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Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed · 3 trials · 4 indications
Anti-diphtheria antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)
Anti-tetanus antibody concentrations will be determined by enzyme-linked immunosorbent assay (ELISA)
Booster response for antibodies to Pertussis Toxoid (PT), Filamentous hemagglutinin (FHA), pertactin (PRN), Fimbriae types 2 and 3 (FIM) will be determined by enzyme-linked immunosorbent assay (ELISA)
A solicited reaction (SR) is an adverse event (AE) that is prelisted in the electronic Case Report Form (eCRF) and considered to be related to vaccination. An SR is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature \& onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and solicited systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.
An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR is therefore an ADR observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.
An SR is an AE that is prelisted in the eCRF and considered to be related to vaccination. An SR is therefore an ADR observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or onset post-vaccination. Solicited injection site reactions: Pain, Erythema, Swelling, Upper limb edema, Extensive limb swelling and systemic reactions: Fever, Headache, Malaise, Myalgia. Number of participants with at least one solicited injection site reactions and systemic reactions were reported.
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. China Food and Drug Administration (CFDA)-defined Grade 3 solicited reactions: Pain, incapacitating, unable to perform usual activities (Children, Group 2) and significant, prevents daily activity (Adults, Group 1); All Participants, Erythema and Swelling \>30 mm; Fever (temperature) \>39˚C; Headache, Malaise, and Myalgia, significant, prevents daily activity.
| Arm | Type | Description |
|---|---|---|
| ADACEL Vaccine Group | EXPERIMENTAL | Children, adolescents and adults randomized to receive a single booster dose of ADACEL (Tdap vaccine) |
| Local DT/Td Vaccine Group | ACTIVE_COMPARATOR | Participants randomized to receive either a single booster dose of local DT vaccine (children aged 4 through 11 years) or local Td vaccine (adolescents and adults aged 12 through 64 years) |
| Adolescents: SP0173 Formulation 1 | EXPERIMENTAL | Healthy participants aged 10-18 years received a single dose of the SP0173 Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed (Tdap) vaccine. |
| Adolescents: SP0173 Formulation 2 | EXPERIMENTAL | Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. |
| Adolescents: SP0173 Formulation 3 | EXPERIMENTAL | Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. |
| Adolescents: SP0173 Formulation 4 | EXPERIMENTAL | Healthy participants aged 10-18 years received a single dose of the SP0173 Tdap vaccine. |
| Adolescents: Adacel® | ACTIVE_COMPARATOR | Healthy participants aged 10-18 years received Adacel®. |
| Adolescents: Boostrix® | ACTIVE_COMPARATOR | Healthy participants aged 10-18 years received Boostrix®. |
| Adults: SP0173 Formulation 1 | EXPERIMENTAL | Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. |
| Adults: SP0173 Formulation 2 | EXPERIMENTAL | Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. |
| Adults: SP0173 Formulation 3 | EXPERIMENTAL | Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. |
| Adults: SP0173 Formulation 4 | EXPERIMENTAL | Healthy participants aged 19-64 years received a single dose of the SP0173 Tdap vaccine. |
| Adults: Adacel® | ACTIVE_COMPARATOR | Healthy participants aged 19-64 years received Adacel®. |
| Adults: Boostrix® | ACTIVE_COMPARATOR | Healthy participants aged 19-64 years received Boostrix®. |
| Older Adults: SP0173 Formulation 1 | EXPERIMENTAL | Healthy participants aged greater than equal to (\>=65) years received a single dose of the SP0173 Tdap vaccine. |
| Older Adults: SP0173 Formulation 2 | EXPERIMENTAL | Healthy participants aged \>=65 years received a single dose of the SP0173 Tdap vaccine. |
| Older Adults: SP0173 Formulation 3 | EXPERIMENTAL | Healthy participants aged \>=65 years received a single dose of the SP0173 Tdap vaccine. |
| Older Adults: SP0173 Formulation 4 | EXPERIMENTAL | Healthy participants aged \>= 65 years received a single dose of the SP0173 Tdap vaccine. |
| Older Adults: Adacel® | ACTIVE_COMPARATOR | Healthy participants aged \>=65 years received Adacel®. |
| Older Adults: Boostrix® | ACTIVE_COMPARATOR | Healthy participants aged \>=65 years received Boostrix®. |
| Group 1: Adults | EXPERIMENTAL | Participants 18 through 64 years of age will receive a single booster dose of Tdap vaccine (ADACEL). |
| Group 2: Children | EXPERIMENTAL | Participants 4 through 8 years of age will receive a single booster dose of Tdap vaccine (ADACEL) |
| Name | Type | Description |
|---|---|---|
| Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap (ADACEL) | BIOLOGICAL | 0.5 mL, Intramuscular |
| DT vaccine (Diphtheria and Tetanus Combined Vaccine, Adsorbed) | BIOLOGICAL | 0.5 mL, Intramuscular |
| Td vaccine (Diphtheria and Tetanus Combined Vaccine for Adults and Adolescents, Adsorbed) | BIOLOGICAL | 0.5 mL, Intramuscular |
| Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1 | BIOLOGICAL | 0.5 milliliter (mL), Intramuscular |
| Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2 | BIOLOGICAL | 0.5 mL, Intramuscular |
| Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3 | BIOLOGICAL | 0.5 mL, Intramuscular |
| Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4 | BIOLOGICAL | 0.5 mL, Intramuscular |
| Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed | BIOLOGICAL | 0.5 mL, Intramuscular |
| Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine | BIOLOGICAL | 0.5 mL, Intramuscular |
| Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap | BIOLOGICAL | 0.5 mL, Intramuscular (IM) |
Inclusion Criteria: * Aged 4 through 64 years on day of inclusion * For children and adolescents (4 through 17 years): Informed consent form has been signed and dated by the parent(s) or another legally acceptable representative and assent form has been signed and dated by the subject if aged 8 thr...
It is a combined vaccine designed to protect against diphtheria and tetanus, with an acellular pertussis component. It is developed by Sanofi and is given as a booster dose. The formulation uses reduced quantities of diphtheria and tetanus toxoids compared with primary vaccination products.
It is used for immunization against diphtheria and tetanus, with the acellular pertussis component included in the combination. Clinical studies have enrolled healthy subjects from 4 years of age and older. The vaccine is studied as a booster dose in children, adolescents, and adults.
Sanofi develops this combined vaccine, with the company's ticker being SNY. The Phase 3 study NCT01993173 evaluated Sanofi Pasteur's Tdap combined vaccine as a booster against local DT vaccine in children and local Td vaccine in adolescents and adults in China.
The vaccine has been studied in Phase 3 clinical development. Two completed trials are recorded, with no active trials currently listed. It is an investigational product in the clinical development setting described by these studies rather than a newly approved product.
Completed studies include NCT02587520, a Phase 1 trial in healthy subjects in the United States with 1,363 participants, and NCT01993173, a Phase 3 trial in China with 1,440 participants. A further completed Phase 1 study, NCT01933776, enrolled 40 participants in China.
Yes, ADACEL is an alternative name for this Tdap vaccine. Other names include Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap, and a version combined with inactivated poliomyelitis vaccine known as Tdap-IPV. These names refer to the same combined vaccine platform.