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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1260-4678 | Registry Identifier | ICTRP | |
| VAP00027 | Other Identifier | Sanofi Identifier | |
| 2022-000577-11 | EudraCT Number |
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The purpose of this study was to demonstrate the non-inferiority (NI) of the HAI immune response of RIV4 in participants aged 9 to 17 years vs participants aged 18 to 49 years and to describe the immunogenicity and safety profile of RIV4 in all participants.
The participation duration was approximately 6 months for each participant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 9 to 17 years old | Experimental | Participants of 9 to 17 years old who received RIV4 single intramuscular (IM) injection at D01 |
|
| Group 18 to 49 years old | Experimental | Participants of 18 to 49 years old who received RIV4 single intramuscular (IM) injection at D01 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quadrivalent Recombinant influenza vaccine (RIV4) season/2022-2023/NH | Biological | Pharmaceutical form: Solution for injection Route of administration: intramuscular |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | GMTs of anti-influenza antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. | Day 29 |
| Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29 | Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination titer less than (<) 1:10 (1/dilution) at Day 1 and a post-vaccination titer greater than or equal to (>=) 1: 40 (1/dilution) at Day 29 or a pre-vaccination titer >= 1:10 at Day 1 and a >= 4-fold increase in post-vaccination titer. | Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| GMTs Against Influenza Vaccine Antibodies at Day 1 | GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. | Pre-vaccination on Day 1 |
| Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Clinical Therapeutics North Tower Site Number : 8400024 | Birmingham | Alabama | 35205 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40412421 | Derived | Folegatti PM, Pepin S, Tabar C, Fries K, Talanova O, See S, Essink B, Bertoch T, Drazan D, Natalini Martinez S, Konieczny M, Kaas-Leach K, De Bruijn I. Comparative assessment of immunogenicity and safety of recombinant influenza vaccine in children, adolescents, and adults: results from a phase 3, immunobridging, open-label, non-randomised study. Lancet Infect Dis. 2025 Oct;25(10):1097-1105. doi: 10.1016/S1473-3099(25)00153-7. Epub 2025 May 21. |
| Label | URL |
|---|---|
| VAP00027 Plain Language Results Summary | View source |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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A total of 1308 participants were enrolled in this study.
This study was conducted at 36 investigational sites in 4 countries between 27 Oct 2022 to 27 Oct 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Participants Aged 9 to 17 Years | Participants received a single intramuscular (IM) injection of RIV4 0.5 milliliter (mL) on Day 1. |
| FG001 | Cohort 2: Participants Aged 18 to 49 Years |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 22, 2022 | May 2, 2024 |
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Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers >=10 and >=40 against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure. |
| On Days 1 and 29 |
| Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | GMTR was the ratio of the individual titers post-vaccination over pre-vaccination. The GMTs were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. | On Days 1 and 29 |
| Number of Participants With Immediate Unsolicited Adverse Events (AEs) | An AE was any untoward medical occurrence in a clinical investigation participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs. | Within 30 minutes post-vaccination on Day 1 |
| Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted in the protocol and CRF and considered as related to the study intervention administered. An injection site reaction was an AR at and around the injection site and were commonly inflammatory reactions. Solicited systemic reactions were systemic AEs and those occurring during the specified collection period were always considered related to the intervention even if there was evidence of alternative etiology. | From Day 1 up to 7 days post-vaccination (up to Day 8) |
| Number of Participants With Unsolicited AEs | An AE was any untoward medical occurrence in a clinical investigation participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. | From Day 1 up to 28 days post-vaccination (up to Day 29) |
| Number of Participants With Medically Attended Adverse Events (MAAEs) | An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or emergency department. | From Day 1 up to 28 days post-vaccination (up to Day 29) |
| Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI) | An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention, events for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. | From Day 1 up to 6 months post-vaccination, 181 days |
| Birmingham Pediatric Associates Site Number : 8400023 |
| Birmingham |
| Alabama |
| 35205 |
| United States |
| The Children's Clinic Of Jonesboro PA Site Number : 8400025 | Jonesboro | Arkansas | 72401 | United States |
| California Research Foundation Site Number : 8400003 | San Diego | California | 92123-1881 | United States |
| Meridian Clinical Research- Sioux City Site Number : 8400007 | Sioux City | Iowa | 51106 | United States |
| AMR - Newton Site Number : 8400021 | Newton | Kansas | 67114 | United States |
| Kentucky Pediatics / Adult Research Site Number : 8400010 | Bardstown | Kentucky | 40004 | United States |
| Velocity Clinical Research Site Number : 8400012 | New Orleans | Louisiana | 70119 | United States |
| Velocity Clinical Research Lincoln Site Number : 8400013 | Lincoln | Nebraska | 68510 | United States |
| Meridian Clinical Research Norfolk Site Number : 8400011 | Norfolk | Nebraska | 68701 | United States |
| Velocity Clinical Research, Omaha Site Number : 8400009 | Omaha | Nebraska | 68134 | United States |
| Meridian Clinical Research Site Number : 8400006 | Binghamton | New York | 13905 | United States |
| Velocity Clinical Research Vestal Site Number : 8400016 | Vestal | New York | 13850 | United States |
| Ohio Pediatric Research Site Number : 8400020 | Dayton | Ohio | 45414 | United States |
| Rainbow Pediatrics Site Number : 8400014 | Barnwell | South Carolina | 29812 | United States |
| Coastal Pediatric Research Charleston Site Number : 8400005 | Charleston | South Carolina | 29414 | United States |
| Coastal Carolina Research Center - N Charleston Site Number : 8400022 | North Charleston | South Carolina | 29405 | United States |
| Benchmark Research - Austin Site Number : 8400004 | Austin | Texas | 78705 | United States |
| JBR Clinical Research Site Number : 8400001 | Salt Lake City | Utah | 84107 | United States |
| J. Lewis Research Site Number : 8400017 | Salt Lake City | Utah | 84109 | United States |
| Velocity Clinical Research Portsmouth Site Number : 8400015 | Portsmouth | Virginia | 23703 | United States |
| Investigational Site Number : 2030001 | Jindřichův Hradec | 37701 | Czechia |
| Investigational Site Number : 6160010 | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-048 | Poland |
| Investigational Site Number : 6160007 | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-079 | Poland |
| Investigational Site Number : 6160004 | PuÃ…'awy | Lubusz Voivodeship | 24-100 | Poland |
| Investigational Site Number : 6160005 | Siemianowice ÅšlÄ…skie | Silesian Voivodeship | 41-103 | Poland |
| Investigational Site Number : 6160003 | Bydgoszcz | 85-796 | Poland |
| Investigational Site Number : 6160006 | Tarnów | 33-100 | Poland |
| Investigational Site Number : 6160008 | Warsaw | 02-637 | Poland |
| Investigational Site Number : 6160012 | Wroclaw | 53-149 | Poland |
| Investigational Site Number : 7240006 | Centelles | Barcelona [Barcelona] | 08540 | Spain |
| Investigational Site Number : 7240018 | Madrid | 28660 | Spain |
| Investigational Site Number : 7240005 | Málaga | 29015 | Spain |
| Investigational Site Number : 7240001 | Móstoles | 28938 | Spain |
| Investigational Site Number : 7240007 | Seville | 41014 | Spain |
Participants received a single IM injection of RIV4 0.5 mL on Day 1.
| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on study participants with data in case report form (CRF).
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Participants Aged 9 to 17 Years | Participants received a single IM injection of RIV4 0.5 mL on Day 1. |
| BG001 | Cohort 2: Participants Aged 18 to 49 Years | Participants received a single IM injection of RIV4 0.5 mL on Day 1. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Geometric Mean Titers (GMTs) Against Influenza Vaccine Antibodies at Day 29 | GMTs of anti-influenza antibodies were measured using individual hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. | Analysis was performed on the Per-protocol analysis set (PPAS)-subset of full analysis set (FAS) which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample. | Posted | Geometric Mean | 95% Confidence Interval | titer | Day 29 |
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| Primary | Percentage of Participants With Seroconversion for Influenza Vaccine Antibodies at Day 29 | Anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Seroconversion was defined as either a pre-vaccination titer less than (<) 1:10 (1/dilution) at Day 1 and a post-vaccination titer greater than or equal to (>=) 1: 40 (1/dilution) at Day 29 or a pre-vaccination titer >= 1:10 at Day 1 and a >= 4-fold increase in post-vaccination titer. | Analysis was performed on the PPAS-subset of FAS which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample. Only participants with data collected for each category at Day 29 are reported. | Posted | Number | 95% Confidence Interval | percentage of participants | Day 29 |
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| Secondary | GMTs Against Influenza Vaccine Antibodies at Day 1 | GMTs of anti-influenza antibodies were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. | Analysis was performed on the PPAS-subset of FAS which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample. Only participants with data collected for each category at Day 1 are reported. | Posted | Geometric Mean | 95% Confidence Interval | titer | Pre-vaccination on Day 1 |
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| Secondary | Percentage of Participants With Detectable HAI Titers >=10 and >=40 for Influenza Vaccine Antibodies at Days 1 and 29 | Antibody titers were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. Percentage of participants with antibody titers >=10 and >=40 against influenza vaccine antibodies at Day 1 and Day 29 were reported in this outcome measure. | Analysis was performed on the PPAS-subset of FAS which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample. Only participants with data collected for each category on Days 1 and 29 are reported. | Posted | Number | 95% Confidence Interval | percentage of participants | On Days 1 and 29 |
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| Secondary | Geometric Mean Titer Ratio (GMTR) of Influenza Vaccine Antibodies | GMTR was the ratio of the individual titers post-vaccination over pre-vaccination. The GMTs were measured using HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata lineages. | Analysis was performed on the PPAS-subset of FAS which included participants who received 1 dose of the study vaccine and had a post-vaccination blood sample. Only participants with data collected for each category on Days 1 and Day 29 are reported. | Posted | Geometric Mean | 95% Confidence Interval | ratio | On Days 1 and 29 |
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| Secondary | Number of Participants With Immediate Unsolicited Adverse Events (AEs) | An AE was any untoward medical occurrence in a clinical investigation participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs. | Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine. | Posted | Count of Participants | Participants | Within 30 minutes post-vaccination on Day 1 |
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| Secondary | Number of Participants With Solicited Injection Site Reactions and Systemic Reactions | A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted in the protocol and CRF and considered as related to the study intervention administered. An injection site reaction was an AR at and around the injection site and were commonly inflammatory reactions. Solicited systemic reactions were systemic AEs and those occurring during the specified collection period were always considered related to the intervention even if there was evidence of alternative etiology. | Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine. Number of participants analyzed signifies those participants with data collected for this outcome measure and number analyzed signifies those participants with data collected for specified category. | Posted | Count of Participants | Participants | From Day 1 up to 7 days post-vaccination (up to Day 8) |
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| Secondary | Number of Participants With Unsolicited AEs | An AE was any untoward medical occurrence in a clinical investigation participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, that is, prelisted in the CRF in terms of diagnosis and/or onset window post-vaccination. | Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine. | Posted | Count of Participants | Participants | From Day 1 up to 28 days post-vaccination (up to Day 29) |
|
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| Secondary | Number of Participants With Medically Attended Adverse Events (MAAEs) | An MAAE was a new onset or a worsening of a condition that prompted the participant or participant's parent/guardian to seek unplanned medical advice at a physician's office or emergency department. | Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine. | Posted | Count of Participants | Participants | From Day 1 up to 28 days post-vaccination (up to Day 29) |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) And Adverse Events of Special Interest (AESI) | An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI was defined as one of scientific and medical concern specific to the Sponsor's study intervention, events for which ongoing monitoring and rapid communication by the investigator to the sponsor was done. | Analysis was performed on the Safety analysis set which included participants who received 1 dose of the study vaccine. | Posted | Count of Participants | Participants | From Day 1 up to 6 months post-vaccination, 181 days |
|
|
From Day 1 up to 6 months post-vaccination, 181 days
Analysis was performed on the Safety analysis set.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Participants Aged 9 to 17 Years | Participants received a single IM injection of RIV4 0.5 mL on Day 1. | 0 | 641 | 3 | 641 | 263 | 641 |
| EG001 | Cohort 2: Participants Aged 18 to 49 Years | Participants received a single IM injection of RIV4 0.5 mL on Day 1. | 0 | 658 | 7 | 658 | 336 | 658 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intentional Overdose | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Spinal Fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Obstructive Pancreatitis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Kidney Infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Gastric Cancer Recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 26.1 | Systematic Assessment |
| |
| Major Depression | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 26.1 | Systematic Assessment |
|
The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi Pasteur | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 6, 2023 | May 2, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Male |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Not Reported |
|
| Unknown |
|
| Multiple |
|
| B/Victoria |
|
| B/Yamagata |
|
Statistical analysis for A/H3N2 |
| GMT Ratio |
| 3.27 |
| 2-Sided |
| 95 |
| 2.76 |
| 3.87 |
| Non-Inferiority |
Non-inferiority was concluded if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was > 0.667 for each strain. |
| Statistical analysis for B/Victoria | GMT Ratio | 1.57 | 2-Sided | 95 | 1.35 | 1.82 | Non-Inferiority | Non-inferiority was concluded if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was > 0.667 for each strain. |
| Statistical analysis for B/Yamagata | GMT Ratio | 1.22 | 2-Sided | 95 | 1.09 | 1.37 | Non-Inferiority | Non-inferiority was concluded if the lower limit of the two-sided 95% CI of the ratio of GMTs between groups (9 to 17 years/18 to 49 years) was > 0.667 for each strain. |
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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