC_MEAN |
| SECONDARY | Seroconversion Rates (SCRs) of Each Virus Strain | 28 days after last vaccination | The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results. | Percentage of participants | NUMBER |
| SECONDARY | Seroprotection Rates of Each Virus Strain | 28 days after last vaccination. | The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results. | Percentage of participants | NUMBER |
| SECONDARY | Geometric Mean Fold Increase (GMFI) of Each Virus Strain | Prevaccination (Day 1) and Postvaccination (28 days after last vaccination) | The Per-Protocol Population comprised all subjects in the Evaluable Population who did not have any protocol deviations that were medically assessed as potentially impacting on immunogenicity results. | Fold Change | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group130
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. | Seqirus QIV | A/H1N1 | 370.0 | 95% Confidence Interval 345.13 to 396.55 | Geometric Mean Titer |
| The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. | Comparator QIV | A/H1N1 | 311.7 | 95% Confidence Interval 276.88 to 350.90 | Geometric Mean Titer |
| The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. | Seqirus QIV | A/H3N2 | 436.8 | 95% Confidence Interval 403.04 to 473.28 | Geometric Mean Titer |
| The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. | Comparator QIV | A/H3N2 | 589.1 | 95% Confidence Interval 516.42 to 671.91 | Geometric Mean Titer |
| The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. | Seqirus QIV | B/YAM | 25.5 | 95% Confidence Interval 23.93 to 27.06 | Geometric Mean Titer |
| The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. | Comparator QIV | B/YAM | 29.7 | 95% Confidence Interval 26.51 to 33.21 | Geometric Mean Titer |
| The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. | Seqirus QIV | B/VIC | 56.8 | 95% Confidence Interval 52.90 to 60.96 | Geometric Mean Titer |
| The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. | Comparator QIV | B/VIC | 57.9 | 95% Confidence Interval 51.04 to 65.62 | Geometric Mean Titer |
| The Difference in Seroconversion Rate (SCR) for Each Virus Strain. | Seqirus QIV | A/H1N1 | 79.1 | 95% Confidence Interval 76.9 to 81.1 | Percentage of participants |
| The Difference in Seroconversion Rate (SCR) for Each Virus Strain. | Comparator QIV | A/H1N1 | 68.8 | 95% Confidence Interval 64.5 to 72.9 | Percentage of participants |
1 to 10 of 130Source ClinicalTrials.gov
See all 130 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Seqirus QIV | 1,687 | |
| Overall Study | STARTED | Comparator QIV | 563 | |
| Overall Study | Included in Clinical Database / FAS | Seqirus QIV | 1,684 | |
| Overall Study | Included in Clinical Database / FAS | Comparator QIV | 563 | |
| Overall Study | COMPLETED | Seqirus QIV | 1,566 | |
| Overall Study | COMPLETED | Comparator QIV | 521 | |
| Overall Study | NOT COMPLETED | Seqirus QIV | 121 | |
| Overall Study | NOT COMPLETED | Comparator QIV | 42 |
Source ClinicalTrials.gov
Adverse events34
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 | Cough | Respiratory, thoracic and mediastinal disorders | Seqirus QIV | 153 | 1,673 | 167 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Comparator QIV | 41 | 559 | 52 |
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Seqirus QIV | 134 | 1,673 | 155 |
| other | Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Comparator QIV | 53 | 559 | 63 |
| other | Pyrexia | Infections and infestations | Seqirus QIV | 91 | 1,673 | 100 |
| other | Pyrexia | Infections and infestations | Comparator QIV | 25 | 559 | 29 |
| other | Upper respiratory tract infection | Infections and infestations | Seqirus QIV | 67 | 1,673 | 72 |
| other | Upper respiratory tract infection | Infections and infestations | Comparator QIV | 17 | 559 | 17 |
| serious | Croup Infectious | Infections and infestations | Seqirus QIV | 2 | 1,673 | 2 |
| serious | Croup Infectious | Infections and infestations | Comparator QIV | 0 | 559 | 0 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Seqirus QIV | 0 | 1,673 |
| Total, all-cause mortality | Comparator QIV | 0 | 559 |
| Total, other adverse events | Seqirus QIV | 320 | 1,673 |
| Total, other adverse events | Comparator QIV | 80 | 559 |
| Total, serious adverse events | Seqirus QIV | 11 | 1,673 |
| Total, serious adverse events | Comparator QIV | 3 | 559 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30057283 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Seqirus QIV vs Comparator QIV: Number of Participants With Cellulitis-like Reactions | Trial comparisons |
| Seqirus QIV vs Comparator QIV: deaths from any cause | Trial comparisons |
| Seqirus QIV vs Comparator QIV: 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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The record and each of its lists are JSON, twenty rows a page. No key.
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