| Primary | Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | Seropositivity rate was reported as percentage of participants with NT level greater than equal to (>=) 10 at 21-35 days after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent confidence interval (CI) was based upon the observed percentage of participants. | Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, "Number of participants analyzed" (N) signifies those participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 21-35 days after first TBE booster vaccination | | | | ID | Title | Description |
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| OG000 | FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000100.0(97.9 to 100.0)
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| Primary | Seropositivity Rate Measured by Neutralization Test (NT) at 38 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | Seropositivity rate was reported as percentage of participants with NT level >=10 at 38 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent confidence interval (CI) was based upon the observed percentage of participants. | Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 38 months after first TBE booster vaccination | | | | ID | Title | Description |
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| OG000 | FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study. |
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| Primary | Seropositivity Rate Measured by Neutralization Test (NT) at 46 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | Seropositivity rate was reported as percentage of participants with NT level >=10 at 46 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants. | Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 46 months after first TBE booster vaccination | | | | ID | Title | Description |
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| OG000 | FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study. |
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| Primary | Seropositivity Rate Measured by Neutralization Test (NT) at 58 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | Seropositivity rate was reported as percentage of participants with NT level >=10 at 58 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants. | Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 58 months after first TBE booster vaccination | | | | ID | Title | Description |
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| OG000 | FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study. |
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| Primary | Seropositivity Rate Measured by Neutralization Test (NT) at 70 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | Seropositivity rate was reported as percentage of participants with NT level >=10 at 70 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants. | Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 70 months after first TBE booster vaccination | | | | ID | Title | Description |
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| OG000 | FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study. |
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| Primary | Seropositivity Rate Measured by Neutralization Test (NT) at 82 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | Seropositivity rate was reported as percentage of participants with NT level >=10 at 82 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants. | Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 82 months after first TBE booster vaccination | | | | ID | Title | Description |
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| OG000 | FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study. |
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| Primary | Seropositivity Rate Measured by Neutralization Test (NT) at 94 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | Seropositivity rate was reported as percentage of participants with NT level >=10 at 94 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants. | Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 94 months after first TBE booster vaccination | | | | ID | Title | Description |
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| OG000 | FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study. |
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| Primary | Seropositivity Rate Measured by Neutralization Test (NT) at 106 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | Seropositivity rate was reported as percentage of participants with NT level >=10 at 106 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants. | Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 106 months after first TBE booster vaccination | | | | ID | Title | Description |
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| OG000 | FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study. |
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| Primary | Seropositivity Rate Measured by Neutralization Test (NT) at 118 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | Seropositivity rate was reported as percentage of participants with NT level >=10 at 118 months after the first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants. | Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. Here, "N" signifies those participants who were evaluable for this outcome measure. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 118 months after first TBE booster vaccination | | | | ID | Title | Description |
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| OG000 | FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study. |
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| Primary | Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 | Seropositivity rate was reported as percentage of participants with NT level >=10 at 21-35 days after the second TBE booster vaccination. Exact 2-sided 95 percent CI was based upon the observed percentage of participants. | Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 21-35 days after second TBE booster vaccination | | | | ID | Title | Description |
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| OG000 | FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study. |
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| Secondary | Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at Each Available Time Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | Seropositivity rate was reported as percentage of participants with ELISA level greater than (>) 126 vienna units per milliliter (VIE U/mL) at each blood sampling time point after first TBE booster vaccination in Study 700401. Exact 2-sided 95 percent CI was based upon the observed percentage of participants. | Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination | | | | ID | Title | Description |
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| OG000 | FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study. |
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| Secondary | Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 | Seropositivity rate was reported as percentage of participants with ELISA level >126 VIE U/mL at 21-35 days after second TBE booster vaccination. Exact 2-sided 95 percent CI was based upon the observed percentage of participants. | Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | 21-35 days after second TBE booster vaccination | | | | ID | Title | Description |
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| OG000 | FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study. |
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| Secondary | Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at Each Available Time-Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | Antibody against TBE booster vaccination was measured as geometric mean concentration (GMC) by ELISA level at different time points after first booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the concentrations. | Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. | Posted | | Geometric Mean | 95% Confidence Interval | VIE U/mL | | 21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination | | | | ID | Title | Description |
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| OG000 | FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study. |
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| Secondary | Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 | Antibody against TBE booster vaccination was measured as GMC by ELISA level after the second booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the concentrations. | Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. | Posted | | Geometric Mean | 95% Confidence Interval | VIE U/mL | | 21-35 days after second TBE booster vaccination | | | | ID | Title | Description |
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| OG000 | FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study. |
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| Secondary | Geometric Mean Titer Measured by Neutralization Test (NT) Each Available Time-Point Blood Draw After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 | Antibody against TBE booster vaccination was measured as geometric mean titer (GMT) by NT level at different time points after first booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers. | Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 21-35 days and 38, 46, 58, 70, 82, 94, 106, 118 months after first TBE booster vaccination | | | | ID | Title | Description |
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| OG000 | FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study. |
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| Secondary | Geometric Mean Titer Measured by Neutralization Test (NT) After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 | Antibody against TBE booster vaccination was measured as GMT by NT level after second booster vaccination. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers. | Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | 21-35 days after second TBE booster vaccination | | | | ID | Title | Description |
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| OG000 | FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study. |
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| Secondary | Geometric Mean Fold Rise (GMFR) in Antibody Concentrations After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | GMFR in antibody concentration from pre-booster (before second booster vaccination) to post-booster (21-35 days after TBE vaccination) was measured by ELISA. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers, concentrations or the fold rises. | Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. | Posted | | Geometric Mean | 95% Confidence Interval | Fold rise | | Before second booster vaccination (pre-vaccination), 21-35 days after second booster vaccination | | | | ID | Title | Description |
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| OG000 | FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study. |
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| Secondary | Geometric Mean Fold Rise (GMFR) in Antibody Titer After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Neutralization Test (NT) | GMFR in antibody titers from pre-booster (before second booster vaccination) to post-booster (21-35 days after TBE vaccination) was measured by ELISA. CIs were computed by back transforming the CIs based on the Student t distribution for the mean logarithm of the titers, concentrations or the fold rises. | Per-protocol population included participants who had been enrolled and meet all inclusion/exclusion criteria at all visits, had available assay results at any blood sampling visit and had no other major protocol deviation. | Posted | | Geometric Mean | 95% Confidence Interval | Fold rise | | Before second booster vaccination (pre-vaccination), 21-35 days after second booster vaccination | | | | ID | Title | Description |
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| OG000 | FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study. |
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| Secondary | Number of Participants With Injection Site Reactions and Systemic Reactions After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 | Injection site reactions included swelling, induration, redness, injection site pain, tenderness, ecchymosis and hematoma. Systemic reaction included headache, nausea, vomiting, muscle pain, joint pain, swelling of the lymph nodes, malaise and fatigue. Participants with any injection site reaction and systemic reaction after second TBE booster vaccination in Study 700802 were reported in this outcome measure. | The safety population included any participant who had received the second booster dose. | Posted | | Number | | Participants | | From second booster vaccination up to 21-35 days after the vaccination | | | | ID | Title | Description |
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| OG000 | FSME-IMMUN 0.25 Milliliters (mL) Junior/0.5 mL | Participants with low tick-borne encephalitis (TBE) serum antibody levels and received first booster vaccination in Study 700401 (NCT00161967) were administered single intramuscular injection of FSME-IMMUN 0.25 mL Junior (less than 16 years of age) or FSME-IMMUN 0.5 mL (16 years or above of age), as second booster vaccination in this study either at Month 40, 48, 60, 72, 84, 96, 108, or 120. Participants were followed up to 21-35 days post vaccination in this study. |
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