Safety of Two Trivalent Influenza Vaccines Evaluated in C... | NCT01857206

ID	Type	Description	Link
U1111-1139-9440	Other Identifier	Universal Trial Number (UTN)

Status Module

Label	Type	Description	Intervention Names
TIVc	Experimental	Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.	Biological: Mammalian cell based flu vaccine
TIVf	Active Comparator	Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.	Biological: Egg based flu vaccine

Name	Type	Description	Arm Group Labels	Other Names
Mammalian cell based flu vaccine	Biological		TIVc
Egg based flu vaccine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number Of Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.	Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following two doses of either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.	Day 1 to Day 7 after any vaccination
Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.	Safety was assessed as the number of subjects who reported unsolicited adverse events following vaccination with either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.	Day 1 to Day49 for subjects aged ≥4 To ≤8 years not previously vaccinated. Day 1 to Day 38 for subjects aged ≥4 To ≤8 years previously vaccinated and all subjects aged ≥9 To ≤17 years.
Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.	Safety was assessed as the number of subjects who reported serious adverse events (SAEs), medically attended AEs and new onset of chronic diseases (NOCD) in subjects aged ≥4 To ≤17 Years.	Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects

Name	Affiliation	Role
Novartis Vaccines and Diagnostics	Novartis Vaccines	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
320, Novartis Investigational Site		Mobile	Alabama	36608	United States
312, Novartis Investigational Site

PubMed Identifier	Type	Citation	Retractions
26643931	Derived	Nolan T, Chotpitayasunondh T, Capeding MR, Carson S, Senders SD, Jaehnig P, de Rooij R, Chandra R. Safety and tolerability of a cell culture derived trivalent subunit inactivated influenza vaccine administered to healthy children and adolescents: A Phase III, randomized, multicenter, observer-blind study. Vaccine. 2016 Jan 4;34(2):230-236. doi: 10.1016/j.vaccine.2015.11.040. Epub 2015 Nov 29.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	TIVc	Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
FG001	TIVf

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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 Subjects Reporting Solicited Local and Systemic Adverse Events and Other Indicators Of Reactogenicity After Any Vaccination.

Safety was assessed as the number of subjects who reported solicited local and systemic adverse events and other indicators of reactogenicity following two doses of either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.

Analysis was done on the solicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination solicited safety data.

Posted

Number

Subjects

Day 1 to Day 7 after any vaccination

ID	Title	Description
OG000	TIVc (≥4 to ≤8 Years)	Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
OG001	TIVf (≥4 to ≤8 Years)	Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
OG002	TIVc (≥9 to ≤17 Years)	Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
OG003	TIVf (≥9 to ≤17 Years)	Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.

Units	Counts
Participants	OG000688 OG001341 OG002682 OG003

Title

Denominators

Categories

Any Local

Title	Measurements
	OG000422 OG001202 OG002370 OG003

Primary

Number Of Subjects Reporting Unsolicited Adverse Events After Any Vaccination.

Safety was assessed as the number of subjects who reported unsolicited adverse events following vaccination with either mammalian cell culture-derived or egg-derived trivalent influenza vaccination in subjects aged ≥4 To ≤17 Years.

Analysis was done on the unsolicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination unsolicited safety data.

Posted

Number

Subjects

Day 1 to Day49 for subjects aged ≥4 To ≤8 years not previously vaccinated. Day 1 to Day 38 for subjects aged ≥4 To ≤8 years previously vaccinated and all subjects aged ≥9 To ≤17 years.

ID	Title	Description
OG000	TIVc (≥4 to ≤8 Years)	Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
OG001	TIVf (≥4 to ≤8 Years)	Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
OG002	TIVc (≥9 to ≤17 Years)	Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.

Primary

Number Of Subjects Reporting Unsolicited Serious Adverse Events After Any Vaccination.

Safety was assessed as the number of subjects who reported serious adverse events (SAEs), medically attended AEs and new onset of chronic diseases (NOCD) in subjects aged ≥4 To ≤17 Years.

Analysis was done on the unsolicited safety dataset, i.e. the subjects in the exposed population who provided postvaccination unsolicited safety data.

Posted

Number

Subjects

Day 1 to Day 183 for previously vaccinated subjects and Day 213 for not-previously vaccinated subjects

ID	Title	Description
OG000	TIVc (≥4 to ≤8 Years)	Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
OG001	TIVf (≥4 to ≤8 Years)	Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
OG002	TIVc (≥9 to ≤17 Years)	Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	TIVc(4-8Years )	Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.	17	688	545	688
EG001	TIVf(4-8Years )	Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.	7	341	267	341
EG002	TIVc(9-17Years )	Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.	7	682	489	682
EG003	TIVf(9-17Years )	Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.	9	341	220	341

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
LYMPHADENITIS	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected688 at risk EG0010 affected341 at risk EG0021 affected682 at risk EG0030 affected341 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected688 at risk EG0010 affected341 at risk EG0021 affected682 at risk EG003
ACUTE SINUSITIS	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected688 at risk EG0010 affected341 at risk EG0020 affected682 at risk EG003
APPENDICITIS PERFORATED	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected688 at risk EG0010 affected341 at risk EG0020 affected682 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected688 at risk EG0010 affected341 at risk EG0020 affected682 at risk EG003
CELLULITIS	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected688 at risk EG0011 affected341 at risk EG0020 affected682 at risk EG003
DENGUE FEVER	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected688 at risk EG0010 affected341 at risk EG0021 affected682 at risk EG003
GASTROENTERITIS	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0002 affected688 at risk EG0010 affected341 at risk EG0020 affected682 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected688 at risk EG0011 affected341 at risk EG0020 affected682 at risk EG003
PHARYNGITIS	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected688 at risk EG0010 affected341 at risk EG0020 affected682 at risk EG003
PHARYNGOTONSILLITIS	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected688 at risk EG0011 affected341 at risk EG0020 affected682 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected688 at risk EG0010 affected341 at risk EG0021 affected682 at risk EG003
RESPIRATORY SYNCYTIAL VIRUS INFECTION	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected688 at risk EG0010 affected341 at risk EG0020 affected682 at risk EG003
SINUSITIS BACTERIAL	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected688 at risk EG0010 affected341 at risk EG0020 affected682 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected688 at risk EG0010 affected341 at risk EG0020 affected682 at risk EG003
WOUND INFECTION	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected688 at risk EG0010 affected341 at risk EG0020 affected682 at risk EG003
ANIMAL BITE	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0003 affected688 at risk EG0013 affected341 at risk EG0020 affected682 at risk EG003
ANIMAL SCRATCH	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected688 at risk EG0011 affected341 at risk EG0021 affected682 at risk EG003
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected688 at risk EG0010 affected341 at risk EG0021 affected682 at risk EG003
INJURY	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected688 at risk EG0010 affected341 at risk EG0020 affected682 at risk EG003
LIGAMENT RUPTURE	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected688 at risk EG0010 affected341 at risk EG0020 affected682 at risk EG003
MULTIPLE INJURIES	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected688 at risk EG0010 affected341 at risk EG0020 affected682 at risk EG003
RADIUS FRACTURE	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected688 at risk EG0010 affected341 at risk EG0021 affected682 at risk EG003
CEREBELLAR ATAXIA	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 affected688 at risk EG0010 affected341 at risk EG0020 affected682 at risk EG003
VISUAL FIELD DEFECT	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected688 at risk EG0010 affected341 at risk EG0020 affected682 at risk EG003
ABORTION SPONTANEOUS	Pregnancy, puerperium and perinatal conditions	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected688 at risk EG0010 affected341 at risk EG0020 affected682 at risk EG003
ADNEXAL TORSION	Reproductive system and breast disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected688 at risk EG0010 affected341 at risk EG0020 affected682 at risk EG003
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected688 at risk EG0011 affected341 at risk EG0020 affected682 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
NAUSEA	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG00061 affected688 at risk EG00127 affected341 at risk EG00245 affected682 at risk EG00317 affected341 at risk
CHILLS	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG00048 affected688 at risk EG00118 affected341 at risk EG00239 affected682 at risk EG003
FATIGUE	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG00095 affected688 at risk EG00136 affected341 at risk EG002109 affected682 at risk EG003
INJECTION SITE ERYTHEMA	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG000164 affected688 at risk EG00168 affected341 at risk EG00285 affected682 at risk EG003
INJECTION SITE HAEMORRHAGE	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG00069 affected688 at risk EG00130 affected341 at risk EG00227 affected682 at risk EG003
INJECTION SITE INDURATION	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG000114 affected688 at risk EG00145 affected341 at risk EG00248 affected682 at risk EG003
INJECTION SITE PAIN	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG000433 affected688 at risk EG001211 affected341 at risk EG002385 affected682 at risk EG003
INJECTION SITE SWELLING	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG00095 affected688 at risk EG00143 affected341 at risk EG00241 affected682 at risk EG003
MALAISE	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG000112 affected688 at risk EG00143 affected341 at risk EG00299 affected682 at risk EG003
PYREXIA	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG00063 affected688 at risk EG00142 affected341 at risk EG00217 affected682 at risk EG003
NASOPHARYNGITIS	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG00036 affected688 at risk EG00117 affected341 at risk EG00221 affected682 at risk EG003
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG000133 affected688 at risk EG00160 affected341 at risk EG00258 affected682 at risk EG003
VIRAL INFECTION	Infections and infestations	MedDRA (Unspecified)	Non-systematic Assessment	EG00035 affected688 at risk EG00114 affected341 at risk EG00214 affected682 at risk EG003
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG00068 affected688 at risk EG00125 affected341 at risk EG00251 affected682 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG00041 affected688 at risk EG00116 affected341 at risk EG00257 affected682 at risk EG003
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG000115 affected688 at risk EG00141 affected341 at risk EG002130 affected682 at risk EG003
HEADACHE	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG000108 affected688 at risk EG00144 affected341 at risk EG002137 affected682 at risk EG003
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment	EG00039 affected688 at risk EG00120 affected341 at risk EG00252 affected682 at risk EG003

ID	Term
D007251	Influenza, Human
D005334	Fever

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D012140	Respiratory Tract Diseases
D001832	Body Temperature Changes
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	TIVc	Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
BG001	TIVf	Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
BG002	TOTAL	Total of all reporting groups