Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vacc... | NCT00973700 | Trialant
NCT00973700
Sponsor
Novartis Vaccines
Status
Completed
Last Update Posted
Dec 2, 2015Estimated
Enrollment
784Actual
Phase
Phase 3
Conditions
Novel 2009 Influenza H1N1
Interventions
MF59-eH1N1_f
eH1N1_f
Countries
Costa Rica
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT00973700
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V112_04
Secondary IDs
Not provided
Brief Title
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)
Official Title
A Randomized, Open Label, Single Center, Dose- and Regimen-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Children and Adults Ages 3 to 64 Years
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
Aug 2009
Primary Completion Date
Oct 2009Actual
Completion Date
Oct 2010Actual
First Submitted Date
Sep 2, 2009
First Submission Date that Met QC Criteria
Sep 7, 2009
First Posted Date
Sep 9, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 20, 2010
Results First Submitted that Met QC Criteria
Apr 22, 2011
Results First Posted Date
May 23, 2011Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Oct 29, 2015
Last Update Posted Date
Dec 2, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis VaccinesINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children, adolescents, and adults.
Detailed Description
Not provided
Conditions Module
Conditions
Novel 2009 Influenza H1N1
Keywords
Swine Flu
Flu
Vaccine
Adjuvant
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
784Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
2x7.5adj
Experimental
Two doses of MF59 adjuvanted (adj) A/H1N1
Biological: MF59-eH1N1_f
7.5adj_1_8
Experimental
MF59 adjuvanted (adj) A/H1N1 on days 1 and 8
Biological: MF59-eH1N1_f
7.5adj_1_22
Experimental
MF59 adjuvanted (adj) A/H1N1 on study days 1 and 22
Biological: MF59-eH1N1_f
15_1_22
Experimental
A/H1N1 on study days 1 and 22
Biological: eH1N1_f
2x15_1_22
Experimental
Two doses of A/H1N1 (one in each arm) on study days 1 and 22
Biological: eH1N1_f
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MF59-eH1N1_f
Biological
MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
2x7.5adj
7.5adj_1_22
7.5adj_1_8
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
The analyses were performed on the Per-Protocol Set (PPS).
Day 1 to day 387
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Analyses were performed on the Per-Protocol set (PPS).
Day 1 to day 387
Secondary Outcomes
Measure
Description
Time Frame
Age Distribution at Baseline
Baseline
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
The analyses were performed on the Per-Protocol Set (PPS).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Children, adolescents, and adults 3 to 64 years of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.
Exclusion Criteria:
History of serious disease.
History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
Known or suspected impairment/alteration of immune function.
Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
For additional entry criteria, please refer to protocol.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
3 Years
Maximum Age
64 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Novartis Vaccines
Novartis Vaccines
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Instituto de Atencion Pediatrica, Avenida 0-2 Calle 22, Paseo Colon del Restaurante La, Bastilla 50 metros Sur, Edificio 5.
Arguedas A, Soley C, Abdelnour A, Sales V, Lindert K, Della Cioppa G, Clemens R; Costa Rican H1N1 Vaccine Study Group. Assessment of the safety, tolerability and kinetics of the immune response to A/H1N1v vaccine formulations with and without adjuvant in healthy pediatric subjects from 3 through 17 years of age. Hum Vaccin. 2011 Jan 1;7(1):58-66. doi: 10.4161/hv.7.1.13411. Epub 2011 Jan 1.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
All enrolled subjects were included in the trial.
Recruitment Details
Participants were enrolled at one center in Costa Rica.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
2x7.5adj
A/H1N1 7.5 mcg with MF59; two doses on day 1
FG001
7.5adj_1_8
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
FG002
7.5adj_1_22
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
FG003
15_1_22
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
FG004
2x15_1_22
A/H1N1 15 mcg no MF59; two doses on days 1 and 22
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00056 subjects
FG00156 subjects
FG002168 subjects
FG003336 subjects
FG004168 subjects
COMPLETED
FG00049 subjects
FG00154 subjects
FG002158 subjects
FG003318 subjects
FG004
NOT COMPLETED
FG0007 subjects
FG0012 subjects
FG00210 subjects
FG00318 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0002 subjects
FG0012 subjects
FG0028 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
2x7.5adj
A/H1N1 7.5 mcg with MF59; two doses on day 1
BG001
7.5adj_1_8
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
The number of participants analyzed for each outcome measure below is not the same with the numbers provided in the participant flow module as this number is based on the age and/or the group analyses.
Outcome Measures Module
Outcome Measures
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
Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
The analyses were performed on the Per-Protocol Set (PPS).
The analysis was done on the per-protocol set.
Posted
Number
95% Confidence Interval
Percentages of Subjects
Day 1 to day 387
ID
Title
Description
OG000
15_1_22
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
Units
Counts
Adverse Events Module
Frequency Threshold
5
Time Frame
All adverse events (AEs) and serious adverse events were collected throughout the duration of the study (day 1 to day 387).
Description
Data provided in Other Adverse Events (>5%) were collected. The data included solicited local and systemic reactions that persisted for more than 7 days after each study vaccination. The number of participants at risk is not the same with the numbers provided in the participant flow module as these numbers are analyzed by age and group.
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
2x7.5adj (18 to 64 Yrs)
A/H1N1 7.5 mcg with MF59; two doses on day 1
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
appendicitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
nasopharyngitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Posting Director
Novartis Vaccines and Diagnostics
RegContactVacUS.nvdit@Novartis.com
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D009976
Orthomyxoviridae Infections
D007251
Influenza, Human
Ancestor Terms
ID
Term
D012327
RNA Virus Infections
D014777
Virus Diseases
D007239
Infections
D012141
Respiratory Tract Infections
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
eH1N1_f
Biological
Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal
15_1_22
2x15_1_22
Day 1 to day 387
HI GMRs, in 3 to <9 Years and 9 to 17 Years
Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers).
The analyses were performed on the the per-protocol set (PPS).
Day 1 to day 387
HI GMR, in Adults 18 to 64 Years
Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers).
The analyses were performed on the Per-Protocol Set (PPS).
Day 1 to day 387
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
The analyses were performed on the per-protocol set (PPS).
7 days and 21 days after each vaccination
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age
Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to <9 years of age).
Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination
7 days after each vaccination
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age
Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age).
Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set.
Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination.
7 days after each vaccination
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age
Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age).
Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination.
The analyses were performed on the safety set.
7 days after each vaccination
158 subjects
10 subjects
4 subjects
FG0044 subjects
Lost to Follow-up
FG0005 subjects
FG0010 subjects
FG0021 subjects
FG0038 subjects
FG0045 subjects
Inappropriate enrolment
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0034 subjects
FG0040 subjects
Unable to Classify
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0032 subjects
FG0041 subjects
BG002
7.5adj_1_22
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
BG003
15_1_22
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
BG004
2x15_1_22
A/H1N1 15 mcg no MF59; two doses on days 1 and 22
BG005
Total
Total of all reporting groups
56
BG00156
BG002168
BG003336
BG004168
BG005784
Number
subjects
Title
Denominators
Categories
3 to < 9 years
Title
Measurements
BG0000± 0
BG0010± 0
BG00256± 1.7
BG00384± 1.7
BG00456± 1.9
BG005196
9 to 17 years
Title
Measurements
BG0000± 0
BG0010± 0
BG00256± 2.5
BG003
18 to 64 years
Title
Measurements
BG00056± 10.8
BG00156± 11.1
BG00256± 11.2
BG003
Sex/Gender, Customized
Number
Subjects
Title
Denominators
Categories
Female (3 to <9 years)
Title
Measurements
BG0000
BG0010
BG00229
BG00346
BG00423
BG00598
Male (3 to < 9 years)
Title
Measurements
BG0000
BG0010
BG00227
BG003
Female (9 to 17 years)
Title
Measurements
BG0000
BG0010
BG00240
BG003
Male (9 to 17 years)
Title
Measurements
BG0000
BG0010
BG00216
BG003
Female (18 to 64 years)
Title
Measurements
BG00033
BG00140
BG00229
BG003
Male (18 to 64 years)
Title
Measurements
BG00023
BG00116
BG00227
BG003
Participants
OG000149
Title
Denominators
Categories
HI Titer ≥40 on day 1
Title
Measurements
OG00026(19 to 33)
HI Titer ≥40 on day 22
Title
Measurements
OG00083(76 to 89)
HI Titer ≥40 on day 29
Title
Measurements
OG00095(91 to 98)
HI Titer ≥40 on day 43
Title
Measurements
OG00092(86 to 96)
HI Titer ≥40 on day 217 (N=129)
Title
Measurements
OG00088(81 to 93)
HI Titer ≥40 on day 387 (N=136)
Title
Measurements
OG00080(72 to 86)
Seroconversion on day 22
Title
Measurements
OG00079(71 to 85)
Seroconversion on day 29
Title
Measurements
OG00092(86 to 96)
Seroconversion on day 43
Title
Measurements
OG00087(81 to 92)
Seroconversion on day 217 (N=129)
Title
Measurements
OG00071(62 to 78)
Seroconversion on day 387 (N=136)
Title
Measurements
OG00063(54 to 71)
Primary
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Analyses were performed on the Per-Protocol set (PPS).
The analysis was done on the per-protocol set.
Posted
Number
95% Confidence Interval
Percentages of Subjects
Day 1 to day 387
ID
Title
Description
OG000
15_1_22
A/H1N1 on study days 1 and 22
Units
Counts
Participants
OG000132
Title
Denominators
Categories
HI Titer ≥40 on day 1
Title
Measurements
OG00018(12 to 26)
HI Titer ≥40 on day 8
Title
Measurements
OG00093(87 to 97)
HI Titer ≥40 on day 15
Secondary
Age Distribution at Baseline
The overall number of baseline participants.
Posted
Mean
Standard Deviation
years
Baseline
ID
Title
Description
OG000
2x7.5adj
A/H1N1 7.5 mcg with MF59; two doses on day 1
OG001
7.5adj_1_8
A/H1N1 7.5 mcg with MF59; two doses on day 1
OG002
7.5adj_1_22
A/H1N1 7.5 mcg with MF59; two doses on day 1
OG003
15_1_22
A/H1N1 7.5 mcg with MF59; two doses on day 1
OG004
2x15_1_22
A/H1N1 7.5 mcg with MF59; two doses on day 1
Units
Counts
Participants
OG00056
OG00156
OG002168
OG003336
OG004
Title
Denominators
Categories
3 to <9 years (N=0, 0, 56, 84, 56)
Title
Measurements
OG000NA± NANot Applicable (NA) as 0 subjects were in this category.
OG001NA± NANot Applicable (NA) as 0 subjects were in this category.
OG002
Secondary
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
The analyses were performed on the Per-Protocol Set (PPS).
The analysis is done on the per-protocol set.
Posted
Number
95% Confidence Interval
Percentages of Subjects
Day 1 to day 387
ID
Title
Description
OG000
7.5adj_1_22
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
OG001
15_1_22
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
OG002
2x15_1_22
A/H1N1 15 mcg no MF59; two doses on days 1 and 22
Units
Counts
Participants
OG00091
OG001149
OG00299
Title
Denominators
Categories
HI Titer ≥40 on day 1 (3 to <9 yrs; N=46,75,47)
Title
Measurements
OG00024(13 to 39)
OG00123(14 to 34)
OG00223(12 to 38)
HI Titer ≥40 on day 22 (3 to <9 yrs; N=46,75,47)
Secondary
HI GMRs, in 3 to <9 Years and 9 to 17 Years
Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers).
The analyses were performed on the the per-protocol set (PPS).
The analysis is done on the per-protocol set.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Day 1 to day 387
ID
Title
Description
OG000
7.5adj_1_22
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
OG001
15_1_22
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
OG002
2x15_1_22
A/H1N1 15 mcg no MF59; two doses on days 1 and 22
Units
Counts
Participants
OG00091
OG001149
OG00299
Title
Denominators
Categories
GMR on day 22 (3 to < 9 yrs; N=46,75,47)
Title
Measurements
OG00031(19 to 50)
OG00112(8.51 to 18)
OG00216(10 to 26)
GMR on day 29 (3 to < 9 yrs; N=46,75,47)
Secondary
HI GMR, in Adults 18 to 64 Years
Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers).
The analyses were performed on the Per-Protocol Set (PPS).
The analysis is done on the per-protocol set.
Posted
Geometric Mean
95% Confidence Interval
Ratio
Day 1 to day 387
ID
Title
Description
OG000
2x7.5adj
A/H1N1 7.5 mcg with MF59; two doses on day 1
OG001
7.5adj_1_8
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
OG002
7.5adj_1_22
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
OG003
15_1_22
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
OG004
2x15_1_22
A/H1N1 15 mcg no MF59; two doses on days 1 and 22
Units
Counts
Participants
OG00041
OG00145
OG00245
OG003
Title
Denominators
Categories
GMR on day 8
Title
Measurements
OG00048(28 to 85)
OG00135(21 to 60)
OG00257(33 to 97)
OG003
Secondary
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
The analyses were performed on the per-protocol set (PPS).
The analysis is done on the per-protocol set.
Posted
Number
95% Confidence Interval
Percentages of Subjects
7 days and 21 days after each vaccination
ID
Title
Description
OG000
2x7.5adj
A/H1N1 7.5 mcg with MF59; two doses on day 1
OG001
7.5adj_1_8
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
OG002
7.5adj_1_22
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
OG003
15_1_22
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
OG004
2x15_1_22
A/H1N1 15 mcg no MF59; two doses on days 1 and 22
Units
Counts
Participants
OG00041
OG00145
OG00245
OG003
Title
Denominators
Categories
HI Titer ≥40 on day 8
Title
Measurements
OG000100(91 to 100)
OG00191(79 to 98)
OG00296(85 to 99)
OG003
Secondary
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age
Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to <9 years of age).
Postvac: postvaccination; Analges: analgesics; Antipyr: antipyretics. The analyses were performed on the safety set. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination
The analysis is done on the safety set.
Posted
Number
Number of subjects
7 days after each vaccination
ID
Title
Description
OG000
7.5adj_1_22
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
OG001
15_1_22
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
OG002
2x15_1_22
A/H1N1 15 mcg no MF59; two doses on days 1 and 22
Units
Counts
Participants
OG00055
OG00184
OG00254
Title
Denominators
Categories
Local Reactions postvac. 1
Title
Measurements
OG00025
OG00131
OG00220
Erythema postvac. 1
Secondary
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age
Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age).
Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set.
Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination.
The analysis is done on the safety set.
Posted
Number
Number of subjects
7 days after each vaccination
ID
Title
Description
OG000
7.5adj_1_22
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
OG001
15_1_22
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
OG002
2x15_1_22
A/H1N1 15 mcg no MF59; two doses on days 1 and 22
Units
Counts
Participants
OG00053
OG00184
OG00257
Title
Denominators
Categories
Local Reactions postvac. 1
Title
Measurements
OG00037
OG00136
OG00229
Erythema postvac. 1
Secondary
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age
Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age).
Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination.
The analyses were performed on the safety set.
The analysis is done on the safety set.
Posted
Number
Number of subjects
7 days after each vaccination
ID
Title
Description
OG000
2x7.5adj
A/H1N1 7.5 mcg with MF59; two doses on day 1
OG001
7.5adj_1_8
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
OG002
7.5adj_1_22
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
OG003
15_1_22
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
OG004
2x15_1_22
A/H1N1 15 mcg no MF59; two doses on days 1 and 22
Units
Counts
Participants
OG00054
OG00156
OG00256
OG003
Title
Denominators
Categories
Local Reactions postvac. 1
Title
Measurements
OG00039
OG00126
OG00238
OG003
2
54
49
54
EG001
7.5adj_1_8 (18 to 64 Yrs)
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
0
56
41
56
EG002
7.5adj_1_22 (18-64 Yrs)
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
1
56
48
56
EG003
15_1_22 (18 to 64 Yrs)
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
4
159
119
159
EG004
2x15_1_22 (18 to 64 Yrs)
A/H1N1 15 mcg no MF59; two doses on days 1 and 22
1
54
35
54
EG005
7.5adj_1_22 (9 to 17 Yrs)
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
1
53
46
53
EG006
15_1_22 (9 to 17 Yrs)
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
1
84
67
84
EG007
2x15_1_22 (9 to 17 Yrs)
A/H1N1 15 mcg no MF59; two doses on days 1 and 22
0
57
43
57
EG008
7.5adj_1_22 (3 to <9 Yrs)
A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
2
55
40
55
EG009
15_1_22 (3 to <9 Yrs)
A/H1N1 15 mcg no MF59; one dose on days 1 and 22
0
84
61
84
EG010
2x15_1_22 (3 to <9 Yrs)
A/H1N1 15 mcg no MF59; two doses on days 1 and 22
0
54
41
54
EG0000 events0 affected54 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected56 at risk
EG0030 events0 affected159 at risk
EG0040 events0 affected54 at risk
EG0050 events0 affected53 at risk
EG0061 events1 affected84 at risk
EG0070 events0 affected57 at risk
EG0080 events0 affected55 at risk
EG0090 events0 affected84 at risk
EG0100 events0 affected54 at risk
rhinoplasty
Surgical and medical procedures
MedDRA 17.1
Non-systematic Assessment
This AE was reported in the Adults (18 to 64 years of age) under group 2x15_1_22.
EG0000 events0 affected54 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected56 at risk
EG0030 events0 affected159 at risk
EG0041 events1 affected54 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected84 at risk
EG0070 events0 affected57 at risk
EG0080 events0 affected55 at risk
EG0090 events0 affected84 at risk
EG0100 events0 affected54 at risk
Precocious Puberty
Endocrine disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected56 at risk
EG0030 events0 affected159 at risk
EG0040 events0 affected54 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected84 at risk
EG0070 events0 affected57 at risk
EG0081 events1 affected55 at risk
EG0090 events0 affected84 at risk
EG0100 events0 affected54 at risk
sexual abuse
Social circumstances
MedDRA 17.1
Non-systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected56 at risk
EG0030 events0 affected159 at risk
EG0040 events0 affected54 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected84 at risk
EG0070 events0 affected57 at risk
EG0081 events1 affected55 at risk
EG0090 events0 affected84 at risk
EG0100 events0 affected54 at risk
abdominal pain
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected56 at risk
EG0030 events0 affected159 at risk
EG0040 events0 affected54 at risk
EG0051 events1 affected53 at risk
EG0060 events0 affected84 at risk
EG0070 events0 affected57 at risk
EG0080 events0 affected55 at risk
EG0090 events0 affected84 at risk
EG0100 events0 affected54 at risk
urinary tract infection
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0001 events1 affected54 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected56 at risk
EG0030 events0 affected159 at risk
EG0040 events0 affected54 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected84 at risk
EG0070 events0 affected57 at risk
EG0080 events0 affected55 at risk
EG0090 events0 affected84 at risk
EG0100 events0 affected54 at risk
intervertebral disc protrusion
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected56 at risk
EG0031 events1 affected159 at risk
EG0040 events0 affected54 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected84 at risk
EG0070 events0 affected57 at risk
EG0080 events0 affected55 at risk
EG0090 events0 affected84 at risk
EG0100 events0 affected54 at risk
brain neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.1
Non-systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected56 at risk
EG0021 events1 affected56 at risk
EG0030 events0 affected159 at risk
EG0040 events0 affected54 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected84 at risk
EG0070 events0 affected57 at risk
EG0080 events0 affected55 at risk
EG0090 events0 affected84 at risk
EG0100 events0 affected54 at risk
breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected54 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected56 at risk
EG0030 events0 affected159 at risk
EG0040 events0 affected54 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected84 at risk
EG0070 events0 affected57 at risk
EG0080 events0 affected55 at risk
EG0090 events0 affected84 at risk
EG0100 events0 affected54 at risk
abortion threatened
Pregnancy, puerperium and perinatal conditions
MedDRA 17.1
Non-systematic Assessment
EG0001 events1 affected54 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected56 at risk
EG0030 events0 affected159 at risk
EG0040 events0 affected54 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected84 at risk
EG0070 events0 affected57 at risk
EG0080 events0 affected55 at risk
EG0090 events0 affected84 at risk
EG0100 events0 affected54 at risk
high risk pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 17.1
Non-systematic Assessment
EG0001 events1 affected54 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected56 at risk
EG0030 events0 affected159 at risk
EG0040 events0 affected54 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected84 at risk
EG0070 events0 affected57 at risk
EG0080 events0 affected55 at risk
EG0090 events0 affected84 at risk
EG0100 events0 affected54 at risk
nephrolithiasis
Renal and urinary disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected56 at risk
EG0031 events1 affected159 at risk
EG0040 events0 affected54 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected84 at risk
EG0070 events0 affected57 at risk
EG0080 events0 affected55 at risk
EG0090 events0 affected84 at risk
EG0100 events0 affected54 at risk
uterine haemorrhage
Reproductive system and breast disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected56 at risk
EG0031 events1 affected159 at risk
EG0040 events0 affected54 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected84 at risk
EG0070 events0 affected57 at risk
EG0080 events0 affected55 at risk
EG0090 events0 affected84 at risk
EG0100 events0 affected54 at risk
hysterectomy
Surgical and medical procedures
MedDRA 17.1
Non-systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected56 at risk
EG0031 events1 affected159 at risk
EG0040 events0 affected54 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected84 at risk
EG0070 events0 affected57 at risk
EG0080 events0 affected55 at risk
EG0090 events0 affected84 at risk
EG0100 events0 affected54 at risk
inguinal hernia repair
Surgical and medical procedures
MedDRA 17.1
Non-systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected56 at risk
EG0031 events1 affected159 at risk
EG0040 events0 affected54 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected84 at risk
EG0070 events0 affected57 at risk
EG0080 events0 affected55 at risk
EG0090 events0 affected84 at risk
EG0100 events0 affected54 at risk
EG00011 events10 affected54 at risk
EG0017 events6 affected56 at risk
EG0028 events8 affected56 at risk
EG00326 events24 affected159 at risk
EG0047 events6 affected54 at risk
EG0057 events7 affected53 at risk
EG00615 events12 affected84 at risk
EG00712 events11 affected57 at risk
EG0086 events4 affected55 at risk
EG00920 events17 affected84 at risk
EG01015 events11 affected54 at risk
upper respiratory tract infection
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0001 events1 affected54 at risk
EG0012 events2 affected56 at risk
EG0026 events5 affected56 at risk
EG0037 events6 affected159 at risk
EG0040 events0 affected54 at risk
EG0051 events1 affected53 at risk
EG0063 events3 affected84 at risk
EG0073 events3 affected57 at risk
EG0085 events4 affected55 at risk
EG0099 events7 affected84 at risk
EG0107 events6 affected54 at risk
cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Non-systematic Assessment
EG0002 events2 affected54 at risk
EG0012 events2 affected56 at risk
EG0021 events1 affected56 at risk
EG0039 events8 affected159 at risk
EG0043 events3 affected54 at risk
EG0050 events0 affected53 at risk
EG0064 events4 affected84 at risk
EG0071 events1 affected57 at risk
EG0080 events0 affected55 at risk
EG0097 events6 affected84 at risk
EG0105 events4 affected54 at risk
headache
Nervous system disorders
MedDRA 17.1
Non-systematic Assessment
EG00031 events27 affected54 at risk
EG00149 events21 affected56 at risk
EG00257 events27 affected56 at risk
EG00391 events56 affected159 at risk
EG00430 events17 affected54 at risk
EG00539 events21 affected53 at risk
EG00648 events29 affected84 at risk
EG00722 events11 affected57 at risk
EG00812 events11 affected55 at risk
EG00931 events21 affected84 at risk
EG01015 events11 affected54 at risk
myalgia
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG00028 events21 affected54 at risk
EG00125 events17 affected56 at risk
EG00234 events21 affected56 at risk
EG00373 events42 affected159 at risk
EG00422 events17 affected54 at risk
EG00522 events18 affected53 at risk
EG00626 events20 affected84 at risk
EG00722 events14 affected57 at risk
EG0088 events5 affected55 at risk
EG00912 events10 affected84 at risk
EG01013 events9 affected54 at risk
injection site erythema
General disorders
MedDRA 17.1
Systematic Assessment
EG0005 events3 affected54 at risk
EG0011 events1 affected56 at risk
EG0024 events3 affected56 at risk
EG0037 events6 affected159 at risk
EG0043 events2 affected54 at risk
EG0051 events1 affected53 at risk
EG0064 events4 affected84 at risk
EG0071 events1 affected57 at risk
EG0084 events3 affected55 at risk
EG0091 events1 affected84 at risk
EG0101 events1 affected54 at risk
injection site pain
General disorders
MedDRA 17.1
Systematic Assessment
EG000130 events39 affected54 at risk
EG00179 events31 affected56 at risk
EG002113 events42 affected56 at risk
EG003173 events79 affected159 at risk
EG004108 events23 affected54 at risk
EG005116 events42 affected53 at risk
EG006117 events52 affected84 at risk
EG007160 events37 affected57 at risk
EG00875 events32 affected55 at risk
EG009102 events43 affected84 at risk
EG010116 events29 affected54 at risk
injection site swelling
General disorders
MedDRA 17.1
Systematic Assessment
EG0002 events1 affected54 at risk
EG0012 events2 affected56 at risk
EG0022 events2 affected56 at risk
EG0035 events5 affected159 at risk
EG0042 events2 affected54 at risk
EG0051 events1 affected53 at risk
EG0062 events2 affected84 at risk
EG0071 events1 affected57 at risk
EG0083 events3 affected55 at risk
EG0092 events2 affected84 at risk
EG0102 events2 affected54 at risk
nausea
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0007 events7 affected54 at risk
EG00123 events13 affected56 at risk
EG00217 events11 affected56 at risk
EG00328 events21 affected159 at risk
EG0048 events5 affected54 at risk
EG0056 events6 affected53 at risk
EG00616 events12 affected84 at risk
EG00711 events6 affected57 at risk
EG00810 events8 affected55 at risk
EG00914 events10 affected84 at risk
EG0105 events5 affected54 at risk
pyrexia
General disorders
MedDRA 17.1
Systematic Assessment
EG0002 events2 affected54 at risk
EG0015 events4 affected56 at risk
EG0028 events6 affected56 at risk
EG00313 events12 affected159 at risk
EG0042 events2 affected54 at risk
EG0054 events3 affected53 at risk
EG0063 events3 affected84 at risk
EG0078 events6 affected57 at risk
EG0088 events8 affected55 at risk
EG00913 events10 affected84 at risk
EG01012 events10 affected54 at risk
fatigue
General disorders
MedDRA 17.1
Systematic Assessment
EG00020 events17 affected54 at risk
EG00134 events20 affected56 at risk
EG00236 events21 affected56 at risk
EG00373 events45 affected159 at risk
EG00430 events18 affected54 at risk
EG00513 events11 affected53 at risk
EG00623 events15 affected84 at risk
EG00726 events14 affected57 at risk
EG0087 events6 affected55 at risk
EG00916 events11 affected84 at risk
EG0109 events6 affected54 at risk
arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0004 events4 affected54 at risk
EG0016 events6 affected56 at risk
EG00214 events10 affected56 at risk
EG00332 events24 affected159 at risk
EG0047 events4 affected54 at risk
EG0052 events2 affected53 at risk
EG0067 events5 affected84 at risk
EG0075 events5 affected57 at risk
EG0080 events0 affected55 at risk
EG0094 events4 affected84 at risk
EG0107 events7 affected54 at risk
vomiting
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected56 at risk
EG0020 events0 affected56 at risk
EG0035 events3 affected159 at risk
EG0042 events1 affected54 at risk
EG0051 events1 affected53 at risk
EG0063 events3 affected84 at risk
EG0071 events1 affected57 at risk
EG0080 events0 affected55 at risk
EG0092 events2 affected84 at risk
EG0105 events5 affected54 at risk
dizziness
Nervous system disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 events1 affected54 at risk
EG0013 events3 affected56 at risk
EG0021 events1 affected56 at risk
EG0031 events1 affected159 at risk
EG0041 events1 affected54 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected84 at risk
EG0071 events1 affected57 at risk
EG0080 events0 affected55 at risk
EG0090 events0 affected84 at risk
EG0100 events0 affected54 at risk
chills
General disorders
MedDRA 17.1
Systematic Assessment
EG0005 events4 affected54 at risk
EG00111 events9 affected56 at risk
EG00212 events8 affected56 at risk
EG00312 events10 affected159 at risk
EG00414 events11 affected54 at risk
EG0053 events3 affected53 at risk
EG0064 events4 affected84 at risk
EG0075 events4 affected57 at risk
EG0086 events4 affected55 at risk
EG0093 events2 affected84 at risk
EG0103 events2 affected54 at risk
diarrhea
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0002 events2 affected54 at risk
EG0014 events2 affected56 at risk
EG0021 events1 affected56 at risk
EG00313 events13 affected159 at risk
EG0045 events3 affected54 at risk
EG0054 events4 affected53 at risk
EG0065 events5 affected84 at risk
EG0070 events0 affected57 at risk
EG0081 events1 affected55 at risk
EG0093 events3 affected84 at risk
EG0105 events5 affected54 at risk
tonsillitis
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0001 events1 affected54 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected56 at risk
EG0030 events0 affected159 at risk
EG0040 events0 affected54 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected84 at risk
EG0070 events0 affected57 at risk
EG0084 events3 affected55 at risk
EG0093 events3 affected84 at risk
EG0106 events6 affected54 at risk
varicella
Infections and infestations
MedDRA 17.1
Non-systematic Assessment
EG0000 events0 affected54 at risk
EG0010 events0 affected56 at risk
EG0020 events0 affected56 at risk
EG0030 events0 affected159 at risk
EG0040 events0 affected54 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected84 at risk
EG0070 events0 affected57 at risk
EG0081 events1 affected55 at risk
EG0090 events0 affected84 at risk
EG0103 events3 affected54 at risk
pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0001 events1 affected54 at risk
EG0013 events3 affected56 at risk
EG0022 events2 affected56 at risk
EG0031 events1 affected159 at risk
EG0041 events1 affected54 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected84 at risk
EG0070 events0 affected57 at risk
EG0080 events0 affected55 at risk
EG0091 events1 affected84 at risk
EG0100 events0 affected54 at risk
backpain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Non-systematic Assessment
EG0000 events0 affected54 at risk
EG0011 events1 affected56 at risk
EG0024 events3 affected56 at risk
EG0033 events2 affected159 at risk
EG0043 events2 affected54 at risk
EG0050 events0 affected53 at risk
EG0060 events0 affected84 at risk
EG0070 events0 affected57 at risk
EG0080 events0 affected55 at risk
EG0090 events0 affected84 at risk
EG0100 events0 affected54 at risk
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
D012140
Respiratory Tract Diseases
84
± 2.3
BG00456± 2.5
BG005196
168
± 11.7
BG00456± 11.0
BG005392
38
BG00433
BG00598
40
BG00430
BG005110
44
BG00426
BG00586
96
BG00429
BG005227
72
BG00427
BG005165
Title
Measurements
OG00099(96 to 100)
HI Titer ≥40 on day 22
Title
Measurements
OG00098(95 to 100)
HI Titer ≥40 on day 29
Title
Measurements
OG00099(96 to 100)
HI Titer ≥40 on Day 43
Title
Measurements
OG000100(97 to 100)
HI Titer ≥40 on Day 217 (N=111)
Title
Measurements
OG00091(84 to 96)
HI Titer ≥40 on Day 387 (N=120)
Title
Measurements
OG00084(76 to 90)
Seroconversion on day 8
Title
Measurements
OG00086(78 to 91)
Seroconversion on day 15
Title
Measurements
OG00094(88 to 97)
Seroconversion on day 22
Title
Measurements
OG00094(88 to 97)
Seroconversion on day 29
Title
Measurements
OG00095(90 to 98)
Seroconversion on day 43
Title
Measurements
OG00095(90 to 98)
Seroconversion on day 217 (N=111)
Title
Measurements
OG00081(73 to 88)
Seroconversion on day 387 (N=120)
Title
Measurements
OG00075(66 to 82)
168
5.5
± 1.7
OG0035.7± 1.7
OG0045.4± 1.9
9 to 17 years (N=0, 0, 56, 84, 56)
Title
Measurements
OG000NA± NANot Applicable (NA) as 0 subjects were in this category.
OG001NA± NANot Applicable (NA) as 0 subjects were in this category.
OG00213.1± 2.5
OG00312.8± 2.3
OG00413.1± 2.5
18 to 64 years (N= 56, 56, 56, 168, 56)
Title
Measurements
OG00035.1± 10.8
OG00138.6± 11.1
OG00237.3± 11.2
OG00337.0± 11.7
OG00437.4± 11.0
Title
Measurements
OG00093(82 to 99)
OG00171(59 to 81)
OG00279(64 to 89)
HI Titer ≥40 on day 29 (3 to < 9 yrs; N=46,75,47)
Title
Measurements
OG000100(92 to 100)
OG00192(83 to 97)
OG00296(85 to 99)
HI Titer ≥40 on day 43 (3 to < 9 yrs; N=46,75,47)
Title
Measurements
OG000100(92 to 100)
OG00185(75 to 92)
OG00296(85 to 99)
HI Titer ≥40 on day 217 (3 to < 9 yrs; N=41,66,40)
Title
Measurements
OG000100(91 to 100)
OG00180(69 to 89)
OG00278(62 to 89)
HI Titer ≥40 on day 387 (3 to < 9 yrs; N=43,70,42)
Title
Measurements
OG00093(81 to 99)
OG00173(61 to 83)
OG00262(46 to 76)
Seroconversion on day 22 (3 to <9 yrs; N=46,75,47)
Title
Measurements
OG00091(79 to 98)
OG00169(58 to 79)
OG00279(64 to 89)
Seroconversion on day 29 (3 to <9 yrs; N=46,75,47)
Title
Measurements
OG00098(88 to 100)
OG00192(83 to 97)
OG00296(85 to 99)
Seroconversion on day 43 (3 to <9 yrs; N=46,75,47)
Title
Measurements
OG00096(85 to 99)
OG00184(74 to 91)
OG00294(82 to 99)
Seroconversion on day 217 (3 to <9 yrs;N=41,66,40)
Title
Measurements
OG00088(74 to 96)
OG00165(52 to 76)
OG00265(48 to 79)
Seroconversion on day 387 (3 to <9 yrs;N=43,70,42)
Title
Measurements
OG00077(61 to 88)
OG00156(43 to 68)
OG00250(34 to 66)
HI Titer ≥40 on day 1 (9 to 17 yrs;N=45,74,52)
Title
Measurements
OG00042(28 to 58)
OG00128(19 to 40)
OG00233(20 to 47)
HI Titer ≥40 on day 22 (9 to 17 yrs; N=45,74,52)
Title
Measurements
OG00098(88 to 100)
OG00196(89 to 99)
OG002100(93 to 100)
HI Titer ≥40 on day 29 (9 to 17 yrs; N=45,74,52)
Title
Measurements
OG000100(92 to 100)
OG00199(93 to 100)
OG002100(93 to 100)
HI Titer ≥40 on day 43 (9 to 17 yrs; N=45,74,52)
Title
Measurements
OG000100(92 to 100)
OG00199(93 to 100)
OG002100(93 to 100)
HI Titer ≥40 on day 217 (9 to 17 yrs; N=37,63,45)
Title
Measurements
OG000100(91 to 100)
OG00195(87 to 99)
OG00298(88 to 100)
HI Titer ≥40 on day 387 (9 to 17 yrs; N=37,66,47)
Title
Measurements
OG00089(75 to 97)
OG00188(78 to 95)
OG00289(77 to 96)
Seroconversion on day 22 (9 to 17 yrs; N=45,74,52)
Title
Measurements
OG00087(73 to 95)
OG00188(78 to 94)
OG00294(84 to 99)
Seroconversion on day 29 (9 to 17 yrs; N=45,74,52)
Title
Measurements
OG00089(76 to 96)
OG00192(83 to 97)
OG00294(84 to 99)
Seroconversion on day 43 (9 to 17 yrs; N=45,74,52)
Title
Measurements
OG00084(71 to 94)
OG00191(81 to 96)
OG00292(81 to 98)
Seroconversion on day 217 (9 to 17 yrs;N=37,63,45)
Title
Measurements
OG00068(50 to 82)
OG00176(64 to 86)
OG00276(60 to 87)
Seroconversion on day 387 (9 to 17 yrs;N=37,66,47)
Title
Measurements
OG00059(42 to 75)
OG00170(57 to 80)
OG00270(55 to 83)
Title
Measurements
OG000169(110 to 260)
OG00135(24 to 49)
OG00253(35 to 82)
GMR on day 43 (3 to < 9 yrs; N=46,75,47)
Title
Measurements
OG000120(75 to 192)
OG00122(15 to 32)
OG00244(27 to 69)
GMR on day 217 (3 to <9 yrs; N=41,66,40)
Title
Measurements
OG00019(12 to 30)
OG0017.79(5.46 to 11)
OG0028.07(5.11 to 13)
GMR on day 387 (3 to <9 yrs; N=43,70,42)
Title
Measurements
OG00014(8.27 to 24)
OG0016.9(4.58 to 10)
OG0025.94(3.5 to 10)
GMR on day 22 (9 to 17 yrs; N=45,74,52)
Title
Measurements
OG00042(24 to 74)
OG00152(34 to 81)
OG00266(39 to 111)
GMR on day 29 (9 to 17 yrs; N=45,74,52)
Title
Measurements
OG00063(36 to 109)
OG00170(45 to 108)
OG00279(47 to 132)
GMR on day 43 (9 to 17 yrs; N=45,74,52)
Title
Measurements
OG00044(25 to 77)
OG00148(31 to 75)
OG00259(35 to 100)
GMR on day 217 (9 to 17 yrs; N=37,63,45)
Title
Measurements
OG00010(5.66 to 18)
OG00117(11 to 26)
OG00213(7.92 to 23)
GMR on day 387 (9 to 17 yrs; N=37,66,47)
Title
Measurements
OG0007.22(3.77 to 14)
OG00116(9.53 to 25)
OG00213(7.53 to 24)
132
OG00447
43
(32 to 59)
OG00463(37 to 106)
GMR on day 15
Title
Measurements
OG000115(70 to 189)
OG001181(113 to 292)
OG002200(124 to 322)
OG003138(104 to 182)
OG004123(77 to 197)
GMR on day 22
Title
Measurements
OG00079(48 to 130)
OG001100(63 to 160)
OG002123(77 to 197)
OG00385(64 to 111)
OG00472(45 to 113)
GMR on day 29
Title
Measurements
OG00056(35 to 89)
OG00176(49 to 118)
OG002160(103 to 248)
OG00383(64 to 107)
OG00466(43 to 101)
GMR on day 43
Title
Measurements
OG00044(27 to 71)
OG00164(40 to 101)
OG002101(63 to 161)
OG00376(58 to 100)
OG00465(41 to 102)
GMR on day (N=0,0,35,111,34)
Title
Measurements
OG000NA(NA to NA)Zero subjects were enrolled in this group.
OG001NA(NA to NA)Zero subjects were enrolled in this group.
OG00230(18 to 48)
OG00316(12 to 20)
OG00416(10 to 27)
GMR on day 387 (N=38,40,38,120,42)
Title
Measurements
OG0006.61(3.92 to 11)
OG00111(6.81 to 19)
OG00221(12 to 36)
OG00312(8.99 to 16)
OG0049.21(5.61 to 15)
132
OG00447
93
(87 to 97)
OG00496(85 to 99)
HI Titer ≥40 on day 15
Title
Measurements
OG000100(91 to 100)
OG001100(92 to 100)
OG00298(88 to 100)
OG00399(96 to 100)
OG004100(92 to 100)
HI Titer ≥40 on day 22
Title
Measurements
OG000100(91 to 100)
OG00198(88 to 100)
OG00298(88 to 100)
OG00398(95 to 100)
OG00498(89 to 100)
HI Titer ≥40 on day 29
Title
Measurements
OG000100(91 to 100)
OG00198(88 to 100)
OG002100(92 to 100)
OG00399(96 to 100)
OG004100(92 to 100)
HI Titer ≥40 on day 43
Title
Measurements
OG00098(87 to 100)
OG001100(92 to 100)
OG00298(88 to 100)
OG003100(97 to 100)
OG004100(92 to 100)
HI Titer ≥40 on day 217 (N=0,0,35,111,34)
Title
Measurements
OG000NA(NA to NA)No subjects were analyzed for this group.
OG001NA(NA to NA)No subjects were analyzed for this group.
OG00297(85 to 100)
OG00391(84 to 96)
OG00497(85 to 100)
HI Titer ≥40 on day 387 (N=38,40,38,120,42)
Title
Measurements
OG00076(60 to 89)
OG00190(76 to 97)
OG00292(79 to 98)
OG00384(76 to 90)
OG00483(69 to 93)
Seroconversion on day 8
Title
Measurements
OG00095(83 to 99)
OG00180(65 to 90)
OG00293(82 to 99)
OG00386(78 to 91)
OG00494(82 to 99)
Seroconversion on day 15
Title
Measurements
OG00098(87 to 100)
OG001100(92 to 100)
OG00298(88 to 100)
OG00394(88 to 97)
OG00498(89 to 100)
Seroconversion on day 22
Title
Measurements
OG00095(83 to 99)
OG00191(79 to 98)
OG00296(85 to 99)
OG00394(88 to 97)
OG00496(85 to 99)
Seroconversion on day 29
Title
Measurements
OG00095(83 to 99)
OG00193(82 to 99)
OG00298(88 to 100)
OG00395(90 to 98)
OG00498(89 to 100)
Seroconversion on day 43
Title
Measurements
OG00085(71 to 94)
OG00193(82 to 99)
OG00296(85 to 99)
OG00395(90 to 98)
OG00498(89 to 100)
Seroconversion on day 217 (N=0,0,35,111,34)
Title
Measurements
OG000NA(NA to NA)No subjects were analyzed for this group.
OG001NA(NA to NA)No subjects were analyzed for this group.
OG00294(81 to 99)
OG00381(73 to 88)
OG00488(73 to 97)
Seroconversion on day 387 (N=38,40,38,120,42)
Title
Measurements
OG00066(49 to 80)
OG00180(64 to 91)
OG00287(72 to 96)
OG00375(66 to 82)
OG00469(53 to 82)
HI Titer ≥40 on day 1
Title
Measurements
OG00020(9 to 35)
OG00122(11 to 37)
OG00213(5 to 27)
OG00318(12 to 26)
OG00421(11 to 36)
Title
Measurements
OG0001
OG0010
OG0020
Induration postvac. 1
Title
Measurements
OG0000
OG0013
OG0021
Swelling postvac. 1
Title
Measurements
OG0003
OG0014
OG0023
Tenderness postvac. 1
Title
Measurements
OG00021
OG00123
OG00217
Pain postvac. 1
Title
Measurements
OG00021
OG00125
OG00217
Systemic Reaction postvac. 1
Title
Measurements
OG00024
OG00128
OG00217
Headache postvac. 1
Title
Measurements
OG0007
OG00112
OG0029
Fatigue postvac. 1
Title
Measurements
OG0006
OG0018
OG0025
Myalgia postvac. 1
Title
Measurements
OG0004
OG0018
OG0026
Arthralgia postvac. 1
Title
Measurements
OG0000
OG0012
OG0022
Chills postvac. 1
Title
Measurements
OG0003
OG0011
OG0022
Nausea postvac. 1
Title
Measurements
OG0005
OG0017
OG0024
Vomiting postvac. 1
Title
Measurements
OG0000
OG0011
OG0022
Diarrhea postvac. 1
Title
Measurements
OG0000
OG0010
OG0021
Other Reactions postvac. 1
Title
Measurements
OG00010
OG00110
OG0026
Analges/Antipyr Used postvac. 1 (N=55, 83, 54)
Title
Measurements
OG0009
OG0018
OG0026
Stayed Home postvac.1(N=55,83,54)
Title
Measurements
OG0001
OG0012
OG0020
Body Temp > 40 C postvac.1
Title
Measurements
OG0000
OG0010
OG0020
Local Reactions postvac. 2 (N=55, 83, 54)
Title
Measurements
OG00020
OG00129
OG00221
Erythema postvac. 2 (N=55, 83, 54)
Title
Measurements
OG0003
OG0011
OG0021
Induration postvac. 2 (N=55, 83, 54)
Title
Measurements
OG0008
OG0011
OG0022
Swelling postvac. 2 (N=55, 83, 54)
Title
Measurements
OG0008
OG0010
OG0022
Tenderness postvac. 2 (N=55, 83, 54)
Title
Measurements
OG00015
OG00127
OG00216
Pain postvac. 2 (N=55, 83, 54)
Title
Measurements
OG00018
OG00123
OG00219
Systemic Reaction postvac. 2 (N=55, 83, 54)
Title
Measurements
OG00013
OG00122
OG00218
Headache postvac. 2 (N=55, 83, 54)
Title
Measurements
OG0005
OG00112
OG0023
Fatigue postvac. 2 (N=55, 83, 54)
Title
Measurements
OG0001
OG0015
OG0022
Myalgia postvac. 2 (N=55, 83, 54)
Title
Measurements
OG0003
OG0012
OG0025
Arthralgia postvac. 2 (N=55, 83, 54)
Title
Measurements
OG0000
OG0012
OG0025
Chills postvac. 2 (N=55, 83, 54)
Title
Measurements
OG0002
OG0012
OG0021
Nausea postvac. 2 (N=55, 83, 54)
Title
Measurements
OG0005
OG0015
OG0021
Vomiting postvac. 2 (N=55, 83, 54)
Title
Measurements
OG0000
OG0011
OG0023
Diarrhea postvac. 2 (N=55, 83, 54)
Title
Measurements
OG0000
OG0011
OG0022
Other Reactions postvac. 2 (N=55, 82, 54)
Title
Measurements
OG0005
OG0017
OG0027
Analges/Antipyr Used postvac. 2 (N=55, 83, 54)
Title
Measurements
OG0004
OG0016
OG0027
Stayed Home postvac. 2 (N=55, 82, 54)
Title
Measurements
OG0001
OG0012
OG0020
Body Temp > 40 C postvac. 2 (N=55, 83, 54)
Title
Measurements
OG0000
OG0010
OG0020
Title
Measurements
OG0001
OG0011
OG0020
Induration postvac. 1
Title
Measurements
OG0001
OG0016
OG0021
Swelling postvac. 1
Title
Measurements
OG0001
OG0014
OG0023
Tenderness postvac. 1
Title
Measurements
OG00026
OG00123
OG00221
Pain postvac. 1
Title
Measurements
OG00032
OG00130
OG00225
Systemic Reaction postvac. 1
Title
Measurements
OG00024
OG00136
OG00216
Headache postvac. 1
Title
Measurements
OG00017
OG00120
OG0028
Fatigue postvac. 1
Title
Measurements
OG0009
OG00113
OG00211
Myalgia postvac. 1
Title
Measurements
OG00011
OG00115
OG00211
Arthralgia postvac. 1
Title
Measurements
OG0002
OG0012
OG0020
Chills postvac. 1
Title
Measurements
OG0001
OG0012
OG0021
Nausea postvac. 1
Title
Measurements
OG0003
OG0017
OG0025
Vomiting postvac. 1
Title
Measurements
OG0000
OG0011
OG0020
Diarrhea postvac. 1
Title
Measurements
OG0002
OG0010
OG0020
Other Reactions postvac. 1
Title
Measurements
OG00011
OG00110
OG0028
Analgesic/Antipyretic Used postvac. 1
Title
Measurements
OG00010
OG00110
OG0027
Stayed Home postvac. 1
Title
Measurements
OG0002
OG0011
OG0022
Body Temp > 40 C postvac. 1
Title
Measurements
OG0000
OG0010
OG0020
Local Reactions postvac. 2 (N=52, 84, 55)
Title
Measurements
OG00031
OG00136
OG00227
Erythema postvac. 2 (N=52, 84, 55)
Title
Measurements
OG0000
OG0013
OG0021
Induration postvac. 2 (N=52, 84, 55)
Title
Measurements
OG0002
OG0013
OG0024
Swelling postvac. 2 (N=52, 84, 55)
Title
Measurements
OG0002
OG0015
OG0023
Tenderness postvac. 2 (N=52, 84, 55)
Title
Measurements
OG00020
OG00125
OG00225
Pain postvac. 2 (N=52, 84, 55)
Title
Measurements
OG00027
OG00130
OG00226
Systemic Reaction postvac. 2 (N=52, 84, 55)
Title
Measurements
OG00018
OG00129
OG00214
Headache postvac. 2 (N=52, 84, 55)
Title
Measurements
OG00012
OG00116
OG0028
Fatigue postvac. 2 (N=52, 84, 55)
Title
Measurements
OG0003
OG0016
OG0029
Myalgia postvac. 2 (N=52, 84, 55)
Title
Measurements
OG0008
OG0019
OG0027
Arthralgia postvac. 2 (N=52, 84, 55)
Title
Measurements
OG0000
OG0014
OG0024
Chills postvac. 2 (N=52, 84, 55)
Title
Measurements
OG0002
OG0012
OG0023
Nausea postvac. 2 (N=52, 84, 55)
Title
Measurements
OG0003
OG0017
OG0022
Vomiting postvac. 2 (N=52, 84, 55)
Title
Measurements
OG0001
OG0010
OG0020
Diarrhea postvac. 2 (N=52, 84, 55)
Title
Measurements
OG0002
OG0013
OG0020
Other Reactions postvac. 2 (N=52, 84, 55)
Title
Measurements
OG0001
OG00110
OG0024
Analges/Antipyr Used postvac. 2 (N=52, 84, 55)
Title
Measurements
OG0001
OG0019
OG0024
Stayed Home postvac. 2 (N=52, 84, 55)
Title
Measurements
OG0000
OG0011
OG0020
Body Temp > 40 C postvac. 2 (N=52, 84, 55)
Title
Measurements
OG0000
OG0010
OG0020
159
OG00454
56
OG00419
Erythema postvac. 1
Title
Measurements
OG0003
OG0010
OG0022
OG0032
OG0041
Induration postvac. 1
Title
Measurements
OG0005
OG0014
OG0025
OG0036
OG0043
Swelling postvac. 1
Title
Measurements
OG0003
OG0013
OG0025
OG0034
OG0042
Tenderness postvac. 1
Title
Measurements
OG00033
OG00121
OG00226
OG00335
OG00414
Pain postvac. 1
Title
Measurements
OG00036
OG00123
OG00232
OG00341
OG00416
Systemic Reaction postvac. 1
Title
Measurements
OG00034
OG00131
OG00231
OG00371
OG00422
Headache postvac. 1
Title
Measurements
OG00026
OG00118
OG00222
OG00342
OG00412
Fatigue postvac. 1
Title
Measurements
OG00017
OG00116
OG00216
OG00332
OG00415
Myalgia postvac. 1
Title
Measurements
OG00021
OG00113
OG00216
OG00328
OG00412
Arthralgia postvac. 1
Title
Measurements
OG0004
OG0011
OG0026
OG00310
OG0042
Chills postvac. 1
Title
Measurements
OG0004
OG0013
OG0026
OG0036
OG0044
Nausea postvac. 1
Title
Measurements
OG0007
OG0019
OG0028
OG00316
OG00413
Vomiting postvac. 1
Title
Measurements
OG0000
OG0010
OG0020
OG0031
OG0041
Diarrhea postvac. 1
Title
Measurements
OG0002
OG0011
OG0020
OG0038
OG0043
Other Reactions postvac. 1
Title
Measurements
OG00014
OG0017
OG00212
OG00313
OG0045
Analgesic/Antipyretic Used postvac. 1
Title
Measurements
OG00014
OG0016
OG00212
OG00313
OG0044
Stayed Home postvac. 1 (N=53,55,56,157,54)
Title
Measurements
OG0002
OG0011
OG0022
OG0030
OG0041
Body Temp > 40 C postvac. 1
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
Local Reactions postvac. 2 (N=0,55,56,158,53)
Title
Measurements
OG0000
OG00121
OG00228
OG00356
OG00417
Erythema postvac. 2 (N=0,55,56,158,53)
Title
Measurements
OG0000
OG0011
OG0022
OG0035
OG0041
Induration postvac. 2 (N=0,55,56,158,53)
Title
Measurements
OG0000
OG0013
OG0024
OG0034
OG0043
Swelling postvac. 2 (N=0,55,56,158,53)
Title
Measurements
OG0000
OG0012
OG0025
OG0037
OG0045
Tenderness postvac. 2 (N=0,55,56,157853)
Title
Measurements
OG0000
OG00116
OG00224
OG00348
OG00416
Pain postvac. 2 (N=0,55,56,158,53)
Title
Measurements
OG0000
OG00119
OG00224
OG00345
OG00415
Systemic Reaction postvac. 2 (N=0,55,56,158,53)
Title
Measurements
OG0000
OG00126
OG00228
OG00353
OG00414
Headache postvac. 2 (N=0,55,56,158, 53)
Title
Measurements
OG0000
OG00118
OG00218
OG00325
OG00411
Fatigue postvac. 2 (N=0,55,56,158, 53)
Title
Measurements
OG0000
OG00114
OG00213
OG00324
OG00410
Myalgia postvac. 2 (N=0,55,56,158, 53)
Title
Measurements
OG0000
OG0019
OG00214
OG00326
OG0047
Arthralgia postvac. 2 (N=0,55,56,158, 53)
Title
Measurements
OG0000
OG0015
OG0027
OG00316
OG0044
Chills postvac. 2 (N=0,55,56,158, 53)
Title
Measurements
OG0000
OG0018
OG0025
OG0035
OG0048
Nausea postvac. 2 (N=0,55,56,158, 53)
Title
Measurements
OG0000
OG0018
OG0025
OG0037
OG0043
Vomiting postvac. 2 (N=0,55,56,158, 53)
Title
Measurements
OG0000
OG0011
OG0020
OG0032
OG0041
Diarrhea postvac. 2 (N=0,55,56,158, 53)
Title
Measurements
OG0000
OG0011
OG0020
OG0034
OG0041
Other Reactions postvac. 2 (N=0,55,56,158, 53)
Title
Measurements
OG0000
OG0018
OG0027
OG00311
OG0047
Analgesi/Antipyr Used postvac 2 (N=0,55,56,158,53)