Influenza, Human
Conditions
Keywords
Influenza, vaccine, children
Brief summary
This study will evaluate the efficacy, safety and immunogenicity of one or two 0.25 mL or 0.5 mL intramuscular injections of an adjuvanted influenza vaccine compared with non-influenza and non-adjuvanted influenza control vaccines in subjects 6 to \<72 months of age.
Interventions
BIOLOGICALAdjuvanted trivalent inactivated subunit influenza vaccine
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.
BIOLOGICALNon-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
For both vaccines, 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.
BIOLOGICALMeningococcal C conjugate vaccine or tick-borne encephalitis vaccine
1. Meningococcal vaccine: two IM injections 2. Tick-borne encephalitis vaccine: two IM injections
Sponsors
Novartis Vaccines
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Months to 71 Months
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 7 days post-vaccination | 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. |
| 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) | 3 weeks after 2nd vaccination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 3 weeks after 2nd vaccination | 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. |
| 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). | 3 weeks after 2nd vaccination | 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. |
| 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 | 3 weeks after 2nd vaccination | 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. |
| 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 | 3 weeks after 2nd vaccination | 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. |
| 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. | 3 weeks after 2nd vaccination | 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. |
| Number of Events of Influenza Like Illness for Combined Seasons 2007/08 and 2008/09. | 3 weeks after 2nd vaccination | 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 |
| 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) | On study days 1, 29, 50 and 181 | 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 |
| 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) | On study days 1, 29, 50 and 181 | 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 should be elicited to show that GMT-TIV-adj is superior to GMT-Flu-control |
| Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | 7 days post-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. |
| Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | On study days 1, 29, 50, 181 | 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%. |
| 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) | On study days 1, 29, 50 , 181 | 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. |
| 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) | On study days 1, 29, 50, 181 | 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 |
| 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 | On study days 1, 29, 50, 181 | 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%. |
| 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) | On study days 1, 29, 50, 181 | 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%. |
| 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 | 7 days post-vaccination | — |
| 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 | 3 weeks after 2nd vaccination | — |
| 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 | 3 weeks after 2nd vaccination | — |
| 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) | On study days 1, 29, 50, 181 | 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%. |
| Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | Study day 1 to Study day 181 | 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 |
Countries
Finland, Germany, Italy
Participant flow
Recruitment details
Participants were enrolled as follows: In season 2007/08: 28 active sites in Germany (Excluding Site 023); In season 2008/09: 83 active sites+ 1 coordinating site in Germany, 15 sites in Finland; In season 2009/10: 15 sites in Finland, 2 sites in Italy
Pre-assignment details
All subjects enrolled were included in the trial. The data entered is for the overall study.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 2,019 |
| 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 | 1,849 |
| 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 | 1,034 |
| Total | 4,902 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 8 | 5 | 1 |
| Overall Study | Inappropriate Enrollment | 1 | 3 | 0 |
| Overall Study | Lost to Follow-up | 37 | 34 | 16 |
| Overall Study | Protocol Deviation/violation | 20 | 19 | 15 |
| Overall Study | Unable to classify | 6 | 2 | 3 |
| Overall Study | Withdrawal by Subject | 52 | 60 | 30 |
Baseline characteristics
| Characteristic | TIV-adj | Flu-control | Non-flu Control | Total |
|---|---|---|---|---|
| Age, Continuous | 31.9 Months STANDARD_DEVIATION 19.8 | 32.6 Months STANDARD_DEVIATION 20.1 | 32.2 Months STANDARD_DEVIATION 19.8 | 32.2 Months STANDARD_DEVIATION 19.9 |
| Sex: Female, Male Female | 962 Participants | 903 Participants | 484 Participants | 2349 Participants |
| Sex: Female, Male Male | 1057 Participants | 946 Participants | 550 Participants | 2553 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1,101 / 1,177 | 769 / 835 | 989 / 1,069 | 686 / 777 | 567 / 607 | 375 / 422 |
| serious Total, serious adverse events | 91 / 1,177 | 31 / 835 | 104 / 1,069 | 65 / 777 | 65 / 607 | 45 / 422 |
Outcome results
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.
Time frame: 7 days post-vaccination
Population: The analysis was done on Safety set - All subjects in the exposed population who provided post-baseline safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIV-adj (6 to <36 Months) | 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. | Injection Site Ecchymosis | 147 Number of subjects |
| TIV-adj (6 to <36 Months) | 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. | Unusual crying | 386 Number of subjects |
| TIV-adj (6 to <36 Months) | 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. | Swelling | 123 Number of subjects |
| TIV-adj (6 to <36 Months) | 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. | Irritability | 387 Number of subjects |
| TIV-adj (6 to <36 Months) | 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. | Any Local | 625 Number of subjects |
| TIV-adj (6 to <36 Months) | 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. | Vomiting | 131 Number of subjects |
| TIV-adj (6 to <36 Months) | 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. | Tender. at inj.site | 330 Number of subjects |
| TIV-adj (6 to <36 Months) | 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. | Diarrhea | 258 Number of subjects |
| TIV-adj (6 to <36 Months) | 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. | Injection Site Erythema | 423 Number of subjects |
| TIV-adj (6 to <36 Months) | 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. | Shivering | 77 Number of subjects |
| TIV-adj (6 to <36 Months) | 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. | Any Systemic | 785 Number of subjects |
| TIV-adj (6 to <36 Months) | 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. | Any Other | 358 Number of subjects |
| TIV-adj (6 to <36 Months) | 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. | Fever (39-39.9°C) (N=1177,1068) | 61 Number of subjects |
| TIV-adj (6 to <36 Months) | 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. | Fever (38-38.9°C) (N=1177,1068) | 169 Number of subjects |
| TIV-adj (6 to <36 Months) | 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. | Change in eat. hab. | 325 Number of subjects |
| TIV-adj (6 to <36 Months) | 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. | Fever (>40.0°C) (N=1177,1068) | 3 Number of subjects |
| TIV-adj (6 to <36 Months) | 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. | Injection Site Induration | 214 Number of subjects |
| TIV-adj (6 to <36 Months) | 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. | Analg.Antipyr.Used (N=1176,1068) | 358 Number of subjects |
| TIV-adj (6 to <36 Months) | 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. | Sleepiness | 380 Number of subjects |
| Flu-control (6 to <36 Months) | 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. | Analg.Antipyr.Used (N=1176,1068) | 317 Number of subjects |
| Flu-control (6 to <36 Months) | 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. | Any Local | 481 Number of subjects |
| Flu-control (6 to <36 Months) | 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. | Injection Site Ecchymosis | 103 Number of subjects |
| Flu-control (6 to <36 Months) | 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. | Injection Site Erythema | 322 Number of subjects |
| Flu-control (6 to <36 Months) | 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. | Injection Site Induration | 131 Number of subjects |
| Flu-control (6 to <36 Months) | 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. | Swelling | 89 Number of subjects |
| Flu-control (6 to <36 Months) | 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. | Tender. at inj.site | 246 Number of subjects |
| Flu-control (6 to <36 Months) | 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. | Any Systemic | 694 Number of subjects |
| Flu-control (6 to <36 Months) | 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. | Change in eat. hab. | 261 Number of subjects |
| Flu-control (6 to <36 Months) | 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. | Sleepiness | 312 Number of subjects |
| Flu-control (6 to <36 Months) | 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. | Unusual crying | 345 Number of subjects |
| Flu-control (6 to <36 Months) | 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. | Irritability | 353 Number of subjects |
| Flu-control (6 to <36 Months) | 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. | Vomiting | 118 Number of subjects |
| Flu-control (6 to <36 Months) | 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. | Diarrhea | 211 Number of subjects |
| Flu-control (6 to <36 Months) | 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. | Shivering | 69 Number of subjects |
| Flu-control (6 to <36 Months) | 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. | Any Other | 317 Number of subjects |
| Flu-control (6 to <36 Months) | 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. | Fever (39-39.9°C) (N=1177,1068) | 43 Number of subjects |
| Flu-control (6 to <36 Months) | 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. | Fever (>40.0°C) (N=1177,1068) | 3 Number of subjects |
| Flu-control (6 to <36 Months) | 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. | Fever (38-38.9°C) (N=1177,1068) | 143 Number of subjects |
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.
Time frame: 3 weeks after 2nd vaccination
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIV-adj (6 to <36 Months) | 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) | Season 2007/2008, Matched strain,N=187,97 | 0 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Season 2008/2009, Matched strain | 0.76 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Season 2008/2009, Matched strain | 4.05 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Season 2007/2008, Matched strain,N=187,97 | 0 Percentage of subjects |
Comparison: Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the population average incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)97.66% CI: [49.24, 93.16]Poisson Regression Model
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)
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 should be elicited to show that GMT-TIV-adj is superior to GMT-Flu-control
Time frame: On study days 1, 29, 50 and 181
Population: The analysis was done on Full Analysis Set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TIV-adj (6 to <36 Months) | 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) | Day 50 A/Brisbane/2007 (A/H3N2) (N=160,162,78) | 510 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 29 A/Brisbane/2007 (A/H1N1) (N=165,163,82) | 105 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 50 A/Brisbane/2007 (A/H1N1) (N=160,162,78) | 513 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 181 A/Brisbane/2007 (A/H1N1) (N=161,163,80) | 118 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 1 A/Brisbane/2007 (A/H3N2) | 5.85 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 29 A/Brisbane/2007 (A/H3N2) (N=165,163,82) | 90 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 1 A/Brisbane/2007 (A/H1N1) | 6.21 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 181 A/Brisbane/2007 (A/H3N2) (N=161,163,80) | 176 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 1 B/Florida/2006 | 6.01 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 29 B/Florida/2006 (N=165,163,82) | 13 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 50 B/Florida/2006 (N=160,162,78) | 86 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 181 B/Florida/2006 (N=161,163,80) | 25 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 1 A/SolomonIslands/2006(A/H1N1) | 6.66 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 29 A/SolomonIslands/2006(A/H1N1)(N=165,163,82) | 14 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 50 A/SolomonIslands/2006(A/H1N1)(N=160,162,78) | 122 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day181 A/SolomonIslands/2006(A/H1N1)(N=161,163,80) | 44 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 1 A/Wisconsin/2009 (A/H3N2) | 6.09 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 29 A/Wisconsin/2009 (A/H3N2)(N=165,163,82) | 28 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 50 A/Wisconsin/2009 (A/H3N2)(N=160,162,78) | 261 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day181 A/Wisconsin/2009 (A/H3N2)(N=161,163,80) | 123 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 1 B/Brisbane/2008 (N=165,165,83) | 5 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 29 B/Brisbane/2008 (N=165,163,82) | 5.38 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 50 B/Brisbane/2008 (N=160,162,78) | 9.64 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day181 B/Brisbane/2008 (N=161,163,80) | 5.21 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 29 B/Brisbane/2008 (N=165,163,82) | 5.08 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 A/Brisbane/2007 (A/H1N1) | 7.52 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 A/SolomonIslands/2006(A/H1N1) | 8.19 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 A/Wisconsin/2009 (A/H3N2) | 6.74 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 29 A/Brisbane/2007 (A/H1N1) (N=165,163,82) | 14 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 50 B/Florida/2006 (N=160,162,78) | 12 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 B/Brisbane/2008 (N=165,165,83) | 5 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 50 A/Brisbane/2007 (A/H1N1) (N=160,162,78) | 35 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 29 A/SolomonIslands/2006(A/H1N1)(N=165,163,82) | 12 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 50 B/Brisbane/2008 (N=160,162,78) | 5.55 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 181 A/Brisbane/2007 (A/H1N1) (N=161,163,80) | 18 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 29 B/Florida/2006 (N=165,163,82) | 8.45 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 29 A/Wisconsin/2009 (A/H3N2)(N=165,163,82) | 7.86 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 A/Brisbane/2007 (A/H3N2) | 5.8 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 50 A/SolomonIslands/2006(A/H1N1)(N=160,162,78) | 16 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 181 B/Florida/2006 (N=161,163,80) | 8.72 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 29 A/Brisbane/2007 (A/H3N2) (N=165,163,82) | 9.17 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 B/Florida/2006 | 6 Titers |
| Flu-control (6 to <36 Months) | 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) | Day181 B/Brisbane/2008 (N=161,163,80) | 5.23 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 50 A/Brisbane/2007 (A/H3N2) (N=160,162,78) | 32 Titers |
| Flu-control (6 to <36 Months) | 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) | Day181 A/SolomonIslands/2006(A/H1N1)(N=161,163,80) | 13 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 50 A/Wisconsin/2009 (A/H3N2)(N=160,162,78) | 20 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 181 A/Brisbane/2007 (A/H3N2) (N=161,163,80) | 36 Titers |
| Flu-control (6 to <36 Months) | 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) | Day181 A/Wisconsin/2009 (A/H3N2)(N=161,163,80) | 34 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 181 A/Brisbane/2007 (A/H3N2) (N=161,163,80) | 12 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 B/Florida/2006 | 5.87 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 29 B/Florida/2006 (N=165,163,82) | 6.19 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 50 B/Florida/2006 (N=160,162,78) | 6.09 Titers |
| Flu-control (6 to <36 Months) | 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) | Day181 A/Wisconsin/2009 (A/H3N2)(N=161,163,80) | 14 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 181 B/Florida/2006 (N=161,163,80) | 6.21 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 50 B/Brisbane/2008 (N=160,162,78) | 5.12 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 A/SolomonIslands/2006(A/H1N1) | 6.24 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 29 A/SolomonIslands/2006(A/H1N1)(N=165,163,82) | 6.08 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 B/Brisbane/2008 (N=165,165,83) | 5 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 50 A/SolomonIslands/2006(A/H1N1)(N=160,162,78) | 6.1 Titers |
| Flu-control (6 to <36 Months) | 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) | Day181 B/Brisbane/2008 (N=161,163,80) | 6.28 Titers |
| Flu-control (6 to <36 Months) | 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) | Day181 A/SolomonIslands/2006(A/H1N1)(N=161,163,80) | 6.2 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 A/Brisbane/2007 (A/H1N1) | 5.93 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 29 A/Brisbane/2007 (A/H1N1) (N=165,163,82) | 6.13 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 A/Wisconsin/2009 (A/H3N2) | 6.16 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 50 A/Brisbane/2007 (A/H1N1) (N=160,162,78) | 6.57 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 29 B/Brisbane/2008 (N=165,163,82) | 5 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 181 A/Brisbane/2007 (A/H1N1) (N=161,163,80) | 6.1 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 A/Brisbane/2007 (A/H3N2) | 5.66 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 29 A/Wisconsin/2009 (A/H3N2)(N=165,163,82) | 5.87 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 29 A/Brisbane/2007 (A/H3N2) (N=165,163,82) | 6.04 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 50 A/Brisbane/2007 (A/H3N2) (N=160,162,78) | 6 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 50 A/Wisconsin/2009 (A/H3N2)(N=160,162,78) | 6.47 Titers |
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [0.67, 1.02]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [5.42, 11]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay95% CI: [11, 21]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay95% CI: [4.83, 8.68]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [0.85, 1.21]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [7.76, 12]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [12, 20]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [3.64, 6.65]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [0.91, 1.1]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [1.19, 1.9]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [5.72, 8.53]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [2.44, 3.5]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [0.64, 1.04]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [0.83, 1.78]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [5.33, 11]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [2.4, 4.55]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [0.74, 1.1]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [2.78, 4.51]GMT
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [10, 16]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [2.61, 4.95]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [1, 1]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [1.02, 1.11]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [1.57, 1.92]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<36 months by HI assay.95% CI: [0.92, 1.08]ANOVA
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
Time frame: On study days 1, 29, 50 and 181
Population: The analysis was done on Full Analysis Set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TIV-adj (6 to <36 Months) | 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) | Day 50:1 A/Brisbane/2007 (A/H3N2) (N=160,162,78) | 86 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 50:1 A/Brisbane/2007 (A/H1N1) (N=160,162,78) | 83 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 181:1 A/Brisbane/2007 (A/H1N1) (N=161,163,80) | 19 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 29:1 A/Brisbane/2007 (A/H3N2) (N=165,163,82) | 15 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 29:1 A/Brisbane/2007 (A/H1N1) (N=165,163,82) | 17 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 181:1 A/Brisbane/2007 (A/H3N1) (N=161,163,80) | 30 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 29:1 B/Florida/2006 (N=165,163,82) | 2.11 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 50:1 B/Florida/2006 (N=160,162,78) | 14 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 181:1 B/Florida/2006 (N=161,163,80) | 4.22 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 29:1A/SolomonIsland/2006(A/H1N1)(N=165,163,82) | 2.1 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 50:1A/SolomonIsland/2006(A/H1N1)(N=160,162,78) | 18 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day181:1A/SolomonIsland/2006(A/H1N1)(N=161,163,80) | 6.52 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 29:1 A/Wisconsin/2009 (A/H3N2)(N=165,163,82) | 4.56 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 50:1 A/Wisconsin/2009 (A/H3N2)(N=160,162,78) | 43 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day181:1 A/Wisconsin/2009 (A/H3N2)(N=161,163,80) | 20 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 29:1 B/Brisbane/2008 (N=164,163,82) | 1.08 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 50:1 B/Brisbane/2008 (N=159,162,78) | 1.94 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day181:1 B/Brisbane/2008 (N=160,163,80) | 1.04 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day181:1 B/Brisbane/2008 (N=160,163,80) | 1.05 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1 A/Brisbane/2007 (A/H1N1) (N=165,163,82) | 1.83 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1A/SolomonIsland/2006(A/H1N1)(N=165,163,82) | 1.41 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1 A/Wisconsin/2009 (A/H3N2)(N=165,163,82) | 1.17 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1 A/Brisbane/2007 (A/H1N1) (N=160,162,78) | 4.55 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day181:1 A/Wisconsin/2009 (A/H3N2)(N=161,163,80) | 5.06 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1 B/Brisbane/2008 (N=164,163,82) | 1.02 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 181:1 A/Brisbane/2007 (A/H1N1) (N=161,163,80) | 2.4 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1A/SolomonIsland/2006(A/H1N1)(N=160,162,78) | 1.96 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1 B/Brisbane/2008 (N=159,162,78) | 1.11 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1 A/Brisbane/2007 (A/H3N2) (N=165,163,82) | 1.58 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 181:1 B/Florida/2006 (N=161,163,80) | 1.45 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1 A/Wisconsin/2009 (A/H3N2)(N=160,162,78) | 3.01 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1 A/Brisbane/2007 (A/H3N2) (N=160,162,78) | 5.57 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1 B/Florida/2006 (N=160,162,78) | 2.05 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day181:1A/SolomonIsland/2006(A/H1N1)(N=161,163,80) | 1.6 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 181:1 A/Brisbane/2007 (A/H3N1) (N=161,163,80) | 6.16 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1 B/Florida/2006 (N=165,163,82) | 1.41 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 181:1 A/Brisbane/2007 (A/H3N1) (N=161,163,80) | 2.1 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1 B/Florida/2006 (N=165,163,82) | 1.06 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1 B/Florida/2006 (N=160,162,78) | 1.02 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day181:1 A/Wisconsin/2009 (A/H3N2)(N=161,163,80) | 2.22 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 181:1 B/Florida/2006 (N=161,163,80) | 1.05 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day181:1 B/Brisbane/2008 (N=160,163,80) | 1.26 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1A/SolomonIsland/2006(A/H1N1)(N=165,163,82) | 0.97 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1A/SolomonIsland/2006(A/H1N1)(N=160,162,78) | 0.98 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1 B/Brisbane/2008 (N=164,163,82) | 1 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day181:1A/SolomonIsland/2006(A/H1N1)(N=161,163,80) | 0.99 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1 A/Brisbane/2007 (A/H1N1) (N=165,163,82) | 1.03 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1 A/Brisbane/2007 (A/H1N1) (N=160,162,78) | 1.11 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1 A/Wisconsin/2009 (A/H3N2)(N=165,163,82) | 0.95 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 181:1 A/Brisbane/2007 (A/H1N1) (N=161,163,80) | 1.02 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1 A/Brisbane/2007 (A/H3N2) (N=165,163,82) | 1.07 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1 A/Brisbane/2007 (A/H3N2) (N=160,162,78) | 1.04 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1 A/Wisconsin/2009 (A/H3N2)(N=160,162,78) | 1.04 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1 B/Brisbane/2008 (N=159,162,78) | 1.02 Ratios |
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
Time frame: On study days 1, 29, 50, 181
Population: The analysis was done on Full Analysis Set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TIV-adj (6 to <36 Months) | 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) | Day 29:1A/Wisconsin/2009(A/H3N2;N=316,313,156) | 6.59 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 29:1A/Brisbane/2007(A/H3N2;N=316,313,156) | 17 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 50:1A/Wisconsin/2009(A/H3N2;N=310,309,150) | 34 Ratios |
| TIV-adj (6 to <36 Months) | 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) | D50:1A/Brisbane/2007(A/H3N2;N=310,309,150) | 60 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 181:1A/Wisconsin/2009(A/H3N2;N=309,310,151) | 18 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 29:1B/Brisbane/2008(N=315,313,156) | 1.25 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 50:1B/Brisbane/2008(N=309,309,150) | 2.38 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 181:1A/Brisbane/2007(A/H3N2;N=309,310,151) | 24 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 181:1B/Brisbane/2008(N=308,310,151) | 1.21 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 29:1A/Brisbane/2007(A/H1N1;N=316,313,156) | 24 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 29:1B/Florida/2006(N=316,313,156) | 3.32 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 50:1B/Florida/2006(N=310,309,150) | 17 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 50:1A/Brisbane/2007(A/H1N1;N=10,309,150) | 76 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 181:1B/Florida/2006(N=309,310,151) | 5.05 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 29:1A/Sol.Island/2006(A/H1N1;N=316,313,156) | 3.51 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 50:1A/Sol.Island/2006A/H1N1;N=310,309,150) | 20 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 181:1A/Brisbane/2007(A/H1N1;N=309,310,151) | 19 Ratios |
| TIV-adj (6 to <36 Months) | 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) | Day 181:1A/Sol.Island/2006A/H1N1;N=309,310,151) | 7.63 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 181:1A/Sol.Island/2006A/H1N1;N=309,310,151) | 2.41 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1A/Wisconsin/2009(A/H3N2;N=316,313,156) | 2.04 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1A/Sol.Island/2006(A/H1N1;N=316,313,156) | 1.96 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1B/Florida/2006(N=316,313,156) | 2.06 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1A/Wisconsin/2009(A/H3N2;N=310,309,150) | 4.6 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1A/Brisbane/2007(A/H1N1;N=316,313,156) | 3.6 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 181:1A/Brisbane/2007(A/H1N1;N=309,310,151) | 4.31 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 181:1A/Wisconsin/2009(A/H3N2;N=309,310,151) | 6.39 Ratios |
| Flu-control (6 to <36 Months) | 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) | D50:1A/Brisbane/2007(A/H3N2;N=310,309,150) | 8.03 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1A/Brisbane/2007(A/H3N2;N=316,313,156) | 2.73 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1B/Brisbane/2008(N=315,313,156) | 1.1 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1B/Florida/2006(N=310,309,150) | 3.29 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1A/Sol.Island/2006A/H1N1;N=310,309,150) | 3.49 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1B/Brisbane/2008(N=309,309,150) | 1.32 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 181:1B/Florida/2006(N=309,310,151) | 1.92 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1A/Brisbane/2007(A/H1N1;N=10,309,150) | 9 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 181:1B/Brisbane/2008(N=308,310,151) | 1.12 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 181:1A/Brisbane/2007(A/H3N2;N=309,310,151) | 7.96 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 181:1B/Brisbane/2008(N=308,310,151) | 1.21 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 181:1A/Brisbane/2007(A/H1N1;N=309,310,151) | 1.02 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1A/Brisbane/2007(A/H1N1;N=10,309,150) | 1.02 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1A/Brisbane/2007(A/H3N2;N=316,313,156) | 1.03 Ratios |
| Flu-control (6 to <36 Months) | 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) | D50:1A/Brisbane/2007(A/H3N2;N=310,309,150) | 0.98 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 181:1A/Brisbane/2007(A/H3N2;N=309,310,151) | 2.21 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1B/Florida/2006(N=316,313,156) | 1.03 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1B/Florida/2006(N=310,309,150) | 1.03 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 181:1B/Florida/2006(N=309,310,151) | 1.06 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1A/Sol.Island/2006(A/H1N1;N=316,313,156) | 0.99 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1A/Sol.Island/2006A/H1N1;N=310,309,150) | 0.97 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 181:1A/Sol.Island/2006A/H1N1;N=309,310,151) | 1.01 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1A/Wisconsin/2009(A/H3N2;N=316,313,156) | 0.93 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1A/Wisconsin/2009(A/H3N2;N=310,309,150) | 0.98 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 181:1A/Wisconsin/2009(A/H3N2;N=309,310,151) | 2.59 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1B/Brisbane/2008(N=315,313,156) | 1.01 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 50:1B/Brisbane/2008(N=309,309,150) | 1.02 Ratios |
| Flu-control (6 to <36 Months) | 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) | Day 29:1A/Brisbane/2007(A/H1N1;N=316,313,156) | 0.99 Ratios |
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.
Time frame: On study days 1, 29, 50 , 181
Population: The analysis was done on Full Analysis Set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| TIV-adj (6 to <36 Months) | 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) | Day 29 B/Florida/2006 (N=316,313,156) | 21 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 1 A/Wisconsin/2009 (A/H3N2) | 15 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 50 B/Florida/2006 (N=310,309,150) | 109 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 29 B/Brisbane/2008 (N=316,313,156) | 6.31 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 181 B/Florida/2006 (N=309,310,151) | 32 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day1A/Brisbane/2007(A/H3N2) | 12 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 1 B/Brisbane/2008 | 5.05 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 1 A/SolomonIslands/2006(A/H1N1) | 11 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day181 A/Wisconsin/2009 (A/H3N2) (N=309,310,151) | 261 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day181A/SolomonIslands/2006(A/H1N1)(N=309,310,151) | 88 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day29 A/SolomonIslands/2006(A/H1N1)(N=316,313,150) | 40 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day50A/Brisbane/2007(A/H1N1) (N=310,309,150) | 735 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day50 A/SolomonIslands/2006(A/H1N1)(N=310,309,150) | 228 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 29 A/Brisbane/2007 (A/H3N2) (N=316,313,156) | 209 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 50 A/Wisconsin/2009 (A/H3N2) (N=310,309,150) | 518 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 1 A/Brisbane/2007 (A/H1N1) | 9.63 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 50 A/Brisbane/2007 (A/H3N2) (N=310,309,150) | 762 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day29A/Brisbane/2007(A/H1N1) (N=316,313,15 | 232 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 181 A/Brisbane/2007 (A/H3N2) (N=309,310,151) | 295 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 29 A/Wisconsin/2009 (A/H3N2) (N=316,313,156) | 98 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day181 B/Brisbane/2008 (N=309,310,151) | 6.12 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 1 B/Florida/2006 | 6.37 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day181A/Brisbane/2007(A/H1N1) (N=309,310,151) | 186 Titers |
| TIV-adj (6 to <36 Months) | 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) | Day 50 B/Brisbane/2008 (N=310,309,150) | 12 Titers |
| Flu-control (6 to <36 Months) | 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) | Day181 B/Brisbane/2008 (N=309,310,151) | 5.67 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 A/Brisbane/2007 (A/H1N1) | 10 Titers |
| Flu-control (6 to <36 Months) | 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) | Day29A/Brisbane/2007(A/H1N1) (N=316,313,15 | 36 Titers |
| Flu-control (6 to <36 Months) | 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) | Day50A/Brisbane/2007(A/H1N1) (N=310,309,150) | 89 Titers |
| Flu-control (6 to <36 Months) | 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) | Day1A/Brisbane/2007(A/H3N2) | 12 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 29 A/Brisbane/2007 (A/H3N2) (N=316,313,156) | 33 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 50 A/Brisbane/2007 (A/H3N2) (N=310,309,150) | 95 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 181 A/Brisbane/2007 (A/H3N2) (N=309,310,151) | 94 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 B/Florida/2006 | 6.57 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 29 B/Florida/2006 (N=316,313,156) | 14 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 181 B/Florida/2006 (N=309,310,151) | 13 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 A/SolomonIslands/2006(A/H1N1) | 12 Titers |
| Flu-control (6 to <36 Months) | 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) | Day29 A/SolomonIslands/2006(A/H1N1)(N=316,313,150) | 23 Titers |
| Flu-control (6 to <36 Months) | 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) | Day50 A/SolomonIslands/2006(A/H1N1)(N=310,309,150) | 41 Titers |
| Flu-control (6 to <36 Months) | 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) | Day181A/SolomonIslands/2006(A/H1N1)(N=309,310,151) | 28 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 50 B/Florida/2006 (N=310,309,150) | 22 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 29 B/Brisbane/2008 (N=316,313,156) | 5.57 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 50 B/Brisbane/2008 (N=310,309,150) | 6.69 Titers |
| Flu-control (6 to <36 Months) | 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) | Day181A/Brisbane/2007(A/H1N1) (N=309,310,151) | 43 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 A/Wisconsin/2009 (A/H3N2) | 15 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 29 A/Wisconsin/2009 (A/H3N2) (N=316,313,156) | 31 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 50 A/Wisconsin/2009 (A/H3N2) (N=310,309,150) | 70 Titers |
| Flu-control (6 to <36 Months) | 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) | Day181 A/Wisconsin/2009 (A/H3N2) (N=309,310,151) | 98 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 B/Brisbane/2008 | 5.05 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 29 B/Brisbane/2008 (N=316,313,156) | 5.11 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 B/Florida/2006 | 6.41 Titers |
| Flu-control (6 to <36 Months) | 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) | Day181 A/Wisconsin/2009 (A/H3N2) (N=309,310,151) | 34 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 50 B/Brisbane/2008 (N=310,309,150) | 5.2 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 181 A/Brisbane/2007 (A/H3N2) (N=309,310,151) | 26 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 29 A/Brisbane/2007 (A/H3N2) (N=316,313,156) | 12 Titers |
| Flu-control (6 to <36 Months) | 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) | Day181 B/Brisbane/2008 (N=309,310,151) | 6.12 Titers |
| Flu-control (6 to <36 Months) | 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) | Day1A/Brisbane/2007(A/H3N2) | 12 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 50 A/Wisconsin/2009 (A/H3N2) (N=310,309,150) | 14 Titers |
| Flu-control (6 to <36 Months) | 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) | Day181A/SolomonIslands/2006(A/H1N1)(N=309,310,151) | 11 Titers |
| Flu-control (6 to <36 Months) | 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) | Day181A/Brisbane/2007(A/H1N1) (N=309,310,151) | 9.65 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 A/Brisbane/2007 (A/H1N1) | 9.48 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 A/Wisconsin/2009 (A/H3N2) | 13 Titers |
| Flu-control (6 to <36 Months) | 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) | Day29 A/SolomonIslands/2006(A/H1N1)(N=316,313,150) | 10 Titers |
| Flu-control (6 to <36 Months) | 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) | Day50A/Brisbane/2007(A/H1N1) (N=310,309,150) | 9.91 Titers |
| Flu-control (6 to <36 Months) | 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) | Day50 A/SolomonIslands/2006(A/H1N1)(N=310,309,150) | 11 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 A/SolomonIslands/2006(A/H1N1) | 10 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 1 B/Brisbane/2008 | 5.08 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 181 B/Florida/2006 (N=309,310,151) | 6.92 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 50 B/Florida/2006 (N=310,309,150) | 6.67 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 50 A/Brisbane/2007 (A/H3N2) (N=310,309,150) | 12 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 29 B/Florida/2006 (N=316,313,156) | 6.54 Titers |
| Flu-control (6 to <36 Months) | 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) | Day 29 A/Wisconsin/2009 (A/H3N2) (N=316,313,156) | 13 Titers |
| Flu-control (6 to <36 Months) | 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) | Day29A/Brisbane/2007(A/H1N1) (N=316,313,15 | 9.42 Titers |
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [0.78, 1.19]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [4.69, 8.76]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [6.36, 11]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [3.38, 5.65]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Brisbane/2007 (A/H3N2) in terms of Geometric Mean Titers GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [0.82, 1.35]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [4.72, 8.73]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [6.2, 10]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Brisbane/2007 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [2.42, 4.05]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [0.9, 1.05]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [1.26, 1.93]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [4.25, 5.88]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Florida/2006 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [2.22, 2.93]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day1 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [0.75, 1.22]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [1.17, 2.51]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [4.08, 7.63]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Solomon Islands/2006 (A/H1N1) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [2.3, 4.2]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [0.74, 1.3]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [2.19, 4.49]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [5.51, 9.82]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain A/Wisconsin/2009 (A/H3N2) in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [2, 3.55]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 1 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [0.98, 1.01]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 29 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [1.05, 1.22]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 50 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [1.63, 1.97]ANOVA
Comparison: To demonstrate superiority of immunogenicity of TIV-adj compared to Flu-control on Day 181 for strain B/Brisbane/2008 in terms of GMTs in subjects aged 6 to \<72 months by HI assay.95% CI: [1, 1.17]ANOVA
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
Time frame: 3 weeks after 2nd vaccination
Population: 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.
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
Time frame: 3 weeks after 2nd vaccination
Population: 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.
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.
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.
Time frame: 3 weeks after 2nd vaccination
Population: The analysis was done on Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIV-adj (6 to <36 Months) | 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. | Mean bed days (6 to <72 mths)(N=419,250,426) | 1.9 Days | Standard Deviation 2.3 |
| TIV-adj (6 to <36 Months) | 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. | Mean bed days (6 to <36 mths)(N=274,160,263) | 2.0 Days | Standard Deviation 2.5 |
| TIV-adj (6 to <36 Months) | 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. | Mean inactive days(6 to <72 mths)(N=417,249,427) | 3.1 Days | Standard Deviation 3.3 |
| TIV-adj (6 to <36 Months) | 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. | Mean inactive days(6 to <36 mths)(N=273,160,264) | 2.9 Days | Standard Deviation 3.3 |
| Flu-control (6 to <36 Months) | 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. | Mean inactive days(6 to <36 mths)(N=273,160,264) | 3.0 Days | Standard Deviation 3.6 |
| Flu-control (6 to <36 Months) | 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. | Mean bed days (6 to <72 mths)(N=419,250,426) | 2.3 Days | Standard Deviation 2.7 |
| Flu-control (6 to <36 Months) | 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. | Mean inactive days(6 to <72 mths)(N=417,249,427) | 3.3 Days | Standard Deviation 3.5 |
| Flu-control (6 to <36 Months) | 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. | Mean bed days (6 to <36 mths)(N=274,160,263) | 2.1 Days | Standard Deviation 2.4 |
| Flu-control (6 to <36 Months) | 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. | Mean inactive days(6 to <36 mths)(N=273,160,264) | 2.6 Days | Standard Deviation 3.3 |
| Flu-control (6 to <36 Months) | 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. | Mean bed days (6 to <36 mths)(N=274,160,263) | 1.8 Days | Standard Deviation 2.4 |
| Flu-control (6 to <36 Months) | 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. | Mean inactive days(6 to <72 mths)(N=417,249,427) | 2.9 Days | Standard Deviation 3.7 |
| Flu-control (6 to <36 Months) | 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. | Mean bed days (6 to <72 mths)(N=419,250,426) | 1.9 Days | Standard Deviation 2.4 |
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
Time frame: 3 weeks after 2nd vaccination
Population: The analysis was done on Full Analysis Set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIV-adj (6 to <36 Months) | Number of Events of Influenza Like Illness for Combined Seasons 2007/08 and 2008/09. | Mean ILI events (6 to <72 mths)(N=425,253,436) | 1.2 Events | Standard Deviation 0.5 |
| TIV-adj (6 to <36 Months) | Number of Events of Influenza Like Illness for Combined Seasons 2007/08 and 2008/09. | Mean ILI events (6 to <36 mths)(N=280,163,272) | 1.3 Events | Standard Deviation 0.5 |
| Flu-control (6 to <36 Months) | Number of Events of Influenza Like Illness for Combined Seasons 2007/08 and 2008/09. | Mean ILI events (6 to <72 mths)(N=425,253,436) | 1.3 Events | Standard Deviation 0.6 |
| Flu-control (6 to <36 Months) | Number of Events of Influenza Like Illness for Combined Seasons 2007/08 and 2008/09. | Mean ILI events (6 to <36 mths)(N=280,163,272) | 1.3 Events | Standard Deviation 0.6 |
| Flu-control (6 to <36 Months) | Number of Events of Influenza Like Illness for Combined Seasons 2007/08 and 2008/09. | Mean ILI events (6 to <72 mths)(N=425,253,436) | 1.2 Events | Standard Deviation 0.5 |
| Flu-control (6 to <36 Months) | Number of Events of Influenza Like Illness for Combined Seasons 2007/08 and 2008/09. | Mean ILI events (6 to <36 mths)(N=280,163,272) | 1.3 Events | Standard Deviation 0.5 |
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.
Time frame: 7 days post-vaccination
Population: The analysis was done on Safety set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Irritability (N=1178,0,1068,0,607,0) | 387 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site induration(N=1178,833,1068,777,607,422) | 214 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fatigue (N=0,833,0,777,0,422) | 0 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Unusual crying (N=1178,0,1068,0,607,0) | 386 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Arthralgia (N=0,833,0,777,0,422) | 0 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Analg.Antipyr.Used (N=1176,833,1068,777,607,422) | 358 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Sweating (N=0,833,0,777,0,422) | 0 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Sleepiness (N=1178,0,1068,0,607,0) | 380 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Any Local | 625 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Shivering (N=1178,0,1068,0,607,0) | 77 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Vomiting (N=1178,0,1068,0,607,0) | 131 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site swelling(N=1178,833,1068,777,607,422) | 123 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Headache (N=0,833,0,777,0,422) | 0 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Diarrhea (N=1178,0,1068,0,607,0) | 258 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Chills shivering (N=0,833,0,777,0,422) | 0 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fever(39-39.9C)(N=1177,833,1068,775,607,421) | 61 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site erythema(N=1178,833,1068,777,607,422) | 423 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site tenderness(N=1178,0,1068,0,607,0) | 330 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site pain (N=0,833,0,777,0,422) | 0 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site ecchymosis(N=1178,833,1068,777,607,422) | 147 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fever(38-38.9C)(N=1177,833,1068,775,607,421) | 169 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Myalgia (N=0,833,0,777,0,422) | 0 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Any Systemic | 785 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Any Other | 358 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Change in eat. hab.(N=1178,0,1068,0,607,0) | 325 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Malaise (N=0,833,0,777,0,422) | 0 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fever(≥40.0C)(N=1177,833,1068,775,607,421) | 3 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Malaise (N=0,833,0,777,0,422) | 196 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Sleepiness (N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Change in eat. hab.(N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Any Local | 569 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Any Systemic | 523 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site induration(N=1178,833,1068,777,607,422) | 168 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Arthralgia (N=0,833,0,777,0,422) | 82 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Unusual crying (N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site tenderness(N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Chills shivering (N=0,833,0,777,0,422) | 130 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Sweating (N=0,833,0,777,0,422) | 69 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Analg.Antipyr.Used (N=1176,833,1068,777,607,422) | 196 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Shivering (N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Irritability (N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fever(38-38.9C)(N=1177,833,1068,775,607,421) | 133 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site ecchymosis(N=1178,833,1068,777,607,422) | 130 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fever(39-39.9C)(N=1177,833,1068,775,607,421) | 50 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Headache (N=0,833,0,777,0,422) | 197 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site pain (N=0,833,0,777,0,422) | 477 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Vomiting (N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fever(≥40.0C)(N=1177,833,1068,775,607,421) | 1 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site erythema(N=1178,833,1068,777,607,422) | 320 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Any Other | 196 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site swelling(N=1178,833,1068,777,607,422) | 155 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fatigue (N=0,833,0,777,0,422) | 337 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Diarrhea (N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Myalgia (N=0,833,0,777,0,422) | 183 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Diarrhea (N=1178,0,1068,0,607,0) | 211 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Shivering (N=1178,0,1068,0,607,0) | 69 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Any Local | 481 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Myalgia (N=0,833,0,777,0,422) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Chills shivering (N=0,833,0,777,0,422) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Malaise (N=0,833,0,777,0,422) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site induration(N=1178,833,1068,777,607,422) | 131 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fever(39-39.9C)(N=1177,833,1068,775,607,421) | 43 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site swelling(N=1178,833,1068,777,607,422) | 89 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Analg.Antipyr.Used (N=1176,833,1068,777,607,422) | 317 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site tenderness(N=1178,0,1068,0,607,0) | 246 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fever(38-38.9C)(N=1177,833,1068,775,607,421) | 143 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site pain (N=0,833,0,777,0,422) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Any Other | 317 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Any Systemic | 694 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Change in eat. hab.(N=1178,0,1068,0,607,0) | 261 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site ecchymosis(N=1178,833,1068,777,607,422) | 103 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fatigue (N=0,833,0,777,0,422) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Sleepiness (N=1178,0,1068,0,607,0) | 312 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Sweating (N=0,833,0,777,0,422) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Unusual crying (N=1178,0,1068,0,607,0) | 345 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Irritability (N=1178,0,1068,0,607,0) | 353 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fever(≥40.0C)(N=1177,833,1068,775,607,421) | 3 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Headache (N=0,833,0,777,0,422) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Vomiting (N=1178,0,1068,0,607,0) | 118 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Arthralgia (N=0,833,0,777,0,422) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site erythema(N=1178,833,1068,777,607,422) | 322 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fever(38-38.9C)(N=1177,833,1068,775,607,421) | 55 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Any Local | 466 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site ecchymosis(N=1178,833,1068,777,607,422) | 93 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site erythema(N=1178,833,1068,777,607,422) | 269 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site induration(N=1178,833,1068,777,607,422) | 152 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site swelling(N=1178,833,1068,777,607,422) | 128 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site tenderness(N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site pain (N=0,833,0,777,0,422) | 360 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Any Systemic | 341 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Change in eat. hab.(N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Sleepiness (N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Unusual crying (N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Irritability (N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Vomiting (N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Diarrhea (N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Shivering (N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Chills shivering (N=0,833,0,777,0,422) | 51 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Malaise (N=0,833,0,777,0,422) | 118 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Myalgia (N=0,833,0,777,0,422) | 100 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Arthralgia (N=0,833,0,777,0,422) | 37 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Headache (N=0,833,0,777,0,422) | 100 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Sweating (N=0,833,0,777,0,422) | 42 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fatigue (N=0,833,0,777,0,422) | 222 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Any Other | 94 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fever(39-39.9C)(N=1177,833,1068,775,607,421) | 17 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fever(≥40.0C)(N=1177,833,1068,775,607,421) | 2 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Analg.Antipyr.Used (N=1176,833,1068,777,607,422) | 94 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Any Local | 315 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Any Other | 159 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fever(≥40.0C)(N=1177,833,1068,775,607,421) | 2 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site pain (N=0,833,0,777,0,422) | 0 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site ecchymosis(N=1178,833,1068,777,607,422) | 69 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site tenderness(N=1178,0,1068,0,607,0) | 171 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Sweating (N=0,833,0,777,0,422) | 0 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fever(38-38.9C)(N=1177,833,1068,775,607,421) | 62 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Irritability (N=1178,0,1068,0,607,0) | 187 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site swelling(N=1178,833,1068,777,607,422) | 82 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Sleepiness (N=1178,0,1068,0,607,0) | 186 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site induration(N=1178,833,1068,777,607,422) | 153 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Arthralgia (N=0,833,0,777,0,422) | 0 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fever(39-39.9C)(N=1177,833,1068,775,607,421) | 34 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Change in eat. hab.(N=1178,0,1068,0,607,0) | 162 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Headache (N=0,833,0,777,0,422) | 0 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site erythema(N=1178,833,1068,777,607,422) | 239 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fatigue (N=0,833,0,777,0,422) | 0 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Diarrhea (N=1178,0,1068,0,607,0) | 114 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Malaise (N=0,833,0,777,0,422) | 0 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Vomiting (N=1178,0,1068,0,607,0) | 66 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Chills shivering (N=0,833,0,777,0,422) | 0 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Any Systemic | 370 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Shivering (N=1178,0,1068,0,607,0) | 50 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Analg.Antipyr.Used (N=1176,833,1068,777,607,422) | 159 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Myalgia (N=0,833,0,777,0,422) | 0 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Unusual crying (N=1178,0,1068,0,607,0) | 175 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Myalgia (N=0,833,0,777,0,422) | 66 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Vomiting (N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Arthralgia (N=0,833,0,777,0,422) | 27 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Irritability (N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fever(≥40.0C)(N=1177,833,1068,775,607,421) | 1 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Headache (N=0,833,0,777,0,422) | 54 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Unusual crying (N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Sleepiness (N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Sweating (N=0,833,0,777,0,422) | 31 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Change in eat. hab.(N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Any Local | 232 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fatigue (N=0,833,0,777,0,422) | 123 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Any Systemic | 211 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site pain (N=0,833,0,777,0,422) | 180 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Any Other | 69 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site tenderness(N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site swelling(N=1178,833,1068,777,607,422) | 55 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fever(38-38.9C)(N=1177,833,1068,775,607,421) | 37 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site induration(N=1178,833,1068,777,607,422) | 80 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Analg.Antipyr.Used (N=1176,833,1068,777,607,422) | 69 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Fever(39-39.9C)(N=1177,833,1068,775,607,421) | 19 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site erythema(N=1178,833,1068,777,607,422) | 129 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Chills shivering (N=0,833,0,777,0,422) | 37 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Inj. site ecchymosis(N=1178,833,1068,777,607,422) | 49 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Malaise (N=0,833,0,777,0,422) | 63 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Shivering (N=1178,0,1068,0,607,0) | 0 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) of 6 to <72 Months Age With Local and Systemic Reactions After Any Vaccination | Diarrhea (N=1178,0,1068,0,607,0) | 0 Number of subjects |
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.
Time frame: 3 weeks after 2nd vaccination
Population: Analysis was done on Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIV-adj (6 to <36 Months) | 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 | Subjects with ILI | 425 Number of subjects |
| TIV-adj (6 to <36 Months) | 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 | Outpatient visits | 290 Number of subjects |
| TIV-adj (6 to <36 Months) | 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 | Inpatient visits | 20 Number of subjects |
| TIV-adj (6 to <36 Months) | 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 | Outcome (Recovered) | 414 Number of subjects |
| TIV-adj (6 to <36 Months) | 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 | Outcome (Alive with sequelae) | 5 Number of subjects |
| TIV-adj (6 to <36 Months) | 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 | Outcome (Lost to follow-up) | 3 Number of subjects |
| TIV-adj (6 to <36 Months) | 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 | Outcome (ILI persisting) | 3 Number of subjects |
| TIV-adj (6 to <36 Months) | 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 | Outcome (Not available) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Inpatient visits | 26 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outcome (ILI persisting) | 1 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outcome (Recovered) | 431 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outcome (Alive with sequelae) | 2 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outcome (Lost to follow-up) | 1 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Subjects with ILI | 436 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outpatient visits | 293 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outcome (Not available) | 1 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Inpatient visits | 19 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outpatient visits | 174 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Subjects with ILI | 253 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outcome (Recovered) | 248 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outcome (ILI persisting) | 3 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outcome (Lost to follow-up) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outcome (Alive with sequelae) | 2 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outcome (Not available) | 0 Number of subjects |
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
Time frame: Study day 1 to Study day 181
Population: The analysis was done on Safety set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | At least possibly related SAEs | 1 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | At least possibly related AEs | 152 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | Any AEs | 1045 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | AEs leading to discontinuation | 6 Number of subjects |
| TIV-adj (6 to <36 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | Serious AEs | 91 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | At least possibly related AEs | 124 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | At least possibly related SAEs | 1 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | Any AEs | 938 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | AEs leading to discontinuation | 9 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | Serious AEs | 104 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | At least possibly related AEs | 90 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | At least possibly related SAEs | 3 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | AEs leading to discontinuation | 1 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | Serious AEs | 65 Number of subjects |
| Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | Any AEs | 530 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | Serious AEs | 122 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | Any AEs | 1714 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | At least possibly related AEs | 262 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | At least possibly related SAEs | 2 Number of subjects |
| Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | AEs leading to discontinuation | 9 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | At least possibly related SAEs | 2 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | Any AEs | 1566 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | AEs leading to discontinuation | 10 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | At least possibly related AEs | 203 Number of subjects |
| Non-Flu-control (6 to <36 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | Serious AEs | 169 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | Any AEs | 867 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | At least possibly related SAEs | 3 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | At least possibly related AEs | 137 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | AEs leading to discontinuation | 1 Number of subjects |
| Non-Flu-control (36 to <72 Months) | Number of Subjects (Unprimed) With Unsolicited Adverse Events Reported After Any Vaccination | Serious AEs | 110 Number of subjects |
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.
Time frame: 3 weeks after 2nd vaccination
Population: Analysis was done on Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIV-adj (6 to <36 Months) | 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 | Inpatient visits | 13 Number of subjects |
| TIV-adj (6 to <36 Months) | 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 | Outpatient visits | 192 Number of subjects |
| TIV-adj (6 to <36 Months) | 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 | Subjects with ILI | 280 Number of subjects |
| TIV-adj (6 to <36 Months) | 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 | Outcome (Recovered) | 269 Number of subjects |
| TIV-adj (6 to <36 Months) | 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 | Outcome (Alive with sequelae) | 5 Number of subjects |
| TIV-adj (6 to <36 Months) | 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 | Outcome (Lost to follow-up) | 3 Number of subjects |
| TIV-adj (6 to <36 Months) | 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 | Outcome (ILI persisting) | 3 Number of subjects |
| TIV-adj (6 to <36 Months) | 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 | Outcome (Not available) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outcome (Recovered) | 159 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outcome (Not available) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Subjects with ILI | 163 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outcome (ILI persisting) | 2 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outcome (Lost to follow-up) | 0 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Inpatient visits | 14 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outpatient visits | 113 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outcome (Alive with sequelae) | 2 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outpatient visits | 183 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Inpatient visits | 19 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outcome (Recovered) | 267 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outcome (Not available) | 1 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outcome (Alive with sequelae) | 2 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outcome (Lost to follow-up) | 1 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Outcome (ILI persisting) | 1 Number of subjects |
| Flu-control (6 to <36 Months) | 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 | Subjects with ILI | 272 Number of subjects |
| Flu-control (36 to <72 Months) | 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 | Outcome (ILI persisting) | 3 Number of subjects |
| Flu-control (36 to <72 Months) | 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 | Outcome (Lost to follow-up) | 3 Number of subjects |
| Flu-control (36 to <72 Months) | 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 | Outcome (Alive with sequelae) | 5 Number of subjects |
| Flu-control (36 to <72 Months) | 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 | Subjects with ILI | 425 Number of subjects |
| Flu-control (36 to <72 Months) | 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 | Inpatient visits | 20 Number of subjects |
| Flu-control (36 to <72 Months) | 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 | Outcome (Recovered) | 414 Number of subjects |
| Flu-control (36 to <72 Months) | 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 | Outcome (Not available) | 0 Number of subjects |
| Flu-control (36 to <72 Months) | 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 | Outpatient visits | 290 Number of subjects |
| Non-Flu-control (6 to <36 Months) | 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 | Outcome (Not available) | 0 Number of subjects |
| Non-Flu-control (6 to <36 Months) | 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 | Subjects with ILI | 253 Number of subjects |
| Non-Flu-control (6 to <36 Months) | 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 | Outcome (Alive with sequelae) | 2 Number of subjects |
| Non-Flu-control (6 to <36 Months) | 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 | Outcome (Lost to follow-up) | 0 Number of subjects |
| Non-Flu-control (6 to <36 Months) | 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 | Outcome (ILI persisting) | 3 Number of subjects |
| Non-Flu-control (6 to <36 Months) | 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 | Outpatient visits | 174 Number of subjects |
| Non-Flu-control (6 to <36 Months) | 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 | Inpatient visits | 19 Number of subjects |
| Non-Flu-control (6 to <36 Months) | 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 | Outcome (Recovered) | 248 Number of subjects |
| Non-Flu-control (36 to <72 Months) | 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 | Outcome (Not available) | 1 Number of subjects |
| Non-Flu-control (36 to <72 Months) | 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 | Outcome (Alive with sequelae) | 2 Number of subjects |
| Non-Flu-control (36 to <72 Months) | 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 | Inpatient visits | 26 Number of subjects |
| Non-Flu-control (36 to <72 Months) | 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 | Outcome (Recovered) | 431 Number of subjects |
| Non-Flu-control (36 to <72 Months) | 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 | Outcome (Lost to follow-up) | 1 Number of subjects |
| Non-Flu-control (36 to <72 Months) | 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 | Outpatient visits | 293 Number of subjects |
| Non-Flu-control (36 to <72 Months) | 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 | Outcome (ILI persisting) | 1 Number of subjects |
| Non-Flu-control (36 to <72 Months) | 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 | Subjects with ILI | 436 Number of subjects |
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
Time frame: 7 days post-vaccination
Population: Adequate data was not available to conduct this analysis.
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%.
Time frame: On study days 1, 29, 50, 181
Population: The analysis was done on Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIV-adj (6 to <36 Months) | 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) | Day1 A/Brisbane/2007(A/H3N2) | 4 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day50 B/Brisbane/2008 (N=160,162,78) | 5 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day181 B/Brisbane/2008 (N=161,163,80) | 0 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day 1 A/Brisbane/2007 (A/H1N1) | 5 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day29 A/Brisbane/2007(A/H1N1)(N=165,163,82) | 92 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day 50 A/Brisbane/2007 (A/H1N1) (N=160,162,78) | 100 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day181A/Brisbane/2007(A/H1N1)(N=161,163,80) | 98 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day29 A/Brisbane/2007(A/H3N2)(N=165,163,82) | 95 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day50 A/Brisbane/2007(A/H3N2)(N=160,162,78) | 99 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day181A/Brisbane/2007(A/H3N2)(N=161,163,80) | 100 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day 1 B/Florida/2006 | 2 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day29 B/Florida/2006 (N=165,163,82) | 12 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day50 B/Florida/2006 (N=160,162,78) | 88 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day181B/Florida/2006 (N=161,163,80) | 40 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day 1 A/SolomonIslands/2006(A/H1N1) | 5 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day29A/Sol.Islands/2006(A/H1N1)(N=165,163,82) | 15 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day50A/Sol.Islands/2006(A/H1N1) (N=160,162,78) | 95 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | D181A/Sol.Islands/2006(A/H1N1) (N=161,163,80) | 61 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day 1 A/Wisconsin/2009 (A/H3N2) | 4 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day29 A/Wisconsin/2009(A/H3N2) (N=165,163,82) | 37 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day50 A/Wisconsin/2009(A/H3N2) (N=160,162,78) | 100 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day181A/Wisconsin/2009(A/H3N2) (N=161,163,80) | 99 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day 1 B/Brisbane/2008 | 0 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day29 B/Brisbane/2008 (N=165,163,82) | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day181 B/Brisbane/2008 (N=161,163,80) | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day50 B/Florida/2006 (N=160,162,78) | 19 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 1 B/Florida/2006 | 2 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day50A/Sol.Islands/2006(A/H1N1) (N=160,162,78) | 24 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day50 B/Brisbane/2008 (N=160,162,78) | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day181A/Brisbane/2007(A/H3N2)(N=161,163,80) | 45 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 1 B/Brisbane/2008 | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 1 A/Brisbane/2007 (A/H1N1) | 11 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day181B/Florida/2006 (N=161,163,80) | 13 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | D181A/Sol.Islands/2006(A/H1N1) (N=161,163,80) | 19 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day29 A/Brisbane/2007(A/H1N1)(N=165,163,82) | 20 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day50 A/Wisconsin/2009(A/H3N2) (N=160,162,78) | 30 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day181A/Wisconsin/2009(A/H3N2) (N=161,163,80) | 42 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 50 A/Brisbane/2007 (A/H1N1) (N=160,162,78) | 38 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 1 A/SolomonIslands/2006(A/H1N1) | 11 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day29 B/Florida/2006 (N=165,163,82) | 12 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day181A/Brisbane/2007(A/H1N1)(N=161,163,80) | 25 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day50 A/Brisbane/2007(A/H3N2)(N=160,162,78) | 45 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day29 A/Wisconsin/2009(A/H3N2) (N=165,163,82) | 6 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day1 A/Brisbane/2007(A/H3N2) | 4 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day29A/Sol.Islands/2006(A/H1N1)(N=165,163,82) | 13 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 1 A/Wisconsin/2009 (A/H3N2) | 5 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day29 A/Brisbane/2007(A/H3N2)(N=165,163,82) | 12 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day29 B/Brisbane/2008 (N=165,163,82) | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day29 A/Brisbane/2007(A/H3N2)(N=165,163,82) | 4 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day50 A/Brisbane/2007(A/H3N2)(N=160,162,78) | 4 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day181A/Brisbane/2007(A/H3N2)(N=161,163,80) | 21 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day29 B/Brisbane/2008 (N=165,163,82) | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 1 B/Florida/2006 | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day29 B/Florida/2006 (N=165,163,82) | 4 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day50 A/Wisconsin/2009(A/H3N2) (N=160,162,78) | 4 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day50 B/Florida/2006 (N=160,162,78) | 3 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day50 B/Brisbane/2008 (N=160,162,78) | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day181B/Florida/2006 (N=161,163,80) | 3 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 1 A/SolomonIslands/2006(A/H1N1) | 5 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day181A/Wisconsin/2009(A/H3N2) (N=161,163,80) | 23 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day29A/Sol.Islands/2006(A/H1N1)(N=165,163,82) | 5 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day29 A/Wisconsin/2009(A/H3N2) (N=165,163,82) | 2 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 1 B/Brisbane/2008 | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day50A/Sol.Islands/2006(A/H1N1) (N=160,162,78) | 5 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 1 A/Brisbane/2007 (A/H1N1) | 5 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day29 A/Brisbane/2007(A/H1N1)(N=165,163,82) | 6 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | D181A/Sol.Islands/2006(A/H1N1) (N=161,163,80) | 5 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 50 A/Brisbane/2007 (A/H1N1) (N=160,162,78) | 6 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day181 B/Brisbane/2008 (N=161,163,80) | 6 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day181A/Brisbane/2007(A/H1N1)(N=161,163,80) | 6 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day1 A/Brisbane/2007(A/H3N2) | 2 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 1 A/Wisconsin/2009 (A/H3N2) | 2 Percentage of subjects |
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%.
Time frame: On study days 1, 29, 50, 181
Population: The analysis was done on Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIV-adj (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day29 B/Brisbane/2008 | 1 Percentage of subjects |
| TIV-adj (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day29A/Sol.Islands/2006(A/H1N1) | 14 Percentage of subjects |
| TIV-adj (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day181A/Brisbane/2007(A/H1N1)(N=161,163,80) | 97 Percentage of subjects |
| TIV-adj (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day181A/Wisconsin/2009(A/H3N2)(N=161,163,80) | 97 Percentage of subjects |
| TIV-adj (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day50A/Sol.Islands/2006(A/H1N1)(N=160,162,78) | 94 Percentage of subjects |
| TIV-adj (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day181A/Brisbane/2007(A/H3N2)(N=161,163,80) | 98 Percentage of subjects |
| TIV-adj (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day50 A/Wisconsin/2009(A/H3N2)(N=160,162,78) | 100 Percentage of subjects |
| TIV-adj (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day181A/Sol.Islands/2006(A/H1N1)(N=161,163,80) | 60 Percentage of subjects |
| TIV-adj (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day50 A/Brisbane/2007(A/H1N1)(N=160,162,78) | 100 Percentage of subjects |
| TIV-adj (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day29 A/Wisconsin/2009(A/H3N2) | 36 Percentage of subjects |
| TIV-adj (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day29 B/Florida/2006 | 12 Percentage of subjects |
| TIV-adj (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day29 A/Brisbane/2007(A/H3N2) | 93 Percentage of subjects |
| TIV-adj (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day29 A/Brisbane/2007(A/H1N1) | 92 Percentage of subjects |
| TIV-adj (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day50 B/Florida/2006 (N=160,162,78) | 88 Percentage of subjects |
| TIV-adj (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day50 A/Brisbane/2007(A/H3N2)(N=160,162,78) | 98 Percentage of subjects |
| TIV-adj (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day 50:1 B/Brisbane/2008 (N=160,162,78) | 5 Percentage of subjects |
| TIV-adj (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day181B/Florida/2006 (N=161,163,80) | 39 Percentage of subjects |
| TIV-adj (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day181 B/Brisbane/2008 (N=161,163,80) | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day29 A/Brisbane/2007(A/H1N1) | 19 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day50 A/Brisbane/2007(A/H1N1)(N=160,162,78) | 38 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day50 A/Brisbane/2007(A/H3N2)(N=160,162,78) | 44 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day181A/Brisbane/2007(A/H3N2)(N=161,163,80) | 42 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day29 B/Florida/2006 | 12 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day50 B/Florida/2006 (N=160,162,78) | 19 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day181B/Florida/2006 (N=161,163,80) | 12 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day29A/Sol.Islands/2006(A/H1N1) | 13 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day50A/Sol.Islands/2006(A/H1N1)(N=160,162,78) | 23 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day181A/Sol.Islands/2006(A/H1N1)(N=161,163,80) | 18 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day50 A/Wisconsin/2009(A/H3N2)(N=160,162,78) | 27 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day181A/Wisconsin/2009(A/H3N2)(N=161,163,80) | 39 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day29 B/Brisbane/2008 | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day 50:1 B/Brisbane/2008 (N=160,162,78) | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day181A/Brisbane/2007(A/H1N1)(N=161,163,80) | 24 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day29 A/Brisbane/2007(A/H3N2) | 10 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day29 A/Wisconsin/2009(A/H3N2) | 4 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day181 B/Brisbane/2008 (N=161,163,80) | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day29 B/Brisbane/2008 | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day50 B/Florida/2006 (N=160,162,78) | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day181A/Sol.Islands/2006(A/H1N1)(N=161,163,80) | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day 50:1 B/Brisbane/2008 (N=160,162,78) | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day181 B/Brisbane/2008 (N=161,163,80) | 6 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day29 B/Florida/2006 | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day181A/Brisbane/2007(A/H3N2)(N=161,163,80) | 19 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day50 A/Brisbane/2007(A/H3N2)(N=160,162,78) | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day29 A/Brisbane/2007(A/H1N1) | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day181A/Brisbane/2007(A/H1N1)(N=161,163,80) | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day29 A/Wisconsin/2009(A/H3N2) | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day50A/Sol.Islands/2006(A/H1N1)(N=160,162,78) | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day29 A/Brisbane/2007(A/H3N2) | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day29A/Sol.Islands/2006(A/H1N1) | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day50 A/Wisconsin/2009(A/H3N2)(N=160,162,78) | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day181A/Wisconsin/2009(A/H3N2)(N=161,163,80) | 20 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day181B/Florida/2006 (N=161,163,80) | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | Percentage (95% CI) of Unprimed Subjects Aged 6 to <36 Months With Seroconversion From Baseline, for Season 2008/09 (Homologous and Heterologous Strains) | Day50 A/Brisbane/2007(A/H1N1)(N=160,162,78) | 1 Percentage of subjects |
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.
Time frame: 3 weeks after 2nd vaccination
Population: Analysis was done on Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIV-adj (6 to <36 Months) | 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). | Any Strain (Season 2007/08)N=187,97,93,136,67,71 | 0 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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). | Any Strain (Season 2008/09) | 0.98 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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). | Any Strain (Season 2007/08)N=187,97,93,136,67,71 | 2.06 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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). | Any Strain (Season 2008/09) | 4.26 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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). | Any Strain (Season 2007/08)N=187,97,93,136,67,71 | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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). | Any Strain (Season 2008/09) | 2.77 Percentage of subjects |
| Flu-control (36 to <72 Months) | 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). | Any Strain (Season 2007/08)N=187,97,93,136,67,71 | 0.74 Percentage of subjects |
| Flu-control (36 to <72 Months) | 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). | Any Strain (Season 2008/09) | 0.43 Percentage of subjects |
| Non-Flu-control (6 to <36 Months) | 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). | Any Strain (Season 2007/08)N=187,97,93,136,67,71 | 2.99 Percentage of subjects |
| Non-Flu-control (6 to <36 Months) | 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). | Any Strain (Season 2008/09) | 6.39 Percentage of subjects |
| Non-Flu-control (36 to <72 Months) | 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). | Any Strain (Season 2007/08)N=187,97,93,136,67,71 | 0 Percentage of subjects |
| Non-Flu-control (36 to <72 Months) | 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). | Any Strain (Season 2008/09) | 3.54 Percentage of subjects |
Comparison: Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the population average incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)95% CI: [54.78, 90.42]Poisson Regression Model
Comparison: Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza. Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)95% CI: [77.35, 97.24]Poisson Regression Model
Comparison: Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.95% CI: [23.21, 83.28]Poisson Regression Model
Comparison: Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.95% CI: [58.95, 94.99]Poisson Regression Model
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.
Time frame: 3 weeks after 2nd vaccination
Population: The analysis was done on Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIV-adj (6 to <36 Months) | 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) | Matched strain(Season2007/08)N=187,97,93,136,67,71 | 0 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Matched strain (Season2008/09) | 0.76 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Matched strain(Season2007/08)N=187,97,93,136,67,71 | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Matched strain (Season2008/09) | 4.05 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Matched strain(Season2007/08)N=187,97,93,136,67,71 | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Matched strain (Season2008/09) | 2.44 Percentage of subjects |
| Flu-control (36 to <72 Months) | 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) | Matched strain(Season2007/08)N=187,97,93,136,67,71 | 0 Percentage of subjects |
| Flu-control (36 to <72 Months) | 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) | Matched strain (Season2008/09) | 0.29 Percentage of subjects |
| Non-Flu-control (6 to <36 Months) | 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) | Matched strain(Season2007/08)N=187,97,93,136,67,71 | 0 Percentage of subjects |
| Non-Flu-control (6 to <36 Months) | 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) | Matched strain (Season2008/09) | 6.11 Percentage of subjects |
| Non-Flu-control (36 to <72 Months) | 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) | Matched strain(Season2007/08)N=187,97,93,136,67,71 | 0 Percentage of subjects |
| Non-Flu-control (36 to <72 Months) | 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) | Matched strain (Season2008/09) | 3.12 Percentage of subjects |
Comparison: Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)95% CI: [49.24, 93.16]Poisson Regression Model
Comparison: Absolute vaccine efficacy (VE) was calculated as (1- the relative risk)100%. Relative Risk for virus-confirmed symptomatic influenza illness in the TIV-adj group vs. the non-flu control group. VE denotes the vaccine efficacy, i.e. 1-Itest/Inon-flu ctrl, where I stands for the incidence of influenza.~Absolute efficacy of TIV-adj is at most 40% (i.e. the probability of an influenza in the test group relative to that in the non-flu vaccine group is at least 0.6)95% CI: [80.92, 98.94]Poisson Regression Model
Comparison: Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.95% CI: [0.13, 0.73]Mantel Haenszel
Comparison: Relative efficacy for TIV-adj was to be calculated as VE = (1-Itest/Ictrl)100%, where I is the incidence of influenza, i.e. percentage of subjects with virus-confirmed symptomatic influenza A or B illness, in the investigational agent (TIV-adj) group or in the flu vaccine control group.95% CI: [0.02, 0.38]Mantel Haenszel
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%.
Time frame: On study days 1, 29, 50, 181
Population: The analysis was done on Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIV-adj (6 to <36 Months) | 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 | Day29A/Brisbane/2007(A/H3N2;N=316,313,156) | 96 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | Day1 A/Brisbane/2007(A/H1N1) | 20 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | Day29A/Brisbane/2007(A/H1N1;N=316,313,156) | 96 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | Day50A/Brisbane/2007(A/H1N1;N=310,309,150) | 100 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | Day181A/Brisbane/2007(A/H1N1;N=309,310,151) | 98 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | Day1A/Brisbane/2007(A/H3N2) | 23 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | Day1A/Sol.Islands/2006(A/H1N1) | 21 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | Day50A/Brisbane/2007(A/H3N2;N=310,309,150) | 99 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | Day181A/Brisbane/2007(A/H3N2;N=309,310,151) | 100 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | Day1B/Florida/2006 | 2 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | Day29B/Florida/2006(N=316,313,156) | 28 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | Day50B/Florida/2006(N=310,309,150) | 93 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | Day181B/Florida/2006(N=309,310,151) | 52 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | D29A/Sol.Islands/2006(A/H1N1;N=316,313,156) | 32 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | D50A/Sol.islands/2006(A/H1N1;N=310,309,150) | 96 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | D181A/Sol.Islands/2006(A/H1N1;N=309,310,151) | 72 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | Day1A/Wisconsin/2009(A/H3N2) | 25 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | Day29A/Wisconsin/2009(A/H3N2;N=316,313,156) | 60 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | Day50A/Wisconsin/2009(A/H3N2;N=310,309,150) | 100 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | D181A/Wisconsin/2009(A/H3N2;N=309,310,151) | 100 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | Day1B/Brisbane/2008 | 0 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | Day29B/Brisbane/2008(N=316,313,156) | 3 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | Day50B/Brisbane/2008(N=310,309,150) | 10 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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 | Day181B/Brisbane/2008(N=309,310,151) | 3 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day29B/Brisbane/2008(N=316,313,156) | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | D29A/Sol.Islands/2006(A/H1N1;N=316,313,156) | 24 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day181B/Florida/2006(N=309,310,151) | 23 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day1A/Wisconsin/2009(A/H3N2) | 25 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day1 A/Brisbane/2007(A/H1N1) | 21 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day29B/Florida/2006(N=316,313,156) | 26 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day1A/Sol.Islands/2006(A/H1N1) | 22 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day29A/Brisbane/2007(A/H1N1;N=316,313,156) | 40 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day50B/Brisbane/2008(N=310,309,150) | 3 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day1B/Brisbane/2008 | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day50A/Brisbane/2007(A/H1N1;N=310,309,150) | 59 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day1B/Florida/2006 | 2 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day29A/Wisconsin/2009(A/H3N2;N=316,313,156) | 29 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day181A/Brisbane/2007(A/H1N1;N=309,310,151) | 49 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | D50A/Sol.islands/2006(A/H1N1;N=310,309,150) | 45 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day50B/Florida/2006(N=310,309,150) | 38 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day1A/Brisbane/2007(A/H3N2) | 22 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day181A/Brisbane/2007(A/H3N2;N=309,310,151) | 65 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day181B/Brisbane/2008(N=309,310,151) | 3 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day29A/Brisbane/2007(A/H3N2;N=316,313,156) | 35 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | D181A/Sol.Islands/2006(A/H1N1;N=309,310,151) | 34 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day50A/Wisconsin/2009(A/H3N2;N=310,309,150) | 54 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day50A/Brisbane/2007(A/H3N2;N=310,309,150) | 65 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | D181A/Wisconsin/2009(A/H3N2;N=309,310,151) | 63 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day50A/Brisbane/2007(A/H3N2;N=310,309,150) | 21 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day181A/Brisbane/2007(A/H3N2;N=309,310,151) | 41 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day1B/Florida/2006 | 4 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day29B/Florida/2006(N=316,313,156) | 4 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | D181A/Wisconsin/2009(A/H3N2;N=309,310,151) | 43 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day50B/Florida/2006(N=310,309,150) | 3 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day50B/Brisbane/2008(N=310,309,150) | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day181B/Florida/2006(N=309,310,151) | 4 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day1A/Sol.Islands/2006(A/H1N1) | 18 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day1B/Brisbane/2008 | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | D50A/Sol.islands/2006(A/H1N1;N=310,309,150) | 18 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day181B/Brisbane/2008(N=309,310,151) | 5 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | D181A/Sol.Islands/2006(A/H1N1;N=309,310,151) | 18 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | D29A/Sol.Islands/2006(A/H1N1;N=316,313,156) | 18 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day1 A/Brisbane/2007(A/H1N1) | 16 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day1A/Wisconsin/2009(A/H3N2) | 21 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day29A/Brisbane/2007(A/H1N1;N=316,313,156) | 17 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day29B/Brisbane/2008(N=316,313,156) | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day50A/Brisbane/2007(A/H1N1;N=310,309,150) | 17 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day181A/Brisbane/2007(A/H1N1;N=309,310,151) | 18 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day29A/Wisconsin/2009(A/H3N2;N=316,313,156) | 21 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day1A/Brisbane/2007(A/H3N2) | 20 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day29A/Brisbane/2007(A/H3N2;N=316,313,156) | 21 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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 | Day50A/Wisconsin/2009(A/H3N2;N=310,309,150) | 21 Percentage of subjects |
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%.
Time frame: On study days 1, 29, 50, 181
Population: The analysis was done on Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TIV-adj (6 to <36 Months) | 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) | Day 29:1 A/Brisbane/2007 (A/H3N2; N=316,313,156) | 94 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day 50:1A/SolomonIsland/2006(A/H1N1;N=310,309,150) | 96 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day 29:1 A/Brisbane/2007 (A/H1N1; N=316,313,156) | 96 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day 50:1 A/Brisbane/2007 (A/H1N1; N=310,309,150) | 100 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day 181:1 A/Brisbane/2007 (A/H1N1; N=309,310,151) | 98 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day 50:1 B/Florida/2006 (N=310,309,150) | 93 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day 50:1 A/Brisbane/2007 (A/H3N2; N=310,309,150) | 97 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day 181:1 A/Brisbane/2007 (A/H3N2; N=309,310,151) | 93 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day 29:1 B/Florida/2006 (N=316,313,156) | 28 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day 181:1 B/Florida/2006 (N=309,310,151) | 50 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day 29:1A/SolomonIsland/2006(A/H1N1;N=316,313,156) | 32 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day181:1A/SolomonIsland/2006(A/H1N1;N=309,310,151) | 72 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day 29:1 A/Wisconsin/2009 (A/H3N2; N=316,313,156) | 58 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day 50:1 A/Wisconsin/2009 (A/H3N2; N=310,309,150) | 98 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day181:1 A/Wisconsin/2009 (A/H3N2;N=309,310,151) | 92 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day 29:1 B/Brisbane/2008 (N=316,313,156) | 3 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day 50:1 B/Brisbane/2008 (N=310,309,150) | 10 Percentage of subjects |
| TIV-adj (6 to <36 Months) | 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) | Day181:1 B/Brisbane/2008 (N=309,310,151) | 2 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day181:1 A/Wisconsin/2009 (A/H3N2;N=309,310,151) | 52 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 181:1 A/Brisbane/2007 (A/H3N2; N=309,310,151) | 56 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 29:1 B/Florida/2006 (N=316,313,156) | 26 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 50:1 B/Florida/2006 (N=310,309,150) | 38 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 181:1 B/Florida/2006 (N=309,310,151) | 19 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 29:1 B/Brisbane/2008 (N=316,313,156) | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 29:1A/SolomonIsland/2006(A/H1N1;N=316,313,156) | 24 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 50:1A/SolomonIsland/2006(A/H1N1;N=310,309,150) | 44 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day181:1A/SolomonIsland/2006(A/H1N1;N=309,310,151) | 33 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day181:1 B/Brisbane/2008 (N=309,310,151) | 3 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 29:1 A/Wisconsin/2009 (A/H3N2; N=316,313,156) | 23 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 29:1 A/Brisbane/2007 (A/H1N1; N=316,313,156) | 40 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 50:1 B/Brisbane/2008 (N=310,309,150) | 3 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 50:1 A/Brisbane/2007 (A/H1N1; N=310,309,150) | 59 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 50:1 A/Wisconsin/2009 (A/H3N2; N=310,309,150) | 49 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 181:1 A/Brisbane/2007 (A/H1N1; N=309,310,151) | 48 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 29:1 A/Brisbane/2007 (A/H3N2; N=316,313,156) | 31 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 50:1 A/Brisbane/2007 (A/H3N2; N=310,309,150) | 63 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 29:1 A/Brisbane/2007 (A/H3N2; N=316,313,156) | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 50:1 B/Brisbane/2008 (N=310,309,150) | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 181:1 A/Brisbane/2007 (A/H3N2; N=309,310,151) | 23 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day181:1 A/Wisconsin/2009 (A/H3N2;N=309,310,151) | 25 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 50:1A/SolomonIsland/2006(A/H1N1;N=310,309,150) | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 29:1 B/Florida/2006 (N=316,313,156) | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 29:1 A/Wisconsin/2009 (A/H3N2; N=316,313,156) | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 50:1 B/Florida/2006 (N=310,309,150) | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day181:1 B/Brisbane/2008 (N=309,310,151) | 5 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 181:1 A/Brisbane/2007 (A/H1N1; N=309,310,151) | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 181:1 B/Florida/2006 (N=309,310,151) | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 29:1 A/Brisbane/2007 (A/H1N1; N=316,313,156) | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 50:1 A/Wisconsin/2009 (A/H3N2; N=310,309,150) | 2 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 29:1A/SolomonIsland/2006(A/H1N1;N=316,313,156) | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 50:1 A/Brisbane/2007 (A/H3N2; N=310,309,150) | 2 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 29:1 B/Brisbane/2008 (N=316,313,156) | 0 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day 50:1 A/Brisbane/2007 (A/H1N1; N=310,309,150) | 1 Percentage of subjects |
| Flu-control (6 to <36 Months) | 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) | Day181:1A/SolomonIsland/2006(A/H1N1;N=309,310,151) | 0 Percentage of subjects |