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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000688-28 | EudraCT Number |
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This study will evaluate the safety and efficacy of 9 different vaccines containing aP (acellular pertussis) and TdaP (acellular pertussis, tetanus and diphtheria) in healthy subjects 18 to 40 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: aP booster | 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. |
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| Group 2: aP booster | 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. |
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| Group 3: aP booster | 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. |
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| Group 4: TdaP booster | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acellular pertussis vaccine | Biological | Acellular pertussis (aP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed and compared to that of licensed comparator in terms of the number of subjects reporting solicited local and systemic adverse events and other adverse events after vaccination. | Day 1 through 7 after vaccination |
| The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed in terms of the number of subjects reporting any unsolicited adverse events (AEs) between day 1 to day 30 , serious adverse events (SAEs) and AEs leading to premature withdrawal between day 1 to day 365, after vaccination. | From day 1 to day 365 |
| Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) on aP booster groups, against pertussis antigens pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), following vaccination with different antigenic formulations of aP versus the response to the commercially available comparator are reported. | Day 1 (baseline) and Day 30 post vaccination |
| GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP Booster Groups against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported. | Day 1 (baseline) and Day 30 post vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | Comparison of antibody responses against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of aP and TdaP booster vaccines and licensed comparator, are reported in terms of the percentages of subjects demonstrating 2- and 4-fold increase in GMCs from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
Individuals who had received vaccines containing T, D, or pertussis (aP or whole cell), been diagnosed with pertussis disease, or who have had a household exposure to pertussis within the past 8 years.
If female, "of childbearing potential", sexually active, and had not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry:
Of childbearing potential was defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.
Acceptable birth control methods were defined as one or more of the following:
If female of childbearing potential and sexually active, refusal to use an "acceptable contraceptive method" through to 3 weeks after last study vaccination.
Any positive or indeterminate pregnancy test.
Female individuals who were pregnant or breastfeeding.
Individuals with contraindications, warnings and/or precautions to vaccination with Boostrix or Td-pur as specified within the summary of product characteristics.
Individuals with a clinically significant active infection (as assessed by the investigator) or oral body temperature ≥38°C/100.4ºF within 3 days of the intended date of vaccination.
Known hypersensitivity or allergy to diphtheria, tetanus, or pertussis vaccine (including excipients of the investigational study vaccines, control or placebo as summarized in protocol section 5.0).
Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, might have interfered with the subject's ability to participate in the study.
Individuals with any progressive or severe neurologic disorder, seizure disorder or Guillian-Barré syndrome.
Individuals with history or any illness that, in the opinion of the investigator, might have interfered with the results of the study or pose additional risk to the individuals due to participation in the study.
Known or suspected impairment/alteration of immune function, including:
Abnormalities of splenic or thymic function.
Individuals with a known bleeding diathesis, or any condition that might have been associated with a prolonged bleeding time.
Individuals with any serious chronic or progressive disease according to judgment of the investigator (neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
Individuals with body mass index (BMI) greater than or equal to 35 kg/m2 (= weight in kg / (height in meters x height in meters)).
Individuals participating in any clinical trial with another investigational product 30 days prior to first study visit or with intent to participate in another clinical study at any time during the conduct of this study.
Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who were planning to receive any vaccine other than Td or placebo within 28 days from the study vaccines.
Individuals who were first degree relatives of subjects involved in trial conduct.
Individuals with history of substance or alcohol abuse within the past 2 years.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Geert Leroux-Roels, Prof. Dr. | Center for Vaccinology (CEVAC), Ghent University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Vaccinology (CEVAC), Ghent University Hospital | De Pintelaan | B-9000 Ghent | 185 | 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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| 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 day 1 of this study. |
| FG001 | Group aP2 | Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Group 5: TdaP booster | 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: TdaP booster | 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: TdaP booster | 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. |
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| Group 8: TdaP booster | 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: TDaP booster | 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: Licensed TdaP booster | 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. |
|
| Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) | Biological | 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. |
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| Licensed TdaP booster vaccine | Biological | Licenced TdaP booster vaccine was administered intramuscularly in the upper deltoid region of the subject's non-dominant arm. |
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| Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany) | Biological | 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. |
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| Saline solution | Other | Subjects received one injection of saline solution at one month after vaccination. |
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| GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP booster groups, against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported. | Day 1 (baseline) and Day 30 post vaccination |
| Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens | The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for different antigenic formulations of aP booster vaccines and for licensed comparator are reported. | Day 30 post vaccination/baseline (Day 1) |
| GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens | The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported. | Day 30 post vaccination/baseline (Day 1) |
| GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens | The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported. | Day 30 post vaccination/baseline (Day 1) |
| Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | The percentages of subjects demonstrating diphtheria and tetanus antitoxin units >= 0.1/mL following vaccination with different antigenic formulations of TdaP booster vaccine, is compared to the response to commercially available comparator. | Day 1 (baseline) and Day 30 post vaccination |
| Day 30 post vaccination |
| GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | The GMCs of antibodies against diphtheria and tetanus antigens following vaccination with different formulations of TdaP booster are compared with the response to the commercially available comparator. | Day 1 (baseline) and Day 30 post vaccination |
| GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | The GMRs of post vaccination versus pre vaccination GMCs of antibodies against diphtheria and tetanus antigens for different formulations of TdaP booster and commercially available comparator versus GMCs at baseline are reported. | Day 30 post vaccination/Day 1 |
| FG002 | Group aP4 | Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this 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 day 1 of this 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 day 1 of this 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 day 1 of this 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 day 1 of this 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 day 1 of this 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 day 1 of this 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 day 1 of this study. |
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Analysis was done on the all enrolled set, ie, all subjects who have signed an informed consent, undergone screening procedures and were randomized.
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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 day 1 of this study. |
| BG001 | Group aP2 | Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study. |
| BG002 | Group aP4 | Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this 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 and a fixed dose of tetanus toxoid) on day 1 of this 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 day 1 of this 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 day 1 of this 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 day 1 of this 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 day 1 of this 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 day 1 of this 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 day 1 of this study. |
| BG010 | 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, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | 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 | |||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed and compared to that of licensed comparator in terms of the number of subjects reporting solicited local and systemic adverse events and other adverse events after vaccination. | Analysis was done on the safety set, ie, all subjects who received the study vaccination and provided post vaccination safety data. | Posted | Number | participants | Day 1 through 7 after vaccination |
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| Primary | The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine | The safety profiles of different antigenic formulations of the aP and TdaP booster vaccines were assessed in terms of the number of subjects reporting any unsolicited adverse events (AEs) between day 1 to day 30 , serious adverse events (SAEs) and AEs leading to premature withdrawal between day 1 to day 365, after vaccination. | Analysis was done on the safety set. | Posted | Number | participants | From day 1 to day 365 |
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| Primary | Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination | The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) on aP booster groups, against pertussis antigens pertussis toxoid (PT), filamentous hemagglutinin (FHA), pertactin (PRN), following vaccination with different antigenic formulations of aP versus the response to the commercially available comparator are reported. | Analysis was done on the per-protocol population, ie, all subjects who correctly received the vaccine, and provided evaluable serum samples at the relevant time points and had no major protocol violation as defined prior to unblinding. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Day 1 (baseline) and Day 30 post vaccination |
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| Primary | GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination | The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP Booster Groups against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported. | Analysis was done on the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Day 1 (baseline) and Day 30 post vaccination |
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| Primary | GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination | The GMCs of antibodies as measured by enzyme-linked immunosorbent assay (ELISA) in TdaP booster groups, against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of TdaP booster versus the response to the commercially available comparator are reported. | Analysis was done on the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Day 1 (baseline) and Day 30 post vaccination |
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| Secondary | Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination. | Comparison of antibody responses against pertussis antigens (PT, FHA and PRN), following vaccination with different antigenic formulations of aP and TdaP booster vaccines and licensed comparator, are reported in terms of the percentages of subjects demonstrating 2- and 4-fold increase in GMCs from baseline. | Analysis was done on the per-protocol population. | Posted | Number | 95% Confidence Interval | percentage of subjects | Day 30 post vaccination |
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| Secondary | GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination | The GMCs of antibodies against diphtheria and tetanus antigens following vaccination with different formulations of TdaP booster are compared with the response to the commercially available comparator. | Analysis was done on the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | Day 1 (baseline) and Day 30 post vaccination |
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| Secondary | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens | The GMRs of post vaccination versus pre vaccination GMCs of antibodies against diphtheria and tetanus antigens for different formulations of TdaP booster and commercially available comparator versus GMCs at baseline are reported. | Analysis was done on the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 30 post vaccination/Day 1 |
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| Primary | Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens | The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for different antigenic formulations of aP booster vaccines and for licensed comparator are reported. | Analysis was done on the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 30 post vaccination/baseline (Day 1) |
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| Primary | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens | The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported. | Analysis was done on the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 30 post vaccination/baseline (Day 1) |
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| Primary | GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens | The GMRs of post-vaccination versus pre-vaccination GMCs of antibodies against pertussis antigens (PT, FHA and PRN) for TdaP booster groups and for licensed comparator are reported. | Analysis was done on the per-protocol population. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 30 post vaccination/baseline (Day 1) |
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| Primary | Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination | The percentages of subjects demonstrating diphtheria and tetanus antitoxin units >= 0.1/mL following vaccination with different antigenic formulations of TdaP booster vaccine, is compared to the response to commercially available comparator. | Analysis was done on the per-protocol population. | Posted | Number | 95% Confidence Interval | percentages of subjects | Day 1 (baseline) and Day 30 post vaccination |
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Solicited and unsolicited AEs collected from Day 1 to Day 7; SAEs, medically attended AEs and AEs leading to withdrawal collected from Day 1 to Day 365.
Analysis was done on the safety population; two subjects, in groups aP4 and T5D4aP1were excluded for not providing any postbaseline safety data. Solicited AEs are categorized as systematic and unsolicited AEs are categorized as non-systematic.
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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 day 1 of this study. | 4 | 42 | 36 | 42 | ||
| EG001 | Group aP2 | Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study. | 1 | 42 | 39 | 42 | ||
| EG002 | Group aP4 | Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study. | 1 | 41 | 36 | 41 | ||
| 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 and a fixed dose of tetanus toxoid) on day 1 of this study. | 1 | 42 | 38 | 42 | ||
| 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 day 1 of this study. | 0 | 42 | 41 | 42 | ||
| 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 day 1 of this study. | 1 | 42 | 42 | 42 | ||
| 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 day 1 of this study. | 1 | 41 | 40 | 41 | ||
| 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 day 1 of this study. | 2 | 42 | 39 | 42 | ||
| 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 day 1 of this study. | 2 | 42 | 40 | 42 | ||
| 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 day 1 of this study. | 1 | 42 | 36 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peritonsillar abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tonsillitis streptococcal | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Polymyalgia rheumatica | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Dysthymic disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Axillary pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site induration | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site movement impairment | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Posting Director | Novartis Vaccines | RegistryContactVaccinesUS@novartis.com |
| ID | Term |
|---|---|
| D014917 | Whooping Cough |
| D013742 | Tetanus |
| D014313 | Trismus |
| D004165 | Diphtheria |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D013035 | Spasm |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
| Male |
|
| Injection site erythema |
|
| Injection site induration |
|
| Injection site pruritus |
|
| Injection site pain |
|
| Any Systemic |
|
| Nausea |
|
| Fatigue |
|
| Generalized myalgia |
|
| Generalized arthralgia |
|
| Headache |
|
| Any Other |
|
| Body temperature (≥40°C) |
|
| Prophylactic use of analgesic/antipyretic |
|
| Therapeutic use of analgesic/antipyretic |
|
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study. |
| OG004 | 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 day 1 of this study. |
| OG005 | 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 day 1 of this study. |
| OG006 | 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 day 1 of this study. |
| OG007 | 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 day 1 of this study. |
| OG008 | 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 day 1 of this study. |
| OG009 | 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 day 1 of this 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 day1 of this 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 day1 of this 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 day 1 of this study. |
|
|
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study. |
| OG004 | 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 day 1 of this study. |
| OG005 | 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 day 1 of this study. |
| OG006 | 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 day 1 of this study. |
| OG007 | 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 day 1 of this study. |
| OG008 | 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 day 1 of this study. |
| OG009 | 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 day 1 of this study. |
|
|
| OG004 | 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 day 1 of this study. |
| OG005 | 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 day 1 of this study. |
| OG006 | 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 day 1 of this study. |
| OG007 | 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 day 1 of this study. |
| OG008 | 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 day 1 of this study. |
| OG009 | 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 day 1 of this study. |
|
|
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
| OG004 | 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 day 1 of this study. |
| OG005 | 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 day 1 of this study. |
| OG006 | 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 day 1 of this study. |
| OG007 | 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 day 1 of this study. |
| OG008 | 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 day 1 of this study. |
| OG009 | 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 day 1 of this study. |
|
|
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 day1 of this 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 day1 of this 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 day 1 of this study. |
|
|
Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
| OG004 | 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 day 1 of this study. |
| OG005 | 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 day 1 of this study. |
| OG006 | 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 day 1 of this study. |
| OG007 | 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 day 1 of this study. |
| OG008 | 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 day 1 of this study. |
| OG009 | 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 day 1 of this study. |
|
|