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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003729-16 | EudraCT Number |
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The purpose of this study is to evaluate the persistence of immune response against the three pertussis antigens (anti- pertussis toxoid (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN)) in subjects who received a booster dose of either aP or Tdap study vaccines or Boostrix® during V113_01 study.
There was only one Clinic Visit at day 1. Eligible subjects went undergo a single blood draw after which they were observed for approximately 15 minutes. Approximately 10.0 mL of blood was withdrawn.
No vaccine was administered and no safety data was collected in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Subjects received acellular pertussis (aP) vaccine with different antigen dose formulations: low dose of PT, FHA, PRN, followed by one fixed dose of diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany) administered one month apart. |
|
| Group 2 | Experimental | Subjects received acellular pertussis (aP) vaccine with different antigen dose formulations: medium dose of PT, FHA, PRN, followed by one fixed dose of diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany) administered one month apart. |
|
| Group 3 | Experimental | Subjects received acellular pertussis (aP) vaccine with different antigen dose formulations: high dose of PT, FHA, PRN, followed by one fixed dose of diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany) administered one month apart |
|
| Group 4 | Experimental | Subjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: low dose of PT, FHA, PRN, low dose of D (diphteria) toxoid, fixed dose of T (tetanus) toxoid, followed by one administration of saline solution one month apart. |
|
| Group 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aP booster | Biological | Acellular pertussis vaccine: Acellular pertussis (aP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm. Biological: Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany) To ensure all subjects receive a tetanus and diphtheria booster vaccination, an injection was administered on Study Day 30, one month after the administration of the investigational vaccine. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1. | The antibody response against the pertussis antigen components (PT, FHA and PRN) at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in aP1, aP2, aP4 Groups versus the response to the commercially available Tdap comparator. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups. | Day 1 |
| Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1. | The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D2aP1, T5D2aP2 and T5D2aP4 Groups versus the response to the commercially available Tdap comparator. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups. | Day 1 |
| Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1. | The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D4aP1, T5D4aP2 and T5D4aP4 Groups versus the response to the commercially available Tdap comparator. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups. | Day 1 |
| Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. |
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Inclusion Criteria:
Exclusion Criteria:
Clinical conditions representing a contraindication to blood draw.
Abnormal function of the immune system resulting from:
Received immunoglobulins or any blood products within 180 days prior to informed consent.
Received an investigational or non-registered medicinal product within 30 days prior to informed consent
Study personnel as an immediate family or household member
Any other clinical condition that, in the opinion of the investigator, could interfere with the results of the study or pose additional risk to the subject due to participation in the study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 02, Center for Vaccinology (CEVAC), Ghent University Hospital | Ghent | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29172945 | Derived | Leroux-Roels G, Lattanzi M, Solis CD, Contorni M, Costantini M, Moraschini L, Bardelli M, Bertholet S, Borgogni E, Buricchi F, Cantisani R, Faenzi E, Finco O, Leuzzi R, Pizza M, Rosa D, Schiavetti F, Seubert A, Spensieri F, Volpini G, Zedda L, Giudice GD, Galgani I. A phase I, randomized, controlled, dose-ranging study of investigational acellular pertussis (aP) and reduced tetanus-diphtheria-acellular pertussis (TdaP) booster vaccines in adults. Hum Vaccin Immunother. 2018 Jan 2;14(1):45-58. doi: 10.1080/21645515.2017.1385686. Epub 2017 Nov 27. |
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All enrolled subjects were included in the trial.
Subjects were enrolled at one site in Belgium.
- V113_01 parent study number: NCT01529645
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| ID | Title | Description |
|---|---|---|
| FG000 | Group aP1 | Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| FG001 | Group aP2 | Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| FG002 | Group aP4 | Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| FG003 | Group T5D2aP1 | Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| FG004 | Group T5D2aP2 | Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| FG005 | Group T5D2aP4 | Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| FG006 | Group T5D4aP1 | Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| FG007 | Group T5D4aP2 | Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| FG008 | Group T5D4aP4 | Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| FG009 | Licensed Tdap | Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group aP1 | Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| BG001 | Group aP2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1. | The antibody response against the pertussis antigen components (PT, FHA and PRN) at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in aP1, aP2, aP4 Groups versus the response to the commercially available Tdap comparator. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups. | Analysis were done on per protocol set (PPS) i.e., All subjects in the all enrolled set who provided immunogenicity data at V113_01E1 visit 1 and:
| Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Day 1 |
|
No Adverse Events data were collected in this study.
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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 | Group aP1 | Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines and Diagnostics | RegistryContactVaccinesUS@novartis.com |
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| ID | Term |
|---|---|
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C505143 | Boostrix |
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| Experimental |
Subjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: medium dose of PT, FHA, PRN, low dose of D toxoid, fixed dose of T toxoid, followed by one administration of saline solution one month apart. |
|
| Group 6 | Experimental | Subjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: high dose of PT, FHA, PRN, low dose of D toxoid, fixed dose of T toxoid, followed by one administration of saline solution one month apart. |
|
| Group 7 | Experimental | Subjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: low dose of PT, FHA, PRN, double dose of D toxoid, fixed dose of T toxoid, followed by one administration of saline solution one month apart. |
|
| Group 8 | Experimental | Subjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: medium dose of PT, FHA, PRN, double dose of D toxoid, fixed dose of T toxoid, followed by one administration of saline solution one month apart |
|
| Group 9 | Experimental | Subjects received tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) with different antigen dose formulations: high dose of PT, FHA, PRN, double dose of D toxoid, fixed dose of T toxoid, followed by one administration of saline solution one month apart. |
|
| Group 10 | Active Comparator | Subject received one dose of a licensed TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) followed by one administration of saline solution one month apart |
|
|
| TdaP booster | Biological | Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) Tetanus, reduced diphtheria, and acellular pertussis (TdaP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm. Other: Saline solution Subjects received one injection of saline solution at one month after vaccination. |
|
| Licensed TdaP booster (Boostrix®) | Biological | Licensed TdaP booster vaccine Licenced TdaP booster vaccine was administered intramuscularly in the upper deltoid region of the subject's non-dominant arm. Other: Saline solution Subjects received one injection of saline solution at one month after vaccination. |
|
Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups. |
| Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1 |
| Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups. | Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1 |
| Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups. | Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1 |
Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| BG002 | Group aP4 | Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| BG003 | Group T5D2aP1 | Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| BG004 | Group T5D2aP2 | Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| BG005 | Group T5D2aP4 | Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| BG006 | Group T5D4aP1 | Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| BG007 | Group T5D4aP2 | Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| BG008 | Group T5D4aP4 | Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| BG009 | Licensed Tdap | Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| BG010 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| Group aP1 |
Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| OG001 | Group aP2 | Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| OG002 | Group aP4 | Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
| OG003 | Licensed Tdap | Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. |
|
|
| Primary | Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1. | The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D2aP1, T5D2aP2 and T5D2aP4 Groups versus the response to the commercially available Tdap comparator. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups. | Analysis were done on per protocol set. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Day 1 |
|
|
|
| Primary | Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1. | The antibody response against the pertussis antigen components (PT, FHA and PRN) in serum at day 1 as measured by Multiplex ELISA and reported as Geometric Mean Concentrations (GMCs) in T5D4aP1, T5D4aP2 and T5D4aP4 Groups versus the response to the commercially available Tdap comparator. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups. | Analysis were done on per protocol set. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Day 1 |
|
|
|
| Primary | Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups. | Analysis were done on per protocol set. Note: Number of participants analyzed for Day 1 of V113_01E1/ Day 180 of V113_01 PT, FHA and PRN was 27, 32, 31, 32 respectively. | Posted | Geometric Mean | 95% Confidence Interval | Ratios | Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1 |
|
|
|
| Primary | Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups. | Analysis were done on per protocol set | Posted | Geometric Mean | 95% Confidence Interval | Ratios | Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1 |
|
|
|
| Primary | Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points. | Geometric Mean Ratios of anti-PT, anti-FHA and anti-PRN antibody were calculated to measure the changes in immunogenicity concentrations within subjects from all V113_01 time points to V113_01E1 day 1. Note: The mean and confidence intervals of Licensed Tdap for the same antigen can be different (from aP to Tdap table) since two different statistical model were fitted within each antigen: one with aP and Licensed Tdap groups and one with Tdap and Licensed Tdap groups. | Analysis were done on per protocol set. Note: Number of participants analyzed for Day 1 of V113_01E1/ Day 180 of V113_01 FHA and PRN was 33, 28, 28, 32 respectively. | Posted | Geometric Mean | 95% Confidence Interval | Ratios | Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Group aP2 | Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. | 0 | 0 | 0 | 0 |
| EG002 | Group aP4 | Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. | 0 | 0 | 0 | 0 |
| EG003 | Group T5D2aP1 | Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. | 0 | 0 | 0 | 0 |
| EG004 | Group T5D2aP2 | Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. | 0 | 0 | 0 | 0 |
| EG005 | Group T5D2aP4 | Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. | 0 | 0 | 0 | 0 |
| EG006 | Group T5D4aP1 | Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. | 0 | 0 | 0 | 0 |
| EG007 | Group T5D4aP2 | Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. | 0 | 0 | 0 | 0 |
| EG008 | Group T5D4aP4 | Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. | 0 | 0 | 0 | 0 |
| EG009 | Licensed Tdap | Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study. | 0 | 0 | 0 | 0 |
The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| FHA |
|
| PRN |
|
| FHA |
|
| PRN |
|
| Day 1 of V113_01E1/ Day 8 of V113_01 (PT) |
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| Day 1 of V113_01E1/ Day 30 of V113_01 (PT) |
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| Day 1 of V113_01E1/ Day 180 of V113_01 (PT) |
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| Day 1 of V113_01E1/ Day 365 of V113_01 (PT) |
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| Day 1 of V113_01E1/ Day 1 of V113_01 (FHA) |
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| Day 1 of V113_01E1/ Day 8 of V113_01 (FHA) |
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| Day 1 of V113_01E1/ Day 30 of V113_01 (FHA) |
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| Day 1 of V113_01E1/ Day 180 of V113_01 (FHA) |
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| Day 1 of V113_01E1/ Day 365 of V113_01 (FHA) |
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| Day 1 of V113_01E1/ Day 1 of V113_01 (PRN) |
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| Day 1 of V113_01E1/ Day 8 of V113_01 (PRN) |
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| Day 1 of V113_01E1/ Day 30 of V113_01 (PRN) |
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| Day 1 of V113_01E1/ Day 180 of V113_01 (PRN) |
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| Day 1 of V113_01E1/ Day 365 of V113_01 (PRN) |
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| Day 1 of V113_01E1/ Day 8 of V113_01 (PT) |
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| Day 1 of V113_01E1/ Day 30 of V113_01 (PT) |
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| Day 1 of V113_01E1/ Day 180 of V113_01 (PT) |
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| Day 1 of V113_01E1/ Day 365 of V113_01 (PT) |
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| Day 1 of V113_01E1/ Day 1 of V113_01 (FHA) |
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| Day 1 of V113_01E1/ Day 8 of V113_01 (FHA) |
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| Day 1 of V113_01E1/ Day 30 of V113_01 (FHA) |
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| Day 1 of V113_01E1/ Day 180 of V113_01 (FHA) |
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| Day 1 of V113_01E1/ Day 365 of V113_01 (FHA) |
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| Day 1 of V113_01E1/ Day 1 of V113_01 (PRN) |
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| Day 1 of V113_01E1/ Day 8 of V113_01 (PRN) |
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| Day 1 of V113_01E1/ Day 30 of V113_01 (PRN) |
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| Day 1 of V113_01E1/ Day 180 of V113_01 (PRN) |
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| Day 1 of V113_01E1/ Day 365 of V113_01 (PRN) |
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| Day 1 of V113_01E1/ Day 8 of V113_01 (PT) |
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| Day 1 of V113_01E1/ Day 30 of V113_01 (PT) |
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| Day 1 of V113_01E1/ Day 180 of V113_01 (PT) |
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| Day 1 of V113_01E1/ Day 365 of V113_01 (PT) |
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| Day 1 of V113_01E1/ Day 1 of V113_01 (FHA) |
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| Day 1 of V113_01E1/ Day 8 of V113_01 (FHA) |
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| Day 1 of V113_01E1/ Day 30 of V113_01 (FHA) |
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| Day 1 of V113_01E1/ Day 180 of V113_01 (FHA) |
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| Day 1 of V113_01E1/ Day 365 of V113_01 (FHA) |
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| Day 1 of V113_01E1/ Day 1 of V113_01 (PRN) |
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| Day 1 of V113_01E1/ Day 8 of V113_01 (PRN) |
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| Day 1 of V113_01E1/ Day 30 of V113_01 (PRN) |
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| Day 1 of V113_01E1/ Day 180 of V113_01 (PRN) |
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| Day 1 of V113_01E1/ Day 365 of V113_01 (PRN) |
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