Safety and Immunogenicity of H1N1 Vaccines in Adults Aged 18 Years and Older

Influenza Clinical Trial

Official title:

A Study to Evaluate the Safety and Immunogenicity of A/California/7/2009 (H1N1)V-like Vaccines GSK2340273A and GSK2340274A in Adults Aged 18 Years and Older

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00985088
• Other study ID #: 113440
• Status: Completed
• Phase: Phase 2
• First received: September 24, 2009
• Last updated: November 13, 2017
• Start date: October 11, 2009
• Est. completion date: December 16, 2010

Study information

• Verified date: November 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to characterize the safety and immunogenicity of the H1N1 (swine) flu vaccines GSK2340273A and GSK2340274A in adults 18 years of age or older.

This protocol posting has been updated for sections impacted by the Protocol amendment 1, Sept 2009.

Description:

Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1343
• Est. completion date: December 16, 2010
• Est. primary completion date: November 9, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects who the investigator believes can and will comply with the requirements of the protocol.

• Written informed consent obtained from the subject.

• Male and female adults, >= 18 years of age at the time of the first vaccination.

• Safety laboratory test results within the parameters specified in the protocol.

• Satisfactory baseline medical assessment by history and physical examination.

• Comprehension of the study requirements, ability to comprehend and comply with procedures for collection of safety data, expressed availability for the required study period, and ability and willingness to attend scheduled visits as documented by signature on the informed consent document.

• Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or other multiple-user device.

• Female subjects of non-childbearing potential may be enrolled in the study.

• 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 first 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:

• Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus

• Previous vaccination at any time with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus.

• Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.

• Presence of a temperature >= 38.0ºC (>=100.4ºF), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.

• Diagnosed with cancer, or treatment for cancer, within 3 years.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

• Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articularly injected, or inhaled glucocorticoids, topical calcineurin inhibitors or imiquimod are allowed.

• Receipt of any immunoglobulins and/or any blood products within 3 months of study enrollment or planned administration of any of these products during the study period.

• Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination, are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.

• An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine

• With the exception of seasonal influenza vaccination, administration of any vaccine(s) within 30 days before study vaccination on Day 0. Seasonal influenza vaccine may be administered up to 14 days prior to study vaccination on Day 0.

• Planned administration of any vaccine not foreseen by the study protocol between Day 0 and the Day 42 phlebotomy, including seasonal influenza vaccine or a monovalent pandemic H1N1 vaccine other than the study vaccines.

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine/product, or planned use during the study period.

• Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.

• Known pregnancy or a positive urine beta-human chorionic gonadotropin test result prior to the first vaccination.

• Lactating or nursing women.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• GSK2340274A
one or two intramuscular injections
• GSK2340273A
one or two intramuscular injections
• Saline placebo
One injection

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Pointe-Claire	Quebec
Canada	GSK Investigational Site	Surrey	British Columbia
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Truro	Nova Scotia
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Edison	New Jersey
United States	GSK Investigational Site	Huntsville	Alabama
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Las Vegas	Nevada
United States	GSK Investigational Site	Lenexa	Kansas
United States	GSK Investigational Site	Meridian	Idaho
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Missoula	Montana
United States	GSK Investigational Site	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects Seropositive for Haemagglutination Inhibition (HI) Antibodies Against the A/California Virus Strain	A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (=) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and subjects older than (>) 60 years.	At Day 0
Primary	Number of Subjects Seropositive for Haemagglutination Inhibition (HI) Antibodies Against the A/California Virus Strain	A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (=) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and subjects > 60 years.	At Day 21
Primary	Number of Subjects Seropositive for (HI) Antibodies Against the A/California Virus Strain	A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (=) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 64 years (y) old and subjects > 64 years.	At Day 0
Primary	Number of Subjects Seropositive for (HI) Antibodies Against the A/California Virus Strain	A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (=) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 64 years (y) old and subjects > 64 years.	At Day 21
Primary	Number of Seroconverted (SCR) Subjects for Haemagglutination Inhibition (HI) Antibodies Against A/California Virus Strain	A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer = 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18 and 60 years of age and older (>60y).	At Day 21
Primary	Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Strain	A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer = 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18 and 64 years and older (>64y).	At Day 21
Primary	Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain	A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer = 1:40. The Flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09) and results were tabulated for subjects between 18 and 60 years and older (>60y).	At Day 0
Primary	Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain	A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer = 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 60 years and older (>60y).	At Day 21
Primary	Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain	A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer = 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years and older (>64y).	At Day 0
Primary	Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain	A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer = 1:40. The Flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years and older (>64y).	At Day 21
Primary	Seroconversion Factor (SCF) for Haemagglutination Inhibition (HI) Antibodies Against A/California Virus Strain	SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 60 years of age and older (>60y).	At Day 21
Primary	Seroconversion Factor (SCF) for HI Antibodies Against A/California Strain	SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18 and 64 years of age and older (>64y).	At Day 21
Secondary	Number of Subjects Seropositive for HI Antibodies Against A/California Virus Strain	A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal haemagglutination inhibition (HI) antibody titers greater than or equal to (=) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.	At Days 0 and 21
Secondary	Titers for HI Antibodies Against A/California Strain	Antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.	At Days 0 and 21
Secondary	Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Virus Strain	A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer = 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.	At Day 21
Secondary	Number of Seroprotected (SPR) Subjects Against HI Antibodies for the A/California Virus Strain	A seroprotected subject was defined as a vaccinated subject with serum HI antibody titers = 1:40. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.	At Days 0 and 21
Secondary	Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain	SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18-60 years of age and older (> 60y) and for subjects between 18-64 years old and > 64 years.	At Day 21
Secondary	Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain	A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal HI antibody titers greater than or equal to (=) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.	At Days 0 and 42
Secondary	Titers for HI Antibodies Against the A/California Virus Strain	Antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.	At Days 0 and 42
Secondary	Number of Seroconverted (SCR) Subjects for HI Antibodies Against A/California Virus Strain	A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer = 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.	At Day 42
Secondary	Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Strain	A seroprotected subject was defined as a vaccinated subject with serum HI antibody titers = 1:40. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.	At Days 0 and 42
Secondary	Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain	SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18-60 years of age and older (> 60y) and for subjects between 18-64 years old and > 64 years.	At Day 42
Secondary	Number of Subjects Seropositive for HI Antibodies Against the A/California Virus Strain	A seropositive subject against the A/California/ virus strain was defined as a subject with H1N1 reciprocal HI antibody titers greater than or equal to (=) the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.	At Days 0 and 182
Secondary	Titers for HI Antibodies Against the A/California Virus Strain	Antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 1:10. Results were tabulated according to age strata: subjects between 18 to 60 years (y) old and > 60 years and subjects between 18 and 64 years old and > 64 years, respectively.	At Days 0 and 182
Secondary	Number of Seroconverted (SCR) Subjects for HI Antibodies	A seroconverted subject was defined as a vaccinated subject who had a post-vaccination titer = 1:40 and at least a 4-fold increase in pre-vaccination titer. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.	At Day 182
Secondary	Number of Seroprotected (SPR) Subjects for HI Antibodies Against A/California Virus Strain	A seroprotected subject was defined as a vaccinated subject with serum HI antibody titers = 1:40. The Flu strain assessed was A/California/7/09 (H1N1)v-like) and results were tabulated for subjects between 18-60 years of age and older (>60y) and for subjects between 18-64 years old and >64 years.	At Days 0 and 182
Secondary	Seroconversion Factor (SCF) for HI Antibodies Against A/California Virus Strain	SCF was defined as the fold increase in serum HI geometric mean ratio (mean[log10(POST/PRE)]) vaccination compared to Day 21. The flu strain assessed was Flu A/CAL/7/09 and results were tabulated for subjects between 18-60 years of age and older (> 60y) and for subjects between 18-64 years old and > 64 years.	At Day 182
Secondary	Adjusted Geometric Mean Titer (GMT) Ratios of A/California Virus Strain	Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled group GSK2340274A F1 and GSK2340273A F3_2D Group.	At Day 21
Secondary	Adjusted Geometric Mean Titer (GMT) Ratios of A/California Strain	Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled groups GSK2340274A F1 and GSK2340273A F2.	At Day 21
Secondary	Adjusted GMT Ratios of A/California Virus Strain	Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled group GSK2340274A F1 and the GSK2340273A F1_1D Group.	At Day 21
Secondary	Adjusted GMT Ratios of A/California Strain	Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled group GSK2340274A F2 and the GSK2340273A F3_2D Group.	At Day 21
Secondary	Adjusted GMT Ratios for A/California Virus Strain	Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled groups GSK2340274A F2 and GSK2340273A F2.	At Day 21
Secondary	Adjusted GMT Ratios for A/California Strain	Titers were presented as geometric mean titers (GMTs). Adjusted GMT was defined as the geometric mean antibody titer adjusted for Previous Vaccination baseline titers and results were tabulated for subjects between 18-60 years, > 60 years, 18-64 years and > 64 years, from the pooled group GSK2340274A F2 and the GSK2340273A F1_1D Group.	At Day 21
Secondary	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.	During the 7-day (Days 0-6) post-vaccination period following each dose and across doses, for subjects between 18-64 years of age
Secondary	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.	During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects > 64 years of age
Secondary	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (=) 38 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = fever = 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.	During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects between 18-64 years of age
Secondary	Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (=) 38 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = fever = 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.	During the 7-day (Day 0-6) post-vaccination period following each dose and across doses, for subjects > 64 years of age
Secondary	Number of Subjects With Any and Grade 3 Solicited Local Symptoms	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activities as assessed by inability to attend/do work or school. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site. Results were tabulated for subjects in GSK2340273A F2_1D Group, who were older than 60 years of age (>60y).	During the 7-day (Days 0-6) post-Dose 3 vaccination period, for subjects > 60 years of age
Secondary	Number of Subjects With Any and Grade 3 Solicited General Symptoms	Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above (=) 38 degrees Celsius (°C)], headache, joint pain at other location, muscle aches, shivering and sweating. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal everyday activities as assessed by inability to attend/do work or school, or required intervention of a physician/healthcare provider. Grade 3 fever = fever = 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. Results were tabulated for subjects in GSK2340273A F2_1D Group, who were older than 60 years of age (>60y).	During the 7-day (Days 0-6) post-Dose 3 vaccination period, for subjects > 60 years of age
Secondary	Number of Subjects With Abnormal Biochemical and Haematological Levels	Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], bilirubin [BIL], bilirubin conjugated/direct [BIL/CD] creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC].; Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above the reference range defined for the specified time point and laboratory parameter.	At Days 7, 21, 28, 42 and 182, for subjects between 18-64 years of age
Secondary	Number of Subjects With Abnormal Biochemical and Haematological Levels	Among biochemical and haematological parameters assessed were alanine aminotransferase [ALT], alkaline phosphatase [AP], aspartate aminotransferase [AST], basophils [BAS], bilirubin [BIL], bilirubin conjugated/direct [BIL/CD] creatinine [CREA], eosinophils [EOS], hematocrit [HEM], haemoglobin [Hgb], lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC], blood urea nitrogen [BUN] and white blood cells [WBC]. Levels of haematological/biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above the reference range defined for the specified time point and laboratory parameter.	At Days 7, 21, 28, 42 and 182, for subjects > 64 years of age
Secondary	Number of Subjects With Any Medically-attended Adverse Events (MAEs)	MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as the occurrence of any MAE regardless of intensity grade or relation to vaccination. Results were tabulated for subjects aged between 18 and 64 years and older (>64y).	Days 0 to 385
Secondary	Number of Subjects Reporting Any Potential Immune-mediated Diseases (pIMDs)	Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Results were tabulated for subjects aged between 18-64 years and above 65 years (+65y).	Days 0 to 365
Secondary	Number of Subjects With Any Unsolicited Adverse Events (AEs)	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.	Within the 42-day (Days 0-41) post-vaccination period
Secondary	Number of Subjects With Any Unsolicited Adverse Events (AEs)	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Results were tabulated for subjects aged between 18-64 years and older (>64y).	Within the 84-day (Days 0-83) post-vaccination period
Secondary	Number of Subjects With Serious Adverse Events (SAEs)	Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Results were tabulated for subjects aged between 18-64 years and older (>64y).	During the entire study period (from Day 0 to Day 385)

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