A Phase 4 interventional study of ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined in Diphtheria, Tetanus and Pertussis, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 2 sites in Korea, Republic of. Open to participants aged 11 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
This safety surveillance study is being conducted in accordance with Korea Food and Drug Administration (KFDA) Notification No. 2009-46 "Basic standard for reexamination of new drug".
The study objective is to assess within 30 days post-administration, the safety of ADACEL™ administered under the real clinical practice.
267 studies on the registry are indexed under Diphtheria; 17 are open to participants now.
This study's enrollment of 659 is above the median of 448 across 241 interventional studies indexed under Diphtheria.
Browse Diphtheria 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.
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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.
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.
Biological: ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined
Drug page: Adacel
0.5 mL, intramuscular (IM)
Also known as: Adacel™
Summary of Adverse Events Reported in Participants That Received a Single Intramuscular Dose of Adacel™
All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.
Time frame: 30 days post-vaccination
Number of Participants Reporting Unexpected Adverse Events After A Single Intramuscular Dose of Adacel™
Unexpected adverse events reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.
Time frame: 30 days post-vaccination
Number of Participants Reporting Adverse Events After A Single Intramuscular Dose of Adacel™
All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.
Time frame: 30 days post-vaccination
Number of Reported Solicited Injection-Site and Systemic Events Following A Single Intramuscular Dose of Adacel™
Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Solicited injection-site: Pain, Prevents daily activities; Erythema and Swelling,\> 10 cm. Grade 3 Solicited systemic reactions: Fever, ≥39.0°C; Headache, Malaise, and Myalgia, Prevents daily activities. All events reported by vaccinated subjects within 7 days post-vaccination during the 6 year post marketing surveillance period.
Time frame: 7 days post-vaccination
The Post Marketing Surveillance period was from 23 June 2009 to 22 June 2015 at 7 clinic centers in South Korea.
| Milestone | Study Subjects |
|---|---|
| Started | 687 |
| Completed | 659 |
| Not completed | 28 |
| Withdrew: Lost to follow-up | 24 |
| Withdrew: Off label usage | 4 |
All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.
| Participants | Study Subjects |
|---|---|
| Adverse events | 168 |
| Serious adverse events | 1 |
| Unexpected adverse events | 68 |
Unexpected adverse events reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.
| Participants | Study Subjects |
|---|---|
| Myalgia | 26 |
| Bronchitis | 11 |
| Rhinitis | 6 |
| Coughing | 3 |
| Rhinorrhoea | 3 |
| Nasopharyngitis | 2 |
| Pharyngitis | 2 |
| Throat sore | 2 |
| Asthma | 1 |
| Nasal obstruction | 1 |
| Sputum | 1 |
| Tonsillitis | 1 |
| Malaise | 14 |
| Influenza | 2 |
| Pain axillary | 1 |
| Purulent discharge | 1 |
| Gastritis | 8 |
| Gastritis acute | 3 |
| Gastroenteritis | 3 |
| Enteritis | 2 |
| Dyspepsia | 1 |
| Dermatitis atopic | 1 |
| Furuncle (excluding genital) | 1 |
| Rash impetiginous | 1 |
| Sweating increased | 1 |
| Dizziness | 3 |
| Allergic conjunctivitis | 1 |
| Conjunctivitis | 1 |
| ALT increased | 1 |
| AST increased | 1 |
| Hand foot mouth disease | 1 |
All adverse event reported by vaccinated subjects within 30 days post-vaccination during the 6 year post marketing surveillance period.
| Participants | Study Subjects |
|---|---|
| Injection-site Pain | 108 |
| Injection-site Erythema | 46 |
| Injection-site Swelling | 42 |
| Injection-site Itching | 5 |
| Injection-site Bruising | 1 |
| Myalgia | 26 |
| Arthralgia | 1 |
| Bronchitis | 11 |
| Rhinitis | 6 |
| Coughing | 3 |
| Rhinorrhoea | 3 |
| Nasopharyngitis | 2 |
| Pharyngitis | 2 |
| Throat sore | 2 |
| Asthma | 1 |
| Nasal obstruction | 1 |
| Sputum | 1 |
| Tonsillitis | 1 |
| Malaise | 14 |
| Fever | 7 |
| Influenza | 2 |
| Knee pain | 1 |
| Pain axillary | 1 |
| Purulent discharge | 1 |
| Gastritis | 8 |
| Gastritis acute | 3 |
| Gastroenteritis | 3 |
| Diarrhoea | 2 |
| Enteritis | 2 |
| Dyspepsia | 1 |
| Nausea | 1 |
| Vomiting | 1 |
| Headache | 13 |
| Dizziness | 3 |
| Dermatitis atopic | 1 |
| Furuncle (excluding genital) | 1 |
| Itching | 1 |
| Rash | 1 |
| Rash impetiginous | 1 |
| Sweating increased | 1 |
| Allergic conjunctivitis | 1 |
| Conjunctivitis | 1 |
| ALT increased | 1 |
| AST increased | 1 |
| Hand foot and mouth disease | 1 |
Solicited injection-site: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 Solicited injection-site: Pain, Prevents daily activities; Erythema and Swelling,\> 10 cm. Grade 3 Solicited systemic reactions: Fever, ≥39.0°C; Headache, Malaise, and Myalgia, Prevents daily activities. All events reported by vaccinated subjects within 7 days post-vaccination during the 6 year post marketing surveillance period.
| Number of Events | Study Subjects |
|---|---|
| Any Injection-site Pain | 108 |
| Grade 3 Injection-site Pain | 0 |
| Any Injection-site Erythema | 46 |
| Grade 3 Injection-site Erythema | 0 |
| Any Injection-site Swelling | 42 |
| Grade 3 Injection-site Swelling | 1 |
| Any Fever | 4 |
| Grade 3 Fever | 1 |
| Any Headache | 12 |
| Grade 3 Headache | 0 |
| Any Malaise | 14 |
| Grade 3 Malaise | 1 |
| Any Myalgia | 24 |
| Grade 3 Myalgia | 0 |
Collected over Adverse event data were collected within 30 days of each vaccination during the 6 years post marketing surveillance period.. Non-serious events are listed at a 5.00% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Subjects | — | 1/659 (0.2%) | 108/659 (16.4%) |
| Event | Study Subjects |
|---|---|
| Knee painGeneral disorders | 1/659 |
| Event | Study Subjects |
|---|---|
| Injection-site PainGeneral disorders | 108/659 |
| Injection-site ErythemaGeneral disorders | 46/659 |
| Injection-site SwellingGeneral disorders | 42/659 |
| Age, Categorical(Participants) | Study Subjects |
|---|---|
| <=18 years | 275 |
| Between 18 and 65 years | 384 |
| >=65 years | 0 |
| Age, Continuous(Years) | Study Subjects |
|---|---|
| Mean | 24.38 ± 13.51 |
| Sex: Female, Male(Participants) | Study Subjects |
|---|---|
| Female | 454 |
| Male | 205 |
| Region of Enrollment(Participants) | Study Subjects |
|---|---|
| Korea, Republic of | 659 |
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
The record gives a start of Jun 2010, a primary completion of Mar 2016 and a completion of Sep 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2017, 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Adacel
Sanofi Pasteur, a Sanofi Company →