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The purpose of this study is to gather additional evidence of the safety and immunogenicity of 1 dose of Fluarix Tetra (0.5 milliliter [mL]) (Northern Hemisphere (NH)2023-2024) in individuals aged 65 years and above to fulfill a post-approval condition imposed by the Indian regulatory authorities (CDSCO) for this age group in India.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quadrivalent seasonal influenza (FLU D-QIV) vaccine group | Experimental | Participants received 1 dose of seasonal FLU vaccine at Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluarix Tetra Vaccine | Biological | A single dose of Fluarix Tetra vaccine administered intramuscularly (IM) on day 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Any Solicited Administration Site Adverse Event | The solicited administration site adverse events included pain, redness and swelling. | Day 1 to Day 7 |
| Number of Participants Reporting Any Solicited Systemic Events | The solicited systemic events included fever, headache, myalgia (muscle pain), arthralgia (joint pain), fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), sweating and shivering. | Day 1 to Day 7 |
| Number of Participants Reporting Unsolicited Adverse Events (AEs) | An unsolicited AE is defined as an event reported in addition to the solicited AEs during the clinical study. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. | Day 1 to Day 21 |
| Number of Participants Reporting Serious Adverse Events (SAEs) | A SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant. | Day 1 to Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies | Serum HI antibodies against the four-influenza vaccine strains are expressed as GMTs, in titers. The assessed strains are: A/Victoria/4897/2022 (H1N1), A/Darwin/9/2021 (H3N2), B/Austria/1359417/2021 and B/Phuket/3073/2013. | At Baseline (Day 1) and Day 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Belagavi | 590010 | India | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41159757 | Derived | Jain V, Cauwberghs F, Qian H, Best-Sule K, Gupta V, Tatchou EN, Struyf F. Reactogenicity, safety, and immunogenicity of a quadrivalent seasonal influenza vaccine in adults aged 65 years and older: Phase 4 study results from India during December 2023-February 2024. Hum Vaccin Immunother. 2025 Dec;21(1):2578084. doi: 10.1080/21645515.2025.2578084. Epub 2025 Oct 29. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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| ID | Title | Description |
|---|---|---|
| FG000 | Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Participants received 1 dose of seasonal FLU vaccine at Day 1. |
| 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 | May 5, 2023 | Feb 14, 2025 |
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| Mean Geometric Increase (MGI) of Serum HI Antibodies |
MGI is defined as the fold increase in post-vaccination serum HI GMTs compared with Baseline. Analysis was performed for four influenza strains: A/Victoria/4897/2022 (H1N1), A/Darwin/9/2021 (H3N2), B/Austria/1359417/2021 and B/Phuket/3073/2013. |
| At Day 22 (compared with Baseline [Day 1]) |
| Number of Participants With Seroconversion Rate (SCR) | SCR is defined as the percentage of participants who have either a pre-vaccination titer less than (<) 1:10 and a postvaccination 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. | At Day 22 |
| Number of Participants With Seroprotection Rate (SPR) | SPR is defined as the percentage of participants with a serum HI titer >=1:40. | At Day 1 and Day 22 |
| Kattankulathur |
| 603211 |
| India |
| GSK Investigational Site | Nashik | 422002 | India |
| GSK Investigational Site | Nashik | 422003 | India |
| GSK Investigational Site | Varanasi | 221010 | India |
| GSK Investigational Site | Visakhapatnam | 530002 | India |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Participants received 1 dose of seasonal FLU vaccine at Day 1. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | YEARS |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Number of Participants Reporting Any Solicited Administration Site Adverse Event | The solicited administration site adverse events included pain, redness and swelling. | The analysis was performed on the Solicited Safety Set (SSS), which included participants that received study intervention and had solicited safety data. | Posted | Count of Participants | Participants | Day 1 to Day 7 |
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| Primary | Number of Participants Reporting Any Solicited Systemic Events | The solicited systemic events included fever, headache, myalgia (muscle pain), arthralgia (joint pain), fatigue, gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain), sweating and shivering. | SSS population | Posted | Count of Participants | Participants | Day 1 to Day 7 |
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| Primary | Number of Participants Reporting Unsolicited Adverse Events (AEs) | An unsolicited AE is defined as an event reported in addition to the solicited AEs during the clinical study. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. | Analysis was performed on Exposed Set (ES) population, which included all participants that received the study intervention. | Posted | Count of Participants | Participants | Day 1 to Day 21 |
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| Primary | Number of Participants Reporting Serious Adverse Events (SAEs) | A SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant. | ES population | Posted | Count of Participants | Participants | Day 1 to Day 21 |
|
| |||||||||||||||||||||||||||
| Secondary | Geometric Mean Titers (GMT) of Serum Hemagglutination-inhibiting (HI) Antibodies | Serum HI antibodies against the four-influenza vaccine strains are expressed as GMTs, in titers. The assessed strains are: A/Victoria/4897/2022 (H1N1), A/Darwin/9/2021 (H3N2), B/Austria/1359417/2021 and B/Phuket/3073/2013. | Analysis was performed on the Per Protocol Set (PPS), which included all participants who received the trial intervention as per protocol, had immunogenicity results pre- and post-dose, complied with the allowed dosing/blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titer | At Baseline (Day 1) and Day 22 |
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| Secondary | Mean Geometric Increase (MGI) of Serum HI Antibodies | MGI is defined as the fold increase in post-vaccination serum HI GMTs compared with Baseline. Analysis was performed for four influenza strains: A/Victoria/4897/2022 (H1N1), A/Darwin/9/2021 (H3N2), B/Austria/1359417/2021 and B/Phuket/3073/2013. | PPS population | Posted | Geometric Mean | 95% Confidence Interval | Fold increase | At Day 22 (compared with Baseline [Day 1]) |
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| Secondary | Number of Participants With Seroconversion Rate (SCR) | SCR is defined as the percentage of participants who have either a pre-vaccination titer less than (<) 1:10 and a postvaccination 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. | PPS population | Posted | Count of Participants | Participants | At Day 22 |
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| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Seroprotection Rate (SPR) | SPR is defined as the percentage of participants with a serum HI titer >=1:40. | PPS population | Posted | Count of Participants | Participants | At Day 1 and Day 22 |
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Solicited AEs were collected during a 7-day period after vaccine administration (from Day 1 to Day 7). Unsolicited AEs and SAEs were collected during a 21-day period after vaccine administration (from Day 1 to Day 21).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Quadrivalent Seasonal Influenza (FLU D-QIV) Vaccine Group | Participants received 1 dose of seasonal FLU vaccine at Day 1. | 0 | 250 | 0 | 250 | 70 | 250 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Administration site erythema | General disorders | v27.0 | Systematic Assessment |
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| Administration site pain | General disorders | v27.0 | Systematic Assessment |
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| Administration site swelling | General disorders | v27.0 | Systematic Assessment |
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| Fatigue | General disorders | v27.0 | Systematic Assessment |
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| Pyrexia | General disorders | v27.0 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | v27.0 | Systematic Assessment |
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| Pustule | Infections and infestations | v27.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | v27.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | v27.0 | Systematic Assessment |
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| Headache | Nervous system disorders | v27.0 | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 17, 2023 | Feb 14, 2025 | 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 |
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| Title | Denominators | Categories |
|---|
| A/Victoria/4897/2022 (H1N1), Day 1 |
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| A/Victoria/4897/2022 (H1N1), Day 22 |
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| A/Darwin/9/2021 (H3N2), Day 1 |
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| A/Darwin/9/2021 (H3N2), Day 22 |
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| B/Austria/1359417/2021, Day 1 |
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| B/Austria/1359417/2021, Day 22 |
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| B/Phuket/3073/2013, Day 1 |
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| B/Phuket/3073/2013, Day 22 |
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