Phase 3
Completed N=6,100
Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age
Influenza Disease
Source: ClinicalTrials.gov NCT01346592 ↗
Enrolled (actual)
6,100
Serious AEs
4.1%
Results posted
May 2014
Primary outcomePrimary: Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains — 28; 24; 27; 1537 Titers
Summary
This Study Aims to Evaluate the Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains |
28; 24; 27; 1537; 629; 480 | — |
| PRIMARY Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titers Against Homologous Strains |
92.9; 84.5; 79.4; 96.5; 92.3; 89.4 | — |
| PRIMARY Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Geometric Mean Titers (GMTs) Against Homologous Strains (6 to <36 Months) |
23; 20; 370; 487; 29; 28 | — |
| PRIMARY Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects 6 to <36 Months of Age |
78.8; 84.1; 89.9; 92.6; 82.7; 85.5 | — |
| SECONDARY Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <24 Months) |
12; 9.87; 12; 1080; 298; 205 | — |
| SECONDARY Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains (6 to <24 Months) |
95.5; 85.1; 77.8; 98.1; 95.6; 92.5 | — |
| SECONDARY Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains (6 to <72 Months)-FAS |
29; 24; 27; 1519; 637; 473 | — |
| SECONDARY Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers Against Homologous Strains (6 to <72 Months)-FAS |
92.8; 83.7; 78.8; 96.4; 92.3; 89.8 | — |
| SECONDARY The HI GMTs Against Homologous Strains, by Vaccine Group |
28; 24; 27; 647; 159; 170 | — |
| SECONDARY Geometric Mean Ratio (GMR) of Post- Versus Pre-vaccination HI Titers Against Homologous Strains |
27; 6.81; 7.13; 58; 27; 19 | — |
| SECONDARY Percentage of Subjects With HI Titers ≥40 Against Homologous Strains, by Vaccine Group |
40.6; 33.1; 36.3; 89.8; 55; 57.9 | — |
| SECONDARY Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Homologous Strains |
83.6; 48.5; 51.5; 92.6; 83.9; 79 | — |
| SECONDARY Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, Subjects at Risk/Not at Risk, by Age Subgroup |
1516; 566; 431; 1341; 478; 366 | — |
| SECONDARY Comparison of Antibody Responses of aTIV Versus Comparator TIV and TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Subgroup |
93; 85; 79; 95; 84; 78 | — |
| SECONDARY Comparison of Antibody Responses of TIV Versus Comparator TIV in Terms of Percentage of Subjects Achieving Seroconversion or ≥4-fold Increase in HI Titer Against Homologous Strains in Subjects at Risk/Not at Risk, by Age Sub Group-FAS |
93; 84; 79; 95; 83; 78 | — |
| SECONDARY Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, at Risk/Not at Risk, by Age Sub Group-FAS |
1509; 569; 422; 1336; 474; 365 | — |
| SECONDARY The HI GMTs Against Heterologous Strains, by Vaccine Group (6 to <72 Months Age Group) |
10; 9.75; 10; 51; 29; 31 | — |
| SECONDARY Percentage of Subjects Achieving Seroconversion or ≥4 Fold Increase in HI Titers, Against Heterologous Strains |
53.16; 36.85; 36.05; 33.95; 19.33; 20.70 | — |
| SECONDARY Comparison of Antibody Responses of aTIV With TIV and Comparator TIV in Terms of GMTs Against Homologous Strains, After One Vaccination |
28; 24; 27; 647; 159; 170 | — |
| SECONDARY Number of Subjects Reporting Solicited Adverse Events After Vaccination |
1082; 292; 311; 191; 72; 86 | — |
| SECONDARY Number of Subjects Reporting Unsolicited Adverse Events After Vaccination |
1541; 859; 808; 158; 101; 84 | — |
Eligibility Criteria
Inclusion Criteria
1.Children 6 months to 72 months of age.
Exclusion Criteria:Children
- Who had been hospitalized at the time of enrollment
- Who had any serious reaction or hypersensitivity to any vaccine component, eggs, or chicken protein
- Who had known impairment of the immune function
- Who had fever interfering with normal daily activities at the time of enrollment
- Who had received licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in the study
- Concomitant participation in another clinical study
- Who had surgery planned during the study period that in the investigator's opinion would have interfered with the study visits schedule.
Data sourced from ClinicalTrials.gov (NCT01346592). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.