CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


Report for D007251: Influenza, Human NIH

(Synonyms: Influen, Influenz, Influenza, Influenza, H, Influenza, Hu, Influenza, Hum, Influenza, Human)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (22)


Name (Synonyms) Correlation
drug1964 Quadrivalent RIV with H3 strain 1 Wiki 0.30
drug2205 Scanning Chest X-rays and performing AI algorithms on images Wiki 0.30
drug1965 Quadrivalent RIV with H3 strain 1 and adjuvant Wiki 0.30
drug1405 MCC IMS Wiki 0.30
drug1967 Quadrivalent RIV with H3 strain 2 and adjuvant Wiki 0.30
drug2744 artus Influenza A/B RT-PCR Test Wiki 0.30
drug1963 Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant Wiki 0.30
drug1966 Quadrivalent RIV with H3 strain 2 Wiki 0.30
drug2511 Throat swab and/or nasopharyngeal swab Wiki 0.30
drug314 Baloxavir Marboxil Wiki 0.30
drug1962 Quadrivalent RIV with 2018-2019 NH H3 strain Wiki 0.30
drug1282 Ivermectin plus Nitazoxanide Wiki 0.30
drug76 ARB Wiki 0.21
drug305 BNT162b2 Wiki 0.21
drug304 BNT162b1 Wiki 0.21
drug719 Data collection Wiki 0.17
drug53 ACE inhibitor Wiki 0.17
drug2300 Standard Care Wiki 0.15
drug1706 Oseltamivir Wiki 0.12
drug698 DAS181 Wiki 0.12
drug923 Favipiravir Wiki 0.07
drug1822 Placebo Wiki 0.03

Correlated MeSH Terms (16)


Name (Synonyms) Correlation
D003384 Coxsackievirus Infections NIH 0.30
D000257 Adenoviridae Infections NIH 0.21
D018184 Paramyxoviridae Infections NIH 0.17
D018357 Respiratory Syncytial Virus Infections NIH 0.12
D053717 Pneumonia, Ventilator-Associated NIH 0.10
D017563 Lung Diseases, Interstitial NIH 0.10
D014777 Virus Diseases NIH 0.07
D012141 Respiratory Tract Infections NIH 0.06
D004630 Emergencies NIH 0.06
D003141 Communicable Diseases NIH 0.05
D007239 Infection NIH 0.05
D011024 Pneumonia, Viral NIH 0.04
D013577 Syndrome NIH 0.03
D018352 Coronavirus Infections NIH 0.02
D011014 Pneumonia NIH 0.02
D045169 Severe Acute Respiratory Syndrome NIH 0.02

Correlated HPO Terms (3)


Name (Synonyms) Correlation
HP:0006515 Interstitial pneumonitis HPO 0.10
HP:0011947 Respiratory tract infection HPO 0.06
HP:0002090 Pneumonia HPO 0.02

There are 11 clinical trials

Clinical Trials


1 An International Observational Study to Characterize Adults Who Are Hospitalized With Influenza or Other Targeted Respiratory Viruses

Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to estimate rates of morbidity and mortality and to examine predictors of severity among participants with 2009 H1N1 infection. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. The current version of the protocol (released in August 2013) further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded.

NCT01056185 Influenza Novel Respiratory Virus-1 Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV) Novel Respiratory Virus-2 Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)
MeSH:Influenza, Human Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome Virus Diseases

Primary Outcomes

Measure: Death

Time: 60-day period following enrollment

Secondary Outcomes

Measure: Recovery from influenza illness (including days lost from normal activities) duration of hospitalization, days in intensive care, days of mechanical ventilation, days of dialysis, pregnancy outcome

Time: approximately 60 days

2 An International Observational Study to Characterize Adults With Influenza or Other Targeted Respiratory Viruses

Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to describe participants seeking medical care in geographically diverse locations with 2009 H1N1 infection and their clinical course over a 14-day period following enrollment. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. This version of the protocol further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded

NCT01056354 Influenza and Other Novel Respiratory Viruses
MeSH:Influenza, Human

Primary Outcomes

Description: Death or hospitalization within 14 days of enrollment or the development of one severe complication.

Measure: Death or Hospitalization

Time: 14-day period following enrollment

Secondary Outcomes

Measure: Days of work/school lost, duration of symptoms, use of antivirals

Time: 14 days

3 Testing of Respiratory Specimens for the Validation of the QIAGEN ResPlex II Advanced Panel Test and the Artus Influenza A/B RT-PCR Test

The study will be conducted using nasopharyngeal swab specimens collected prospectively from individuals suspected of having the signs and symptoms of an acute respiratory tract infection caused by a respiratory virus. A series of standard viral culture tests validated for routine use in the clinical laboratory, and/or a series of PCR-based Laboratory Developed Tests (PCR-LDT) validated by a central reference laboratory will be used to verify the performance of the investigational artus Influenza A/B RT-PCR test and the QIAGEN ResPlex II Advanced Panel test. From each specimen five (5) aliquots will be prepared: (a) one aliquot will be tested in real-time using the assigned viral culture reference methods; (b) one aliquot will be used to extract nucleic acid in real-time for investigational testing; (c) one aliquot of the specimen will be stored at --70C for subsequent shipment to the reference laboratory for PCR-LDT testing, (d) one aliquot will be archived at -70C for subsequent follow-up by the reference laboratory (e.g., bi-directional sequencing of positive specimens), and (e) any remaining specimen will be stored for the Fresh vs. Frozen Study. The extracted nucleic acid generated from the second aliquot (i.e., "b" above) will be split and subjected to testing by both the artus Influenza A/B RT-PCR test and the ResPlex II Advanced Panel test.

NCT01302418 QIAGEN ResPlex II Advanced Panel Influenza A Respiratory Respiratory Syncytial Virus Infections Infection Due to Human Parainfluenza Virus 1 Parainfluenza Type 2 Parainfluenza Type 3 Parainfluenza Type 4 Human Metapneumovirus A/B Rhinovirus Coxsackie Virus/Echovirus Adenovirus Types B/C/E Coronavirus Subtypes 229E Coronavirus Subtype NL63 Coronavirus Subtype OC43 Coronavirus Subtype HKU1 Human Bocavirus Artus Influenza A/B RT-PCR Test Influenza B Device: artus Influenza A/B RT-PCR Test
MeSH:Infection Communicable Diseases Influenza, Human Coronavirus Infections Adenoviridae Infections Respiratory Syncytial Virus Infections Paramyxoviridae Infections Coxsackievirus Infections Virus Diseases

Primary Outcomes

Description: The presence of Influenza A or Influenza B virus.

Measure: Detection of Respiratory Viruses

Time: Specimens will be taken within 5 days of the appearance of symptoms.

4 SEA022 Oseltamivir Treatment in Children Under One Year of Age With Moderate or Severe Influenza Lower Respiratory Tract Infection - a Clinical and Pharmacokinetic Study.

Currently, there is no treatment for children less than one year of age with influenza related lower respiratory tract infection that is either considered standard or registered in any country. This dismal scenario exists even though influenza related LRTI is a significant illness causing morbidity and mortality, especially in children less than 6 months of age. Avian influenza has been reported rarely in children less than one. There are no data in Vietnam and very few data in Thailand on the burden of influenza in children less than one. This young age group suffers high mortality. Oseltamivir may be beneficial in such children. This is basis of this trial.

NCT01546935 Influenza Drug: Oseltamivir
MeSH:Infection Respiratory Tract Infections Influenza, Human
HPO:Respiratory tract infection

Primary Outcomes

Description: Viral clearance on Day 5 (human influenza) on a throat swab, assessed by RT PCR. Viral clearance on Day 10 (avian influenza) on a throat swab, assessed by RT PCR.

Measure: Viral clearance

Time: 5-10 days

Description: • Cmax, Tmax, AUC, apparent volume of distribution, clearance, terminal elimination half-life

Measure: Pharmacokinetics of Oseltamivir

Time: Day 0 and Day 9

Secondary Outcomes

Description: Time to viral clearance on a throat swab, assessed by RT PCR. The time to no detectable influenza virus by culture for the throat swab. Change in viral load (log10 copies/mL) over time for all virological samples (lower limit of detection: 1000 copies/mL) Viral susceptibility of cultured influenza virus to antiviral drugs at baseline and post treatment, assessed by genotypical and phenotypical analyses

Measure: Viral end points

Time: 5-10 days

Description: Time to fever clearance In hospital mortality and mortality by follow up Time to death Time to trans cutaneous O2 saturation of ≥ 95% on room air Clinical course: pneumothorax, encephalitis/encephalopathy Number of days in hospital Number of days ventilated

Measure: Clinical Efficacy Endpoints

Time: 5-10 days

Description: Documented serious adverse events (SAEs) and relationships to oseltamivir AEs leading to drug withdrawal Grade 3 & 4 clinical and laboratory AEs that are probably or definitely related to oseltamivir Skin rashes of any grade Changes in haematological and biochemical parameters over time

Measure: Safety Endpoints

Time: 5-10 days

5 Burden of Influenza-related Hospitalizations and Emergency Room Visits in Children in Spain

This study aims to quantify the inpatient and ER visits burden of laboratory-confirmed influenza, and compare the clinical features, severity, complications, risk factors and socioeconomic impact of influenza in children presenting with acute respiratory illness (ARI) and/or isolated fever, with or without laboratory-confirmed influenza.

NCT01592799 Influenza Procedure: Throat swab and/or nasopharyngeal swab Other: Data collection
MeSH:Influenza, Human Emergencies

Primary Outcomes

Description: ARI was defined as one or more of the following symptoms: sore throat (in children greater than or equal to (≥) 3 years old), coryza (runny nose), cough, breathing difficulties. Isolated fever was defined as: oral temperature ≥37.5°C / axillary temperature ≥37.5°C / Rectal temperature ≥38°C / tympanic temperature on oral setting ≥37.5°C / tympanic temperature on rectal setting ≥38°C without an obvious cause.

Measure: Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever

Time: Day 0 till Day 28-37

Description: Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days.

Measure: Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza

Time: Day 0 till Day 28-37

Secondary Outcomes

Description: Among the other laboratory-confirmed respiratory viruses there were:adenovirus, respiratory syncytial virus, parainfluenza virus 1, 2 and 3, metapneumovirus, bocavirus, rhinovirus or coronavirus. The outcome was assessed in subjects with an acute respiratory illness (ARI) and/or isolated fever episode.

Measure: Number of Subjects With Other Laboratory-confirmed Respiratory Viruses

Time: Day 0 till Day 28-37

Description: Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed.

Measure: Number of Subjects With Fatal Outcomes

Time: Day 0 till Day 28-37

Description: The outcome assessed the various complications by laboratory-confirmed influenza status.

Measure: Number of Subjects With Secondary Bacterial Infections

Time: Day 0 till Day 28-37

Description: Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status.

Measure: Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status

Time: Day 0 till Day 28-37

Description: The outcomes was assessed in subjects with laboratory-confirmed influenza status

Measure: Number of Days of Hospitalization

Time: Day 0 till Day 28-37 (between October 2010 until May 2011)

Description: ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

Measure: Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status

Time: Day 0 till Day 28-37

Description: ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

Measure: Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status

Time: Day 0 till Day 28-37

Description: ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

Measure: Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status

Time: Day 0 till Day 28-37

Description: ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

Measure: Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit

Time: Day 0 till Day 28-37

Description: School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status.

Measure: Number of Days of School Absenteeism

Time: Day 0 till Day 28-37

Description: This outcome assessed absenteeism among caregivers to provide patient care during the follow-up period by laboratory-confirmed influenza status.

Measure: Number of Days of Parent or Caregiver Time Off Work

Time: Day 0 till Day 28-37

Description: This outcome assessed the number of cases with household contacts presenting influenza like illness symptoms during the follow-up period by laboratory-confirmed influenza status.

Measure: Number of Subjects With Household Members With Influenza-like Illness

Time: Day 0 till Day 28-37

Description: This outcome assessed the proportion of influenza like illness (ILI) among household members of children < 15 years with and without laboratory-confirmed influenza.

Measure: Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever)

Time: Day 0 till Day 28-37

6 A Multicenter, Single-Arm, Open-Label Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients From Birth to < 1 Year With Influenza-Like Symptoms

This study will evaluate the safety, pharmacokinetics and efficacy of baloxavir marboxil in healthy pediatric participants from birth to <1 year with influenza like symptoms

NCT03653364 Influenza Drug: Baloxavir Marboxil
MeSH:Influenza, Human

Primary Outcomes

Description: An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.

Measure: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time: Up to Day 29

Secondary Outcomes

Measure: Plasma Concentrations of Baloxavir Marboxil and S-033447

Time: Day 2 and Day 4

Measure: Area Under the Concentration to Time Curve from Time 0 to Infinity (AUC0-inf) of baloxavir marboxil and S-033447

Time: Up to Day 10

Measure: Maximum Plasma Concentration (Cmax) of baloxavir marboxil and S-033447

Time: Up to Day 10

Measure: Time to Maximum Plasma Concentration (Tmax) of baloxavir marboxil and S-033447

Time: Up to Day 10

Measure: Apparent Half-Life (T1/2) of baloxavir marboxil and S-033447

Time: Up to Day 10

Description: Time to alleviation of influenza signs and symptoms is defined as the length of time taken from the start of treatment to the point at which all of the following criteria are met and remain so for at least 21.5 hours: A score of 0 (no problem) or 1 (minor problem) for cough and nasal symptoms (items 14 and 15 of the Canadian Acute Respiratory Illness and Flu Scale [CARIFS]) A "yes" response to the following question on the CARIFS: "Since the last assessment has the subject been able to return to day care/school, or resume his or her normal daily activity in the same way as performed prior to developing the flu?" First return to afebrile state (tympanic temperature ≤37.2 degree Celsius [°C])

Measure: Time to Alleviation of Influenza Signs and Symptoms

Time: Up to Day 15

Description: Length of time taken by participants to return to afebrile state [tympanic temperature ≤ 37.2°C] and remaining so for at least 21.5 hours.

Measure: Duration of Fever

Time: Up to Day 15

Description: The efficacy of baloxavir marboxil is evaluated by duration of symptoms i.e., alleviation of all symptoms as defined by a score of 0 [no problem] or 1 [minor problem] and remaining so for at least 21.5 hours, for all 18 symptoms specified in the CARIFS questionnaire).

Measure: Duration of Symptoms

Time: Up to Day 15

Measure: Time to Return to Normal Health and Activity

Time: Up to Day 15

Description: The influenza related complications include death, hospitalization, radiologically confirmed pneumonia, bronchitis, sinusitis, otitis media, encephalitis/encephalopathy, febrile seizures, myositis.

Measure: Frequency of Influenza-Related Complications

Time: Up to Day 29

Measure: Percentage of Participants Requiring Antibiotics

Time: Up to Day 29

Measure: Time to Cessation of Viral Shedding by Virus Titer and by RT-PCR

Time: Day 1 - Day 29

Measure: Change from Baseline in Influenza Virus Titer and in the Amount of Virus RNA (RT-PCR) at Day 2, 4, 6, 10, 15, 29

Time: Baseline, Day 2, 4, 6, 10, 15, 29

Measure: Percentage of Participants with Positive Influenza Virus Titer and Positive by RT-PCR at Day 2, 4, 6, 10, 15, 29

Time: Day 2, 4, 6, 10, 15, 29

Measure: Area Under the Curve in Virus Titer and in the Amount of Virus RNA (RT-PCR)

Time: Day 1 - Day 29

7 Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling

Multicapillary Ion mobility spectrometry of nasal air aspirates shall be investigated as screening tool for the detection of Influenza and SARS-CoV-2- infection.

NCT04282135 Influenza Diagnostic Test: MCC IMS
MeSH:Influenza, Human

Primary Outcomes

Description: Cluster Analysis of MCC IMS spectra will be obtained immediately after sampling

Measure: Cluster Analysis of MCC IMS spectra.

Time: immediatly after sampling

8 A Phase IIb Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Severe Influenza Infection

This is a Phase IIb study consisting of two cohorts to evaluate efficacy, safety and pharmacokinetics of DAS181 in IFV infection. An approximate total of 280 subjects will be enrolled into this study.

NCT04298060 Influenza Infection SAD-RV Infection and COVID-19 Drug: DAS181 Drug: Placebo
MeSH:Infection Communicable Diseases Influenza, Human

Primary Outcomes

Description: Percent of subjects who have returned to room air

Measure: Percent of subjects who have returned to room air

Time: 7 days

Description: Percent change of subjects return to baseline oxygen requirement by Day 7 compared to Day 1

Measure: Percent change of subjects return to baseline oxygen requirement

Time: 7 days

9 The Benefits of Artificial Intelligence Algorithms (CNNs) for Discriminating Between COVID-19 and Influenza Pneumonitis in an Emergency Department Using Chest X-Ray Examinations

This project aims to use artificial intelligence (image discrimination) algorithms, specifically convolutional neural networks (CNNs) for scanning chest radiographs in the emergency department (triage) in patients with suspected respiratory symptoms (fever, cough, myalgia) of coronavirus infection COVID 19. The objective is to create and validate a software solution that discriminates on the basis of the chest x-ray between Covid-19 pneumonitis and influenza

NCT04313946 COVID-19 Pneumonia, Viral Influenza With Pneumonia Flu Symptom Flu Like Illness Pneumonia, Interstitial Pneumonia, Ventilator-Associated Pneumonia Atypical Diagnostic Test: Scanning Chest X-rays and performing AI algorithms on images
MeSH:Pneumonia, Ventilator-Associated Influenza, Human Pneumonia, V Pneumonia, Viral Pneumonia Lung Diseases, Interstitial
HPO:Interstitial pneumonitis Interstitial pulmonary abnormality Pneumonia

Primary Outcomes

Description: Number of participants with pneumonitis on Chest X-Ray and COVID 19 positive

Measure: COVID-19 positive X-Rays

Time: 6 months

Description: Number of participants with pneumonitis on Chest X-Ray and COVID 19 negative

Measure: COVID-19 negative X-Rays

Time: 6 months

10 Evaluation of Influenza Vaccination and Treatment With ACEI and ARB in the Evolution of SARS-Covid19 Infection

Some authors have proposed the use of the flu vaccine to reduce the severity of COVID-19 cases, while some have proposed the use of ACE Inhibitors (ACEI) or Angiotensin Receptor blockers (ARB), since this virus shares hemagglutinin as a transmission mechanism and acts on the ACE2 enzyme during infection. The aim is to evaluate whether the admitted patients who are previously vaccinated or those who were already receiving treatment show a better evolution.

NCT04367883 COVID19 Influenza Vaccination ACE Inhibitors ARB Drug: ACE inhibitor Drug: ARB
MeSH:Influenza, Human

Primary Outcomes

Description: exitus vs hospital output

Measure: hospital output

Time: from March 1, 2020.

Secondary Outcomes

Description: lenght of the hospital stay

Measure: hospital stay

Time: From March 1, 2020.

11 Safety and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Formulations Containing Different H3 Hemagglutinin Antigens Without or With Adjuvant in Healthy Adult Subjects

The primary objectives of the study are: - To describe the safety profile of the different formulations in all participants - To describe the hemagglutinin inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (H1, H3, B/Victoria, and B/Yamagata) antigens present in the control vaccine in all groups at all timepoints. The secondary objectives are: - To describe antigenic coverage in each group by assessing the HAI and SN antibody responses against a panel of H3 antigens (not present in any of the vaccine formulations). - To describe SN antibody responses in each group against each of the H3 antigens. - To compare H3 HAI and SN antibody responses for the groups with quadrivalent recombinant influenza vaccine (RIV) formulations with H3 antigens to those of the quadrivalent RIV control group. - To compare the HAI and SN antibody responses for the groups with quadrivalent RIV formulation with adjuvant to the group without adjuvant.

NCT04451954 Influenza Biological: Quadrivalent RIV with H3 strain 1 Biological: Quadrivalent RIV with H3 strain 1 and adjuvant Biological: Quadrivalent RIV with H3 strain 2 Biological: Quadrivalent RIV with H3 strain 2 and adjuvant Biological: Quadrivalent RIV with 2018-2019 NH H3 strain Biological: Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant
MeSH:Influenza, Human

Primary Outcomes

Description: Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination

Measure: Number of participants with immediate adverse events

Time: Within 30 minutes after vaccination

Description: Solicited injection site reactions: injection site pain, erythema, swelling, induration and bruising; solicited systemic reactions: fever, headache, malaise, and myalgia

Measure: Number of participants with solicited injection site or systemic reactions

Time: From Day 0 to Day 7

Description: Unsolicited (spontaneously reported) adverse events not not fulfilling criteria for solicited reactions

Measure: Number of participants with unsolicited adverse events

Time: From Day 0 to Day 28

Description: Serious adverse events are collected throughout the study

Measure: Number of participants with serious adverse events

Time: From Day 0 to Day 365

Description: Adverse events of special interest are collected throughout the study

Measure: Number of participants with adverse events of special interest

Time: From Day 0 to Day 365

Description: Laboratory tests include complete blood count (CBC), platelet count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, serum creatinine, serum lipase, and serum amylase)

Measure: Clinical safety laboratory test results

Time: From Day 0 to Day 7

Description: Influenza antibody titers are measured by HAI and SN assays

Measure: HAI and SN antibody titers against influenza antigens in the quadrivalent RIV control vaccine

Time: From Day 0 to Day 365

Description: Titers ratio is calculated for the following time points: Day 7/Day 0, Day 28/Day 0, and Day 90/Day 0

Measure: Individual HAI and SN titers ratio against influenza antigens in the quadrivalent RIV control vaccine

Time: From Day 0 to Day 90

Description: Seroconversion is defined as HAI antibody titer < 10 [1/dil] at Day 0 and post-injection titer ≥ 40 [1/dil] at Day 28, or titer ≥ 10 [1/dil] at Day 0 and a ≥ 4-fold increase in titer [1/dil] at Day 28)

Measure: Number of participants with seroconversion to influenza antigens in the quadrivalent RIV control vaccine

Time: From Day 0 to Day 28

Description: Influenza vaccine antibody titers are measured by HAI assay

Measure: HAI Ab titer ≥ 40 [1/dil]

Time: From Day 0 to Day 365

Description: Influenza vaccine antibody titers are measured by SN assay

Measure: 2-fold and 4-fold increase in SN titers

Time: From Day 0 to Day 28

Secondary Outcomes

Description: Influenza vaccine antibody titers are measured by HAI and SN assays

Measure: HAI antibody titers against influenza H3 antigens not present in the vaccine formulations and the SN antibody titers against each of the H3 antigens

Time: Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365

Description: Titer ratio is calculated for the following time points: Day 7/Day 0, Day 28/Day 0, Day 90/Day 0

Measure: Individual HAI titer ratios against influenza H3 antigens not present in the vaccine formulations and individual SN titer ratio against each of the H3 antigens

Time: From Day 0 to Day 90

Description: Seroconversion is defined as HAI antibody titer < 10 [1/dil] at Day 0 and post-injection titer ≥ 40 [1/dil] at Day 28, or titer ≥ 10 [1/dil] at Day 0 and a ≥ 4-fold increase in titer [1/dil] at Day 28)

Measure: Number of participants with seroconversion to influenza H3 antigens not present in the vaccine formulations

Time: Day 0 and Day 28

Description: Influenza vaccine antibody titers a are measured by SN assay

Measure: 2-fold and 4-fold rise in SN antibody titers against each of the H3 antigens

Time: Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365


HPO Nodes