Safety of a Influenza Vaccine Produced Either in Mammalia... | NCT00560066

ID	Type	Description	Link
2007-002872-32

Label	Type	Description	Intervention Names
cTIV	Experimental	Subjects received one vaccination of cell culture-derived influenza vaccine	Biological: Cell-derived influenza vaccine
TIV	Active Comparator	Subjects received one vaccination of egg-derived influenza vaccine	Biological: Egg-derived influenza vaccine

Name	Type	Description	Arm Group Labels	Other Names
Cell-derived influenza vaccine	Biological	1 dose of 0.5 mL in the deltoid region of the non-dominant arm	cTIV

Measure	Description	Time Frame
Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV	Safety was assessed as the number of all subjects who reported at least one sign of reactogenicity after one vaccination of egg-derived (TIV) or cell culture-derived (cTIV) influenza virus vaccine from Day 1 through Day 7 post-vaccination.	From Day 1 up to and including Day 7 post-vaccination

Measure	Description	Time Frame
Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV	Analysis was performed on a subset of safety population which included the healthy adults (≥18 to ≤60 years) and elderly (≥61 years).	From Day 1 through Day 7 post-vaccination

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects 18 years of age and above, mentally competent, willing and able to give informed consent prior to study entry;
Able to comply with all study procedures and requirements.

Exclusion Criteria:

History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to any vaccine component;
Fatal prognosis of an underlying medical condition (<12 months life expectancy);
History of Guillain-Barre syndrome;
Bleeding diathesis or receiving anticoagulants of the coumarin type;
Hospitalization or residence in a nursing care facility;
Planned to receive seasonal influenza vaccine outside of this study;
Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study;
Fever (defined as axillary temperature ≥38.0°C) or any acute illness within 3 days prior to study vaccination;
Receipt of another investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and unwilling to refuse participation in another clinical study through the end safety follow up period of the study;
Any condition, which, in the opinion of the investigator, might prevent the subject from participation or interfere with the evaluation of the study objectives;
Females who were pregnant or nursing (breastfeeding) mothers, or females of childbearing potential who were sexually active and had not used or did not plan to use acceptable birth control measures during the first 3 weeks after vaccination. Oral, injected or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device were considered acceptable forms of birth control.

Name	Affiliation	Role
Novartis Vaccines	Novartis Vaccines	Study Chair

ID	Title	Description
FG000	Egg-derived Vaccine (TIV)	Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine.
FG001	Cell Culture-derived Vaccine (cTIV)	Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine.

ID	Title	Description
BG000	Egg-derived Vaccine (TIV)	Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine
BG001	Cell Culture-derived Vaccine (cTIV)	Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000396 BG0011002 BG0021398

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

Secondary

Number of Healthy Adults and Elderly Who Reported Solicited Local and Systemic Adverse Events (AEs) After One Vaccination of TIV or cTIV

Analysis was performed on a subset of safety population which included the healthy adults (≥18 to ≤60 years) and elderly (≥61 years).

Analysis was done on a subset of safety population (i.e. all subjects in the exposed population who provide postvaccination safety data) which included the healthy adults and elderly.

Posted

Number

Subjects

From Day 1 through Day 7 post-vaccination

ID	Title	Description
OG000	TIV (Adults)	Subjects ≥18 to ≤60 years years-old received one vaccination of egg-derived influenza virus vaccine
OG001	cTIV (Adults)	Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
OG002	TIV (Elderly)	Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
OG003	cTIV (Elderly)	Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine

Units	Counts
Participants	OG00070 OG001235 OG0027 OG003

Title

Denominators

Categories

Pain (N=66,226,7,11)

Title	Measurements
	OG00024 OG001107 OG0021 OG003

Secondary

Number of Adults and Elderly With Underlying Medical Conditions Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIV or cTIV

Analysis was performed on a subset of safety population which included the adults (≥18 to ≤60 years) and elderly (≥61 years) with underlying medical conditions.

Analysis was done on the subset of safety population which included the adults and elderly with underlying medical conditions.

Posted

Number

Subjects

From Day 1 through Day 7 post-vaccination

ID	Title	Description
OG000	TIV (Adults)	Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
OG001	cTIV (Adults)	Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
OG002	TIV (Elderly)	Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
OG003	cTIV (Elderly)	Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine

Secondary

Percentages Of Subjects With Underlying Medical Conditions Who Achieved Hemagglutination Inhibition (HI) Titer ≥40 After One Vaccination of TIV or cTIV

Immunogenicity was measured as the percentage of adults (≥18 to ≤60 years) and elderly (≥61 years) achieving HI titers ≥40 at baseline (Day 1) and three weeks (Day 22) after one vaccination of TIV or cTIV for each of three vaccine strains, evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% (≥18 to ≤60 years), or >60% (≥61 years).

Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions (full analysis set [FAS]: all enrolled subjects who received a study vaccine and provided one evaluable serum sample before and after baseline)

Posted

Number

95% Confidence Interval

Percentages of Subjects

Before vaccination (Day 1) and three weeks after vaccination (Day 22)

ID	Title	Description
OG000	TIV (Adults)	Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
OG001	cTIV (Adults)	Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
OG002	TIV (Elderly)

Secondary

Percentages Of Subjects Who Achieved Seroconversion Or Significant Increase In HI Titers After One Vaccination of TIV or cTIV

Seroconversion or significant increase in HI titer as per CHMP criteria for each of the three strains is defined as the percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion/significant increase should be >40% (≥18 to ≤60 years) or >30% (≥61 years).

Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.

Posted

Number

95% Confidence Interval

Percentages of Subjects

Three weeks post-vaccination (Day 22)

ID	Title	Description
OG000	TIV (Adults)	Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
OG001	cTIV (Adults)	Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
OG002	TIV (Elderly)	Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine

Secondary

Geometric Mean Titers of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV

Immunogenicity was measured as HI geometric mean titers (GMTs) of subjects with underlying conditions, directed against each of three vaccine strains at baseline (Day 1) and three weeks after vaccination (Day 22) in adults (≥18 to ≤60 years) and elderly (≥61 years).

Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.

Posted

Geometric Mean

95% Confidence Interval

Titers

Before vaccination (Day 1) and three weeks after vaccination (Day 22)

ID	Title	Description
OG000	TIV (Adults)	Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
OG001	cTIV (Adults)	Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
OG002	TIV (Elderly)	Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
OG003	cTIV (Elderly)

Secondary

Geometric Mean Ratio of Subjects With Underlying Medical Conditions After One Vaccination of TIV or cTIV

Immunogenicity was measured as the geometric mean ratio (GMR), calculated as the ratio of postvaccination to prevaccination HI GMTs for each of the three strains, three weeks after one vaccination (Day 22) of TIV or cTIV. CHMP criteria is considered fulfilled for each of the three strains if the geometric mean increase GMR (Day 22/Day 1) in HI antibody titer is >2.5 (≥18 to ≤60 years) or >2.0 (≥61 Years).

Analysis was performed on the immunogenicity subset of adults and elderly with underlying medical conditions.

Posted

Geometric Mean

95% Confidence Interval

Ratio

Three weeks post-vaccination (Day 22)

ID	Title	Description
OG000	TIV (Adults)	Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
OG001	cTIV (Adults)	Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
OG002	TIV (Elderly)	Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
OG003

Primary

Number of Subjects Who Reported At Least One Reactogenicity Sign After One Vaccination of TIV or cTIV

Safety was assessed as the number of all subjects who reported at least one sign of reactogenicity after one vaccination of egg-derived (TIV) or cell culture-derived (cTIV) influenza virus vaccine from Day 1 through Day 7 post-vaccination.

Analysis was performed on the safety dataset, i.e. all subjects in the exposed set who provided post-baseline safety data.

Posted

Number

Subjects

From Day 1 up to and including Day 7 post-vaccination

ID	Title	Description
OG000	Egg-derived Vaccine (TIV)	Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine
OG001	Cell Culture-derived Vaccine (cTIV)	Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Acute Chest Syndrome	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected396 at risk EG0011 affected1,001 at risk
Angina Pectoris	Cardiac disorders	Non-systematic Assessment	EG0001 affected396 at risk EG0010 affected1,001 at risk
Aortic Valve Incompetence	Cardiac disorders	Non-systematic Assessment	EG0000 affected396 at risk EG0011 affected1,001 at risk
Aortic Valve Stenosis	Cardiac disorders	Non-systematic Assessment	EG0000 affected396 at risk EG0011 affected1,001 at risk
Atrial Fibrillation	Cardiac disorders	Non-systematic Assessment	EG0001 affected396 at risk EG0010 affected1,001 at risk
Myocardial Infarction	Cardiac disorders	Non-systematic Assessment	EG0000 affected396 at risk EG0011 affected1,001 at risk
Tachycardia	Cardiac disorders	Non-systematic Assessment	EG0000 affected396 at risk EG0011 affected1,001 at risk
Sudden Hearing Loss	Ear and labyrinth disorders	Non-systematic Assessment	EG0000 affected396 at risk EG0011 affected1,001 at risk
Haemorrhoidal Haemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected396 at risk EG0011 affected1,001 at risk
Chest Pain	General disorders	Non-systematic Assessment	EG0001 affected396 at risk EG0010 affected1,001 at risk
Device Occlusion	General disorders	Non-systematic Assessment	EG0001 affected396 at risk EG0010 affected1,001 at risk
Cholecystitis	Hepatobiliary disorders	Non-systematic Assessment	EG0000 affected396 at risk EG0011 affected1,001 at risk
Cholelithiasis	Hepatobiliary disorders	Non-systematic Assessment	EG0001 affected396 at risk EG0010 affected1,001 at risk
Device Related Infection	Infections and infestations	Non-systematic Assessment	EG0000 affected396 at risk EG0011 affected1,001 at risk
Herpes Zoster	Infections and infestations	Non-systematic Assessment	EG0000 affected396 at risk EG0011 affected1,001 at risk
Otitis Media	Infections and infestations	Non-systematic Assessment	EG0000 affected396 at risk EG0011 affected1,001 at risk
Sinusitis	Infections and infestations	Non-systematic Assessment	EG0000 affected396 at risk EG0012 affected1,001 at risk
Urinary Tract Infection	Infections and infestations	Non-systematic Assessment	EG0001 affected396 at risk EG0011 affected1,001 at risk
Animal Bite	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected396 at risk EG0011 affected1,001 at risk
Joint Dislocation	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected396 at risk EG0010 affected1,001 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected396 at risk EG0011 affected1,001 at risk
Ovarian Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 affected396 at risk EG0011 affected1,001 at risk
Pancreatic Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 affected396 at risk EG0010 affected1,001 at risk
Cerebrovascular Accident	Nervous system disorders	Non-systematic Assessment	EG0000 affected396 at risk EG0011 affected1,001 at risk
Optic Neuritis	Nervous system disorders	Non-systematic Assessment	EG0001 affected396 at risk EG0010 affected1,001 at risk
Syncope	Nervous system disorders	Non-systematic Assessment	EG0000 affected396 at risk EG0011 affected1,001 at risk
Transient Ischaemic Attack	Nervous system disorders	Non-systematic Assessment	EG0001 affected396 at risk EG0011 affected1,001 at risk
Urethral Caruncle	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected396 at risk EG0011 affected1,001 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected396 at risk EG0012 affected1,001 at risk
Deep Vein Thrombosis	Vascular disorders	Non-systematic Assessment	EG0001 affected396 at risk EG0011 affected1,001 at risk
Hypertensive Crisis	Vascular disorders	Non-systematic Assessment	EG0000 affected396 at risk EG0011 affected1,001 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Balve			Germany

Term	Organ System	Assessment Type	Statistical Information
Fatigue	General disorders	Systematic Assessment	EG00063 affected396 at risk EG001185 affected1,001 at risk
Injection site pain	General disorders	Systematic Assessment	EG000117 affected396 at risk EG001330 affected1,001 at risk
Malaise	General disorders	Systematic Assessment	EG00039 affected396 at risk EG00189 affected1,001 at risk
Bronchitis	Infections and infestations	Non-systematic Assessment	EG00014 affected396 at risk EG00159 affected1,001 at risk
Nasopharyngitis	Infections and infestations	Non-systematic Assessment	EG00010 affected396 at risk EG00190 affected1,001 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00022 affected396 at risk EG00176 affected1,001 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00057 affected396 at risk EG001150 affected1,001 at risk
Headache	Nervous system disorders	Systematic Assessment	EG00073 affected396 at risk EG001198 affected1,001 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG00021 affected396 at risk EG00156 affected1,001 at risk

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Egg-derived Vaccine (TIV)	Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine			10	396	204	396
EG001	Cell Culture-derived Vaccine (cTIV)	Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine			20	1,001	568	1,001