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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-001356-59 | EudraCT Number |
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The purpose of this study is to continue the evaluation of antibody persistence through 11 to 15 years after first booster with Tick-Borne Encephalitis (TBE) vaccine. This study will further investigate the booster response in subjects who will receive their second booster dose* in this study.
* Any booster given in this study will be the second that the subject has received (with regard to the follow-up of the previous study).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Group | Experimental | Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10. |
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| Accelerated/Rapid Group | Experimental | Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. |
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| Accelerated Conventional Group | Experimental | Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Encepur Adults | Biological | One dose of the vaccine can be administered at any one unscheduled visit depending on the detection of NT below 10. It will be administered intramuscularly into the non-dominant deltoid. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 11 | Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers >= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period. | At Year 11 |
| Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 12 | Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers >= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period. | At Year 12 |
| Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 13 | Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers >= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period. | At Year 13 |
| Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 14 | Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers >= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period. | At Year 14 |
| Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 15 | Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers >= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 2 and Equal to or Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group | Immunogenicity was planned to be measured in terms of percentage of participants with TBE Neutralizing Antibody Titers >= 2 and >= 10 at 21 days after the booster vaccination. | At 21 days after the booster vaccination |
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Inclusion Criteria:
Inclusion criteria for all subjects:
Additional inclusion criteria for subjects who will need a second booster dose:
Exclusion Criteria:
Each subject must not be:
Each subject must not have:
Each subject who will receive the second booster vaccination in this study additionally to the exclusion criteria above must not have:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Hradec Králové | 50002 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37142462 | Background | Beran J, Lattanzi M, Costantini M, Pammolli A, Galgani I. Sustained antibody persistence for at least 15 years after a booster vaccination against tick-borne encephalitis following different primary vaccination schedules: Third 5-year follow-up. Vaccine. 2023 May 26;41(23):3518-3524. doi: 10.1016/j.vaccine.2023.04.061. Epub 2023 May 3. |
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No participant received vaccination in study V48P7E2 (NCT01562444).
194 subjects, who participated in study V48P7E2(NCT01562444), received in a parent V48P7 study one of the following primary schedules: rapid(R), conventional(C), or accelerated conventional(AC), who received a booster dose in study V48P7E1(NCT00387634) or before study V48P7E1(only R-schedule), and agreed to participate in this study, were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Group | Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 23, 2018 | Oct 21, 2022 |
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All subjects will come to the yearly scheduled blood draw visit for investigation of 11 to 15 year persistence of Neutralization Test (NT) titres. Subjects who have an NT titre below 10 at one of the scheduled visits will receive a second booster dose 6 months after this visit at an unscheduled visit. Subsequent data of these subjects will be analysed separately in a subgroup.
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| At Year 15 |
| Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 11 | Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 11. GMTs were assessed for following age subgroups: 25 to 49 years, equal to or above (>=) 50 years and >= 60 years. | At Year 11 |
| Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 12 | Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 12. GMTs were assessed for following age subgroups: 25 to 49 years, >= 50 years and >= 60 years. | At Year 12 |
| Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 13 | Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 13. GMTs were assessed for following age subgroups: 25 to 49 years, >= 50 years and >= 60 years. | At Year 13 |
| Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 14 | Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 14. GMTs were assessed for following age subgroups: 25 to 49 years, >= 50 years and >= 60 years. | At Year 14 |
| Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 15 | Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 15. GMTs were assessed for following age subgroups: 25 to 49 years, >= 50 years and >= 60 years. | At Year 15 |
| Geometric Mean Antibody Titers (GMTs) as Measured by GSK Biologicals' NT, Overall and by Study Group | Immunogenicity was planned to be measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at 21 days after the booster vaccination. | At 21 days after the booster vaccination |
| Geometric Mean Ratios (GMRs) Blood Draw After/Before Booster as Measured by GSK Biologicals' NT, Overall and by Study Group | Immunogenicity was planned to be measured in terms of GMRs of serum TBE Neutralizing Antibody Titers at 21 days after the booster vaccination. | At 21 days after the booster vaccination |
| Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to and Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group | Immunogenicity was measured in terms of percentage of participants with TBE Neutralizing Antibody Titers >= 10 from Year 1 to Year 15. | From Year 1 up to Year 15 |
| Number of Participants With Serious Adverse Events (SAEs) | SAEs are defined as any untoward medical occurrence that results in death, is life- threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. | From Day 0 to Day 21 after booster vaccination |
| FG001 | Accelerated/Rapid Group | Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. |
| FG002 | Accelerated Conventional Group | Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional Group | Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10. |
| BG001 | Accelerated/Rapid Group | Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. |
| BG002 | Accelerated Conventional Group | Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 11 | Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers >= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period. | The analysis was performed on the Per Protocol set-1 (PPS-1) which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Year 11 |
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| Primary | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 12 | Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers >= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period. | The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Year 12 |
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| Primary | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 13 | Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers >= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period. | The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Year 13 |
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| Primary | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 14 | Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers >= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period. | The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Year 14 |
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| Primary | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 10 at Year 15 | Antibody titers were measured by GSK Biologicals' Neutralization test. Analysis of the percentages of participants with antibody titers >= 2 was not performed as planned in the protocol, as only 3 participants had antibody titers between 2 and 10 during the whole study period. | The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation. | Posted | Number | 95% Confidence Interval | Percentage of participants | At Year 15 |
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| Primary | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 11 | Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 11. GMTs were assessed for following age subgroups: 25 to 49 years, equal to or above (>=) 50 years and >= 60 years. | The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Year 11 |
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| Primary | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 12 | Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 12. GMTs were assessed for following age subgroups: 25 to 49 years, >= 50 years and >= 60 years. | The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Year 12 |
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| Primary | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 13 | Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 13. GMTs were assessed for following age subgroups: 25 to 49 years, >= 50 years and >= 60 years. | The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Year 13 |
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| Primary | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 14 | Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 14. GMTs were assessed for following age subgroups: 25 to 49 years, >= 50 years and >= 60 years. | The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Year 14 |
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| Primary | Geometric Mean Antibody Titers (GMTs) by Age Categories at Year 15 | Immunogenicity was measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at Year 15. GMTs were assessed for following age subgroups: 25 to 49 years, >= 50 years and >= 60 years. | The analysis was performed on the PPS-1 which consisted of all participants who provided evaluable serum samples at the relevant time points and have no major protocol violation. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Year 15 |
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| Secondary | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to or Above 2 and Equal to or Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group | Immunogenicity was planned to be measured in terms of percentage of participants with TBE Neutralizing Antibody Titers >= 2 and >= 10 at 21 days after the booster vaccination. | The analysis was planned to be performed on the PPS-2 which consisted of all participants who provided evaluable serum samples after booster dose and have no major protocol violation. However only 1 participant received the booster dose, therefore the analysis was not performed. | Posted | At 21 days after the booster vaccination |
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| Secondary | Geometric Mean Antibody Titers (GMTs) as Measured by GSK Biologicals' NT, Overall and by Study Group | Immunogenicity was planned to be measured in terms of GMTs of serum TBE Neutralizing Antibody Titers at 21 days after the booster vaccination. | The analysis was planned to be performed on the PPS-2 which consisted of all subjects who provided evaluable serum samples after booster dose and have no major protocol violation. However only 1 participant received the booster dose, therefore the analysis was not performed. | Posted | At 21 days after the booster vaccination |
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| Secondary | Geometric Mean Ratios (GMRs) Blood Draw After/Before Booster as Measured by GSK Biologicals' NT, Overall and by Study Group | Immunogenicity was planned to be measured in terms of GMRs of serum TBE Neutralizing Antibody Titers at 21 days after the booster vaccination. | The analysis was planned to be performed on the PPS-2 which consisted of all subjects who provided evaluable serum samples after booster dose and have no major protocol violation. However only 1 participant received the booster dose, therefore the analysis was not performed. | Posted | At 21 days after the booster vaccination |
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| Secondary | Percentage of Participants With Detectable TBE Neutralizing Antibody Titers Equal to and Above 10 as Measured by GSK Biologicals' NT, Overall and by Study Group | Immunogenicity was measured in terms of percentage of participants with TBE Neutralizing Antibody Titers >= 10 from Year 1 to Year 15. | The analysis was performed on the set of subjects who completed the entire 15-year follow-up with no protocol deviations related to the persistence analysis. Here, 'number analyzed' = participants with available data for each specified category. | Posted | Number | 95% Confidence Interval | Percentage of participants | From Year 1 up to Year 15 |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) | SAEs are defined as any untoward medical occurrence that results in death, is life- threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. | The analysis was performed on the Safety population which included all subjects who received a booster vaccination in this study. Only one participant (from the Conventional Group) received a booster dose. | Posted | Count of Participants | Participants | From Day 0 to Day 21 after booster vaccination |
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Serious adverse events that led to withdrawal or were related to study vaccination were collected throughout the study period (Year 11 to Year 15). Other serious adverse events were collected only after the booster vaccination administration (Day 0-Day 21).
Other adverse events were not collected as per protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional Group | Participants who received primary vaccination in study V48P7 on Days 0, 28 (+10) and 300 (+21) (55 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (55 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their Neutralization Test (NT) titer resulted below 10. | 1 | 50 | 1 | 50 | 0 | 0 |
| EG001 | Accelerated/Rapid Group | Participants who received primary vaccination in study V48P7 on Days 0, 7 (+3) and 21 (+7) (66 participants) and who received a booster vaccination either in study V48P7E1 (NCT00387634) (9 participants) or before enrolment in study V48P7E1 (NCT00387634) (40 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. | 0 | 43 | 0 | 43 | 0 | 0 |
| EG002 | Accelerated Conventional Group | Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. | 1 | 101 | 1 | 101 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death due to glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Death due to primary COVID-19 pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
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GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 4, 2017 | Oct 21, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
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| Male |
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| OG002 | Accelerated Conventional Group | Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. |
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| OG002 | Accelerated Conventional Group | Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. |
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| OG002 | Accelerated Conventional Group | Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. |
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| OG002 | Accelerated Conventional Group | Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. |
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| OG002 | Accelerated Conventional Group | Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. |
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| OG002 | Accelerated Conventional Group | Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. |
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| OG002 | Accelerated Conventional Group | Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. |
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| OG002 | Accelerated Conventional Group | Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. |
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| OG002 | Accelerated Conventional Group | Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. |
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| OG002 | Accelerated Conventional Group | Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. |
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| OG002 | Accelerated Conventional Group | Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. |
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| OG002 | Accelerated Conventional Group | Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. |
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| OG002 | Accelerated Conventional Group | Participants who received primary vaccination in study V48P7 on Days 0, 14 (+3) and 300 (+21) (133 participants) and who received a booster vaccination in study V48P7E1 (NCT00387634) (109 participants). For these participants a second booster vaccination within six months after the annual blood draw was to be administered within the present study only in case their NT titer resulted below 10. |
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