Study to Evaluate the Efficacy, Safety and Immunogenicity... | NCT00644059

NCT00644059

ID	Type	Description	Link
Eudract number 2007-003786-41

Status Module

Name	Class
Novartis Vaccines	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TIV-adj	Experimental	Adjuvanted trivalent inactivated subunit influenza vaccine	Biological: Adjuvanted trivalent inactivated subunit influenza vaccine
Flu-control	Active Comparator	Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine	Biological: Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
Non-flu Control	Sham Comparator	Novartis meningococcal C conjugate vaccine or tick-borne encephalitis vaccine	Biological: Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adjuvanted trivalent inactivated subunit influenza vaccine	Biological	Either two intramuscular (IM) injections of half dose or one IM injection of full dose, depending on age of subject, were administered in the deltoid muscle preferably of the non-dominant arm.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.	Safety was assessed in terms of number of subjects experiencing each of the local and systemic reactions within 7-days after any vaccination for all seasons, comparison of adjuvanted Trivalent influenza vaccine (aTIV) and flu vaccine control.	7 days post-vaccination
Percentage of Subjects (Unprimed) Aged 6 to <36 Months With Virus-Confirmed Influenza, Comparison of aTIV and Non-flu Vaccine Control (Men C/TBE Vaccine)	Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in 6 to <36 month unprimed subjects for Absolute Efficacy. This primary endpoint is only for homologous strains.	3 weeks after 2nd vaccination

Secondary Outcomes

Measure	Description	Time Frame
Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination	Safety was assessed as the number of subjects aged 6 to <72 months who reported solicited local or systemic adverse events after any vaccination with TIV-adj for all seasons.	7 days post-vaccination

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children whose parents/legal guardians have given written informed consent prior to study entry: a) aged 6 to <72 months (Part I and II of the study; influenza seasons 2007/2008 and 2008/2009) b) aged 6 to <36 months (Part III of the study; influenza season 2009/2010)
In good health as determined by: a) medical history, b) physical examination, c) clinical judgment of the investigator

Exclusion criteria:

Administration of licensed vaccines (including H1N1sw vaccines) within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study. Routine vaccines, according to local recommendations, or any other vaccines not foreseen in the protocol could be given after the active trial phase (i.e., 21 days after last vaccination) has been concluded.
Receipt of another investigational vaccine or any investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and participation in another clinical trial during the present study.
Experience of a severe acute infectious disease in the month prior to study start or experience of a mild acute infection disease in the week prior the study start (untreated common cold is acceptable). The severity of the infectious disease occurred will be based on the investigator's judgment.
Any severe acute respiratory disease and infection requiring systemic antibiotic or antiviral therapy ongoing or resolved within 2 days prior to study start.
Experience an axillary temperature equal to or greater than 37.8°C (rectal temperature equal to or greater than 38.3°C) within the 2 days before enrollment.
Any serious disease in the opinion of the investigator including, for example: a) cancer, b) autoimmune disease (including rheumatoid arthritis under immunosuppressive therapy), c) insulin dependent diabetes mellitus, d) chronic pulmonary disease, asthma under inhalative therapy only is acceptable, e) acute or progressive hepatic disease, f) acute or progressive renal disease.
Known or suspected impairment/alteration of immune function, for example, resulting from: a) receipt of immunosuppressive therapy (corticosteroid -except topical or inhaled steroids- or cancer chemotherapy), b) receipt of immunostimulants, c) receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 90 days and for the full length of the study, d) high risk for developing an immunocompromising disease (suspected or known HIV infection or HIV-related disease).
Bleeding diathesis.
History of hypersensitivity to any component of the study medication or chemically related substances.
History of any anaphylaxis, serious vaccine reactions, or allergy to eggs, egg products or any other vaccine component.
Laboratory confirmed influenza disease.
History of neurological disorder or seizures (febrile seizures allowed).
Received any influenza vaccine.
Major surgery planned during the study period.
Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives, e.g., planned travel or relocation of residence that would interfere with completion of study.

Name	Affiliation	Role
Novartis Vacccines and Diagnostics	Novartis	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
East Vantaa Clinic		East Vaanta		01300	Finland
Espoo Vaccine Research Clinic

PubMed Identifier	Type	Citation	Retractions
21995388	Result	Vesikari T, Knuf M, Wutzler P, Karvonen A, Kieninger-Baum D, Schmitt HJ, Baehner F, Borkowski A, Tsai TF, Clemens R. Oil-in-water emulsion adjuvant with influenza vaccine in young children. N Engl J Med. 2011 Oct 13;365(15):1406-16. doi: 10.1056/NEJMoa1010331.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	TIV-adj	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
FG001	Flu-control

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	TIV-adj	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
BG001	Flu-control	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
BG002	Non-flu Control	Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
BG003	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control.

Safety was assessed in terms of number of subjects experiencing each of the local and systemic reactions within 7-days after any vaccination for all seasons, comparison of adjuvanted Trivalent influenza vaccine (aTIV) and flu vaccine control.

The analysis was done on Safety set - All subjects in the exposed population who provided post-baseline safety data.

Posted

Number

Number of subjects

7 days post-vaccination

ID	Title	Description
OG000	TIV-adj (6 to <36 Months)	Subjects aged 6 to <36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
OG001	Flu-control (6 to <36 Months)	Subjects aged 6 to <36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine

Units	Counts
Participants	OG0001178 OG0011068

Title

Denominators

Categories

Any Local

Title	Measurements
	OG000625 OG001481

Injection Site Ecchymosis

Title	Measurements
	OG000

Primary

Percentage of Subjects (Unprimed) Aged 6 to <36 Months With Virus-Confirmed Influenza, Comparison of aTIV and Non-flu Vaccine Control (Men C/TBE Vaccine)

Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in 6 to <36 month unprimed subjects for Absolute Efficacy. This primary endpoint is only for homologous strains.

Analysis was done on Full Analysis Set (FAS) - All subjects in the enrolled set who received study vaccination and provided at least one evaluable serum sample both before and after baseline.

Posted

Number

Percentage of subjects

3 weeks after 2nd vaccination

ID	Title	Description
OG000	TIV-adj (6 to <36 Months)	Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
OG001	Non-flu Control (6 to <36 Months)	Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine

Units	Counts
Participants

Secondary

Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination

Safety was assessed as the number of subjects aged 6 to <72 months who reported solicited local or systemic adverse events after any vaccination with TIV-adj for all seasons.

The analysis was done on Safety set

Posted

Number

Number of subjects

7 days post-vaccination

ID	Title	Description
OG000	TIV-adj (6 to <36 Months)	Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
OG001	TIV-adj (36 to <72 Months)	Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
OG002	Flu-control (6 to <36 Months)	Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
OG003	Flu-control (36 to <72 Months)

Secondary

Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination

Number of subjects aged 6 to <36 months and in the overall age cohort (unprimed children aged 6 to <72 months) experiencing each of the unsolicited adverse events (AEs) throughout the study

The analysis was done on Safety set

Posted

Number

Number of subjects

Study day 1 to Study day 181

ID	Title	Description
OG000	TIV-adj (6 to <36 Months)	Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
OG001	Flu-control (6 to <36 Months)	Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
OG002	Non-Flu-control (6 to <36 Months)	Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
OG003	TIV-adj (6 to <72 Months )

Secondary

Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu-vaccine Control (Matched Strains)

Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in subjects aged 6 to <72 months (unprimed) for Absolute Efficacy.

For Relative efficacy, the comparison was made between adjuvanted influenza vaccine (TIV-adj) and flu vaccine control.

The analysis was done on Full Analysis Set

Posted

Number

Percentage of subjects

3 weeks after 2nd vaccination

ID	Title	Description
OG000	TIV-adj (6 to < 36 Months)	Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
OG001	Non-flu Control (6 to <36 Months)	Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
OG002	Flu Control (6 to < 36 Months)	Subjects aged 6 to < 36 months received 0.25 mL of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine

Secondary

Percentage of Subjects (Unprimed) Aged 6 to <72 Months With Virus-Confirmed Influenza, Comparison of aTIV to Non-flu Vaccine Control and Flu Vaccine Control (Any Strains).

Virus-confirmed influenza illnesses (regardless of antigenic match to those contained in the vaccine) were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in subjects aged 6 to <72 months (unprimed) for Absolute Efficacy.

For Relative efficacy, the comparison was made between adjuvanted influenza vaccine (TIV-adj) and flu vaccine control.

Analysis was done on Full Analysis Set

Posted

Number

Percentage of subjects

3 weeks after 2nd vaccination

ID	Title	Description
OG000	TIV-adj (6 to < 36 Months)	Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
OG001	Non-flu Control (6 to < 36 Months)	Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
OG002	Flu Control (6 to < 36 Months)	Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine

Secondary

Number of Subjects (Unprimed) With Influenza Like Illnesses (ILIs) in the 6 to <72 Months Age Cohort for Combined Seasons 2007/08 and 2008/09

Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine in 6 to <72 month old subjects for Influenza like illnesses for seasons 2007/08 and 2008/09.

Analysis was done on Full Analysis Set

Posted

Number

Number of subjects

3 weeks after 2nd vaccination

ID	Title	Description
OG000	TIV-adj	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
OG001	Flu-control	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
OG002	Non-flu Control	Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine

Secondary

Number of Subjects With Influenza Like Illnesses (ILIs) in the 6 to <36 Months and in Overall Age Cohort (Unprimed Subjects Aged 6 to <72 Months) for Combined Seasons 2007/08 and 2008/09

Virus-confirmed influenza illnesses were assessed and trivalent adjuvanted influenza vaccine (TIV-adj) was compared with Non-flu control vaccine and Flu-control vaccine for Influenza like illnesses for seasons 2007/08 and 2008/09.

Analysis was done on Full Analysis Set

Posted

Number

Number of subjects

3 weeks after 2nd vaccination

ID	Title	Description
OG000	TIV-adj (6 to < 36 Months)	Subjects aged 6 to <36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
OG001	Non-flu Control (6 to < 36 Months)	Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
OG002	Flu-control (6 to < 36 Months)	Subjects aged 6 to <36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine

Secondary

Loss of Days of Usual Activity (Job, School, Day Care, Household/Family/Community Activities) Due to Influenza Like Illness (ILI) in Subjects in Aged 6 to <72 and 6 to <36 Months and in Direct Caregivers Living in the Household.

The analysis was done on Full Analysis Set

Posted

Mean

Standard Deviation

Days

3 weeks after 2nd vaccination

ID	Title	Description
OG000	TIV-adj	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
OG001	Non-flu Control	Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
OG002	Flu-control	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine

Secondary

Number of Events of Influenza Like Illness for Combined Seasons 2007/08 and 2008/09.

The number of events of Influenza like Illness reported by subjects aged 6 to <72 months was assessed for combined seasons 2007/08 and 2008/09

The analysis was done on Full Analysis Set

Posted

Mean

Standard Deviation

Events

3 weeks after 2nd vaccination

ID	Title	Description
OG000	TIV-adj	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
OG001	Non-flu Control	Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
OG002	Flu-control	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine

Secondary

Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <36 Months or Season 2008/09 (Homologous and Heterologous Strains)

The immunogenicity was assessed in terms of Geometric mean titer ratios (GMRs) of study day 29/study day 1, study day 50/study day 1, study day 181/study day 1 were evaluated.

The criteria for evaluation is GMR >2.5

The analysis was done on Full Analysis Set

Posted

Geometric Mean

95% Confidence Interval

Ratios

On study days 1, 29, 50 and 181

ID	Title	Description
OG000	TIV-adj	Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
OG001	Flu-control	Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
OG002	Non-flu-control	Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine

Secondary

Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of Geometric Mean Titers (GMTs), in Unprimed Subjects Aged 6 to <36 Months for Season 2008/09 (Homologous and Heterologous Strains)

Superiority analysis: GMT-TIV-adj/GMT-Flu-control >1 should be elicited to show that GMT-TIV-adj is superior to GMT-Flu-control

The analysis was done on Full Analysis Set

Posted

Geometric Mean

95% Confidence Interval

Titers

On study days 1, 29, 50 and 181

ID	Title	Description
OG000	TIV-adj	Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
OG001	Flu-control	Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
OG002	Non-flu-control	Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine

Secondary

Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With HI Titer ≥1:40 in Season 2008/09 HI Assay(Homologous and Heterologous Strains)

Percentage of subjects achieving seroprotection (i.e., with HI titer ≥1:40) at study day 1, study day 29, study day 50 and a study day 181 and associated 95% CI. The lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%.

The analysis was done on Full Analysis Set

Posted

Number

95% Confidence Interval

Percentage of subjects

On study days 1, 29, 50, 181

ID	Title	Description
OG000	TIV-adj	Subjects aged 6 to < 36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
OG001	Flu-control	Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
OG002	Non-flu-control	Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine

Secondary

Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains)

HI assay was used for the analysis. Seroconversion is defined as negative pre-vaccination serum (<10)/ post-vaccination HI titer ≥1:40.

Seroconversion is defined as either pre-vaccination HI titer <10 and a post-vaccination HI titer ≥1:40 or a prevaccination HI titer ≥10 and a minimum four-fold rise in post-vaccination HI antibody titer.

The lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%.

The analysis was done on Full Analysis Set

Posted

Number

95% Confidence Interval

Percentage of subjects

On study days 1, 29, 50, 181

ID	Title	Description
OG000	TIV-adj	Subjects aged 6 to < 36 months received 0.25 mL of each injection of Adjuvanted trivalent inactivated subunit influenza vaccine
OG001	Flu-control	Subjects aged 6 to < 36 months received 0.25 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
OG002	Non-flu-control

Secondary

Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMTs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)

Immunogenicity was analyzed in terms of Geometric Mean Titers (GMTs) as measured by hemagglutination inhibition (HI) assay. For each strain and each vaccine group, least squares GMTs, associated 2-sided 95% confidence interval were determined for all time points Superiority analysis: GMT-TIV-adj/GMT-Flu-control >1 and GMT-TIV-adj/GMT-Non Flu-control >1 should be elicited to show that GMT-TIV-adj is superior to GMT-Flu-control/Non Flu-control.

The analysis was done on Full Analysis Set

Posted

Geometric Mean

95% Confidence Interval

Titers

On study days 1, 29, 50 , 181

ID	Title	Description
OG000	TIV-adj	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
OG001	Flu-control	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
OG002	Non-flu-control

Secondary

Immunogenicity of aTIV, Compared to Flu and Non-Flu-control, in Terms of GMRs, in Unprimed Subjects Aged 6 to <72 Months for Season 2008/09 (Homologous and Heterologous Strains)

Hemagglutination Inhibition (HI) assay was used for the analysis. Geometric mean titer ratios (GMRs) of study day 29/study day 1, study day 50/study day 1, study day 181/study day 1 were evaluated.

The criteria for evaluation is GMR >2.5

The analysis was done on Full Analysis Set

Posted

Geometric Mean

95% Confidence Interval

Ratios

On study days 1, 29, 50, 181

ID	Title	Description
OG000	TIV-adj	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
OG001	Flu-control	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
OG002	Non-flu-control	Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine

Secondary

Percentages of Subjects With HI Titers ≥ 1:40 in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 Homologous and Heterologous Strains

Hemagglutination Inhibition (HI) assay was used for the analysis.

Percentage of subjects achieving seroprotection (i.e., with HI titer ≥1:40) at study day 1, study day 29, study day 50 and a study day 181 and associated 95% Confidence Intervals. The lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70%.

The analysis was done on Full Analysis Set

Posted

Number

95% Confidence Interval

Percentage of subjects

On study days 1, 29, 50, 181

ID	Title	Description
OG000	TIV-adj	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
OG001	Flu-control	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
OG002	Non-flu-control	Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine

Secondary

Percentages of Subjects With Seroconversion and Vaccine Group Differences in Unprimed Subjects 6 to <72 Months of Age for Season 2008/09 (Homologous and Heterologous Strains)

HI assay was used for the analysis. Seroconversion is defined as negative pre-vaccination serum (<10)/ post-vaccination HI titer ≥1:40.

Seroconversion is defined as either pre-vaccination HI titer <10 and a post-vaccination HI titer ≥1:40 or a prevaccination HI titer ≥10 and a minimum 4-fold rise in post-vaccination HI antibody titer. The lower bound of the two-sided 95% confidence interval (CI) for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40%.

The analysis was done on Full Analysis Set

Posted

Number

95% Confidence Interval

Percentage of subjects

On study days 1, 29, 50, 181

ID	Title	Description
OG000	TIV-adj	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
OG001	Flu-control	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
OG002	Non-flu-control

Secondary

Number of Subjects With Local and Systemic Reactions for Egg and Cell Derived Inactivated Novel Swine Origin A/H1N1 Subunit Influenza Vaccines After Each Vaccination for All Seasons

Adequate data was not available to conduct this analysis.

Posted

7 days post-vaccination

ID	Title	Description
OG000	TIV-adj	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
OG001	Flu-control	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
OG002	Non-flu Control	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Novartis meningococcal C conjugate vaccine or tick-borne encephalitis vaccine

Units	Counts

Secondary

Indirect Protective Effect of Fluad (NH Composition 2007/2008), Compared to Non-flu Control and Flu Control, in Connection to Household-contact Persons Via a Questioning of the Parents About ILI of Persons Living in the Same Household as the Study Child

As per an amendment to the protocol, the Secondary efficacy endpoints were evaluated in enrolled subjects only and the household members were not included in the trial for the evaluation of indirect vaccine efficacy.

Posted

3 weeks after 2nd vaccination

ID	Title	Description
OG000	TIV-adj	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
OG001	Non-flu Control	Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
OG002	Flu-Control	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine

Secondary

Incidence Rate of the 2009-2010 H1N1 Swine Pandemic Caused by a Novel Influenza A (H1N1) Virus of Swine Origin in Unprimed Children Aged 6 to <36 and 6 to <72 Months

Adequate data was not available for assessing the incidence rates of the 2009-2010 swine pandemic caused by a novel influenza A (H1N1) virus of swine origin.

Posted

3 weeks after 2nd vaccination

ID	Title	Description
OG000	TIV-adj	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine
OG001	Non-flu Control	Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine
OG002	Flu-Control	Subjects aged 6 to < 36 months received 0.25 mL and those aged 36 to <72 months received 0.5 mL of each injection of

Units	Counts

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	TIV-adj_0.25	Subjects aged 6 to < 36 months received 0.25 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine	91	1,177	1,101	1,177
EG001	TIV-adj_0.5	Subjects aged 36 to < 72 months received 0.5 mL of each injection of adjuvanted trivalent inactivated subunit influenza vaccine	31	835	769	835
EG002	Flu-control_0.25	Subjects aged 6 to < 36 months received 0.25 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine	104	1,069	989	1,069
EG003	Flu-control_0.5	Subjects aged 36 to < 72 months received 0.5 mL of each injection of non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine	65	777	686	777
EG004	Non-Flu-control (TBE/Men C Vaccine)	Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine	65	607	567	607
EG005	Non-Flu-control (TBE Vaccine)	Subjects aged 6 to <12 months received 2 doses of 0.5 mL of Novartis Meningococcal C conjugate vaccine and subjects aged 12 to <72 months received 2 doses of 0.25 mL of TBE vaccine	45	422	375	422

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenitis	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG0031 affected777 at risk EG0040 affected607 at risk EG0050 affected422 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Cyanosis	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Hydrocele	Congenital, familial and genetic disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0011 affected835 at risk EG0020 affected1,069 at risk EG003
Autoimmune thyroiditis	Endocrine disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0011 affected835 at risk EG0020 affected1,069 at risk EG003
Aphthous stomatitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Stomatitis	Gastrointestinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0023 affected1,069 at risk EG003
Developmental delay	General disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Gait disturbance	General disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Pyrexia	General disorders	MedDRA	Non-systematic Assessment	EG0002 affected1,177 at risk EG0011 affected835 at risk EG0021 affected1,069 at risk EG003
Allergy to arthropod bite	Immune system disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Appendicitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Arthropod infestation	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0011 affected835 at risk EG0020 affected1,069 at risk EG003
Bronchiolitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Bronchitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0008 affected1,177 at risk EG0013 affected835 at risk EG0027 affected1,069 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0011 affected835 at risk EG0022 affected1,069 at risk EG003
Campylobacter infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Exanthema subitum	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Febrile infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG00014 affected1,177 at risk EG0011 affected835 at risk EG00213 affected1,069 at risk EG003
Gastroenteritis rotavirus	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0011 affected835 at risk EG0025 affected1,069 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
H1N1 influenza	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Hand-foot and mouth disease	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Influenza	Infections and infestations	MedDRA	Non-systematic Assessment	EG00012 affected1,177 at risk EG0018 affected835 at risk EG00239 affected1,069 at risk EG003
Laryngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0011 affected835 at risk EG0022 affected1,069 at risk EG003
Lymphangitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Oral herpes	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Otitis media	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Peritonsillar abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Pharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Pharyngotonsillitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Pneumococcal infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Pneumococcal sepsis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Pneumonia	Infections and infestations	MedDRA	Non-systematic Assessment	EG0005 affected1,177 at risk EG0012 affected835 at risk EG0025 affected1,069 at risk EG003
Pneumonia viral	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Pseudocroup	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0022 affected1,069 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Respiratory syncytial virus infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0004 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected1,177 at risk EG0011 affected835 at risk EG0020 affected1,069 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0002 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Tonsillitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0022 affected1,069 at risk EG003
Tooth abscess	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Tracheitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0022 affected1,069 at risk EG003
Viral infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Accidental exposure to product	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0002 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0006 affected1,177 at risk EG0012 affected835 at risk EG0021 affected1,069 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0002 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Electric shock	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0011 affected835 at risk EG0020 affected1,069 at risk EG003
Perineal Injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0011 affected835 at risk EG0020 affected1,069 at risk EG003
Poisoning	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0011 affected835 at risk EG0021 affected1,069 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Skull fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Skull fractured base	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
spinal cord injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Vaccination failure	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Paracentesis	Investigations	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Acetonaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0012 affected835 at risk EG0021 affected1,069 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Feeding disorder of Infancy or Early childhood	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Fistula	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Ataxia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Convulsion	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0011 affected835 at risk EG0021 affected1,069 at risk EG003
Febrile convulsion	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0002 affected1,177 at risk EG0011 affected835 at risk EG0024 affected1,069 at risk EG003
Petit mal epilepsy	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Attention deficit / Hyperactivity disorder	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Dysphemia	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Scrotal oedema	Reproductive system and breast disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0002 affected1,177 at risk EG0010 affected835 at risk EG0022 affected1,069 at risk EG003
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0011 affected835 at risk EG0020 affected1,069 at risk EG003
Tonsillar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Erythema multiforme	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Henoch-schonlein purpura	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Child abuse	Social circumstances	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Adenoidectomy	Surgical and medical procedures	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0011 affected835 at risk EG0020 affected1,069 at risk EG003
Brain tumour operation	Surgical and medical procedures	MedDRA	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Patent ductus arteriosus repair	Surgical and medical procedures	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Toe amputation	Surgical and medical procedures	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0011 affected835 at risk EG0020 affected1,069 at risk EG003
Tonsillectomy	Surgical and medical procedures	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0011 affected835 at risk EG0020 affected1,069 at risk EG003
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Abnormal behaviour	Psychiatric disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Colonoscopy	Investigations	MedDRA 17.1	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Foreign body	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Brain contusion	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0000 affected1,177 at risk EG0011 affected835 at risk EG0020 affected1,069 at risk EG003
Accidental poisoning	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Skin infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected1,177 at risk EG0011 affected835 at risk EG0020 affected1,069 at risk EG003
Rotavirus infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Lice infestation	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Gastroenteritis norovirus	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Cellulitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Malabsorption	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0021 affected1,069 at risk EG003
Epilepsy	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0000 affected1,177 at risk EG0011 affected835 at risk EG0020 affected1,069 at risk EG003
Adenoidal hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0011 affected835 at risk EG0020 affected1,069 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Exposure via ingestion	Injury, poisoning and procedural complications	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Encephalitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003
Acquired epileptic aphasia	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG0010 affected835 at risk EG0020 affected1,069 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Conjunctivitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG000164 affected1,177 at risk EG00183 affected835 at risk EG002156 affected1,069 at risk EG00365 affected777 at risk EG00491 affected607 at risk EG00545 affected422 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG000309 affected1,177 at risk EG00145 affected835 at risk EG002260 affected1,069 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG000188 affected1,177 at risk EG00164 affected835 at risk EG002166 affected1,069 at risk EG003
Chills	General disorders	MedDRA	Systematic Assessment	EG00077 affected1,177 at risk EG001131 affected835 at risk EG00269 affected1,069 at risk EG003
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0001 affected1,177 at risk EG001338 affected835 at risk EG0022 affected1,069 at risk EG003
Injection site erythema	General disorders	MedDRA	Systematic Assessment	EG000423 affected1,177 at risk EG001321 affected835 at risk EG002325 affected1,069 at risk EG003
Injection site haemorrhage	General disorders	MedDRA	Non-systematic Assessment	EG000146 affected1,177 at risk EG001131 affected835 at risk EG002107 affected1,069 at risk EG003
Injection site induration	General disorders	MedDRA	Systematic Assessment	EG000214 affected1,177 at risk EG001169 affected835 at risk EG002131 affected1,069 at risk EG003
Injection site pain	General disorders	MedDRA	Systematic Assessment	EG000334 affected1,177 at risk EG001478 affected835 at risk EG002250 affected1,069 at risk EG003
Injection site swelling	General disorders	MedDRA	Systematic Assessment	EG000123 affected1,177 at risk EG001156 affected835 at risk EG00290 affected1,069 at risk EG003
Malaise	General disorders	MedDRA	Systematic Assessment	EG0000 affected1,177 at risk EG001196 affected835 at risk EG0021 affected1,069 at risk EG003
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG000482 affected1,177 at risk EG001299 affected835 at risk EG002412 affected1,069 at risk EG003
Bronchitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG000169 affected1,177 at risk EG00168 affected835 at risk EG002153 affected1,069 at risk EG003
Ear infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG000131 affected1,177 at risk EG00157 affected835 at risk EG002132 affected1,069 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA	Non-systematic Assessment	EG000178 affected1,177 at risk EG00175 affected835 at risk EG002152 affected1,069 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG000153 affected1,177 at risk EG00178 affected835 at risk EG002161 affected1,069 at risk EG003
Otitis media	Infections and infestations	MedDRA	Non-systematic Assessment	EG000250 affected1,177 at risk EG001109 affected835 at risk EG002226 affected1,069 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG00076 affected1,177 at risk EG00129 affected835 at risk EG00262 affected1,069 at risk EG003
Rhinitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG000260 affected1,177 at risk EG001122 affected835 at risk EG002219 affected1,069 at risk EG003
Tonsillitis	Infections and infestations	MedDRA	Non-systematic Assessment	EG00064 affected1,177 at risk EG00138 affected835 at risk EG00242 affected1,069 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA	Non-systematic Assessment	EG000362 affected1,177 at risk EG001170 affected835 at risk EG002306 affected1,069 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Non-systematic Assessment	EG0000 affected1,177 at risk EG001183 affected835 at risk EG0020 affected1,069 at risk EG003
Crying	General disorders	MedDRA	Non-systematic Assessment	EG000373 affected1,177 at risk EG0015 affected835 at risk EG002325 affected1,069 at risk EG003
Headache	Nervous system disorders	MedDRA	Non-systematic Assessment	EG0006 affected1,177 at risk EG001201 affected835 at risk EG0026 affected1,069 at risk EG003
Somnolence	Nervous system disorders	MedDRA	Non-systematic Assessment	EG000381 affected1,177 at risk EG0011 affected835 at risk EG002315 affected1,069 at risk EG003
Eating disorder	Psychiatric disorders	MedDRA	Non-systematic Assessment	EG000327 affected1,177 at risk EG0013 affected835 at risk EG002263 affected1,069 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Non-systematic Assessment	EG000246 affected1,177 at risk EG001176 affected835 at risk EG002210 affected1,069 at risk EG003
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG00076 affected1,177 at risk EG0014 affected835 at risk EG00262 affected1,069 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected1,177 at risk EG00169 affected835 at risk EG0021 affected1,069 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 affected1,177 at risk EG00185 affected835 at risk EG0021 affected1,069 at risk EG003
Viral infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG00063 affected1,177 at risk EG00135 affected835 at risk EG00260 affected1,069 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG00054 affected1,177 at risk EG00123 affected835 at risk EG00260 affected1,069 at risk EG003

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

ID	Term
C478243	fluad vaccine
C410218	serogroup C meningococcal conjugate vaccine