Trial · NCT02545543
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| 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 |
| Secondary | Immunogenicity Endpoint: Geometric Mean Fold Increase (GMFI) | 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 fold increase (GMFI): geometric mean fold titer rise from Day 1 to Exit Visit |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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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