Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a study to assess the immune (antibody) response and safety of a Seqirus split virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US licensed 2016/2017 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric population 6 months through 59 months of age.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seqirus QIV Cohort A | Experimental | Seqirus Quadrivalent Inactivated Influenza Vaccine - Subjects 6 months through 35 months of age |
|
| Seqirus QIV Cohort B | Experimental | Seqirus Quadrivalent Inactivated Influenza Vaccine - Subjects 36 months through 59 months of age |
|
| Comparator QIV Cohort A | Active Comparator | Comparator Quadrivalent Inactivated Influenza Vaccine - Subjects 6 months through 35 months of age |
|
| Comparator QIV Cohort B | Active Comparator | Comparator Quadrivalent Inactivated Influenza Vaccine - Subjects 36 months through 59 months of age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seqirus Quadrivalent Inactivated Influenza Vaccine | Biological | The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season). Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle of the arm if muscle mass is adequate) in children 12 months through 35 months of age. |
| Measure | Description | Time Frame |
|---|---|---|
| The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. | 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 | Postvaccination (28 days after last vaccination) |
| The Difference in Seroconversion Rate (SCR) for Each Virus Strain. | 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. | Postvaccination (28 days after last vaccination) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Solicited Local Adverse Reactions and Solicited Systemic Adverse Events (AE) | Frequency and severity of solicited local adverse reactions and systemic AEs for 7 days after each vaccination dose | Postvaccination (up to 7 days after vaccination) |
| Number of Participants With Cellulitis-like Reactions |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 434 | Birmingham | Alabama | 35205 | United States | ||
| Site 442 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30057283 | Derived | Statler VA, Albano FR, Airey J, Sawlwin DC, Graves Jones A, Matassa V, Heijnen E, Edelman J, Marshall GS. Immunogenicity and safety of a quadrivalent inactivated influenza vaccine in children 6-59 months of age: A phase 3, randomized, noninferiority study. Vaccine. 2019 Jan 7;37(2):343-351. doi: 10.1016/j.vaccine.2018.07.036. Epub 2018 Jul 26. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A total of 2339 subjects were screened. A total of 2250 subjects were randomized to study treatment. Due to not having valid informed consent, 3 subjects were removed from the clinical database. Therefore, overall 2247 subjects gave informed consent and were included in the analysis set.
Subjects were enrolled from 27 September 2016 to 11 August 2017 from 39 study sites in the United States of America.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Seqirus QIV | Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine. |
| FG001 | Comparator QIV | Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 24, 2016 | Sep 17, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Comparator Quadrivalent Inactivated Influenza Vaccine | Biological | The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season. Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection of the non-dominant arm in children 36 months through 59 months of age. |
|
|
Frequency of cellulitis-like reactions for at least 28 days after each vaccination dose |
| Postvaccination (up to 28 days after each vaccination) |
| Number of Participants With Unsolicited AEs | Frequency and severity of unsolicited AEs for at least 28 days after each vaccination dose | Postvaccination (up to 28 days after vaccination) |
| Number of Participants With Serious Adverse Events (SAE) | Frequency of SAEs for 180 days after the last vaccination dose. SAE = serious adverse events, AESI = adverse event of special interest | 180 days after the last vaccination dose. |
| Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain | 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. | 28 days after last vaccination. |
| Seroconversion Rates (SCRs) of Each Virus Strain | 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. | 28 days after last vaccination |
| Seroprotection Rates of Each Virus Strain | 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. | 28 days after last vaccination. |
| Geometric Mean Fold Increase (GMFI) of Each Virus Strain | 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. | Prevaccination (Day 1) and Postvaccination (28 days after last vaccination) |
| Mobile |
| Alabama |
| 36608 |
| United States |
| Site 430 | Anaheim | California | 92804 | United States |
| Site 437 | Anaheim | California | 92804 | United States |
| Site 423 | Downey | California | 90241 | United States |
| Site 397 | Ontario | California | 91762 | United States |
| Site 445 | Paramount | California | 90723 | United States |
| Site 402 | Sacramento | California | 95822 | United States |
| Site 425 | San Diego | California | 92103 | United States |
| Site 418 | Miami | Florida | 33175 | United States |
| Site 426 | Miami | Florida | 33176 | United States |
| Site 289 | Meridian | Idaho | 83642 | United States |
| Site 390 | Augusta | Kansas | 67010 | United States |
| Site 421 | Newton | Kansas | 67114 | United States |
| Site 422 | Wichita | Kansas | 67205 | United States |
| Site 443 | Louisville | Kentucky | 40202 | United States |
| Site 420 | Louisville | Kentucky | 40291 | United States |
| Site 441 | Louisville | Kentucky | 40291 | United States |
| Site 393 | Metairie | Louisiana | 70002 | United States |
| Site 436 | Metairie | Louisiana | 70006 | United States |
| Site 285 | Binghamton | New York | 13901 | United States |
| Site 429 | Asheboro | North Carolina | 27203 | United States |
| Site 446 | Cincinnati | Ohio | 45229 | United States |
| Site 427 | Dayton | Ohio | 45419 | United States |
| Site 419 | Charleston | South Carolina | 29407 | United States |
| Site 439 | Spartanburg | South Carolina | 29303 | United States |
| Site 308 | Bristol | Tennessee | 37620 | United States |
| Site 444 | Kingsport | Tennessee | 37660 | United States |
| Site 283 | Austin | Texas | 78705 | United States |
| Site 282 | Fort Worth | Texas | 76135 | United States |
| Site 288 | San Angelo | Texas | 76904 | United States |
| Site 395 | Layton | Utah | 84041 | United States |
| Site 431 | Salt Lake City | Utah | 84109 | United States |
| Site 424 | Salt Lake City | Utah | 84121 | United States |
| Site 428 | Salt Lake City | Utah | 84124 | United States |
| Site 440 | West Jordan | Utah | 84084 | United States |
| Site 433 | West Jordan | Utah | 84088 | United States |
| Site 435 | West Jordan | Utah | 84088 | United States |
| Site 438 | Charlottesville | Virginia | 22902 | United States |
|
| Included in Clinical Database / FAS |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Full Analysis Set was used for analysis of subject characteristics and comprised all subjects whose parent(s)/guardian(s) had given informed consent and who were randomized to treatment. Screening failures were not included in the FAS.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Seqirus QIV | Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine. |
| BG001 | Comparator QIV | Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | months |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kilograms |
| |||||||||||||||
| Prevaccination Axillary Temperature | Mean | Standard Deviation | °F |
| |||||||||||||||
| Vaccination against influenza 2015/2016 season | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Geometric Mean Titer (GMT) Ratio of Each Virus Strain. | 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 | 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. | Posted | Geometric Mean | 95% Confidence Interval | Geometric Mean Titer | Postvaccination (28 days after last vaccination) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | The Difference in Seroconversion Rate (SCR) for Each Virus Strain. | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Postvaccination (28 days after last vaccination) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Solicited Local Adverse Reactions and Solicited Systemic Adverse Events (AE) | Frequency and severity of solicited local adverse reactions and systemic AEs for 7 days after each vaccination dose | 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. | Posted | Count of Participants | Participants | Postvaccination (up to 7 days after vaccination) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Cellulitis-like Reactions | Frequency of cellulitis-like reactions for at least 28 days after each vaccination dose | 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. | Posted | Count of Participants | Participants | Postvaccination (up to 28 days after each vaccination) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Unsolicited AEs | Frequency and severity of unsolicited AEs for at least 28 days after each 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. | Posted | Count of Participants | Participants | Postvaccination (up to 28 days after vaccination) |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Serious Adverse Events (SAE) | Frequency of SAEs for 180 days after the last vaccination dose. SAE = serious adverse events, AESI = adverse event of special interest | 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. | Posted | Count of Participants | Participants | 180 days after the last vaccination dose. |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean of Hemagglutination Titers (HI GMTs) Prevaccination (Day 1) and Postvaccination (Study Exit Visit) of Each Virus Strain | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Titers | 28 days after last vaccination. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Seroconversion Rates (SCRs) of Each Virus Strain | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 28 days after last vaccination |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Seroprotection Rates of Each Virus Strain | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 28 days after last vaccination. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Geometric Mean Fold Increase (GMFI) of Each Virus Strain | 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. | 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. | Posted | Geometric Mean | 95% Confidence Interval | Fold Change | Prevaccination (Day 1) and Postvaccination (28 days after last vaccination) |
|
Non-serious unsolicited AEs and serious AEs were collected from Day 1 through Day 180
Of the 2247 subjects who provided consent, 7 subjects discontinued from the study and did not receive any vaccination; and 8 subjects had no reported safety data. Therefore, 2232 subjects were included in the overall safety population.
Seqirus QIV N = 1673 Comparator QIV N = 559
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Seqirus QIV | Subjects 6 months through 59 months of age who received Seqirus Quadrivalent Inactivated Influenza Vaccine. | 0 | 1,673 | 11 | 1,673 | 320 | 1,673 |
| EG001 | Comparator QIV | Subjects 6 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine. | 0 | 559 | 3 | 559 | 80 | 559 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Croup Infectious | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Foreign body aspiration | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Systematic Assessment |
| |
| Pyrexia | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
|
Seqirus agreements and restrictions on publishing may vary with individual investigators; however, Seqirus will not prohibit any investigator from publishing. Seqirus supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Disclosure Manager | Seqirus | 1-855-358-8966 | Seqirus.ClinicalTrials@Seqirus.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 22, 2016 | Sep 17, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| 36 through 59 months |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| A/H3N2 |
|
|
| B/YAM |
|
|
| B/VIC |
|
|
| Non-inferiority of immune responses to A/H3N2 vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination | Geometric Mean Titer Ratio | 1.27 | 2-Sided | 95 | 1.15 | 1.42 | Non-Inferiority | The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5 |
| Non-inferiority of immune responses to B/YAM vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination | Geometric Mean Titer Ratio | 1.12 | 2-Sided | 95 | 1.01 | 1.24 | Non-Inferiority | The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5 |
| Non-inferiority of immune responses to B/VIC vaccine strain measured in terms of Geometric Mean Titer ratios 28 days after the last vaccination | Geometric Mean Titer Ratio | 0.97 | 2-Sided | 95 | 0.86 | 1.09 | Non-Inferiority | The non-inferiority criterion for the GMT ratio (adjusted analysis) was that the upper bound of the two-sided 95% CI of the GMT ratio for the Comparator QIV GMT, divided by the Seqirus QIV GMT, should not exceed 1.5 |
| Participants |
|
|
|
|
|
|
|
| Comparator QIV Cohort B |
Subjects 36 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine. |
|
|
| OG003 | Comparator QIV Cohort B | Subjects 36 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine. |
|
|
| Comparator QIV Cohort B |
Subjects 36 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine. |
|
|
| Comparator QIV Cohort B |
Subjects 36 months through 59 months of age who received Comparator Quadrivalent Inactivated Influenza Vaccine. |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|