Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Acellular pertussis vaccine · 1 trial · 5 indications
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.
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.
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.
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Licensed TdaP booster vaccine | BIOLOGICAL | Licenced TdaP booster vaccine was administered intramuscularly in the upper deltoid region of the subject's non-dominant arm. |
| 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. |
| Saline solution | OTHER | Subjects received one injection of saline solution at one month after vaccination. |
Inclusion Criteria: 1. Healthy male and female individuals between 18 and 40 years of age (inclusive) who had provided informed consent. 2. Individuals who were able to be contacted for the duration of the study. Exclusion Criteria: 1. Individuals who had received vaccines containing T, D, or per...
The acellular pertussis vaccine is a vaccine designed to protect against pertussis, also known as whooping cough. Novartis AG is developing this vaccine candidate, which is in Phase 1 clinical development. It is intended for use in healthy adults and is being studied as a booster vaccine, including in combination with tetanus and diphtheria components.
The acellular pertussis vaccine is being developed for the prevention of pertussis, commonly called whooping cough. The Phase 1 trial also listed tetanus and diphtheria among the conditions studied, reflecting a combination booster approach. It is intended for healthy adults ages 18 to 40 years.
Novartis AG, which trades under the ticker NVS, is the developer of this acellular pertussis vaccine candidate. The company sponsored the Phase 1 clinical trial evaluating the vaccine in healthy adults.
The acellular pertussis vaccine is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The vaccine is investigational and has not been approved by the FDA.
The acellular pertussis vaccine has been studied in one completed Phase 1 trial, NCT01529645. Titled a safety and dose ranging study of acellular pertussis and acellular pertussis-tetanus-diphtheria booster vaccines, it enrolled 420 healthy adults ages 18 to 40 in Belgium. It was randomized, double blind, and active controlled.