Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ADACEL™
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap · 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 combination vaccine designed to protect against tetanus, diphtheria, and pertussis (whooping cough). It contains tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis components adsorbed onto an adjuvant. It is developed by Sanofi and is studied as a booster in children, adolescents, and adults.
It is used for immunization against diphtheria and tetanus, with pertussis also listed among the conditions studied in its clinical trials. The vaccine is evaluated as a booster dose in healthy children, adolescents, and adults. Trial populations have included participants from age 4 and from age 10 upward.
Sanofi, ticker SNY, develops this vaccine. Its Sanofi Pasteur unit conducted the clinical studies of the Tdap combined vaccine, including the Phase 3 booster trial in China that compared it with local DT and Td vaccines in children, adolescents, and adults.
The vaccine is in Phase 3 development. Two completed trials are listed, including the Phase 3 study NCT01993173 in China, which enrolled 1,440 participants. The program also includes earlier-phase work, such as the Phase 1 study NCT01933776 with 40 participants and the Phase 1/Phase 2 study NCT02587520 with 1,363 participants.
Completed trials include NCT01993173, a Phase 3 booster study versus local DT and Td vaccines in China with 1,440 participants, and NCT01933776, a Phase 1 booster study in China with 40 participants. NCT02587520 was a Phase 1/Phase 2 study in healthy subjects in the United States with 1,363 participants.
Yes. ADACEL is an alternative name for this Tdap vaccine, and the Phase 1 China booster study NCT01933776 refers to the Tdap combined vaccine as ADACEL. Other listed names include Tdap and a formulation combined with inactivated poliomyelitis vaccine (Tdap-IPV).