Influenza
Conditions
Keywords
Quadrivalent influenza vaccine, Safety, Children, Adults, Immunogenicity
Brief summary
The purpose of this trial is to demonstrate the acceptable safety profile and the immunological non-inferiority of the FLU D-QIV vaccine manufactured with this investigational process (FLU D-QIV Investigational Process \[IP\]) compared to FLU D-QIV manufactured with the current licensed process (FLU D-QIV Licensed Process \[LP\]).
Detailed description
This study will enroll 3 age cohorts: Adults: 18-49 years, Children: 3-17 years and 6-35 months of age.
Interventions
BIOLOGICALInflusplit Tetra™ vaccine produced by investigational process (IP)
Influsplit Tetra™ vaccine using a new manufacturing process administered intramuscularly (IM) in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.
BIOLOGICALInflusplit Tetra™ vaccine produced by licensed process (LP)
Influsplit Tetra™ vaccine using a licensed manufacturing process administered IM in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 49 Years
Healthy volunteers
Yes
Inclusion criteria
Adults 18-49 years cohort: * A male or female between, and including, 18 and 49 years of age at the time of vaccination. * Subjects who the investigator believes that they/their parent(s)/Legally Acceptable Representatives (LAR(s)) can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject/parent(s)/LAR(s) of the subject. * Written informed assent obtained from the subject if/as required by local regulations. * Healthy subjects or those with chronic well-controlled disease as established by medical history and clinical examination before entering into the study. * Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy. * Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception for 2 months after vaccination. Pediatric cohort: United States: • A male or female subject between, and including, the ages of 3 and 17 years in the United States. Rest of the World: • A male or female subject between, and including, the ages of 6 months to 17 years all countries with the exception of the United States. All participating countries: * Subjects who the investigator believes that they/their parent(s)/Legally Acceptable Representatives (LAR(s)) can and will comply with the requirements of the protocol. * Written informed consent obtained from the subject/parent(s)/LAR(s) of the subject. * Written informed assent obtained from the subject if/as required by local regulations. * Healthy subjects or those with chronic well-controlled disease as established by medical history and clinical examination before entering into the study. * Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy. * Female subjects of childbearing potential may be enrolled in the study, if the subject: has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion criteria
Adults aged 18-49 years cohort: * Child in care. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical or device). * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose. Inhaled and topical steroids are allowed. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period. * Administration of an influenza vaccine during the 6 months preceding entry into the study. * Administration of a vaccine not foreseen by the study protocol within 30 days before vaccination or planned administration during the study period. * Administration of immunoglobulins and/or any blood products within the 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 (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine. * Acute or un-controlled, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests. * Any history of Guillain-Barré Syndrome. * Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥ 38.0ºC/100.4ºF. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions. * History of chronic alcohol consumption and/or drug abuse. * Any contra-indication to intramuscular administration of influenza vaccines. * Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study. Pediatric cohort * Child in care. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical or device). * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccination dose. Inhaled and topical steroids are allowed. * Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration during the study period. * Administration of an influenza vaccine during the 6 months preceding entry into the study. * Administration of a vaccine not foreseen by the study protocol within 30 days before vaccination or planned administration during the study period. * Administration of immunoglobulins and/or any blood products within the 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 (including egg proteins); a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine. * Acute or un-controlled, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests. * Any history of Guillain-Barré Syndrome. * Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥ 38.0ºC/100.4ºF. * Pregnant or lactating female. * Female planning to become pregnant or planning to discontinue contraceptive precautions. * History of chronic alcohol consumption and/or drug abuse. * Any contra-indication to intramuscular administration of influenza vaccines. * Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). | During the 7-day (Days 0-6) post-vaccination period | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 100 millimeters (mm) i.e. \>100mm. |
| Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | During the 7-day (Days 0-6) post-vaccination period | Solicited general symptoms assessed were fatigue,gastrointestinal symptoms, headache, Joint Pain, myalgia, shivering and fever. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (\< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature ≥39.0°C. |
| Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | During the 7-day (Days 0-6) post-vaccination period | Duration was defined as number of days with any grade of local and general symptoms. |
| Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | During the 3-day (Days 0-2) post-vaccination period | Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any was defined as any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 ORS was defined as ORS symptoms that prevented normal activities. Related ORS was defined as ORS symptom(s) assessed by the investigator as causally related to the vaccination. |
| Number of Subjects Aged 18-49 Years Reporting the Occurrence of Medically Attended Events (MAEs). | During the entire study period (approximately 21 days following vaccination) | MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was defined as MAE that prevented normal activities. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination. |
| Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | During the 7-day (Days 0-6) post-vaccination period | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. \>50mm. |
| Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | During the 7-day (Days 0-6) post-vaccination period | Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (\< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (\>) 39.0°C. |
| Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | During the 7-day (Days 0-6) post-vaccination period | Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain, myalgia, shivering and fever (Fever = temperature above 38.0 degrees Celsius (°C)). Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature \< 38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever = temperature above 39.0°C. |
| Duration of Solicited Local AEs in Subjects Aged 3-17 Years. | During the 7-day (Days 0-6) post-vaccination period | Duration was defined as number of days with any grade of local symptoms. |
| Duration of Solicited General AEs in Subjects Aged 3-4 Years. | During the 7-day (Days 0-6) post-vaccination period | Duration was defined as number of days with any grade of general symptoms. |
| Duration of Solicited General AEs in Subjects Aged 5-17 Years. | During the 7-day (Days 0-6) post-vaccination period | Duration was defined as number of days with any grade of general symptoms. |
| Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | During the 3-day (Days 0-2) post-vaccination period | Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any = occurrence of any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 = ORS symptoms that prevented normal activities. Related = ORS symptom assessed by the investigator as causally related to the vaccination. |
| Number of Subjects Aged 3-17 Years Reporting the Occurrence of All Medically Attended Events (MAEs) . | During the entire study period (approximately 28 days (primed subjects) and 56 days (unprimed subjects) following vaccination | MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was a MAE that prevented normal activities. Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination. |
| Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | During the 21-day (Days 0-20) follow-up period after vaccination | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and 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. |
| Number of Subjects Aged 3-17 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | During the 28-day (Days 0-27) follow-up period after vaccination | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and 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. |
| Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC Across Doses. | During 7 days (Days 0-6) post-vaccination | Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature \< 38°C but with missing values (MC) for at least one day during the solicited period. |
| Number of Subjects Aged 18-49 Years, Reporting Any and Related Serious Adverse Events (SAEs) | During the entire study period (approximately 21 days) | A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Aged 3-17 Years, Reporting Any and Related Serious Adverse Events (SAEs) | During the entire study period [approximately 28 days (primed subjects) and 56 days (unprimed subjects)] | A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. |
| Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | At Day 28 post last vaccination | HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | At Day 28 post last vaccination | HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Aged 6-35 Months Reporting the Occurrence of All Medically Attended Events (MAEs) | During the entire study period (approximately 28 days (primed subjects) and 56 days (unprimed subjects) following vaccination | MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was a MAE that prevented normal activities. Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination. |
| Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | At Day 0 and Day 21 | HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Number of Subjects Aged 6-35 Months, Reporting Any and Related Serious Adverse Events (SAEs) | During the entire study period [approximately 28 days (primed subjects) and 56 days (unprimed subjects)] | A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | During the 28-day (Days 0-27) follow-up period after vaccination | An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and 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 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination. |
| Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | At Day 21 | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | At Day 0 and Day 21 | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years. | At Day 21 | MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Number of Subjects Aged 5-17 Years Reporting Myalgia Across Doses. | During the 7-day (Days 0-6) post-vaccination period | Any = occurrence of any myalgia symptom regardless of intensity grade or relationship to vaccination. |
| Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | At Day 0 and Day 28 post last vaccination | HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | At Day 28 post last vaccination | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | At Day 0 and Day 28 post last vaccination | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years. | At Day 28 post last vaccination | MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | At Day 0 and Day 28 post last vaccination | HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | At Day 28 post last vaccination | A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | At Day 0 and Day 28 post last vaccination | A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months. | At Day 28 post last vaccination | MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria). |
| Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2. | During 7 days (Days 0-6) post-vaccination | Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature \< 38°C but with missing values (MC) for at least one day during the solicited period. Fever = temperature of ≥ 38°C/100.4°F by any route |
| Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | During the 7-day (Days 0-6) post-vaccination period | Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. \> 50mm. |
| Number of Subjects Aged 6 Months to <5 Years, Reporting Fever ≥38ºC (100.4°F) and >39.0°C (102.2ºF) Across Doses. | During the 2 days (Day 0-Day 1) post-vaccination period | Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature \< 38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever = temperature above 39.0°C/102.2ºF. Data of 2 independent groups were pooled. |
| Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | During the 7-day (Days 0-6) post-vaccination period | Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (\< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (\>)39.0°C. |
| Duration of Solicited Local AEs in Subjects Aged 6-35 Months. | During the 7-day (Days 0-6) post-vaccination period | Duration was defined as number of days with any grade of local symptoms. |
| Duration of Solicited General AEs in Subjects Aged 6-35 Months. | During the 7-day (Days 0-6) post-vaccination period | Duration was defined as number of days with any grade of general symptoms. |
| Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | During a 3 day (Days 0-2) follow-up period after vaccination | Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any = occurrence of any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 = ORS symptoms that prevented normal activities. Related = ORS symptom assessed by the investigator as causally related to the vaccination. |
Countries
Bangladesh, Czechia, France, Germany, Poland, Spain, United States
Participant flow
Recruitment details
Primed subjects: Received 2 doses of seasonal influenza vaccine separated by at least one month during the last season or had received at least 1 dose prior to last season. Unprimed subjects: Did not receive any seasonal influenza vaccine in the past or received only 1 dose for the first time in the last influenza season.
Pre-assignment details
For 5 subjects, study vaccine dose not administered at all but subject number was allocated. Some data has been analysed in sub-groups by age: 3-4 years, 5-17 years, 6 months to \<5 years.
Participants by arm
| Arm | Count |
|---|---|
| Influsplit Tetra_IP Adult Group Subjects in the Influsplit Tetra\_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm. | 60 |
| Influsplit Tetra_LP Adult Group Subjects in the Influsplit Tetra\_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm. | 60 |
| Influsplit Tetra_IP 3-17y Group Subjects in the Influsplit Tetra\_IP group aged between 3 years to \<9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | 410 |
| Influsplit Tetra_LP 3-17y Group Subjects in the Influsplit Tetra\_LP group aged between 3 years to \<9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28). | 411 |
| Influsplit Tetra_IP 6-35m Group Subjects in the Influsplit Tetra\_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | 466 |
| Influsplit Tetra_LP 6-35m Group Subjects in the Influsplit Tetra\_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28). | 474 |
| Total | 1,881 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 2 | 1 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 | 1 | 5 |
| Overall Study | Migrated/moved from study area | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 | 3 | 7 |
Baseline characteristics
| Characteristic | Influsplit Tetra_IP Adult Group | Influsplit Tetra_LP Adult Group | Influsplit Tetra_IP 3-17y Group | Influsplit Tetra_LP 3-17y Group | Influsplit Tetra_IP 6-35m Group | Influsplit Tetra_LP 6-35m Group | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | NA Months | NA Months | NA Months | NA Months | 19.7 Months STANDARD_DEVIATION 8 | 19.9 Months STANDARD_DEVIATION 8.3 | 19.8 Months STANDARD_DEVIATION 8.15 |
| Sex: Female, Male Female | 41 Participants | 35 Participants | 196 Participants | 187 Participants | 223 Participants | 209 Participants | 891 Participants |
| Sex: Female, Male Male | 19 Participants | 25 Participants | 214 Participants | 224 Participants | 243 Participants | 265 Participants | 990 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 60 | 0 / 410 | 0 / 411 | 0 / 466 | 0 / 474 |
| other Total, other adverse events | 51 / 60 | 42 / 60 | 327 / 410 | 324 / 411 | 315 / 466 | 319 / 474 |
| serious Total, serious adverse events | 1 / 60 | 1 / 60 | 1 / 410 | 0 / 411 | 7 / 466 | 11 / 474 |
Outcome results
Primary
Duration of Solicited General AEs in Subjects Aged 3-4 Years.
Duration was defined as number of days with any grade of general symptoms.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 4 years, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 3-4 Years. | Drowsiness, Dose 1 | 1.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 3-4 Years. | Drowsiness, Dose 2 | 1.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 3-4 Years. | Irritability, Dose 1 | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 3-4 Years. | Irritability, Dose 2 | 1.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 3-4 Years. | Loss of appetite, Dose 1 | 3.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 3-4 Years. | Loss of appetite, Dose 2 | 1.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 3-4 Years. | Fever, Dose 1 | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 3-4 Years. | Fever, Dose 2 | NA Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 3-4 Years. | Fever, Dose 2 | 1.5 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 3-4 Years. | Drowsiness, Dose 1 | 1.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 3-4 Years. | Loss of appetite, Dose 1 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 3-4 Years. | Drowsiness, Dose 2 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 3-4 Years. | Fever, Dose 1 | 1.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 3-4 Years. | Irritability, Dose 1 | 1.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 3-4 Years. | Loss of appetite, Dose 2 | 4.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 3-4 Years. | Irritability, Dose 2 | 1.0 Days |
Primary
Duration of Solicited General AEs in Subjects Aged 5-17 Years.
Duration was defined as number of days with any grade of general symptoms.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Fatigue, Dose 1 | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Fatigue, Dose 2 | 1.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Gastrointestinal symptoms, Dose 1 | 1.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Gastrointestinal symptoms, Dose 2 | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Headache, Dose 1 | 1.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Headache, Dose 2 | 2.5 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Joint Pain, Dose 1 | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Joint Pain, Dose 2 | 1.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Myalgia, Dose 1 | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Myalgia, Dose 2 | 1.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Shivering, Dose 1 | 1.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Shivering, Dose 2 | 1.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Fever, Dose 1 | 1.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Fever, Dose 2 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Shivering, Dose 1 | 1.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Fatigue, Dose 1 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Joint Pain, Dose 2 | 1.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Fatigue, Dose 2 | 1.5 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Fever, Dose 1 | 1.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Gastrointestinal symptoms, Dose 1 | 1.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Myalgia, Dose 1 | 1.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Gastrointestinal symptoms, Dose 2 | 1.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Shivering, Dose 2 | 1.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Headache, Dose 1 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Myalgia, Dose 2 | 1.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Headache, Dose 2 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Fever, Dose 2 | NA Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 5-17 Years. | Joint Pain, Dose 1 | 1.0 Days |
Primary
Duration of Solicited Local AEs in Subjects Aged 3-17 Years.
Duration was defined as number of days with any grade of local symptoms.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local AEs in Subjects Aged 3-17 Years. | Redness, Dose 1 | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local AEs in Subjects Aged 3-17 Years. | Redness, Dose 2 | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local AEs in Subjects Aged 3-17 Years. | Swelling, Dose 1 | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local AEs in Subjects Aged 3-17 Years. | Pain, Dose 2 | 1.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local AEs in Subjects Aged 3-17 Years. | Swelling, Dose 2 | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local AEs in Subjects Aged 3-17 Years. | Pain, Dose 1 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local AEs in Subjects Aged 3-17 Years. | Swelling, Dose 2 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local AEs in Subjects Aged 3-17 Years. | Pain, Dose 1 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local AEs in Subjects Aged 3-17 Years. | Pain, Dose 2 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local AEs in Subjects Aged 3-17 Years. | Redness, Dose 2 | 1.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local AEs in Subjects Aged 3-17 Years. | Swelling, Dose 1 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local AEs in Subjects Aged 3-17 Years. | Redness, Dose 1 | 2.0 Days |
Primary
Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years.
Duration was defined as number of days with any grade of local and general symptoms.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.~N = Number of subjects with the symptom and without the missing confirmed grade
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | Headache | 1.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | Pain | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | Gastrointestinal symptoms | 1.5 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | Joint Pain | 1.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | Shivering | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | Fatigue | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | Swelling | 1.5 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | Myalgia | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | Fever | 1.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | Redness | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | Fever | 1.5 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | Fatigue | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | Gastrointestinal symptoms | 1.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | Headache | 1.5 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | Joint Pain | 3.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | Myalgia | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | Pain | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | Redness | 1.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | Shivering | 3.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local and General AEs in Subjects Aged 18-49 Years. | Swelling | 2.5 Days |
Primary
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.
HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Day 28 post last vaccination
Population: Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | H1N1 | 698.0 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | H3N2 | 158.2 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | Yamagata | 479.0 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | Victoria | 237.6 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | Victoria | 253.7 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | H1N1 | 694.1 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | Yamagata | 527.6 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | H3N2 | 171.4 Titers |
Comparison: The adjusted GMT of HI antibodies for H1N1 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/ Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.95% CI: [0.85, 1.11]ANCOVA
Comparison: The adjusted GMT of HI antibodies for H3N2 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.95% CI: [0.94, 1.18]ANCOVA
Comparison: The adjusted GMT of HI antibodies for Yamagata strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.95% CI: [0.91, 1.16]ANCOVA
Comparison: The adjusted GMT of HI antibodies for Victoria strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.95% CI: [0.9, 1.21]ANCOVA
Primary
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.
HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Day 28 post last vaccination
Population: Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 to 35 months, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | H1N1 | 97.5 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | H3N2 | 45.2 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | Yamagata | 100.8 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | Victoria | 32.1 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | Victoria | 38.0 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | H1N1 | 105.5 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | Yamagata | 105.4 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. | H3N2 | 59.9 Titers |
Comparison: The adjusted GMT of HI antibodies for H1N1 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.95% CI: [0.9, 1.28]ANCOVA
Comparison: The adjusted GMT of HI antibodies for H3N2 strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.95% CI: [1, 1.39]ANCOVA
Comparison: The adjusted GMT of HI antibodies for Yamagata strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate.95% CI: [0.91, 1.27]ANCOVA
Comparison: The adjusted GMT of HI antibodies for Victoria strain at post-vaccination of each vaccine, the GMT ratio of Influsplit Tetra\_LP/Influsplit Tetra\_IP and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination antibody titer as covariate95% CI: [0.99, 1.38]ANCOVA
Primary
Number of Subjects Aged 18-49 Years, Reporting Any and Related Serious Adverse Events (SAEs)
A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time frame: During the entire study period (approximately 21 days)
Population: The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years, Reporting Any and Related Serious Adverse Events (SAEs) | Any SAEs | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years, Reporting Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years, Reporting Any and Related Serious Adverse Events (SAEs) | Any SAEs | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years, Reporting Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Subjects |
Primary
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms.
Solicited general symptoms assessed were fatigue,gastrointestinal symptoms, headache, Joint Pain, myalgia, shivering and fever. Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (\< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature ≥39.0°C.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Fever (≥38.0°C) | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 32 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 28 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal symptoms | 6 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal symptoms | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal symptoms | 4 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 30 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 26 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Joint Pain | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Joint Pain | 8 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Joint Pain | 8 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia | 21 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 20 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 9 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 8 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | ≥38.0°C Related Fever | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Joint Pain | 5 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Joint Pain | 5 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue | 20 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia | 13 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue | 20 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia | 13 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal symptoms | 6 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal symptoms | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal symptoms | 4 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Fever (≥38.0°C) | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Headache | 16 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering | 6 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Headache | 14 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Joint Pain | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | ≥38.0°C Related Fever | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever | 2 Subjects |
Primary
Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and 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.
Time frame: During the 21-day (Days 0-20) follow-up period after vaccination
Population: The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any Unsolicited AEs | 14 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 Unsolicited AEs | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related Unsolicited AEs | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Any Unsolicited AEs | 14 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Grade 3 Unsolicited AEs | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) | Related Unsolicited AEs | 1 Subjects |
Primary
Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs).
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 100 millimeters (mm) i.e. \>100mm.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Pain | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Redness | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). | Any Pain | 41 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). | Any Swelling | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). | Any Redness | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Swelling | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Swelling | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). | Any Pain | 32 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Pain | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). | Any Redness | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Redness | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Local Adverse Events (AEs). | Any Swelling | 4 Subjects |
Primary
Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms.
Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any was defined as any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 ORS was defined as ORS symptoms that prevented normal activities. Related ORS was defined as ORS symptom(s) assessed by the investigator as causally related to the vaccination.
Time frame: During the 3-day (Days 0-2) post-vaccination period
Population: The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Cough | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Red Eyes | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Hoarseness | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Red Eyes | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Chest Tightness | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Sore Throat | 4 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Hoarseness | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Sore Throat | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Difficulty Breathing | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Chest Tightness | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swallowing Difficulty | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Difficulty Breathing | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swallowing Difficulty | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Cough | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swallowing Difficulty | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Difficulty Breathing | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Sore Throat | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swelling of the face | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Hoarseness | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swelling of the face | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swelling of the face | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Cough | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Wheezing | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Chest Tightness | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Wheezing | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Wheezing | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Red Eyes | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Sore Throat | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Wheezing | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Difficulty Breathing | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Chest Tightness | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Chest Tightness | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Chest Tightness | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Cough | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Cough | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Cough | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Hoarseness | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Difficulty Breathing | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Difficulty Breathing | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Hoarseness | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Sore Throat | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Hoarseness | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Red Eyes | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Red Eyes | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Red Eyes | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Sore Throat | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swelling of the face | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swallowing Difficulty | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swallowing Difficulty | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swallowing Difficulty | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swelling of the face | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swelling of the face | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Wheezing | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Wheezing | 0 Subjects |
Primary
Number of Subjects Aged 18-49 Years Reporting the Occurrence of Medically Attended Events (MAEs).
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was defined as MAE that prevented normal activities. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination.
Time frame: During the entire study period (approximately 21 days following vaccination)
Population: The analysis was performed on the Adult-Total Vaccinated cohort which included all subjects aged 18 to 49 years with at least one vaccine administration documented.~1 subject withdrew consent in the Influsplit Tetra\_LP Adult Group and did not complete the study but was administered a study vaccine dose.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting the Occurrence of Medically Attended Events (MAEs). | Related MAE(s) | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting the Occurrence of Medically Attended Events (MAEs). | Any MAE(s) | 9 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years Reporting the Occurrence of Medically Attended Events (MAEs). | Grade 3 MAE(s) | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting the Occurrence of Medically Attended Events (MAEs). | Any MAE(s) | 8 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting the Occurrence of Medically Attended Events (MAEs). | Grade 3 MAE(s) | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years Reporting the Occurrence of Medically Attended Events (MAEs). | Related MAE(s) | 0 Subjects |
Primary
Number of Subjects Aged 3-17 Years, Reporting Any and Related Serious Adverse Events (SAEs)
A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time frame: During the entire study period [approximately 28 days (primed subjects) and 56 days (unprimed subjects)]
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years, Reporting Any and Related Serious Adverse Events (SAEs) | Any SAEs | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years, Reporting Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years, Reporting Any and Related Serious Adverse Events (SAEs) | Any SAEs | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years, Reporting Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Subjects |
Primary
Number of Subjects Aged 3-17 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and 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.
Time frame: During the 28-day (Days 0-27) follow-up period after vaccination
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 months to 17 years, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Any Unsolicited AEs | 83 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Grade 3 Unsolicited AEs | 12 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Related Unsolicited AEs | 10 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Any Unsolicited AEs | 86 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Grade 3 Unsolicited AEs | 8 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Related Unsolicited AEs | 7 Subjects |
Primary
Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs).
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. \>50mm.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Redness, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Any Swelling, Dose 1 | 102 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Any Swelling, Dose 2 | 16 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Any Redness, Dose 1 | 118 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Swelling, Dose 2 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Swelling, Dose 1 | 7 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Any Pain, Across Doses | 252 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Pain, Dose 1 | 14 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Pain, Across Doses | 14 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Any Pain, Dose 2 | 36 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Any Redness, Across Doses | 129 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Redness, Dose 1 | 8 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Redness, Across Doses | 8 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Pain, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Any Swelling, Across Doses | 109 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Any Pain, Dose 1 | 243 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Swelling, Across Doses | 8 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Any Redness, Dose 2 | 25 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Swelling, Across Doses | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Any Pain, Dose 1 | 253 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Pain, Dose 1 | 20 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Any Redness, Dose 1 | 119 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Redness, Dose 1 | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Any Swelling, Dose 1 | 100 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Swelling, Dose 1 | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Any Pain, Dose 2 | 39 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Pain, Dose 2 | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Redness, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Any Swelling, Dose 2 | 17 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Swelling, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Any Pain, Across Doses | 264 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Pain, Across Doses | 21 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Any Redness, Across Doses | 128 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Grade 3 Redness, Across Doses | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Any Swelling, Across Doses | 110 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Local Adverse Events (AEs). | Any Redness, Dose 2 | 21 Subjects |
Primary
Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms.
Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any = occurrence of any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 = ORS symptoms that prevented normal activities. Related = ORS symptom assessed by the investigator as causally related to the vaccination.
Time frame: During the 3-day (Days 0-2) post-vaccination period
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swallowing Difficulty, Dose 1 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Red Eyes, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Hoarseness, Dose 1 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Sore Throat, Dose 2 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swelling of the face, Dose 1 | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Sore Throat, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Cough, Dose 1 | 12 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Sore Throat, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swelling of the face, Dose 1 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swallowing Difficulty, Dose 2 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Hoarseness, Dose 1 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swallowing Difficulty, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swelling of the face, Dose 1 | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swallowing Difficulty, Dose 2 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Chest Tightness, Dose 1 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swelling of the face, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Wheezing, Dose 1 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swelling of the face, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Red Eyes, Dose 1 | 14 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swelling of the face, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Wheezing, Dose 1 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Wheezing, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Difficulty Breathing, Dose 1 | 5 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Wheezing, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Wheezing, Dose 1 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Wheezing, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Red Eyes, Dose 1 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Chest Tightness, Across Doses | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Chest Tightness, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Chest Tightness, Across Doses | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Chest Tightness, Dose 1 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Chest Tightness, Across Doses | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Chest Tightness, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Cough, Across Doses | 39 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Red Eyes, Dose 1 | 6 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Cough, Across Doses | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Chest Tightness, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Cough, Across Doses | 13 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Difficulty Breathing, Dose 1 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Difficulty Breathing, Across Doses | 5 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Cough, Dose 2 | 6 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Difficulty Breathing, Across Doses | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Sore throat, Dose 1 | 14 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Difficulty Breathing, Across Doses | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Cough, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Hoarseness, Across Doses | 11 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Cough, Dose 1 | 35 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Hoarseness, Across Doses | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Cough, Dose 2 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Hoarseness, Across Doses | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Sore throat, Dose 1 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Red Eyes, Across Doses | 14 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Difficulty Breathing, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Red Eyes, Across Doses | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Difficulty Breathing, Dose 1 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Red Eyes, Across Doses | 6 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Difficulty Breathing, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Sore Throat, Across Doses | 15 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Sore throat, Dose 1 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Sore Throat, Across Doses | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Difficulty Breathing, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Sore Throat, Across Doses | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Chest Tightness, Dose 1 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swallowing Difficulty, Across Doses | 6 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Hoarseness, Dose 2 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swallowing Difficulty, Across Doses | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swallowing Difficulty, Dose 1 | 5 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swallowing Difficulty, Across Doses | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Hoarseness, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swelling of the face, Across Doses | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Hoarseness, Dose 1 | 10 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swelling of the face, Across Doses | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Hoarseness, Dose 2 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swelling of the face, Across Doses | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swallowing Difficulty, Dose 1 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Wheezing, Across Doses | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Red Eyes, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Wheezing, Across Doses | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Cough, Dose 1 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Wheezing, Across Doses | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Red Eyes, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Wheezing, Across Doses | 4 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Chest Tightness, Dose 1 | 6 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Chest Tightness, Dose 1 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Chest Tightness, Dose 1 | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Cough, Dose 1 | 31 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Cough, Dose 1 | 10 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Difficulty Breathing, Dose 1 | 11 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Difficulty Breathing, Dose 1 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Difficulty Breathing, Dose 1 | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Hoarseness, Dose 1 | 12 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Hoarseness, Dose 1 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Hoarseness, Dose 1 | 6 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Red Eyes, Dose 1 | 12 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Red Eyes, Dose 1 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Red Eyes, Dose 1 | 9 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Sore throat, Dose 1 | 18 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Sore throat, Dose 1 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Sore throat, Dose 1 | 9 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swallowing Difficulty, Dose 1 | 6 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swallowing Difficulty, Dose 1 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swallowing Difficulty, Dose 1 | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swelling of the face, Dose 1 | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swelling of the face, Dose 1 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swelling of the face, Dose 1 | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Wheezing, Dose 1 | 5 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Wheezing, Dose 1 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Wheezing, Dose 1 | 4 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Chest Tightness, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Chest Tightness, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Chest Tightness, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Cough, Dose 2 | 13 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Cough, Dose 2 | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Cough, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Difficulty Breathing, Dose 2 | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Difficulty Breathing, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Difficulty Breathing, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Hoarseness, Dose 2 | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Hoarseness, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Hoarseness, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Red Eyes, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Red Eyes, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Red Eyes, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Sore Throat, Dose 2 | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Sore Throat, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Sore Throat, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swallowing Difficulty, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swallowing Difficulty, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swallowing Difficulty, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swelling of the face, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swelling of the face, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swelling of the face, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Wheezing, Dose 2 | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Wheezing, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Wheezing, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Chest Tightness, Across Doses | 6 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Chest Tightness, Across Doses | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Chest Tightness, Across Doses | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Cough, Across Doses | 39 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Cough, Across Doses | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Cough, Across Doses | 11 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Difficulty Breathing, Across Doses | 13 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Difficulty Breathing, Across Doses | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Difficulty Breathing, Across Doses | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Hoarseness, Across Doses | 15 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Hoarseness, Across Doses | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Hoarseness, Across Doses | 6 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Red Eyes, Across Doses | 13 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Red Eyes, Across Doses | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Red Eyes, Across Doses | 10 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Sore Throat, Across Doses | 21 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Sore Throat, Across Doses | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Sore Throat, Across Doses | 9 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swallowing Difficulty, Across Doses | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swallowing Difficulty, Across Doses | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swallowing Difficulty, Across Doses | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swelling of the face, Across Doses | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swelling of the face, Across Doses | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swelling of the face, Across Doses | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Wheezing, Across Doses | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Wheezing, Across Doses | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Cough, Dose 1 | 1 Subjects |
Primary
Number of Subjects Aged 3-17 Years Reporting the Occurrence of All Medically Attended Events (MAEs) .
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was a MAE that prevented normal activities. Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.
Time frame: During the entire study period (approximately 28 days (primed subjects) and 56 days (unprimed subjects) following vaccination
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 17 years, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting the Occurrence of All Medically Attended Events (MAEs) . | Any MAE(s) | 59 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting the Occurrence of All Medically Attended Events (MAEs) . | Grade 3 MAE(s) | 7 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years Reporting the Occurrence of All Medically Attended Events (MAEs) . | Related MAE(s) | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting the Occurrence of All Medically Attended Events (MAEs) . | Any MAE(s) | 52 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting the Occurrence of All Medically Attended Events (MAEs) . | Grade 3 MAE(s) | 6 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years Reporting the Occurrence of All Medically Attended Events (MAEs) . | Related MAE(s) | 0 Subjects |
Primary
Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms.
Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (\< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (\>) 39.0°C.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 3 to 4 years, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss of appetite, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability ,Across Doses | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Across Doses | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability, Across Doses | 7 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Loss of appetite, Dose 2 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Loss of appetite,Across Doses | 13 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness, Dose 2 | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss of appetite, Across Doses | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Loss of appetite, Across Doses | 8 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability, Dose 2 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Across Doses | 5 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Fever (≥38.0°C), Dose 2] | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Fever (≥38.0°C), Across Doses | 4 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | ≥38.0°C Related Fever, Across Doses | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability, Dose 1 | 9 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability, Dose 1 | 6 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Loss of appetite, Dose 1 | 9 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss of appetite, Dose 1 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Loss of appetite, Dose 1 | 6 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness, Dose 1 | 14 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Dose 1 | 5 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Fever (≥38.0°C), Dose 1 | 4 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | ≥38.0°C Related Fever, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Dose 1 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability, Dose 2 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Dose 1 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness, Across Doses | 16 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | ≥38.0°C Related Fever, Dose 1 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Across Doses | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness, Dose 2 | 5 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness, Across Doses | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness, Dose 1 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness, Dose 1 | 10 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Loss of appetite, Dose 2 | 4 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness, Across Doses | 10 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability, Dose 1 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability, Across Doses | 10 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Dose 1 | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Fever (≥38.0°C), Across Doses | 9 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Across Doses | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Across Doses | 6 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | ≥38.0°C Related Fever, Across Doses | 5 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness, Dose 2 | 6 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability, Dose 2 | 8 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability, Dose 2 | 6 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Loss of appetite, Dose 2 | 6 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss of appetite, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Loss of appetite, Dose 2 | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Dose 2 | 4 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Fever (≥38.0°C), Dose 2] | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Dose 2 | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | ≥38.0°C Related Fever, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness, Across Doses | 11 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness, Across Doses | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness, Across Doses | 8 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability, Across Doses | 16 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability ,Across Doses | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability, Across Doses | 11 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Loss of appetite,Across Doses | 16 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss of appetite, Across Doses | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Loss of appetite, Across Doses | 8 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Across Doses | 10 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness, Dose 1 | 4 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability, Dose 1 | 8 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Loss of appetite, Dose 1 | 14 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss of appetite, Dose 1 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Loss of appetite, Dose 1 | 6 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Fever (≥38.0°C), Dose 1 | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Dose 1 | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Dose 1 | 5 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | ≥38.0°C Related Fever, Dose 1 | 5 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness, Dose 1 | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness, Dose 1 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability, Dose 1 | 12 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability, Dose 1 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-4 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness, Dose 2 | 4 Subjects |
Primary
Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms.
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain, myalgia, shivering and fever (Fever = temperature above 38.0 degrees Celsius (°C)). Gastrointestinal symptoms included nausea, vomiting, diarrhoea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature \< 38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever = temperature above 39.0°C.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Dose 2 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal, Across Doses | 18 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Joint Pain, Dose 2 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Joint Pain, Dose 1 | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Joint Pain, Dose 2 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering, Across Doses | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Joint Pain, Dose 2 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Dose 1 | 94 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Dose 2 | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Dose 1 | 70 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Dose 2 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Joint Pain, Dose 1 | 25 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Dose 2 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Dose 1 | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering, Dose 2 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Dose 1 | 8 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Dose 1 | 55 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Dose 1 | 65 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Dose 2 | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering, Dose 1 | 20 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Fever (≥38.0°C), Dose 2 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Dose 2 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering, Dose 1 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal, Dose 1 | 35 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering, Dose 1 | 16 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Across Doses | 8 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Dose 1 | 46 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Across Doses | 66 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal, Across Doses | 38 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Fever (≥38.0°C), Dose 1 | 11 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal, Across Doses | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal, Dose 1 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Dose 1 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Across Doses | 83 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Dose 2 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Across Doses | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Dose 1 | 10 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Across Doses | 48 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal, Dose 1 | 18 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Joint Pain, Across Doses | 35 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | ≥38.0°C Related Fever, Dose 1 | 9 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Joint Pain, Across Doses | 4 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Dose 1 | 12 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Joint Pain, Across Doses | 25 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Dose 2 | 8 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Across Doses | 71 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Dose 1 | 82 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Across Doses | 4 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Across Doses | 56 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | ≥38.0°C Related Fever, Dose 2 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering, Across Doses | 21 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Dose 2 | 4 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Dose 1 | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering, Across Doses | 16 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Across Doses | 14 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Across Doses | 97 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Fever (≥38.0°C), Across Doses | 12 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Dose 2 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Across Doses | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal, Dose 2 | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Across Doses | 12 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | ≥38.0°C Related Fever, Across Doses | 10 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Joint Pain, Dose 1 | 34 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | ≥38.0°C Related Fever, Across Doses | 6 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering, Dose 1 | 20 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Across Doses | 72 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Dose 1 | 99 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Dose 1 | 70 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal, Dose 1 | 32 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal, Dose 1 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal, Dose 1 | 16 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Dose 1 | 76 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Dose 1 | 9 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Dose 1 | 50 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Joint Pain, Dose 1 | 38 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Joint Pain, Dose 1 | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Joint Pain, Dose 1 | 29 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Dose 1 | 84 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Dose 1 | 5 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Dose 1 | 72 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering, Dose 1 | 29 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering, Dose 1 | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Dose 1 | 9 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Fever (≥38.0°C), Dose 1 | 8 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Dose 1 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Dose 1 | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | ≥38.0°C Related Fever, Dose 1 | 6 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Dose 2 | 4 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fatigue, Dose 2 | 4 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Dose 2 | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Dose 2 | 4 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Joint Pain, Dose 2 | 4 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Joint Pain, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Joint Pain, Dose 2 | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Dose 2 | 9 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Dose 2 | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering, Dose 2 | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Fever (≥38.0°C), Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | ≥38.0°C Related Fever, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fatigue, Across Doses | 101 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Across Doses | 13 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Gastrointestinal, Across Doses | 32 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Gastrointestinal, Across Doses | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Gastrointestinal, Across Doses | 16 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Headache, Across Doses | 80 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Headache, Across Doses | 9 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Headache, Across Doses | 53 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Joint Pain, Across Doses | 42 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Joint Pain, Across Doses | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Joint Pain, Across Doses | 32 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Myalgia, Across Doses | 88 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Myalgia, Across Doses | 5 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Myalgia, Across Doses | 76 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Shivering, Across Doses | 31 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Shivering, Across Doses | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Shivering, Across Doses | 21 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Across Doses | 9 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Fever (≥38.0°C), Across Doses | 8 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Across Doses | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Across Doses | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fatigue, Dose 1 | 13 Subjects |
Primary
Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC Across Doses.
Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature \< 38°C but with missing values (MC) for at least one day during the solicited period.
Time frame: During 7 days (Days 0-6) post-vaccination
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC Across Doses. | Any Fever | 76 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC Across Doses. | Fever (≥38°C) | 72 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC Across Doses. | Any Fever | 70 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC Across Doses. | Fever (≥38°C) | 69 Subjects |
Secondary
Duration of Solicited General AEs in Subjects Aged 6-35 Months.
Duration was defined as number of days with any grade of general symptoms.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 6-35 Months. | Drowsiness, Dose 1 | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 6-35 Months. | Drowsiness, Dose 2 | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 6-35 Months. | Irritability, Dose 1 | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 6-35 Months. | Irritability, Dose 2 | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 6-35 Months. | Loss of appetite, Dose 1 | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 6-35 Months. | Loss of appetite, Dose 2 | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 6-35 Months. | Fever, Dose 1 | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited General AEs in Subjects Aged 6-35 Months. | Fever, Dose 2 | 1.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 6-35 Months. | Fever, Dose 2 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 6-35 Months. | Drowsiness, Dose 1 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 6-35 Months. | Loss of appetite, Dose 1 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 6-35 Months. | Drowsiness, Dose 2 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 6-35 Months. | Fever, Dose 1 | 1.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 6-35 Months. | Irritability, Dose 1 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 6-35 Months. | Loss of appetite, Dose 2 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited General AEs in Subjects Aged 6-35 Months. | Irritability, Dose 2 | 2.0 Days |
Secondary
Duration of Solicited Local AEs in Subjects Aged 6-35 Months.
Duration was defined as number of days with any grade of local symptoms.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local AEs in Subjects Aged 6-35 Months. | Pain, Dose 1 | 1.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local AEs in Subjects Aged 6-35 Months. | Pain, Dose 2 | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local AEs in Subjects Aged 6-35 Months. | Redness, Dose 1 | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local AEs in Subjects Aged 6-35 Months. | Redness, Dose 2 | 2.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local AEs in Subjects Aged 6-35 Months. | Swelling, Dose 1 | 1.0 Days |
| Influsplit Tetra_IP Adult Group | Duration of Solicited Local AEs in Subjects Aged 6-35 Months. | Swelling, Dose 2 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local AEs in Subjects Aged 6-35 Months. | Swelling, Dose 1 | 1.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local AEs in Subjects Aged 6-35 Months. | Pain, Dose 1 | 1.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local AEs in Subjects Aged 6-35 Months. | Redness, Dose 2 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local AEs in Subjects Aged 6-35 Months. | Pain, Dose 2 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local AEs in Subjects Aged 6-35 Months. | Swelling, Dose 2 | 2.0 Days |
| Influsplit Tetra_LP Adult Group | Duration of Solicited Local AEs in Subjects Aged 6-35 Months. | Redness, Dose 1 | 2.0 Days |
Secondary
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains
HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Day 0 and Day 21
Population: The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [H1N1, Day 0] | 48.3 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [Yamagata, Day 0] | 133.3 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [Yamagata, Day 21] | 591.4 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [H3N2, Day 0] | 16.7 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [Victoria, Day 0] | 38.6 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [H1N1, Day 21] | 655.7 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [Victoria, Day 21] | 263.4 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [H3N2, Day 21 | 80.5 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [Victoria, Day 21] | 302.9 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [H1N1, Day 0] | 53.6 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [H1N1, Day 21] | 632.2 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [H3N2, Day 0] | 16.0 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [H3N2, Day 21 | 73.0 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [Yamagata, Day 21] | 598.6 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [Victoria, Day 0] | 34.8 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 18-49 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [Yamagata, Day 0] | 101.6 Titers |
Secondary
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains
HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Day 0 and Day 28 post last vaccination
Population: The analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were avail
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [H1N1, Day 0] | 80.2 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [H1N1, Day 28] | 698.0 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [H3N2, Day 0] | 38.9 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [H3N2, Day 28] | 158.2 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [Yamagata, Day 0] | 58.1 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [Yamagata, Day 28] | 479.0 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [Victoria, Day 0] | 27.3 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [Victoria, Day 28] | 237.6 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [Victoria, Day 28] | 253.7 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [H1N1, Day 0] | 87.7 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [Yamagata, Day 0] | 70.8 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [H1N1, Day 28] | 694.1 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [Victoria, Day 0] | 28.8 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [H3N2, Day 0] | 41.9 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [Yamagata, Day 28] | 527.6 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 3-17 Years by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | [H3N2, Day 28] | 171.4 Titers |
Secondary
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains
HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Day 0 and Day 28 post last vaccination
Population: Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | H1N1, Day 0 | 11.1 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | H1N1, Day 28 | 97.5 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | H3N2, Day 0 | 7.5 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | H3N2, Day 28 | 45.2 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | Yamagata, Day 0 | 8.3 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | Yamagata, Day 28 | 100.8 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | Victoria, Day 0 | 5.7 Titers |
| Influsplit Tetra_IP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | Victoria, Day 28 | 32.1 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | Victoria, Day 28 | 38.0 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | H1N1, Day 0 | 11.2 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | Yamagata, Day 0 | 7.9 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | H1N1, Day 28 | 105.5 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | Victoria, Day 0 | 5.7 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | H3N2, Day 0 | 8.4 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | Yamagata, Day 28 | 105.4 Titers |
| Influsplit Tetra_LP Adult Group | Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects Aged 6-35 Months by Calculating Serum Anti-haemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains | H3N2, Day 28 | 59.9 Titers |
Secondary
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years.
MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Day 21
Population: The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years. | H1N1 | 13.6 Fold increase |
| Influsplit Tetra_IP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years. | H3N2 | 4.8 Fold increase |
| Influsplit Tetra_IP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years. | Yamagata | 4.4 Fold increase |
| Influsplit Tetra_IP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years. | Victoria | 6.8 Fold increase |
| Influsplit Tetra_LP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years. | Victoria | 8.6 Fold increase |
| Influsplit Tetra_LP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years. | H1N1 | 11.5 Fold increase |
| Influsplit Tetra_LP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years. | Yamagata | 6.0 Fold increase |
| Influsplit Tetra_LP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 18-49 Years. | H3N2 | 4.6 Fold increase |
Secondary
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years.
MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Day 28 post last vaccination
Population: Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years. | H1N1 | 8.7 Fold increase |
| Influsplit Tetra_IP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years. | H3N2 | 4.1 Fold increase |
| Influsplit Tetra_IP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years. | Yamagata | 8.2 Fold increase |
| Influsplit Tetra_IP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years. | Victoria | 8.7 Fold increase |
| Influsplit Tetra_LP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years. | Victoria | 8.8 Fold increase |
| Influsplit Tetra_LP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years. | H1N1 | 7.9 Fold increase |
| Influsplit Tetra_LP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years. | Yamagata | 7.4 Fold increase |
| Influsplit Tetra_LP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 3-17 Years. | H3N2 | 4.1 Fold increase |
Secondary
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months.
MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Day 28 post last vaccination
Population: Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months. | H3N2 | 6.0 Fold increase |
| Influsplit Tetra_IP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months. | Yamagata | 12.2 Fold increase |
| Influsplit Tetra_IP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months. | Victoria | 5.6 Fold increase |
| Influsplit Tetra_IP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months. | H1N1 | 8.8 Fold increase |
| Influsplit Tetra_LP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months. | Victoria | 6.6 Fold increase |
| Influsplit Tetra_LP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months. | H1N1 | 9.5 Fold increase |
| Influsplit Tetra_LP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months. | Yamagata | 13.3 Fold increase |
| Influsplit Tetra_LP Adult Group | Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains in Subjects Aged 6-35 Months. | H3N2 | 7.1 Fold increase |
Secondary
Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Day 21
Population: The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H3N2 | 30 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H1N1 | 42 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Victoria | 36 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Yamagata | 27 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Victoria | 40 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H1N1 | 42 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Yamagata | 36 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Seroconverted Subjects Aged 18-49 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H3N2 | 29 Subjects |
Secondary
Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Day 28 post last vaccination
Population: Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 3 to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H1N1 | 274 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H3N2 | 192 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Victoria | 285 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Yamagata | 273 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Victoria | 287 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H3N2 | 183 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Yamagata | 268 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Seroconverted Subjects Aged 3-17 Years for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H1N1 | 269 Subjects |
Secondary
Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Day 28 post last vaccination
Population: Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H1N1 | 287 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Yamagata | 318 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H3N2 | 217 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Victoria | 213 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Victoria | 211 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H1N1 | 275 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H3N2 | 236 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Seroconverted Subjects Aged 6-35 Months for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Yamagata | 321 Subjects |
Secondary
Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Day 0 and Day 21
Population: The analysis was performed on the Adult According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 18 to 49 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [H1N1, Day 0] | 35 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [Yamagata, Day 0] | 52 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [H3N2, Day 0] | 15 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [Yamagata, Day 21] | 57 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [H1N1, Day 21] | 56 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [Victoria, Day 0] | 34 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [H3N2, Day 21] | 49 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [Victoria, Day 21] | 57 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [Victoria, Day 21] | 57 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [H1N1, Day 0] | 35 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [H1N1, Day 21] | 57 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [H3N2, Day 0] | 14 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [H3N2, Day 21] | 49 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [Yamagata, Day 0] | 50 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [Yamagata, Day 21] | 57 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 18-49 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [Victoria, Day 0] | 32 Subjects |
Secondary
Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Day 0 and Day 28 post last vaccination
Population: Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [H1N1, Day 28] | 393 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [H1N1, Day 0] | 308 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [H3N2, Day 0] | 245 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [H3N2, Day 28] | 377 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [Yamagata, Day 0] | 266 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [Yamagata, Day 28] | 396 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [Victoria, Day 0] | 192 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [Victoria, Day 28] | 375 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [Victoria, Day 28] | 374 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [Yamagata, Day 0] | 281 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [H1N1, Day 0] | 314 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [H1N1, Day 28] | 395 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [Victoria, Day 0] | 195 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [H3N2, Day 0] | 252 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [Yamagata, Day 28] | 395 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 3-17 Years, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | [H3N2, Day 28] | 378 Subjects |
Secondary
Number of Subjects Aged 5-17 Years Reporting Myalgia Across Doses.
Any = occurrence of any myalgia symptom regardless of intensity grade or relationship to vaccination.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 5 to 17 years, with at least one vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 5-17 Years Reporting Myalgia Across Doses. | 71 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 5-17 Years Reporting Myalgia Across Doses. | 88 Subjects |
Secondary
Number of Subjects Aged 6-35 Months, Reporting Any and Related Serious Adverse Events (SAEs)
A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time frame: During the entire study period [approximately 28 days (primed subjects) and 56 days (unprimed subjects)]
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months, Reporting Any and Related Serious Adverse Events (SAEs) | Any SAEs | 7 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months, Reporting Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months, Reporting Any and Related Serious Adverse Events (SAEs) | Any SAEs | 11 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months, Reporting Any and Related Serious Adverse Events (SAEs) | Related SAEs | 0 Subjects |
Secondary
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms.
Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (\< )38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (\>)39.0°C.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability, Dose 2 | 87 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Dose 1 | 16 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability, Across Doses | 98 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | ≥38.0°C Related Fever, Dose 1 | 14 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness, Across Doses | 115 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness, Dose 2 | 63 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Loss Of Appetite, Dose 2 | 39 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness, Dose 2 | 6 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness, Dose 1 | 87 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness, Dose 2 | 46 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness, Across Doses | 8 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness, Dose 1 | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability, Dose 2 | 5 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Loss Of Appetite, Across Doses | 127 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability, Dose 2 | 59 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness, Dose 1 | 54 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Loss Of Appetite, Dose 2 | 64 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness, Across Doses | 78 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss Of Appetite, Dose 2 | 4 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability, Dose 1 | 10 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability, Dose 1 | 75 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Dose 2 | 41 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss Of Appetite, Across Doses | 13 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Fever (≥38.0°C), Dose 2 | 40 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Loss of appetite, Dose 1 | 94 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Dose 2 | 10 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability, Across Doses | 155 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Dose 2 | 19 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss of appetite, Dose 1 | 9 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | ≥38.0°C Related Fever, Dose 2 | 19 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Loss Of Appetite, Across Doses | 69 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Loss of appetite, Dose 1 | 47 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Across Doses | 76 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Dose 1 | 42 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Fever (≥38.0°C), Across Doses | 72 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability, Across Doses | 15 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Across Doses | 18 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Fever (≥38.0°C), Dose 1 | 39 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Across Doses | 32 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Dose 1 | 8 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | ≥38.0°C Related Fever, Across Doses | 30 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability, Dose 1 | 124 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | ≥38.0°C Related Fever, Across Doses | 34 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability, Dose 1 | 96 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability, Dose 1 | 10 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Loss of appetite, Dose 1 | 40 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Fever (≥38.0°C), Dose 1 | 42 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | ≥38.0°C Related Fever, Dose 2 | 17 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness, Across Doses | 103 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness, Across Doses | 13 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness, Across Doses | 66 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability, Across Doses | 141 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability, Across Doses | 17 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability, Across Doses | 87 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Loss Of Appetite, Across Doses | 116 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness, Dose 1 | 77 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness, Dose 1 | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness, Dose 1 | 50 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability, Dose 1 | 58 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Loss of appetite, Dose 1 | 76 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss of appetite, Dose 1 | 8 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Dose 1 | 44 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Dose 1 | 5 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Dose 1 | 23 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | ≥38.0°C Related Fever, Dose 1 | 22 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Drowsiness, Dose 2 | 58 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Drowsiness, Dose 2 | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Drowsiness, Dose 2 | 35 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Irritability, Dose 2 | 87 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Irritability, Dose 2 | 8 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Irritability, Dose 2 | 50 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Loss Of Appetite, Dose 2 | 69 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss Of Appetite, Dose 2 | 10 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Loss Of Appetite, Dose 2 | 37 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Dose 2 | 40 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Fever (≥38.0°C), Dose 2 | 40 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Dose 2 | 9 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Dose 2 | 17 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Loss Of Appetite, Across Doses | 17 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Loss Of Appetite, Across Doses | 61 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Any Fever, Across Doses | 70 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Fever (≥38.0°C), Across Doses | 69 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Grade 3 Fever, Across Doses | 14 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Solicited General Symptoms. | Related Fever, Across Doses | 35 Subjects |
Secondary
Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and 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 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination.
Time frame: During the 28-day (Days 0-27) follow-up period after vaccination
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Grade 3 Unsolicited AEs | 33 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Any Unsolicited AEs | 243 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Related Unsolicited AEs | 6 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Any Unsolicited AEs | 262 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Grade 3 Unsolicited AEs | 31 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). | Related Unsolicited AEs | 3 Subjects |
Secondary
Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2.
Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature \< 38°C but with missing values (MC) for at least one day during the solicited period. Fever = temperature of ≥ 38°C/100.4°F by any route
Time frame: During 7 days (Days 0-6) post-vaccination
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2. | Any Fever, Dose 1 | 42 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2. | Fever (≥38°C), Dose 1 | 39 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2. | Any Fever, Dose 2 | 41 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2. | Fever (≥38°C), Dose 2 | 40 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2. | Fever (≥38°C), Dose 2 | 40 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2. | Any Fever, Dose 1 | 44 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2. | Any Fever, Dose 2 | 40 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Fever ≥38ºC After Dose 1 and After Dose 2. | Fever (≥38°C), Dose 1 | 42 Subjects |
Secondary
Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs).
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. \> 50mm.
Time frame: During the 7-day (Days 0-6) post-vaccination period
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Any Redness, Dose 2 | 61 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Grade 3 Pain, Dose 1 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Grade 3 Redness, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Any Swelling, Dose 1 | 33 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Any Swelling, Dose 2 | 32 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Any Pain, Dose 1 | 69 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Grade 3 Swelling, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Grade 3 Swelling, Dose 1 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Any Pain, Across Doses | 89 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Any Redness, Dose 1 | 88 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Grade 3 Pain, Across Doses | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Any Pain, Dose 2 | 47 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Any Redness, Across Doses | 106 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Grade 3 Swelling, Across Doses | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Grade 3 Redness, Across Doses | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Grade 3 Pain, Dose 2 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Any Swelling, Across Doses | 50 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Grade 3 Redness, Dose 1 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Any Swelling, Across Doses | 51 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Any Pain, Dose 1 | 77 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Grade 3 Pain, Dose 1 | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Any Redness, Dose 1 | 86 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Grade 3 Redness, Dose 1 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Any Swelling, Dose 1 | 42 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Grade 3 Swelling, Dose 1 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Any Pain, Dose 2 | 48 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Grade 3 Pain, Dose 2 | 4 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Any Redness, Dose 2 | 66 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Grade 3 Redness, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Any Swelling, Dose 2 | 27 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Grade 3 Swelling, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Any Pain, Across Doses | 98 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Grade 3 Pain, Across Doses | 4 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Any Redness, Across Doses | 106 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Grade 3 Redness, Across Doses | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Local Adverse Events (AEs). | Grade 3 Swelling, Across Doses | 1 Subjects |
Secondary
Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms.
Oculorespiratory syndrome (ORS) was defined as the occurrence within 24 hours after vaccination of one or more of the following newly onset symptoms: bilateral red eyes, cough, wheeze, chest tightness, difficulty breathing, difficulty swallowing, hoarseness, sore throat, facial swelling. Any = occurrence of any ORS symptom regardless of intensity grade or relationship to vaccination. Grade 3 = ORS symptoms that prevented normal activities. Related = ORS symptom assessed by the investigator as causally related to the vaccination.
Time frame: During a 3 day (Days 0-2) follow-up period after vaccination
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Wheezing, Across Doses | 7 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Chest Tightness, Dose 1 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Chest Tightness, Dose 1 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Cough, Dose 1 | 47 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Cough, Dose 1 | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Cough, Dose 1 | 16 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Difficulty Breathing, Dose 1 | 15 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Difficulty Breathing, Dose 1 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Difficulty Breathing, Dose 1 | 4 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Hoarseness, Dose 1 | 13 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Hoarseness, Dose 1 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Hoarseness, Dose 1 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Red Eyes, Dose 1 | 10 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Red Eyes, Dose 1 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Red Eyes, Dose 1 | 6 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Sore throat, Dose 1 | 6 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Sore throat, Dose 1 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Sore throat, Dose 1 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swallowing Difficulty, Dose 1 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swallowing Difficulty, Dose 1 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swallowing Difficulty, Dose 1 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swelling of the face, Dose 1 | 4 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swelling of the face, Dose 1 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swelling of the face, Dose 1 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Wheezing, Dose 1 | 9 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Wheezing, Dose 1 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Wheezing, Dose 1 | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Chest Tightness, Dose 2 | 9 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Chest Tightness, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Chest Tightness, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Cough, Dose 2 | 37 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Cough, Dose 2 | 5 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Cough, Dose 2 | 8 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Difficulty Breathing, Dose 2 | 19 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Difficulty Breathing, Dose 2 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Difficulty Breathing, Dose 2 | 5 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Hoarseness, Dose 2 | 13 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Hoarseness, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Hoarseness, Dose 2 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Red Eyes, Dose 2 | 10 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Red Eyes, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Red Eyes, Dose 2 | 6 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Sore Throat, Dose 2 | 7 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Sore Throat, Dose 2 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Sore Throat, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swallowing Difficulty, Dose 2 | 8 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swallowing Difficulty, Dose 2 | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swallowing Difficulty, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swelling of the face, Dose 2 | 5 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swelling of the face, Dose 2 | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swelling of the face, Dose 2 | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Wheezing, Dose 2 | 11 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Wheezing, Dose 2 | 3 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Wheezing, Dose 2 | 4 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Chest Tightness, Across Doses | 10 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Chest Tightness, Across Doses | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Chest Tightness, Across Doses | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Cough, Across Doses | 73 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Cough, Across Doses | 8 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Cough, Across Doses | 22 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Difficulty Breathing, Across Doses | 31 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Difficulty Breathing, Across Doses | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Difficulty Breathing, Across Doses | 8 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Hoarseness, Across Doses | 23 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Hoarseness, Across Doses | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Hoarseness, Across Doses | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Red Eyes, Across Doses | 18 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Red Eyes, Across Doses | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Red Eyes, Across Doses | 10 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Sore Throat, Across Doses | 12 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Sore Throat, Across Doses | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Sore Throat, Across Doses | 1 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swallowing Difficulty, Across Doses | 8 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swallowing Difficulty, Across Doses | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swallowing Difficulty, Across Doses | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swelling of the face, Across Doses | 9 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swelling of the face,Across Doses | 0 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swelling of the face,Across Doses | 2 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Wheezing, Across Doses | 19 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Wheezing, Across Doses | 4 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Chest Tightness, Dose 1 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swelling of the face,Across Doses | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Red Eyes, Dose 1 | 11 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Wheezing, Across Doses | 5 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Red Eyes, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Chest Tightness, Dose 1 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Chest Tightness, Dose 1 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Difficulty Breathing, Across Doses | 25 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Chest Tightness, Dose 1 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Red Eyes, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Cough, Dose 1 | 50 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Sore Throat, Across Doses | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Cough, Dose 1 | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Sore Throat, Dose 2 | 11 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Cough, Dose 1 | 13 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Difficulty Breathing, Across Doses | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Difficulty Breathing, Dose 1 | 12 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Sore Throat, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Difficulty Breathing, Dose 1 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swelling of the face, Across Doses | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Difficulty Breathing, Dose 1 | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Sore Throat, Dose 2 | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Hoarseness, Dose 1 | 11 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Difficulty Breathing, Across Doses | 4 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Hoarseness, Dose 1 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swallowing Difficulty, Dose 2 | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Hoarseness, Dose 1 | 4 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Sore Throat, Across Doses | 5 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swallowing Difficulty, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Red Eyes, Dose 1 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Hoarseness, Across Doses | 17 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Red Eyes, Dose 1 | 5 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swallowing Difficulty, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Sore throat, Dose 1 | 7 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Wheezing, Across Doses | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Sore throat, Dose 1 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swelling of the face, Dose 2 | 4 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Sore throat, Dose 1 | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Hoarseness, Across Doses | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swallowing Difficulty, Dose 1 | 5 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swelling of the face, Dose 2 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swallowing Difficulty, Dose 1 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swallowing Difficulty, Across Doses | 12 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swallowing Difficulty, Dose 1 | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swelling of the face, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Swelling of the face, Dose 1 | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Hoarseness, Across Doses | 5 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swelling of the face, Dose 1 | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Wheezing, Dose 2 | 16 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swelling of the face, Dose 1 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swelling of the face,Across Doses | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Wheezing, Dose 1 | 12 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Wheezing, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Wheezing, Dose 1 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Red Eyes, Across Doses | 19 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Wheezing, Dose 1 | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Wheezing, Dose 2 | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Chest Tightness, Dose 2 | 4 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Swallowing Difficulty, Across Doses | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Chest Tightness, Dose 2 | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Chest Tightness, Across Doses | 5 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Chest Tightness, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Red Eyes, Across Doses | 0 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Cough, Dose 2 | 53 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Chest Tightness, Across Doses | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Cough, Dose 2 | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Wheezing, Across Doses | 26 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Cough, Dose 2 | 8 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Chest Tightness, Across Doses | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Difficulty Breathing, Dose 2 | 18 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Red Eyes, Across Doses | 5 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Difficulty Breathing, Dose 2 | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Cough, Across Doses | 85 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Difficulty Breathing, Dose 2 | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Swallowing Difficulty, Across Doses | 3 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Hoarseness, Dose 2 | 9 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Cough, Across Doses | 6 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Grade 3 Hoarseness, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Sore Throat, Across Doses | 17 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Hoarseness, Dose 2 | 1 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Related Cough, Across Doses | 18 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting Solicited Oculorespiratory Syndrome (ORS) Like Symptoms. | Any Red Eyes, Dose 2 | 11 Subjects |
Secondary
Number of Subjects Aged 6-35 Months Reporting the Occurrence of All Medically Attended Events (MAEs)
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s). Grade 3 was a MAE that prevented normal activities. Related was defined as a MAE assessed by the investigator to be causally related to the study vaccination.
Time frame: During the entire study period (approximately 28 days (primed subjects) and 56 days (unprimed subjects) following vaccination
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 to 35 months, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting the Occurrence of All Medically Attended Events (MAEs) | Any MAE(s) | 235 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting the Occurrence of All Medically Attended Events (MAEs) | Grade 3 MAE(s) | 35 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months Reporting the Occurrence of All Medically Attended Events (MAEs) | Related MAE(s) | 2 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting the Occurrence of All Medically Attended Events (MAEs) | Any MAE(s) | 252 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting the Occurrence of All Medically Attended Events (MAEs) | Grade 3 MAE(s) | 29 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months Reporting the Occurrence of All Medically Attended Events (MAEs) | Related MAE(s) | 0 Subjects |
Secondary
Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Massachusetts/02/2012 (Yamagata) and Flu B/Brisbane/60/2008 (Victoria).
Time frame: At Day 0 and Day 28 post last vaccination
Population: Analysis was performed on the Pediatric According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects aged 6 months to 17 years, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H1N1, Day 0 | 84 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H1N1, Day 28 | 303 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H3N2, Day 0 | 55 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H3N2, Day 28 | 232 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Yamagata, Day 0 | 53 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Yamagata, Day 28 | 329 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Victoria, Day 0 | 17 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Victoria, Day 28 | 214 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Victoria, Day 28 | 217 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H1N1, Day 0 | 83 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Yamagata, Day 0 | 49 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H1N1, Day 28 | 289 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Victoria, Day 0 | 16 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H3N2, Day 0 | 67 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | Yamagata, Day 28 | 331 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6-35 Months, Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. | H3N2, Day 28 | 259 Subjects |
Secondary
Number of Subjects Aged 6 Months to <5 Years, Reporting Fever ≥38ºC (100.4°F) and >39.0°C (102.2ºF) Across Doses.
Any fever = all subjects with a documented temperature of ≥ 38°C/100.4°F by any route and all subjects reporting temperature \< 38°C but with missing values (MC) for at least one day during the solicited period. Grade 3 fever = temperature above 39.0°C/102.2ºF. Data of 2 independent groups were pooled.
Time frame: During the 2 days (Day 0-Day 1) post-vaccination period
Population: The analysis was performed on the Pediatric-Total Vaccinated cohort which included all subjects aged 6 months to \<5 years, with at least one vaccine administration documented.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6 Months to <5 Years, Reporting Fever ≥38ºC (100.4°F) and >39.0°C (102.2ºF) Across Doses. | Any Fever | 29 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6 Months to <5 Years, Reporting Fever ≥38ºC (100.4°F) and >39.0°C (102.2ºF) Across Doses. | Fever (≥38°C) | 28 Subjects |
| Influsplit Tetra_IP Adult Group | Number of Subjects Aged 6 Months to <5 Years, Reporting Fever ≥38ºC (100.4°F) and >39.0°C (102.2ºF) Across Doses. | Grade 3 Fever | 4 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6 Months to <5 Years, Reporting Fever ≥38ºC (100.4°F) and >39.0°C (102.2ºF) Across Doses. | Any Fever | 31 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6 Months to <5 Years, Reporting Fever ≥38ºC (100.4°F) and >39.0°C (102.2ºF) Across Doses. | Fever (≥38°C) | 31 Subjects |
| Influsplit Tetra_LP Adult Group | Number of Subjects Aged 6 Months to <5 Years, Reporting Fever ≥38ºC (100.4°F) and >39.0°C (102.2ºF) Across Doses. | Grade 3 Fever | 1 Subjects |