A Phase 4 interventional study of Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine and Tetanus and Diphtheria Toxoids Adsorbed For Adult Use in Tetanus, Diphtheria and Pertussis, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 33 sites in 2 countries. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-28.
Sponsored by Sanofi Pasteur, a Sanofi Company (part of Sanofi) · Phase 4, Interventional, and Prevention
The purpose of this study is to describe the safety and immunogenicity of repeat administration of Adacel vaccine approximately 10 years following initial administration of the vaccine. Antibody levels prior to revaccination will also be used to characterize antibody persistence following initial vaccination 10 years earlier.
Primary Objectives:
Secondary Objectives:
Healthy adults \< 65 years of age who received Adacel vaccine 10 years previously will be randomized to receive either Adacel or TENIVAC (Td Adsorbed) vaccine. They will be assessed for immunogenicity at baseline and post-vaccination. Safety data will be collected for 6 months following vaccination.
318 studies on the registry are indexed under Tetanus; 29 are open to participants now.
This study's enrollment of 1,330 is above the median of 418 across 280 interventional studies indexed under Tetanus.
Browse Tetanus studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 374 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
First submitted after Sanofi Pasteur became part of Sanofi.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to receive a repeat dose of Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine (Adacel®)
Biological: Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine
Participants randomized to receive Subjects randomized to receive a Tetanus and Diphtheria Toxoids Adsorbed For Adult Use (TENIVAC) vaccine.
Biological: Tetanus and Diphtheria Toxoids Adsorbed For Adult Use
Drug page: Tetanus Toxoid
0.5 mL, Intramuscular
Also known as: Adacel®
Drug page: Tetanus and Diphtheria Toxoids Adsorbed
0.5 mL, Intramuscular
Also known as: TENIVAC
Percentage of Participants With Diphtheria and Tetanus Seroprotection
Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus antibodies were assessed using an enzyme-linked immunosorbent assay. Seroprotection was defined as the following: Anti-Diphtheria and Anti-Tetanus ≥ 0.1 IU/mL.
Time frame: 1 month post-booster vaccination
Percentage of Participants With Diphtheria and Tetanus Booster Response
Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus antibodies were assessed using an enzyme-linked immunosorbent assay. A booster response was defined as a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with pre-vaccination antibody concentrations ≤2.56 IU/mL for diphtheria and ≤ 2.7 IU/mL for tetanus. If the pre vaccination antibody concentrations were \> 2.56 IU/mL for diphtheria and \> 2.7 IU/mL for tetanus, then a 2-fold increase in response rate was defined as a booster response.
Time frame: 1 month post-booster vaccination
Geometric Mean Concentrations (GMC) of Anti Pertussis Antibodies
Anti-Pertussis antibodies (Pertussis toxoid, Filamentous Hemagglutinin (FHA), Pertactin, Fimbriae types 2 and 3) were assessed using an enzyme-linked immunosorbent assay. Anti-pertussis GMCs further to Adacel vaccination was compared to an historical control group with Daptacel (NCT00255047 for pertussis toxoid and PMID 8538705 for FHA, Pertactin and Fimbriae) since Td Adsorbed Vaccine does not contain any pertussis antigens.
Time frame: 1 month post-booster vaccination
Percentage of Subjects With Pertussis Antigen Booster Response
Anti-Pertussis antibodies (Pertussis toxoid, Filamentous Hemagglutinin \[FHA\], Pertactin, Fimbriae (types 2 and 3) were assessed using an enzyme-linked immunosorbent assay. Booster response is defined as a minimum rise in antibody concentration from pre- to post-vaccination. The minimum rise is at least 2 times if the pre-vaccination concentration is above the cutoff value, or at least 4 times if it is at or below the cutoff value. Anti-pertussis toxoid booster response rates further to Adacel vaccination was compared to an expected booster rates based on study Td506 (PMID 15933223) since Td Adsorbed Vaccine does not contain any pertussis antigens.
Time frame: 1 month post-booster vaccination
Percentage of Participants Reporting a Solicited Injection Site or Systemic Reactions
Injection site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection site reactions: Pain, Significant, prevents daily activity. Erythema and Swelling, \>100 mm. Grade 3 Systemic reactions: Fever, ≥39°C or ≥102.1 F; Headache, Malaise, and Myalgia, Significant; prevents daily activity.
Time frame: Day 0 up to Day 7 post-vaccination
Study participants were enrolled from 30 November 2011 to 13 August 2015 at 31 clinic sites in the United States and 2 clinic sites in Canada.
| Milestone | Adacel Vaccine | Td Adsorbed Vaccine |
|---|---|---|
| Started | 1002 | 328 |
| Completed | 981 | 326 |
| Not completed | 21 | 2 |
| Withdrew: Protocol violation | 3 | 0 |
| Withdrew: Lost to follow-up | 11 | 1 |
| Withdrew: Withdrawal by subject | 7 | 1 |
Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus antibodies were assessed using an enzyme-linked immunosorbent assay. Seroprotection was defined as the following: Anti-Diphtheria and Anti-Tetanus ≥ 0.1 IU/mL.
| Percentage of participants | Adacel Vaccine | Td Adsorbed Vaccine |
|---|---|---|
| Tetanus | 100.0 | 100.0 |
| Diphtheria | 99.8 | 99.4 |
Anti-Diphtheria antibodies were assessed by a toxin neutralization test. Anti-Tetanus antibodies were assessed using an enzyme-linked immunosorbent assay. A booster response was defined as a 4-fold increase in pre- to post-vaccination antibody concentrations for subjects with pre-vaccination antibody concentrations ≤2.56 IU/mL for diphtheria and ≤ 2.7 IU/mL for tetanus. If the pre vaccination antibody concentrations were \> 2.56 IU/mL for diphtheria and \> 2.7 IU/mL for tetanus, then a 2-fold increase in response rate was defined as a booster response.
| Percentage of participants | Adacel Vaccine | Td Adsorbed Vaccine |
|---|---|---|
| Tetanus | 74.5 | 81.6 |
| Diphtheria | 83.2 | 84.1 |
Anti-Pertussis antibodies (Pertussis toxoid, Filamentous Hemagglutinin (FHA), Pertactin, Fimbriae types 2 and 3) were assessed using an enzyme-linked immunosorbent assay. Anti-pertussis GMCs further to Adacel vaccination was compared to an historical control group with Daptacel (NCT00255047 for pertussis toxoid and PMID 8538705 for FHA, Pertactin and Fimbriae) since Td Adsorbed Vaccine does not contain any pertussis antigens.
| Concentrations (1/dil) | Adacel Vaccine |
|---|---|
| Pertussis Toxoid | 102 (94.9 to 110) |
| FHA | 209 (200 to 217) |
| Pertactin | 318 (302 to 334) |
| Fimbriae types 2 and 3 | 745 (711 to 781) |
Anti-Pertussis antibodies (Pertussis toxoid, Filamentous Hemagglutinin \[FHA\], Pertactin, Fimbriae (types 2 and 3) were assessed using an enzyme-linked immunosorbent assay. Booster response is defined as a minimum rise in antibody concentration from pre- to post-vaccination. The minimum rise is at least 2 times if the pre-vaccination concentration is above the cutoff value, or at least 4 times if it is at or below the cutoff value. Anti-pertussis toxoid booster response rates further to Adacel vaccination was compared to an expected booster rates based on study Td506 (PMID 15933223) since Td Adsorbed Vaccine does not contain any pertussis antigens.
| Percentage of subjects | Adacel Vaccine |
|---|---|
| Pertussis Toxoid | 77.5 |
| FHA | 68.9 |
| Pertactin | 65.3 |
| Fimbriae (types 2 and 3) | 56.8 |
Injection site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Injection site reactions: Pain, Significant, prevents daily activity. Erythema and Swelling, \>100 mm. Grade 3 Systemic reactions: Fever, ≥39°C or ≥102.1 F; Headache, Malaise, and Myalgia, Significant; prevents daily activity.
| Percentage of participants | Adacel Vaccine | Td Adsorbed Vaccine |
|---|---|---|
| Any Injection site Pain | 87.1 | 87.4 |
| Grade 3 Injection site Pain | 3.6 | 2.8 |
| Any Injection site Erythema | 6.4 | 5.5 |
| Grade 3 Injection site Erythema | 0.2 | 0 |
| Any Injection site Swelling | 6.9 | 8.0 |
| Grade 3 Injection site Swelling | 0.3 | 0 |
| Any Fever | 0.9 | 1.8 |
| Grade 3 Fever | 0.2 | 0.3 |
| Any Headache | 41.4 | 39.1 |
| Grade 3 Headache | 2.6 | 4.0 |
| Any Malaise | 33.3 | 30.8 |
| Grade 3 Malaise | 3.0 | 3.7 |
| Any Myalgia | 58.1 | 58.2 |
| Grade 3 Myalgia | 3.0 | 3.1 |
Collected over Adverse event data were collected from Day 0 up to 1 month post-booster vaccination.. Non-serious events are listed at a 5.00% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adacel Vaccine | 0/999 (0%) | 8/999 (0.8%) | 855/999 (85.6%) |
| Td Adsorbed Vaccine | 0/328 (0%) | 1/328 (0.3%) | 284/328 (86.6%) |
| Event | Adacel Vaccine | Td Adsorbed Vaccine |
|---|---|---|
| Upper limb fractureInjury, poisoning and procedural complications | 0/999 | 1/328 |
| Abdominal painGastrointestinal disorders | 1/999 | 0/328 |
| Crohn's diseaseGastrointestinal disorders | 1/999 | 0/328 |
| Intestinal obstructionGastrointestinal disorders | 1/999 | 0/328 |
| Infectious mononucleosisInfections and infestations | 1/999 | 0/328 |
| Neoplasm malignantNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/999 | 0/328 |
| Abortion spontaneousNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/999 | 0/328 |
| Pickwickian syndromeRespiratory, thoracic and mediastinal disorders | 1/999 | 0/328 |
| Tonsillar haemorrhageRespiratory, thoracic and mediastinal disorders | 1/999 | 0/328 |
| Event | Adacel Vaccine | Td Adsorbed Vaccine |
|---|---|---|
| Injection site PainGeneral disorders | 855/999 | 284/328 |
| MyalgiaMusculoskeletal and connective tissue disorders | 571/999 | 189/328 |
| HeadacheNervous system disorders | 407/999 | 127/328 |
| MalaiseGeneral disorders | 327/999 | 100/328 |
| Injection site SwellingGeneral disorders | 68/999 | 26/328 |
| Injection site ErythemaGeneral disorders | 63/999 | 18/328 |
| Age, Categorical(Participants) | Adacel Vaccine | Td Adsorbed Vaccine | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1002 | 328 | 1330 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(Years) | Adacel Vaccine | Td Adsorbed Vaccine | Total |
|---|---|---|---|
| Age Continuous | 28.9 ± 10.0 | 29.2 ± 10.6 | 29 ± 10.3 |
| Sex: Female, Male(Participants) | Adacel Vaccine | Td Adsorbed Vaccine | Total |
|---|---|---|---|
| Female | 646 | 212 | 858 |
| Male | 356 | 116 | 472 |
| Region of Enrollment(Participants) | Adacel Vaccine | Td Adsorbed Vaccine | Total |
|---|---|---|---|
| United States | 270 | 84 | 354 |
| Canada | 732 | 244 | 976 |
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Studies of the drug tested here: Tetanus Toxoid
Sanofi Pasteur, a Sanofi Company →