Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents
Official Title
A Combined Phase II/III, Observer-Blind, Randomized, Multi-center Study to Evaluate Safety, Tolerability and Immunogenicity of Trivalent Subunit Influenza Vaccines, Produced Either in Mammalian Cell Culture or in Embryonated Hen Eggs, in Healthy Children and Adolescents
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Oct 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2007
Primary Completion Date
Feb 2008Actual
Completion Date
Jul 2008Actual
First Submitted Date
Mar 21, 2008
First Submission Date that Met QC Criteria
Mar 21, 2008
First Posted Date
Mar 27, 2008Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 21, 2012
Results First Submitted that Met QC Criteria
Jan 15, 2013
Results First Posted Date
Jan 16, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Mar 25, 2011
Certification/Extension First Submitted that Passed QC Review
Mar 25, 2011
Certification/Extension First Posted Date
Apr 4, 2011Estimated
Last Update Submitted Date
Oct 20, 2015
Last Update Posted Date
Nov 23, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
NovartisINDUSTRY
Collaborators
Name
Class
Novartis Vaccines
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The present study is the first study designed to evaluate safety, tolerability and immunogenicity of the cell culture-derived influenza vaccine in healthy children and adolescents aged 3 to 17 years. A step-down approach is utilized in which reactogenicity and safety will be assessed in children and adolescents 9 to 17 years of age (Cohort 1) prior to enrolling additional children and adolescents 9 to 17 years of age (Cohort 2) and children 3 to 8 years of age (Cohort 3).
Detailed Description
Not provided
Conditions Module
Conditions
Influenza
Keywords
Influenza
Flu
Cell Culture-Derived
Egg-Derived
Healthy Children
Healthy Adolescents
Safety
Immunogenicity
Trivalent
Inactivated
Vaccination
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
3,604Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohorts 1 + Cohort 2 (9-17 Yrs) cTIV
Experimental
All subjects received one 0.5 mL IM injection, of cell culture-derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like, and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere
All subjects received one 0.5 mL injection, of egg -derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere.
All subjects received two 0.5 mL injections, administered four weeks apart, of cell culture-derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere
All subjects received two 0.5 mL injections, administered four weeks apart of egg -derived trivalent influenza vaccine containing 15μg of HA for each strain (A/Solomon Islands/3/2006 [H1N1]-like, A/Wisconsin/67/2005 [H3N2]-like and B/Malaysia/ 2506/2004-like), recommended for the 2007-2008 influenza season in the Northern Hemisphere
One 0.5 ml injection of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Geometric Mean Titers of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children
To demonstrate non-inferiority of the post vaccination hemagglutination inhibition (HI) geometric mean titer (GMT) of the cell culture-derived influenza (cTIV) vaccine to the corresponding GMT of the egg-derived (eTIV) influenza vaccine, for all three strains, after two injections administered four weeks apart to a subset of children 3 to 8 years of age.
GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay.
Day 50 post vaccination
Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children
To demonstrate non-inferiority of the cell culture-derived influenza (cTIV) vaccine to the egg-derived (eTIV) influenza vaccine in the percentage of subjects achieving seroconversion or significant increase in antibody titer post vaccination, for all three strains, after two injections administered four weeks apart in children 3 to 8 years of age.
Seroconversion rate was evaluated using two assays- HI egg derived antigen assay and HI cell derived antigen assay.
Day 50 post vaccination
Secondary Outcomes
Measure
Description
Time Frame
Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents
To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 9 to 17 years of age after one injection of either cTIV vaccine or eTIV.
GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects aged 9 to 17 years (Cohorts 1 and 2) and 3 to 8 years (Cohort 3), whose parents/legal guardians have given written informed consent prior to study entry. Assent will be obtained from subjects according to age requirements of the ECs/IRBs;
In good health as determined by:
medical history,
physical examination,
clinical judgment of the Investigator;
Able to comply with all study procedures and available for all clinic visits and telephone calls scheduled in the study.
History of any anaphylaxis or serious reaction following administration of vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, polymyxin, or any other vaccine component, chemically related substance, or component of the potential packaging materials;
Known or suspected impairment/alteration of immune function, including:
use of immunosuppressive therapy such as systemic corticosteroids known to be associated with the suppression of hypothalamic-pituitary-adrenal (HPA) axis or chronic use of inhaled high-potency corticosteroids within 60 days prior to Visit 1,
cancer chemotherapy,
receipt of immunostimulants within 60 days prior to Visit 1,
receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study,
known HIV infection or HIV-related disease;
History of Guillain-Barré syndrome;
Bleeding diathesis;
Surgery planned during the study period;
Receipt of another investigational agent within 90 days, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the study;
Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Visit 1;
Laboratory-confirmed influenza disease within 6 months prior to Visit 1;
For subjects aged 3 to 8 years old, ever received two doses of an influenza vaccine in one influenza season;
Receipt of an influenza vaccine within 6 months prior to Visit 1;
Experienced a temperature 38.0°C [100.4°F]) and/or any acute illness within 3 days prior to Visit 1;
Pregnant or nursing mother;
Female of childbearing potential who is sexually active and has not used acceptable birth control measures for at least 2 months prior to study entry and who does not plan to use acceptable birth control measures during the 3 weeks following vaccination or refuses to have a urine pregnancy test prior to enrollment. Oral, injected, inserted or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device are considered acceptable forms of birth control;
Children of research staff or those living with research staff directly involved with the clinical study. Research staff are individuals with direct study subject contact, indirect contact with study subjects, or study site personnel who have access to any study documents containing subject information. This would include receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians, etc.;
Any condition, which in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
Vesikari T, Block SL, Guerra F, Lattanzi M, Holmes S, Izu A, Gaitatzis N, Hilbert AK, Groth N. Immunogenicity, safety and reactogenicity of a mammalian cell-culture-derived influenza vaccine in healthy children and adolescents three to seventeen years of age. Pediatr Infect Dis J. 2012 May;31(5):494-500. doi: 10.1097/INF.0b013e31824bb179.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
All subjects enrolled were included in the trial.
Recruitment Details
Participants were enrolled from 14 sites in Finland, 16 in the US, 9 in Croatia, 5 in Italy, 6 in Lithuania, 2 in Romania, 8 in Hungary.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1+2 cTIV (9-17 Years)
All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
Two 0.5 mL injections,of the cell culture-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm, administered four weeks apart.
Cohort 3 (3-8 Yrs) cTIV
Egg derived influenza subunit vaccine (eTIV)
Biological
Two 0.5 mL injections of the conventional egg-derived influenza vaccine in the deltoid muscle, preferably of the nondominant arm,administered four weeks apart.
Cohort 3 (3-8 Yrs) eTIV
Day 29 post vaccination
Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.
Immunogenicity was evaluated in terms of Geometric Mean Ratio (GMRs) in 9 to 17 year-old children and adolescents after one injection of either cTIV vaccine or eTIV.
The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (day29/day1) in HI antibody titer is >2.5.
Day 29 post vaccination
Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents
To evaluate immunogenicity in terms of percentage of 9 to 17 year-old children and adolescents achieving HI titers ≥40, after one injection of either the cTIV vaccine or the eTIV vaccine.
This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% and according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%.
Day 29 post vaccination
Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents
Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be >40%.
According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%.
Day 29 post vaccination
Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children
To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 3 to 8 years of age after two doses of either cTIV vaccine or eTIV,administered 4 weeks apart.
Day 29 and Day 50 post vaccination
Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children
To evaluate immunogenicity in terms of Geometric Mean Ratio (GMR) in children 3 to 8 years of age after two doses of either the cTIV vaccine or the eTIV vaccine, administered 4 weeks apart according to the CHMP criteria.
The criterion is met according to the European (CHMP) guideline if the mean geometric increase (GMR day 29/day 1 and GMR day 50/day 1) in HI antibody titer is >2.5
Day 29 and Day 50 post vaccination
Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children
To evaluate immunogenicity in terms of HI titers ≥40, in children 3-8 years of age after two doses of either cTIV vaccine or eTIV vaccine, administered 4 weeks apart.
The criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% and according to the US (CBER) guideline if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%.
Day 29 and Day 50 post vaccination
Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children
Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be >40%.
According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%.
Day 29 and Day 50 post vaccination
Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.
To evaluate safety and tolerability in terms of number of 9 to 17 year-old children and adolescents (cohorts 1 and 2) reporting local and systemic reactions following of one injection of the cTIV or the eTIV vaccine .
up to 7 days after vaccination
Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children.
To evaluate the safety and tolerability of the cTIV and the eTIV influenza vaccines in 3 to 8 year-old children terms of number of participants reporting local and systemic reactions after each vaccination.
up to 7 days after each vaccination
Downey
California
90241
United States
Site 02
Bardstown
Kentucky
40004
United States
Site 14
Metairie
Louisiana
70006
United States
Site 01
St Louis
Missouri
63104
United States
Site 11
Omaha
Nebraska
68134
United States
Site 04
Edison
New Jersey
08817
United States
Site 05
Endwell
New York
13760
United States
Site 16
Fort Worth
Texas
76135
United States
Site 13
San Angelo
Texas
76904
United States
Site 12
San Antonio
Texas
78205
United States
Site 08
Bountiful
Utah
84010
United States
Site 07
Salt Lake City
Utah
84109
United States
Site 03
Salt Lake City
Utah
84121
United States
Site 06
Burke
Virginia
22105
United States
Site 15
Spokane
Washington
99202
United States
Site 27:Institute of Public Health
Zagreb
City of Zagreb
Croatia
Site 29: Institute of Public Health
Zagreb
City of Zagreb
Croatia
Site 40:Spec. Pediatric Dispensary
Zagreb
City of Zagreb
Croatia
Site 49: Spec. Pediatric Dispensary
Zagreb
City of Zagreb
Croatia
Site 50: Spec. Pediatric Dispensary
Zagreb
City of Zagreb
Croatia
Site 86: Spec. Pediatric Dispensary
Zagreb
City of Zagreb
Croatia
Site 44:Spec. Pediatric Dispensary
Đakovo
Dakovo
Croatia
Site 43: Spec. Pediatric Dispensary
Sisak
Sisak
Croatia
Site 83
Ljudevita Gaja 2, Djakovo
Croatia
Site 70: Espoon rokotetutkimusklinikka
Heikintori
Espoo
02100
Finland
Site 71: Etelä-Helsingin rokotetutkimusklinikka
Helsinki
Helsinki
00100
Finland
Site 72: Itä-Helsingin rokotetutkimusklinikka
Helsinki
Helsinki
00930
Finland
Site 76: Järvenpään rokotetutkimusklinikka
Jarvenpaa
Järvenpää
04400
Finland
Site 79: Kokkola Vaccine Research Clinic
Rantakatu 7
Kokkola
67100
Finland
Site 77: Kotkan rokotetutkimusklinikka
Kotka
Kotka
48600
Finland
Site 78: Kuopio Vaccine Research Clinic
Microkatu 1,Osa/Section A, 3rd Floor Pl1188
Kuopio
70211
Finland
Site 67: Lahden rokotetutkimusklinikka
Lahti
Lahti
15140
Finland
Site 75: Oulun rokotetutkimusklinikka
Oulu
Oulu
90100
Finland
Site 66: Tampereen rokotetutkimusklinikka
Tampere
Pirkanmaa
33100
Finland
Site 68: Porin rokotetutkimusklinikka
Pori
Pori
28120
Finland
Site 69: Turun rokotetutkimusklinikka
Turku
Turku
20520
Finland
Site 73: Itä-Vantaan rokotetutkimusklinikka
Vantaa
Vantaa
01300
Finland
Site 74: Länsi-Vantaan rokotetutkimusklinikka
Vantaa
Vantaa
01600
Finland
Site 57: Házi Gyermekorvosi Rendelő
Budapest
Budapest
1042
Hungary
Site 53: Heim Pál Gyermekkórház
Budapest
Budapest
1089
Hungary
Site 52: Ferencvárosi Gyermekorvos Kft.
Budapest
Budapest
1097
Hungary
Site 56: Házi Gyermekorvosi Rendelő
Budapest
Budapest
1136
Hungary
Site 54: Házi Gyermekorvosi Rendelő
Budapest
Budapest
1173
Hungary
Site 51: 5053. számú Gyermekorvosi Rendelő
Miskolc
Miskolc
3534
Hungary
Site 55: Revamed kft.
Nyíregyháza
Nyíregyháza
4481
Hungary
Site 59: Vas Megyei Markusovszky Lajos, Általános, Rehabilitációs és Gyógyfürdő Kórház, Egyetemi Oktató Kórház
Szombathely
Szombathely
9700
Hungary
Site 42: Dipartimento di Medicina Clinica e Sperimentale - Sezione di Igiene e Medicina Preventiva
Ferrara
Ferrara
44100
Italy
Site 47: Dipartimento Scienze della Salute, Sezione di Igiene e Medicina Preventiva, Univesità di Genova
Genova
Genova
16132
Italy
Site 41: Ospedale Maggiore della Carità-Clinica Pediatrica
Novara
Novara
28100
Italy
Site 46: USL 2 Perugia, Distretto del perugino, Centro di Salute n. 4 (Madonna Alta) e n. 6 (Ellera di Corciano del distretto del perugino)
Perugia
Perugia
06070
Italy
Site 45: AUSL 7
Ragusa
Ragusa
97100
Italy
Site 35
Kaunas
Kaunas County
48259
Lithuania
Site 36
Vilnius
Vilnius County
01117
Lithuania
Site 32
Vilnius
Vilnius County
02169
Lithuania
Site 34
Vilnius
Vilnius County
04318
Lithuania
Site 31
Vilnius
Vilnius County
10207
Lithuania
Site 33
Vilnius
Vilnius County
11200
Lithuania
Site 25
Campulung Muscel
Argeş
115100
Romania
Site 21
Craiova
Dolj
200642
Romania
All subjects aged 9-17 years received one 0.5 mL injection, of egg -derived trivalent influenza vaccine.
FG002
Cohort 3 cTIV (3-8 Years)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
FG003
Cohort 3 eTIV (3-8 Years)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
FG000656 subjects
FG001318 subjects
FG0021608 subjects
FG0031022 subjects
COMPLETED
FG000643 subjects
FG001312 subjects
FG0021457 subjects
FG003919 subjects
NOT COMPLETED
FG00013 subjects
FG0016 subjects
FG002151 subjects
FG003103 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
Withdrawal by Subject
FG0002 subjects
FG0011 subjects
FG00219 subjects
FG00321 subjects
Lost to Follow-up
FG00010 subjects
FG0015 subjects
FG002124 subjects
FG00375 subjects
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Inappropriate enrollment
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0031 subjects
Unable to classify
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0034 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1+2 cTIV (9-17 Years)
All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
BG001
Cohort 1+2 eTIV (9-17 Years)
All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
BG002
Cohort 3 cTIV (3-8 Years)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
BG003
Cohort 3 eTIV (3-8 Years)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000656
BG001318
BG0021608
BG0031022
BG0043604
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00012.6± 2.6
BG00112.6± 2.5
BG0025.5± 1.7
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000304
BG001154
BG002
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 of the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children
To demonstrate non-inferiority of the post vaccination hemagglutination inhibition (HI) geometric mean titer (GMT) of the cell culture-derived influenza (cTIV) vaccine to the corresponding GMT of the egg-derived (eTIV) influenza vaccine, for all three strains, after two injections administered four weeks apart to a subset of children 3 to 8 years of age.
GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay.
The analysis was performed on the per-protocol dataset
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 50 post vaccination
ID
Title
Description
OG000
Cohort 3 cTIV (3-8 Years)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
OG001
Cohort 3 eTIV (3-8 Years)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg - derived trivalent influenza vaccine.
Units
Counts
Participants
OG000524
OG001513
Title
Denominators
Categories
A/H1N1 (egg derived antigen assay)
Title
Measurements
OG000407(358 to 462)
OG001477(419 to 542)
A/H3N2 (egg derived antigen assay)
Title
Measurements
OG000
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI egg-derived antigen assay
ANOVA
Ratio of GMTs
0.85
2-Sided
95
0.72
1.01
Yes
Non-Inferiority or Equivalence
Cell derived vaccine was considered non-inferior to egg-derived vaccine in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was >0.667.
Primary
Percentages of Subjects Who Attained Seroconversion or Significant Increase in Antibody Titers in the Cell Culture-derived Vaccine Compared With the Egg-derived Vaccine in 3 to 8 Year-old Children
To demonstrate non-inferiority of the cell culture-derived influenza (cTIV) vaccine to the egg-derived (eTIV) influenza vaccine in the percentage of subjects achieving seroconversion or significant increase in antibody titer post vaccination, for all three strains, after two injections administered four weeks apart in children 3 to 8 years of age.
Seroconversion rate was evaluated using two assays- HI egg derived antigen assay and HI cell derived antigen assay.
The analysis was performed on the per-protocol dataset
Posted
Number
95% Confidence Interval
Percentages of subjects
Day 50 post vaccination
ID
Title
Description
OG000
Cohort 3 cTIV (3-8 Years)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
OG001
Cohort 3 eTIV (3-8 Years)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
Units
Counts
Secondary
Geometric Mean Titers After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents
To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 9 to 17 years of age after one injection of either cTIV vaccine or eTIV.
GMTs were evaluated using two assays, HI egg derived antigen assay and HI cell derived antigen assay.
The analysis was performed on the per-protocol dataset.
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 29 post vaccination
ID
Title
Description
OG000
Cohort 1 cTIV (9-17 Years)
All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine
OG001
Cohort 1 eTIV (9-17 Years)
All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
Units
Counts
Participants
OG000
Secondary
Geometric Mean Ratio After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.
Immunogenicity was evaluated in terms of Geometric Mean Ratio (GMRs) in 9 to 17 year-old children and adolescents after one injection of either cTIV vaccine or eTIV.
The criterion is met according to European (CHMP) guideline if the mean geometric increase GMR (day29/day1) in HI antibody titer is >2.5.
The analysis was performed on the per-protocol dataset.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Day 29 post vaccination
ID
Title
Description
OG000
Cohort 1 cTIV (9-17 Years)
All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
OG001
Cohort 1 eTIV (9-17 Years)
All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
Units
Counts
Participants
Secondary
Percentages of Subjects Who Achieved HI Titers ≥40 After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents
To evaluate immunogenicity in terms of percentage of 9 to 17 year-old children and adolescents achieving HI titers ≥40, after one injection of either the cTIV vaccine or the eTIV vaccine.
This criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% and according to the US (CBER) guideline is met if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%.
The analysis was performed on the per-protocol dataset.
Posted
Number
95% Confidence Interval
Percentages of subjects
Day 29 post vaccination
ID
Title
Description
OG000
Cohort 1 cTIV (9-17 Years)
All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
OG001
Cohort 1 eTIV (9-17 Years)
All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
Units
Counts
Participants
Secondary
Percentages of Subjects Who Attained Seroconversion or Significant Increase After 1 Dose of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents
Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be >40%.
According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%.
The analysis was performed on the per-protocol dataset.
Posted
Number
95% Confidence Interval
Percentages of subjects
Day 29 post vaccination
ID
Title
Description
OG000
Cohort 1 cTIV (9-17 Years)
All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
OG001
Cohort 1 eTIV (9-17 Years)
All subjects aged 9-17 years received one 0.5 mL injection, of egg-derived trivalent influenza vaccine.
Secondary
Geometric Mean Titers After Two Doses of the Cell Derived or the Egg Derived Vaccine in 3 to 8 Year-old Children
To evaluate immunogenicity in terms of Geometric Mean Titers (GMTs) in children 3 to 8 years of age after two doses of either cTIV vaccine or eTIV,administered 4 weeks apart.
The analysis was performed on the per-protocol dataset.
Posted
Geometric Mean
95% Confidence Interval
Titers
Day 29 and Day 50 post vaccination
ID
Title
Description
OG000
Cohort 3 cTIV (3-8 Years)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
OG001
Cohort 3 eTIV (3-8 Years)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
Units
Counts
Participants
OG000
Secondary
Geometric Mean Ratio After Two Doses of the Cell-derived or the Egg-derived Vaccine in 3 to 8 Year-old Children
To evaluate immunogenicity in terms of Geometric Mean Ratio (GMR) in children 3 to 8 years of age after two doses of either the cTIV vaccine or the eTIV vaccine, administered 4 weeks apart according to the CHMP criteria.
The criterion is met according to the European (CHMP) guideline if the mean geometric increase (GMR day 29/day 1 and GMR day 50/day 1) in HI antibody titer is >2.5
The analysis was performed on the per-protocol dataset.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Day 29 and Day 50 post vaccination
ID
Title
Description
OG000
Cohort 3 cTIV (3-8 Years)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
OG001
Cohort 3 eTIV (3-8 Years)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
Units
Counts
Participants
Secondary
Percentages of Subjects Who Achieved HI Titers ≥40 After Two Doses of the Cell Culture Derived or the Egg Derived Influenza Vaccine in 3 to 8 Year-old Children
To evaluate immunogenicity in terms of HI titers ≥40, in children 3-8 years of age after two doses of either cTIV vaccine or eTIV vaccine, administered 4 weeks apart.
The criterion is met according to European (CHMP) guideline if the percentage of subjects achieving HI titers ≥40 is >70% and according to the US (CBER) guideline if the lower bound of the two sided 95%CI for percentage of subjects achieving HI titers ≥40 is ≥70%.
The analysis was performed on the per-protocol dataset.
Posted
Number
95% Confidence Interval
Percentages of subjects
Day 29 and Day 50 post vaccination
ID
Title
Description
OG000
Cohort 3 cTIV (3-8 Years)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
OG001
Cohort 3 eTIV (3-8 Years)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
Units
Counts
Secondary
Percentages of Subjects Who Achieved Seroconversion or Significant Increase in HI Titers After Two Doses of the Cell Culture-derived Vaccine or the Egg-derived Influenza Vaccine in 3 to 8 Year-old Children
Seroconversion or significant increase as per CHMP criteria is defined as percentage of subjects with a pre vaccination HI titer <10 to a post vaccination titer ≥40 or a pre vaccination HI titer ≥10 and a ≥4-fold increase in post vaccination HI antibody titer. According to the CHMP criteria, the percentage of subjects achieving seroconversion or significant increase should be >40%.
According to the CBER criteria, the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion/significant increase should be ≥40%.
The analysis was performed on the per-protocol dataset.
Posted
Number
95% Confidence Interval
Percentages of subjects
Day 29 and Day 50 post vaccination
ID
Title
Description
OG000
Cohort 3 cTIV (3-8 Years)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
OG001
Cohort 3 eTIV (3-8 Years)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
Secondary
Number of Subjects Reporting Local and Systemic Reactions After 1 Dose of the Cell Culture-derived or the Egg-derived Influenza Vaccine in 9 to 17 Year-old Children and Adolescents.
To evaluate safety and tolerability in terms of number of 9 to 17 year-old children and adolescents (cohorts 1 and 2) reporting local and systemic reactions following of one injection of the cTIV or the eTIV vaccine .
The analysis was performed on the safety dataset
Posted
Number
Subjects
up to 7 days after vaccination
ID
Title
Description
OG000
Cohort 1+2 cTIV (9-17 Years)
All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
OG001
Cohort 1+2 eTIV (9-17 Years)
All subjects aged 9-17 years received one 0.5 mL injection, of egg -derived trivalent influenza vaccine.
Units
Counts
Participants
OG000
Secondary
Number of Subjects Reporting Local and Systemic Reactions After One and Two Doses of the Cell Culture-derived Vaccine or Egg-derived Influenza Vaccine in 3 to 8 Year-old Children.
To evaluate the safety and tolerability of the cTIV and the eTIV influenza vaccines in 3 to 8 year-old children terms of number of participants reporting local and systemic reactions after each vaccination.
The analysis was performed on the safety dataset set.
Posted
Number
Subjects
up to 7 days after each vaccination
ID
Title
Description
OG000
Cohort 3 cTIV (3-8 Years)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
OG001
Cohort 3 eTIV (3-8 Years)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg- derived trivalent influenza vaccine.
Units
Counts
Participants
OG000
Time Frame
Throughout the study period (Day 1-181 for Cohorts 1 and 2, and Day 1-209 for cohort 3)
Description
Solicited AEs - day 1 through day 7 after vaccination. All AEs- day 1 through day 29 ( cohort 1&2); day 1 through day 50 (cohort 3). SAEs, onset of chronic illness, and AEs that lead to withdrawal from the study and associated concomitant medications-day 29 to day 181 (cohort 1&2); day 50 through day 209 (cohort 3)
All-Cause Mortality Comment
Not provided
Arm/Groups
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+2 cTIV (9-17 Years)
All subjects aged 9-17 years received one 0.5 mL injection, of Cell Culture-derived trivalent influenza vaccine.
5
652
328
652
EG001
Cohort 1+2 eTIV (9-17 Years)
All subjects aged 9-17 years received one 0.5 mL injection, of egg -derived trivalent influenza vaccine.
3
316
168
316
EG002
Cohort 3 cTIV (3-8 Yrs; 1st Vaccination)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
2
1,599
799
1,599
EG003
Cohort 3 eTIV (3-8 Yrs; 1st Vaccination)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
0
1,013
507
1,013
EG004
Cohort 3 cTIV (3-8 Yrs; 2nd Vaccination)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart, of Cell Culture-derived trivalent influenza vaccine.
7
1,557
670
1,557
EG005
Cohort 3 eTIV (3-8 Yrs; 2nd Vaccination)
All subjects aged 3-8 years received two 0.5 mL injections, administered four weeks apart of egg-derived trivalent influenza vaccine.
5
977
413
977
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Thalassemia beta
Congenital, familial and genetic disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 events0 affected652 at risk
EG0010 events0 affected316 at risk
EG0020 events0 affected1,599 at risk
EG0030 events0 affected1,013 at risk
EG004
Abdominal pain
Gastrointestinal disorders
MedDRA (11.1)
Non-systematic Assessment
EG0001 events1 affected652 at risk
EG0010 events0 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Appendix disorder
Gastrointestinal disorders
MedDRA (11.1)
Non-systematic Assessment
EG0001 events1 affected652 at risk
EG0010 events0 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Abscess limb
Infections and infestations
MedDRA (11.1)
Non-systematic Assessment
EG0000 events0 affected652 at risk
EG0010 events0 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Gastroentritis
Infections and infestations
MedDRA (11.1)
Non-systematic Assessment
EG0000 events0 affected652 at risk
EG0010 events0 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Infectious mononucleosis
Infections and infestations
MedDRA (11.1)
Non-systematic Assessment
EG0000 events0 affected652 at risk
EG0010 events0 affected316 at risk
EG0021 events1 affected1,599 at risk
EG003
Influenza
Infections and infestations
MedDRA (11.1)
Non-systematic Assessment
EG0000 events0 affected652 at risk
EG0011 events1 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Otitis media chronic
Infections and infestations
MedDRA (11.1)
Non-systematic Assessment
EG0000 events0 affected652 at risk
EG0010 events0 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA (11.1)
Non-systematic Assessment
EG0001 events1 affected652 at risk
EG0010 events0 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA (11.1)
Non-systematic Assessment
EG0000 events0 affected652 at risk
EG0010 events0 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA (11.1)
Non-systematic Assessment
EG0000 events0 affected652 at risk
EG0011 events1 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA (11.1)
Non-systematic Assessment
EG0000 events0 affected652 at risk
EG0010 events0 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Streptococcal bacteraemia
Infections and infestations
MedDRA (11.1)
Non-systematic Assessment
EG0000 events0 affected652 at risk
EG0011 events1 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Viral infection
Infections and infestations
MedDRA (11.1)
Non-systematic Assessment
EG0001 events1 affected652 at risk
EG0010 events0 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA (11.1)
Non-systematic Assessment
EG0000 events0 affected652 at risk
EG0010 events0 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (11.1)
Non-systematic Assessment
EG0000 events0 affected652 at risk
EG0010 events0 affected316 at risk
EG0021 events1 affected1,599 at risk
EG003
Eye injury
Injury, poisoning and procedural complications
MedDRA (11.1)
Non-systematic Assessment
EG0000 events0 affected652 at risk
EG0010 events0 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Post procedural haemorrhage
Nervous system disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 events0 affected652 at risk
EG0010 events0 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Body height below normal
Investigations
MedDRA (11.1)
Non-systematic Assessment
EG0001 events1 affected652 at risk
EG0010 events0 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (11.1)
Non-systematic Assessment
EG0001 events1 affected652 at risk
EG0010 events0 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 events0 affected652 at risk
EG0010 events0 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Major depression
Psychiatric disorders
MedDRA (11.1)
Non-systematic Assessment
EG0001 events1 affected652 at risk
EG0010 events0 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Ovarian torsion
Reproductive system and breast disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 events0 affected652 at risk
EG0011 events1 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Bronchitis chronic
Respiratory, thoracic and mediastinal disorders
MedDRA (11.1)
Non-systematic Assessment
EG0000 events0 affected652 at risk
EG0010 events0 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Tonsillectomy
Surgical and medical procedures
MedDRA (11.1)
Non-systematic Assessment
EG0000 events0 affected652 at risk
EG0010 events0 affected316 at risk
EG0020 events0 affected1,599 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Fatigue
General disorders
MedDRA (11.1)
Systematic Assessment
EG00067 events57 affected652 at risk
EG00147 events41 affected316 at risk
EG002171 events155 affected1,599 at risk
EG003143 events119 affected1,013 at risk
EG004110 events99 affected1,557 at risk
EG00592 events82 affected977 at risk
Injection site erythema
General disorders
MedDRA (11.1)
Systematic Assessment
EG00094 events91 affected652 at risk
EG00145 events45 affected316 at risk
EG002198 events197 affected1,599 at risk
EG003
Injection site induration
General disorders
MedDRA (11.1)
Systematic Assessment
EG00044 events44 affected652 at risk
EG00129 events28 affected316 at risk
EG00289 events87 affected1,599 at risk
EG003
Injection site pain
General disorders
MedDRA (11.1)
Systematic Assessment
EG000227 events220 affected652 at risk
EG001122 events120 affected316 at risk
EG002462 events451 affected1,599 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA (11.1)
Systematic Assessment
EG00037 events34 affected652 at risk
EG00111 events10 affected316 at risk
EG002106 events98 affected1,599 at risk
EG003
Malaise
General disorders
MedDRA (11.1)
Systematic Assessment
EG00068 events60 affected652 at risk
EG00141 events34 affected316 at risk
EG002118 events103 affected1,599 at risk
EG003
Pyrexia
General disorders
MedDRA (11.1)
Systematic Assessment
EG00013 events12 affected652 at risk
EG0017 events5 affected316 at risk
EG00296 events88 affected1,599 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA (11.1)
Systematic Assessment
EG000107 events99 affected652 at risk
EG00167 events59 affected316 at risk
EG002150 events141 affected1,599 at risk
EG003
Headache
Nervous system disorders
MedDRA (11.1)
Systematic Assessment
EG000125 events99 affected652 at risk
EG00156 events47 affected316 at risk
EG002167 events143 affected1,599 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA (11.1)
Non-systematic Assessment
EG00010 events10 affected652 at risk
EG0014 events4 affected316 at risk
EG002130 events124 affected1,599 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Posting Director
Novartis Vaccines and Diagnostics
RegistryContactVaccinesUS@novartis.com
ID
Term
D007251
Influenza, Human
Ancestor Terms
ID
Term
D012141
Respiratory Tract Infections
D007239
Infections
D009976
Orthomyxoviridae Infections
D012327
RNA Virus Infections
D014777
Virus Diseases
D012140
Respiratory Tract Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
5.4
± 1.7
BG0047.4± 3.7
795
BG003494
BG0041747
Male
BG000352
BG001164
BG002813
BG003528
BG0041857
768
(666 to 885)
OG0011293(1121 to 1491)
B (egg derived antigen assay)
Title
Measurements
OG00025(21 to 29)
OG00144(38 to 51)
A/H1N1 (cell derived antigen assay) (N=522,513)
Title
Measurements
OG000563(501 to 634)
OG001610(542 to 686)
A/H3N2 (cell derived antigen assay) (N=522,513)
Title
Measurements
OG000858(744 to 990)
OG0011329(1152 to 1533)
B (cell derived antigen assay) (N=522,513)
Title
Measurements
OG00053(46 to 62)
OG00162(53 to 72)
OG000
OG001
Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI egg-derived antigen assay.
ANOVA
Ratio of GMTs
0.59
2-Sided
95
0.49
0.72
Yes
Non-Inferiority or Equivalence
Cell derived vaccine (cTIV ) was considered non-inferior to egg-derived vaccine (eTIV) in postvaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs(cTIV/eTIV) was >0.667.
OG000
OG001
Non-inferiority of cTIV to eTIV against influenza B strain as measured by HI egg-derived antigen assay.
ANOVA
Ratio of GMTs
0.56
2-Sided
95
0.46
0.68
Yes
Non-Inferiority or Equivalence
Cell derived vaccine (cTIV ) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was >0.667.
OG000
OG001
Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI cell-derived antigen assay.
ANOVA
Ratio of GMTs
0.92
2-Sided
95
0.79
1.08
Yes
Non-Inferiority or Equivalence
Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV) in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was >0.667.
OG000
OG001
Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI cell-derived antigen assay.
ANOVA
Ratio of GMTs
0.65
2-Sided
95
0.54
0.78
Yes
Non-Inferiority or Equivalence
Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV) was >0.667.
OG000
OG001
Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI cell-derived antigen assay.
ANOVA
Ratio of GMTs
0.87
2-Sided
95
0.71
1.06
Yes
Non-Inferiority or Equivalence
Cell derived vaccine (cTIV) was considered non-inferior to egg-derived vaccine (eTIV)in post vaccination HI GMTs if, for all three influenza strains, the lower limit of the two-sided 95% confidence interval (CI) for day 50 ratio of GMTs (cTIV/eTIV)was >0.667.
Participants
OG000524
OG001513
Title
Denominators
Categories
A/H1N1 (egg derived antigen assay)
Title
Measurements
OG00094(92 to 96)
OG00196(94 to 97)
A/H3N2 (egg derived antigen assay)
Title
Measurements
OG00077(73 to 81)
OG00186(82 to 89)
B (egg derived antigen assay)
Title
Measurements
OG00038(34 to 42)
OG00153(49 to 58)
A/H1N1 (cell derived antigen assay) (N=522,513)
Title
Measurements
OG00096(93 to 97)
OG00196(94 to 98)
A/H3N2 (cell derived antigen assay) (N=522,513)
Title
Measurements
OG00080(76 to 83)
OG00185(82 to 88)
B (cell derived antigen assay) (N=522,513)
Title
Measurements
OG00058(54 to 63)
OG00158(54 to 63)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI egg-derived antigen assay.
binomial or the method of Miettinen and
Difference in % (cTIV minus eTIV)
-1
2-Sided
95
-4
1
Yes
Non-Inferiority or Equivalence
cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was >-10%.
OG000
OG001
Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI egg-derived antigen assay.
binomial or Miettinen & Nurimen method
Difference % (cTIV - eTIV)
-9
2-Sided
95
-13
-4
Yes
Non-Inferiority or Equivalence
cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was >-10%.
OG000
OG001
Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI egg-derived antigen assay.
binominal or Miettinen &Nurimen method
Difference % (cTIV minus eTIV)
-15
2-Sided
95
-21
-9
Yes
Non-Inferiority or Equivalence
cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was >-10%.
OG000
OG001
Non-inferiority of cTIV to eTIV against A/H1N1 influenza strain as measured by HI cell-derived antigen assay.
binominal or Miettinen &Nurimen method
Difference % (cTIV minus eTIV)
-1
2-Sided
95
-3
2
Yes
Non-Inferiority or Equivalence
cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was >-10%
OG000
OG001
Non-inferiority of cTIV to eTIV against A/H3N2 influenza strain as measured by HI cell-derived antigen assay.
binominal or Miettinen &Nurimen method
Difference % (cTIV minus eTIV)
-5
2-Sided
95
-9.5
0
Yes
Non-Inferiority or Equivalence
cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was >-10%.
OG000
OG001
Non-inferiority of cTIV to eTIV against B influenza strain as measured by HI cell-derived antigen assay.
binominal or Miettinen &Nurimen method
Difference % (cTIV minus eTIV)
0
2-Sided
95
-6
6
Yes
Non-Inferiority or Equivalence
cTIV was considered non-inferior to eTIV in terms of the percentages of subjects achieving seroconversion or significant increase in antibody titer at day 50 if for all three strains, the lower limit of the two-sided 95% CI around the differences in the percentages of subjects achieving seroconversion and significant increase (cTIV minus eTIV) was >-10%.