| This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the A/H1N1 strain. | Chi-squared | | 0.0036 | The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint | Difference in seroconversion rates | 4.5 | | | 2-Sided | 95 | 1.4 | 7.5 | | | | Yes | Non-Inferiority or Equivalence | This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group. | |
| This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the A/H1N1 strain. | Chi-squared | | 0.1465 | The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint | Difference in seroconversion rates | -3.0 | | | 2-Sided | 95 | -7.0 | 1.0 | | | | Yes | Non-Inferiority or Equivalence | This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group. | |
| This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the A/H3N2 strain. | Chi-squared | | <0.001 | The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint | Difference in seroconversion rates | 8.0 | | | 2-Sided | 95 | 3.3 | 12.7 | | | | Yes | Non-Inferiority or Equivalence | This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group. | |
| This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the A/H3N2 strain. | Chi-squared | | 0.7493 | The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint | Difference in seroconversion rates | 0.9 | | | 2-Sided | 95 | -4.5 | 6.2 | | | | Yes | Non-Inferiority or Equivalence | This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group. | |
| This statistical anaylsis evaluated the non-inferiority of 0.5 mL Inflexal V vs. 0.25 mL Agrippal for the B-strain. | Chi-squared | | 0.0000 | The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint | Difference in seroconversion rates | 20.2 | | | 2-Sided | 95 | 13.5 | 27.0 | | | | Yes | Non-Inferiority or Equivalence | This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group. | |
| This statistical anaylsis evaluated the non-inferiority of 0.25 mL Inflexal V vs. 0.25 mL Agrippal for the B-strain. | Chi-squared | | 0.0029 | The significance level α = 0.05 (one-sided) was adjusted to α = 0.025 (one-sided) for the primary endpoint | Difference in seroconversion rates | 10.7 | | | 2-Sided | 95 | 3.7 | 17.6 | | | | Yes | Non-Inferiority or Equivalence | This study evaluated the non-inferiority of 0.5 mL Inflexal V and 0.25 mL Inflexal V in comparison to 0.25 mL Agrippal. Seroconversion rate was the primary endpoint. The difference in seroconversion rates between each Inflexal V and the control group was used for the evaluation of non-inferiority. If the lower limit of the 95% CI of this difference was greater than -10% for all 3 strains, the Inflexal V group was considered non-inferior to the control group. | |