Trial · NCT02545543
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age
NCT02545543, Phase 3, Completed, Seqirus; results first posted 2017-04-18
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 5 Through 17 Years of Age. Trials, record NCT02545543. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02545543
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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 5 Through 17 Years of Age
- NCT number
- NCT02545543
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,278 participants, actual
- Lead sponsor
- Seqirus
- Conditions
- Influenza, Human
- Interventions
- Seqirus QIV, Comparator QIV
- First posted
- 2015-09-10
- Last updated
- 2018-05-23
- Results first posted
- 2017-04-18
Source ClinicalTrials.gov
Registered outcomes11
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. | 28 days after last vaccination. | Noninferiority of Seqirus QIV compared to comparator QIV was assessed by the eight co-primary endpoints of hemagglutination inhibition (HI) antibody geometric mean titer (GMT) and seroconversion rate (SCR) 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. |
| Primary | The Difference in Seroconversion Rate (SCR) for Each Virus Strain. | 28 days after last vaccination. | Noninferiority of Seqirus QIV compared to Comparator QIV was assessed by the eight co-primary endpoints of HI geometric mean titer (GMT) and seroconversion rate (SCR) for each viral strain. The rate of 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 virus strain will be determined. |
| Secondary | Safety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions. | 7 days after each vaccination. | Frequency and severity of solicited local adverse reactions (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose |
| Secondary | Safety Endpoint: The Frequency and Severity of Solicited Systemic Adverse Events (AEs). | 7 days after each vaccination. | Frequency and severity of solicited systemic adverse events (AEs) for 7 days (ie, day of vaccination and 6 subsequent days) after each vaccination dose |
| Secondary | Safety Endpoint: The Frequency of Cellulitis-like Reaction. | 28 days after each vaccination. | Frequency of cellulitis-like reaction for at least 28 days after each vaccination dose |
| Secondary | Safety Endpoint: The Frequency and Severity of Unsolicited Adverse Events (AEs). | 28 days after each vaccination. | Frequency and severity of unsolicited AEs for at least 28 days (ie, day of vaccination and 27 subsequent days) after each vaccination dose |
| Secondary | Safety Endpoint: The Frequency of Serious Adverse Events (SAEs). | 180 days after the last vaccination dose. | Frequency of serious adverse events (SAEs) for 180 days after the last vaccination dose. |
| Secondary | Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit) | 28 days after last vaccination. | The humoral immune response was assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate: \- Geometric mean of HI titers prevaccination \& postvaccination |
| Secondary | Immunogenicity Endpoint: Seroconversion Rate (SCR) | 28 days after last vaccination. | The humoral immune response was assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate: \- SCRs: % 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 | Immunogenicity Endpoint: Seroprotection Rate | 28 days after last vaccination. | The humoral immune response was assessed for Seqirus QIV \& comparator QIV. Serum HI titers against the 4 influenza vaccine strains was used to calculate: \- The % of subjects with a titer ≥40 (seroprotection rates) at Day 1 and at Exit Visit |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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. | 28 days after last vaccination. | The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding. | Ratio | GEOMETRIC_MEAN |
| PRIMARY | The Difference in Seroconversion Rate (SCR) for Each Virus Strain. | 28 days after last vaccination. | The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding. | percentage of participants | NUMBER |
| SECONDARY | Safety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions. | 7 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 provided any evaluable data on solicited events. | participants | NUMBER |
| SECONDARY | Safety Endpoint: The Frequency and Severity of Solicited Systemic Adverse Events (AEs). | 7 days after each vaccination. | The Solicited Safety Population comprised all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable data on solicited events. | participants | NUMBER |
| SECONDARY | Safety Endpoint: The Frequency of Cellulitis-like Reaction. | 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 provided any evaluable data on solicited events. | participants | NUMBER |
| SECONDARY | Safety Endpoint: The Frequency and Severity of Unsolicited Adverse Events (AEs). | 28 days after each vaccination. | The Overall Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable follow-up safety data. | participants | NUMBER |
| SECONDARY | Safety Endpoint: The Frequency of Serious Adverse Events (SAEs). | 180 days after the last vaccination dose. | The Overall Safety Population comprises all subjects in the FAS who received at least one dose or partial dose of Study Vaccine and provided any evaluable follow-up safety data | participants | NUMBER |
| SECONDARY | Immunogenicity Endpoint: GMTs - Geometric Mean of HI Titers Prevaccination (Day 1) and Postvaccination (Study Exit Visit) | 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 | Titer | GEOMETRIC_MEAN |
| SECONDARY | Immunogenicity Endpoint: Seroconversion Rate (SCR) | 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 | Immunogenicity Endpoint: Seroprotection Rate | 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 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group72
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. | GMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV | A/H1N1 | 1.01 | 95% Confidence Interval 0.93 to 1.09 | Ratio |
| The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. | GMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV | A/H3N2 | 1.05 | 95% Confidence Interval 0.96 to 1.15 | Ratio |
| The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. | GMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV | B/Yamagata | 0.89 | 95% Confidence Interval 0.81 to 0.98 | Ratio |
| The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. | GMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV | B/Victoria | 0.92 | 95% Confidence Interval 0.83 to 1.02 | Ratio |
| The Difference in Seroconversion Rate (SCR) for Each Virus Strain. | SCR Difference = Comparator QIV SCR % Minus Seqirus QIV SCR % | A/H1N1 | -3.1 | 95% Confidence Interval -8.0 to 1.8 | percentage of participants |
| The Difference in Seroconversion Rate (SCR) for Each Virus Strain. | SCR Difference = Comparator QIV SCR % Minus Seqirus QIV SCR % | A/H3N2 | 0.4 | 95% Confidence Interval -4.5 to 5.3 | percentage of participants |
| The Difference in Seroconversion Rate (SCR) for Each Virus Strain. | SCR Difference = Comparator QIV SCR % Minus Seqirus QIV SCR % | B/Yamagata | -3.4 | 95% Confidence Interval -8.3 to 1.5 | percentage of participants |
| The Difference in Seroconversion Rate (SCR) for Each Virus Strain. | SCR Difference = Comparator QIV SCR % Minus Seqirus QIV SCR % | B/Victoria | -2.0 | 95% Confidence Interval -6.9 to 2.9 | percentage of participants |
| Safety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions. | Seqirus Quadrivalent Influenza Vaccine | Frequency of Solicited Local AEs | 909 | participants | |
| Safety Endpoint: The Frequency and Severity of Solicited Local Adverse Reactions. | Comparator Quadrivalent Influenza Vaccine | Frequency of Solicited Local AEs | 279 | participants |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Seqirus Quadrivalent Influenza Vaccine | 1,709 | |
| Overall Study | STARTED | Comparator Quadrivalent Influenza Vaccine | 569 | |
| Overall Study | COMPLETED | Seqirus Quadrivalent Influenza Vaccine | 1,628 | |
| Overall Study | COMPLETED | Comparator Quadrivalent Influenza Vaccine | 535 | |
| Overall Study | NOT COMPLETED | Seqirus Quadrivalent Influenza Vaccine | 81 | |
| Overall Study | NOT COMPLETED | Comparator Quadrivalent Influenza Vaccine | 34 |
Source ClinicalTrials.gov
Adverse events44
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 | Pain | General disorders | Seqirus Quadrivalent Influenza Vaccine | 833 | 1,692 | |
| other | Pain | General disorders | Comparator Quadrivalent Influenza Vaccine | 254 | 560 | |
| other | Swelling | General disorders | Seqirus Quadrivalent Influenza Vaccine | 224 | 1,692 | |
| other | Swelling | General disorders | Comparator Quadrivalent Influenza Vaccine | 62 | 560 | |
| other | Redness | General disorders | Seqirus Quadrivalent Influenza Vaccine | 278 | 1,692 | |
| other | Redness | General disorders | Comparator Quadrivalent Influenza Vaccine | 93 | 560 | |
| other | Nausea | Gastrointestinal disorders | Seqirus Quadrivalent Influenza Vaccine | 120 | 1,692 | |
| other | Nausea | Gastrointestinal disorders | Comparator Quadrivalent Influenza Vaccine | 44 | 560 | |
| other | Diarrhea | Gastrointestinal disorders | Seqirus Quadrivalent Influenza Vaccine | 86 | 1,692 | |
| other | Diarrhea | Gastrointestinal disorders | Comparator Quadrivalent Influenza Vaccine | 21 | 560 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Seqirus Quadrivalent Influenza Vaccine | ||
| Total, all-cause mortality | Comparator Quadrivalent Influenza Vaccine | ||
| Total, other adverse events | Seqirus Quadrivalent Influenza Vaccine | 1,019 | 1,692 |
| Total, other adverse events | Comparator Quadrivalent Influenza Vaccine | 319 | 560 |
| Total, serious adverse events | Seqirus Quadrivalent Influenza Vaccine | 8 | 1,692 |
| Total, serious adverse events | Comparator Quadrivalent Influenza Vaccine | 2 | 560 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28390934 | 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 Quadrivalent Influenza Vaccine vs Comparator Quadrivalent Influenza Vaccine: Safety Endpoint: The Frequency of Serious Adverse Events (SAEs). | Trial comparisons |
| Seqirus Quadrivalent Influenza Vaccine vs Comparator Quadrivalent Influenza Vaccine: Safety Endpoint: The Frequency of Cellulitis-like Reaction. | Trial comparisons |
| Seqirus Quadrivalent Influenza Vaccine vs Comparator Quadrivalent Influenza 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/NCT02545543
GET https://conductscience.org/api/trials/v1/NCT02545543/results?page=2