Influenza
Conditions
Keywords
Vaccine, Seasonal Flu, Efficacy, Children
Brief summary
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine comparators in children 6 to 35 months of age. Recruitment will encompass at least 4 independent cohorts: a first cohort in the Northern Hemisphere (2011-2012), a second cohort in subtropical countries (2012), third cohort in the Northern Hemisphere (2012-2013) and a fourth cohort and additional independent cohorts possibly in NH countries (end 2013) and subtropical countries (beginning 2014).
Interventions
BIOLOGICALQuadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A
Intramuscular injection
BIOLOGICALHavrix Junior
Intramuscular injection administered to subjects aged 12 months or older
BIOLOGICALPrevenar 13
Intramuscular injection administered to subjects less than 12 months of age
BIOLOGICALVarivax/ProVarivax
Intramuscular injection administered to subjects more than 12 months of age
BIOLOGICALVarilrix
Subcutaneous injection administered to subjects more than 12 months of age
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 35 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parents/Legally Acceptable Representative (LARs) can and will comply with the requirements of the protocol. * A male or female between, and including, 6 and 35 months of age at the time of first vaccination; children are eligible regardless of history of influenza vaccination. * Written informed consent obtained from the parent(s) /LAR(s) of the subject. * Subjects in stable health as determined by medical history and clinical examination before entering into the study.
Exclusion criteria
* Participation in a previous FLU-D-QIV-004 study (115345) cohort. * Child in care. * Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Prior receipt of any influenza vaccine within 6 months preceding the first dose of study vaccine, or planned use of such vaccines during the study period. * Children with underlying illness who are at risk of complications of influenza and for whom yearly (seasonal) influenza vaccination is recommended in their respective country. * Any confirmed or suspected immunosuppressive or immunodeficient condition (including HIV), based on medical history and physical examination. * Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccine dose. Inhaled and topical steroids are allowed. * Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period. * Any known or suspected allergy to any constituent of influenza vaccines, non-influenza vaccine comparators and latex; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous vaccination. * Any contraindication to intramuscular injection. * Acute disease and/or fever at the time of enrolment. * Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study. * Additional criteria for children ≥ 12 months of age: * Prior receipt of any licensed varicella vaccine\* or any licensed hepatitis A vaccine or planned use of these vaccines during the study period. Other routine registered childhood vaccinations are permitted. \* For countries with varicella vaccine administered as 2-dose schedule, prior receipt of a single dose of a varicella vaccine is allowed if administered at least 2 weeks before the first study vaccination. * Any history of hepatitis A or varicella diseases. * Additional criteria for children 6 - 11 months of age in countries without universal mass vaccination recommendation for pneumococcal vaccine: * Prior receipt of any pneumococcal conjugated vaccine or planned use of this vaccine during the study period. Other routine registered childhood vaccinations are permitted.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza. | During the surveillance period (approximately 6 to 8 months) | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. |
| Number of Subjects With RT-PCR Confirmed Influenza of Any Severity. | During the surveillance period (approximately 6 to 8 months) | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Antigenically-matching Influenza Strains | During the surveillance period (approximately 6 to 8 months) | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. |
| Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Any Seasonal Influenza Strain. | During the surveillance period (approximately 6 to 8 months) | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. |
| Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Any Seasonal Influenza Strain. | During the surveillance period (approximately 6 to 8 months) | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. |
| Number of Subjects With First Occurrence of Acute Otitis Media (AOM) With RT-PCR Confirmed Influenza A and/or B Infection Due to Any Seasonal Influenza Strain. | At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months) | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. |
| Number of Subjects With First Occurrence of RT-PCR Confirmed Severe Influenza A and/or B Due to Any Seasonal Influenza Strain. | During the surveillance period (approximately 6 to 8 months) | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. |
| Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) | At Days 0 and 28/56 | Titers were expressed as geometric mean antibody titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects |
| Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | At Day 0 and Day 28/56 | A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects. |
| Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | At Day 28/56 (POST) | Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer \< 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4 fold increase in post vaccination reciprocal titer against the vaccine virus. PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects |
| Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only). | At Day 28/56 (POST) | MGI also known as the seroconversion factor \[SCF\] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects. |
| Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza. | At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months) | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2) | Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that resulted crying when limb was moved/ spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. \>50mm. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2) | Solicited general symptoms assessed were Drowsiness, Irritability/fussiness, Loss of appetite and Temperature (Axillary). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination. |
| Duration of Solicited Local Symptoms | During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2) | Duration was defined as number of days with any grade of local symptoms. |
| Duration of Solicited General Symptoms | During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2) | Duration was defined as number of days with any grade of general symptoms. |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During the 28-day (Days 0-27) post-vaccination period | Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination. |
| Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs) | During the entire study period (approximately 6- 8 months per subject) | MAVs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was defined as MAVs that prevented normal activities and related was defined as MAVs assessed by the investigator to be causally related to the study vaccination. |
| Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs). | During the entire study period (approximately 6- 8 months per subject) | pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = pIMDs that prevented normal activities. Related = symptom assed by the investigator as causally related to the study vaccination. |
| Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | During the entire study period (approximately 6- 8 months per subject) | SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination. |
| Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | At Day 0 and Day 28/56 | Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects |
| Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains. | During the surveillance period (approximately 6 to 8 months) | Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event. |
Countries
Bangladesh, Belgium, Czechia, Dominican Republic, Honduras, India, Lebanon, Philippines, Poland, Spain, Thailand, Turkey (Türkiye), United Kingdom
Participant flow
Pre-assignment details
Out of the 12046 enrolled subjects, 21 subjects were excluded from all statistical analyses due to an invalid informed consent form (ICF) and 7 subjects did not receive any study vaccine despite being allocated a subject number, hence only 12018 subjects started this study.
Participants by arm
| Arm | Count |
|---|---|
| D-QIV Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A). | 6,006 |
| Control In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®). | 6,012 |
| Total | 12,018 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 16 |
| Overall Study | Lost to Follow-up | 43 | 58 |
| Overall Study | Others | 10 | 5 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 140 | 129 |
Baseline characteristics
| Characteristic | Control | Total | D-QIV |
|---|---|---|---|
| Age, Continuous | 21.8 Months STANDARD_DEVIATION 8 | 21.9 Months STANDARD_DEVIATION 8 | 21.9 Months STANDARD_DEVIATION 8 |
| Race/Ethnicity, Customized African Heritage / African American | 20 Participants | 44 Participants | 24 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 1053 Participants | 2115 Participants | 1062 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 1666 Participants | 3327 Participants | 1661 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Other | 1642 Participants | 3281 Participants | 1639 Participants |
| Race/Ethnicity, Customized White - Arabic / North African Heritage | 149 Participants | 291 Participants | 142 Participants |
| Race/Ethnicity, Customized White - Caucasian / European Heritage | 1482 Participants | 2953 Participants | 1471 Participants |
| Sex: Female, Male Female | 2925 Participants | 5858 Participants | 2933 Participants |
| Sex: Female, Male Male | 3087 Participants | 6160 Participants | 3073 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3,427 / 6,006 | 3,501 / 6,012 |
| serious Total, serious adverse events | 217 / 6,006 | 201 / 6,012 |
Outcome results
Primary
Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza.
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Time frame: During the surveillance period (approximately 6 to 8 months)
Population: The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| D-QIV | Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza. | 90 Participants |
| Control | Number of Subjects With Moderate to Severe RT-PCR Confirmed Influenza. | 242 Participants |
Comparison: The efficacy of the D-QIV vaccine would be demonstrated if the LL of the two-sided 97.5% CI for vaccine efficacy (VE) is above (\>) 25%.97.5% CI: [51.8, 72.3]Regression, Cox
Primary
Number of Subjects With RT-PCR Confirmed Influenza of Any Severity.
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Time frame: During the surveillance period (approximately 6 to 8 months)
Population: The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| D-QIV | Number of Subjects With RT-PCR Confirmed Influenza of Any Severity. | 344 Participants |
| Control | Number of Subjects With RT-PCR Confirmed Influenza of Any Severity. | 662 Participants |
Comparison: The efficacy of the D-QIV vaccine would be demonstrated if the LL of the two-sided 97.5% CI for VE is above 15%.97.5% CI: [41.8, 56.8]Regression, Cox
Secondary
Duration of Solicited General Symptoms
Duration was defined as number of days with any grade of general symptoms.
Time frame: During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| D-QIV | Duration of Solicited General Symptoms | Drowsiness, Dose 1 | 2.0 Days |
| D-QIV | Duration of Solicited General Symptoms | Drowsiness, Dose 2 | 2.0 Days |
| D-QIV | Duration of Solicited General Symptoms | Irritability, Dose 1 | 2.0 Days |
| D-QIV | Duration of Solicited General Symptoms | Irritability, Dose 2 | 2.0 Days |
| D-QIV | Duration of Solicited General Symptoms | Loss of appetite, Dose 1 | 2.0 Days |
| D-QIV | Duration of Solicited General Symptoms | Loss of appetite, Dose 2 | 3.0 Days |
| D-QIV | Duration of Solicited General Symptoms | Fever, Dose 1 | 1.0 Days |
| D-QIV | Duration of Solicited General Symptoms | Fever, Dose 2 | 2.0 Days |
| Control | Duration of Solicited General Symptoms | Fever, Dose 2 | 1.0 Days |
| Control | Duration of Solicited General Symptoms | Drowsiness, Dose 1 | 2.0 Days |
| Control | Duration of Solicited General Symptoms | Loss of appetite, Dose 1 | 2.0 Days |
| Control | Duration of Solicited General Symptoms | Drowsiness, Dose 2 | 2.0 Days |
| Control | Duration of Solicited General Symptoms | Fever, Dose 1 | 1.0 Days |
| Control | Duration of Solicited General Symptoms | Irritability, Dose 1 | 2.0 Days |
| Control | Duration of Solicited General Symptoms | Loss of appetite, Dose 2 | 2.0 Days |
| Control | Duration of Solicited General Symptoms | Irritability, Dose 2 | 2.0 Days |
Secondary
Duration of Solicited Local Symptoms
Duration was defined as number of days with any grade of local symptoms.
Time frame: During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| D-QIV | Duration of Solicited Local Symptoms | Pain, Dose 1 | 1.0 Days |
| D-QIV | Duration of Solicited Local Symptoms | Pain, Dose 2 | 1.0 Days |
| D-QIV | Duration of Solicited Local Symptoms | Redness, Dose 1 | 2.0 Days |
| D-QIV | Duration of Solicited Local Symptoms | Redness, Dose 2 | 2.0 Days |
| D-QIV | Duration of Solicited Local Symptoms | Swelling, Dose 1 | 2.0 Days |
| D-QIV | Duration of Solicited Local Symptoms | Swelling, Dose 2 | 1.0 Days |
| Control | Duration of Solicited Local Symptoms | Swelling, Dose 1 | 2.0 Days |
| Control | Duration of Solicited Local Symptoms | Pain, Dose 1 | 1.0 Days |
| Control | Duration of Solicited Local Symptoms | Redness, Dose 2 | 2.0 Days |
| Control | Duration of Solicited Local Symptoms | Pain, Dose 2 | 1.0 Days |
| Control | Duration of Solicited Local Symptoms | Swelling, Dose 2 | 2.0 Days |
| Control | Duration of Solicited Local Symptoms | Redness, Dose 1 | 2.0 Days |
Secondary
Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only)
Titers were expressed as geometric mean antibody titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects
Time frame: At Days 0 and 28/56
Population: The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| D-QIV | Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) | H1N1, PRE | 11.9 Titers |
| D-QIV | Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) | H1N1, POST | 165.3 Titers |
| D-QIV | Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) | H3N2, PRE | 14.8 Titers |
| D-QIV | Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) | H3N2, POST | 132.1 Titers |
| D-QIV | Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) | Victoria, PRE | 10.0 Titers |
| D-QIV | Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) | Victoria, POST | 92.6 Titers |
| D-QIV | Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) | Yamagata, PRE | 7.3 Titers |
| D-QIV | Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) | Yamagata, POST | 121.4 Titers |
| Control | Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) | Yamagata, POST | 7.6 Titers |
| Control | Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) | H1N1, PRE | 11.9 Titers |
| Control | Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) | Victoria, PRE | 9.2 Titers |
| Control | Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) | H1N1, POST | 12.6 Titers |
| Control | Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) | Yamagata, PRE | 7.3 Titers |
| Control | Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) | H3N2, PRE | 13.4 Titers |
| Control | Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) | Victoria, POST | 9.2 Titers |
| Control | Humoral Immune Response in Terms of Haemagglutination-inhibition (HI) Antibody Titres Against Each of Four Vaccine Strains Contained in the D-QIV (in Immuno Subcohort of Subjects Only) | H3N2, POST | 14.7 Titers |
Secondary
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only).
MGI also known as the seroconversion factor \[SCF\] was defined as the fold increase in serum HI GMTs post vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects.
Time frame: At Day 28/56 (POST)
Population: The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| D-QIV | Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only). | H1N1 | 14 Fold change |
| D-QIV | Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only). | H3N2 | 9.0 Fold change |
| D-QIV | Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only). | Victoria | 9.3 Fold change |
| D-QIV | Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only). | Yamagata | 16.7 Fold change |
| Control | Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only). | Yamagata | 1.1 Fold change |
| Control | Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only). | H1N1 | 1.1 Fold change |
| Control | Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only). | Victoria | 1.0 Fold change |
| Control | Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the 4 Vaccine Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only). | H3N2 | 1.1 Fold change |
Secondary
Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)
Seroconversion rate (SCR) was defined as the number of subjects who have either a pre-vaccination reciprocal HI titer \< 1:10 and a post-vaccination reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 10 and at least a 4 fold increase in post vaccination reciprocal titer against the vaccine virus. PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects
Time frame: At Day 28/56 (POST)
Population: The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| D-QIV | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | H1N1 | 596 Participants |
| D-QIV | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | H3N2 | 513 Participants |
| D-QIV | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Victoria | 514 Participants |
| D-QIV | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Yamagata | 605 Participants |
| Control | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Yamagata | 13 Participants |
| Control | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | H1N1 | 20 Participants |
| Control | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Victoria | 5 Participants |
| Control | Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | H3N2 | 24 Participants |
Secondary
Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)
A seropositive subject was a subject whose HI antibody titer was greater than or equal to the assay cut-off value of 1:10. The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects.
Time frame: At Day 0 and Day 28/56
Population: The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| D-QIV | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | H1N1, PRE | 200 Participants |
| D-QIV | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | H1N1, POST | 728 Participants |
| D-QIV | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | H3N2, PRE | 266 Participants |
| D-QIV | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | H3N2, POST | 740 Participants |
| D-QIV | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Victoria, PRE | 205 Participants |
| D-QIV | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Victoria, POST | 701 Participants |
| D-QIV | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Yamagata, PRE | 134 Participants |
| D-QIV | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Yamagata, POST | 719 Participants |
| Control | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Yamagata, POST | 108 Participants |
| Control | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | H1N1, PRE | 152 Participants |
| Control | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Victoria, PRE | 138 Participants |
| Control | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | H1N1, POST | 170 Participants |
| Control | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Yamagata, PRE | 93 Participants |
| Control | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | H3N2, PRE | 187 Participants |
| Control | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Victoria, POST | 147 Participants |
| Control | Number of Seropositive Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | H3N2, POST | 210 Participants |
Secondary
Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only)
Seroprotection rate (SPR) was defined as the number of subjects with H1N1 reciprocal HI titers ≥ 1:40 against the tested vaccine virus.The vaccine strains assessed were A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Brisbane/3/2007 (Yamagata). PRE= Pre-vaccination at Day 0; POST = Post-vaccination 1 at Day 28 for primed subjects or post-vaccination 2 at Day 56 for unprimed subjects
Time frame: At Day 0 and Day 28/56
Population: The ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. These included subjects for whom assay results were available for antibodies against at least one study vaccine strain after vaccination.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| D-QIV | Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | H1N1, PRE | 182 Participants |
| D-QIV | Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | H1N1, POST | 640 Participants |
| D-QIV | Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | H3N2, PRE | 238 Participants |
| D-QIV | Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | H3N2, POST | 612 Participants |
| D-QIV | Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Victoria, PRE | 143 Participants |
| D-QIV | Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Victoria, POST | 539 Participants |
| D-QIV | Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Yamagata, PRE | 73 Participants |
| D-QIV | Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Yamagata, POST | 638 Participants |
| Control | Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Yamagata, POST | 64 Participants |
| Control | Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | H1N1, PRE | 134 Participants |
| Control | Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Victoria, PRE | 103 Participants |
| Control | Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | H1N1, POST | 146 Participants |
| Control | Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Yamagata, PRE | 59 Participants |
| Control | Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | H3N2, PRE | 159 Participants |
| Control | Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | Victoria, POST | 101 Participants |
| Control | Number of Seroprotected Subjects for HI Antibodies Against Each of the 4 Influenza Strains Contained in the D-QIV Vaccine (in Immuno Subcohort of Subjects Only) | H3N2, POST | 175 Participants |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that resulted crying when limb was moved/ spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. \>50mm.
Time frame: During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| D-QIV | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain, Dose 1 | 1015 Participants |
| D-QIV | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain, Dose 1 | 23 Participants |
| D-QIV | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness, Dose 1 | 775 Participants |
| D-QIV | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness, Pain, Dose 1 | 1 Participants |
| D-QIV | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling, Dose 1 | 467 Participants |
| D-QIV | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling, Dose 1 | 0 Participants |
| D-QIV | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain, Dose 2 | 808 Participants |
| D-QIV | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain, Dose 2 | 21 Participants |
| D-QIV | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness, Dose 2 | 587 Participants |
| D-QIV | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness, Dose 2 | 2 Participants |
| D-QIV | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling, Dose 2 | 375 Participants |
| D-QIV | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling, Dose 2 | 2 Participants |
| D-QIV | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain, Across doses | 1350 Participants |
| D-QIV | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain, Across doses | 42 Participants |
| D-QIV | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness, Across doses | 980 Participants |
| D-QIV | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness, Across doses | 3 Participants |
| D-QIV | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling, Across doses | 665 Participants |
| D-QIV | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling, Across doses | 2 Participants |
| Control | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain, Across doses | 48 Participants |
| Control | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain, Dose 1 | 1047 Participants |
| Control | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness, Dose 2 | 0 Participants |
| Control | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain, Dose 1 | 30 Participants |
| Control | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling, Across doses | 3 Participants |
| Control | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness, Dose 1 | 831 Participants |
| Control | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling, Dose 2 | 409 Participants |
| Control | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness, Pain, Dose 1 | 0 Participants |
| Control | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness, Across doses | 1091 Participants |
| Control | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling, Dose 1 | 518 Participants |
| Control | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling, Dose 2 | 3 Participants |
| Control | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Swelling, Dose 1 | 0 Participants |
| Control | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Swelling, Across doses | 742 Participants |
| Control | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain, Dose 2 | 820 Participants |
| Control | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Pain, Across doses | 1375 Participants |
| Control | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Pain, Dose 2 | 21 Participants |
| Control | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Grade 3 Redness, Across doses | 0 Participants |
| Control | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. | Any Redness, Dose 2 | 631 Participants |
Secondary
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the entire study period (approximately 6- 8 months per subject)
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| D-QIV | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | Any SAEs | 217 Participants |
| D-QIV | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | Related SAEs | 6 Participants |
| D-QIV | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | Fatal SAEs | 1 Participants |
| D-QIV | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | Related fatal SAEs | 0 Participants |
| Control | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | Related fatal SAEs | 0 Participants |
| Control | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | Any SAEs | 201 Participants |
| Control | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | Fatal SAEs | 3 Participants |
| Control | Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs). | Related SAEs | 2 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs)
MAVs were defined as AEs with a medically-attended visit i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was defined as MAVs that prevented normal activities and related was defined as MAVs assessed by the investigator to be causally related to the study vaccination.
Time frame: During the entire study period (approximately 6- 8 months per subject)
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs) | Any MAVs | 3885 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs) | Grade 3 MAVs | 200 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs) | Related MAVs | 57 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs) | Any MAVs | 3988 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs) | Grade 3 MAVs | 211 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related AEs With Medically Attended Visits (MAVs) | Related MAVs | 58 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs).
pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Grade 3 = pIMDs that prevented normal activities. Related = symptom assed by the investigator as causally related to the study vaccination.
Time frame: During the entire study period (approximately 6- 8 months per subject)
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs). | Any pIMDs | 5 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs). | Grade 3 pIMDs | 3 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs). | Related pIMDs | 3 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs). | Any pIMDs | 0 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs). | Grade 3 pIMDs | 0 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Potential Immune-mediated Diseases (pIMDs). | Related pIMDs | 0 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Solicited general symptoms assessed were Drowsiness, Irritability/fussiness, Loss of appetite and Temperature (Axillary). Any was defined as any general symptom reported irrespective of intensity or relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activity. Related was defined as general symptom assessed by the investigator to have a causal relationship to vaccination.
Time frame: During the 7-day post-vaccination period (Days 0-6 for Dose 1, Days 28-34 for Dose 2)
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented. The analysis of solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e. symptom screen/sheet completed).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Loss of appetite, Dose 2 | 652 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability, Dose 1 | 617 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss of appetite, Dose 2 | 47 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Dose 1 | 78 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Loss of appetite, Dose 2 | 378 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability, Dose 1 | 955 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Dose 2 | 336 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Dose 1 | 243 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Dose 2 | 65 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Loss of appetite, Dose 1 | 847 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Dose 2 | 195 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness, Dose 2 | 519 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness, Across Doses | 1024 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness, Dose 1 | 490 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness, Across Doses | 61 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness, Dose 2 | 25 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness, Across Doses | 673 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss of appetite, Dose 1 | 68 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability, Across Doses | 1383 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness, Dose 2 | 324 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability, Across Doses | 77 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability, Dose 1 | 42 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability, Across Doses | 905 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability, Dose 2 | 777 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Loss of appetite, Across Doses | 1227 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Loss of appetite, Dose 1 | 541 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade3 Loss of appetite,Across Doses | 111 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability, Dose 2 | 36 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Loss of appetite,AcrossDoses | 774 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness, Dose 1 | 39 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Across Doses | 659 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability, Dose 2 | 488 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Across Doses | 137 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Dose 1 | 372 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Across Doses | 413 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness, Dose 1 | 739 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Across Doses | 476 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness, Dose 1 | 829 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness, Dose 1 | 52 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness, Dose 1 | 535 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability, Dose 1 | 1029 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability, Dose 1 | 62 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability, Dose 1 | 669 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Loss of appetite, Dose 1 | 872 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss of appetite, Dose 1 | 60 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Loss of appetite, Dose 1 | 523 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Dose 1 | 425 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Dose 1 | 76 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Dose 1 | 287 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness, Dose 2 | 558 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness, Dose 2 | 24 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness, Dose 2 | 361 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability, Dose 2 | 777 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability, Dose 2 | 52 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability, Dose 2 | 495 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Loss of appetite, Dose 2 | 681 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss of appetite, Dose 2 | 44 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Loss of appetite, Dose 2 | 413 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Dose 2 | 363 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Dose 2 | 70 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Dose 2 | 215 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness, Across Doses | 1129 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness, Across Doses | 73 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness, Across Doses | 738 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability, Across Doses | 1427 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability, Across Doses | 107 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability, Across Doses | 940 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Loss of appetite, Across Doses | 1288 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade3 Loss of appetite,Across Doses | 97 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Loss of appetite,AcrossDoses | 809 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Across Doses | 732 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Across Doses | 141 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Time frame: During the 28-day (Days 0-27) post-vaccination period
Population: The Total Vaccinated cohort included all subjects with at least one vaccine administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any unsolicited AEs | 2640 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AEs | 160 Participants |
| D-QIV | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related unsolicited AEs | 106 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any unsolicited AEs | 2679 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AEs | 149 Participants |
| Control | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related unsolicited AEs | 116 Participants |
Secondary
Number of Subjects With First Occurrence of Acute Otitis Media (AOM) With RT-PCR Confirmed Influenza A and/or B Infection Due to Any Seasonal Influenza Strain.
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Time frame: At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)
Population: The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| D-QIV | Number of Subjects With First Occurrence of Acute Otitis Media (AOM) With RT-PCR Confirmed Influenza A and/or B Infection Due to Any Seasonal Influenza Strain. | 12 Participants |
| Control | Number of Subjects With First Occurrence of Acute Otitis Media (AOM) With RT-PCR Confirmed Influenza A and/or B Infection Due to Any Seasonal Influenza Strain. | 28 Participants |
Secondary
Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Antigenically-matching Influenza Strains
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Time frame: During the surveillance period (approximately 6 to 8 months)
Population: The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| D-QIV | Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Antigenically-matching Influenza Strains | 88 Participants |
| Control | Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Antigenically-matching Influenza Strains | 216 Participants |
Secondary
Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Any Seasonal Influenza Strain.
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Time frame: During the surveillance period (approximately 6 to 8 months)
Population: The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| D-QIV | Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Any Seasonal Influenza Strain. | 303 Participants |
| Control | Number of Subjects With First Occurrence of Culture-confirmed Influenza A and/or B Disease of Any Severity Due to Any Seasonal Influenza Strain. | 602 Participants |
Secondary
Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains.
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Time frame: During the surveillance period (approximately 6 to 8 months)
Population: The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| D-QIV | Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains. | 20 Participants |
| Control | Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Antigenically-matching Influenza Strains. | 88 Participants |
Secondary
Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Any Seasonal Influenza Strain.
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Time frame: During the surveillance period (approximately 6 to 8 months)
Population: The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| D-QIV | Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Any Seasonal Influenza Strain. | 79 Participants |
| Control | Number of Subjects With First Occurrence of Culture-confirmed Moderate to Severe Influenza A and/or B Disease Due to Any Seasonal Influenza Strain. | 216 Participants |
Secondary
Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza.
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Time frame: At any time starting 7 days before the onset of LRI and ending 7 days after end of LRI during the surveillance period (approximately 6 to 8 months)
Population: The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| D-QIV | Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza. | 28 Participants |
| Control | Number of Subjects With First Occurrence of Lower Respiratory Illness (LRI) With RT-PCR Confirmed Influenza. | 61 Participants |
Secondary
Number of Subjects With First Occurrence of RT-PCR Confirmed Severe Influenza A and/or B Due to Any Seasonal Influenza Strain.
Attack rate (AR) was defined as the number/percentage of subjects with at least 1 RT-PCR confirmed influenza event.
Time frame: During the surveillance period (approximately 6 to 8 months)
Population: The ATP cohort for efficacy - Time to event included all eligible subjects who received study vaccine(s) according to their random assignment, for whom vaccine administration site was known, who had a swab collected during the window (0-7 days) of episode onset and who would be censored but not eliminated based on protocol criteria.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| D-QIV | Number of Subjects With First Occurrence of RT-PCR Confirmed Severe Influenza A and/or B Due to Any Seasonal Influenza Strain. | 2 Participants |
| Control | Number of Subjects With First Occurrence of RT-PCR Confirmed Severe Influenza A and/or B Due to Any Seasonal Influenza Strain. | 3 Participants |