臨床研究等提出・公開システム

TRIBIK Drug Use Surveillance

TRIBIK Drug Use Surveillance

921

The mean age (mean plus/minus standard deviation) was 32.7 plus/minus 15.34 years old. With regard to persons requiring special attention for vaccination, 97.1% of the subjects were not designated and 2.9% were designated. Complications were absent in 72.0% of the subjects and present in 28.0%. Serious medical history was absent in 97.1% of the subjects and present in 2.8%. Concomitant drugs were absent in 76.6% of the subjects and present in 23.4%.

A total of 921 participants (35 sites) were enrolled in this surveillance. The CRF was collected from 920 participants; of these participants, 869 were evaluated for safety.

The incidence of adverse reactions in 869 subjects included in the safety analysis was 55.35% (481/869 subjects), and there were no serious adverse reactions. Major adverse reactions with an incidence of >= 2% were injection site erythema in 31.19% (271/869 subjects), injection site swelling in 26.12% (227/869 subjects), injection site induration in 24.17% (210/869 subjects), injection site pain in 18.64% (162/869 subjects), injection site pruritus in 18.53% (161/869 subjects), injection site warmth in 5.98% (52/869 subjects), and both headache and pyrexia in 3.11% (27/869 subjects). Shock, anaphylaxis, and vasovagal syncope were not reported. Of the 869 subjects included in the safety analysis, 25 subjects were designated as persons requiring special attention for vaccination, and the incidence of adverse reactions was 48.00% (12/25 subjects). Two hundred forty three subjects had complications, and the incidence of adverse reactions was 61.73% (150/243 subjects). Twenty four subjects had serious medical history, and the incidence of adverse reactions was 50.00% (12/24 subjects). Two hundred three subjects were taking concomitant drugs, and the incidence of adverse reactions was 61.58% (125/203 subjects).

Refer to "Adverse Events" section.

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The incidence of adverse reactions in 869 subjects included in the safety analysis was 55.35%, and no significant adverse reactions were reported. There were no occurrence of shock, anaphylaxis, or vasovagal syncope. The results of this surveillance did not identify any new safety concern to be included in the RMP.

Feb. 10, 2021

https://mol.medicalonline.jp/archive/search?jo=aa9syrsc&ye=2021&vo=70&issue=2

No

Same as primary sponsor

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Same as primary sponsor

+81-875-25-4835

completed

Mar. 09, 2018

Observational

Postmarketing surveillance

other

N/A

Vaccinees who meet both of the following conditions [1] and [2]:
[1] Vaccinees who received TRIBIK at the age of 90 months and over.
[2] Vaccinees who are able to participate in a questionnaire survey on the health status after vaccination with TRIBIK ( or vaccinees whose guardians are able to participate in the questionnaire survey).

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Both

Diphtheria, Pertussis, Tetanus

investigational material(s)
Generic name etc : TRIBIK(Adsorbed Diphtheria-purified Pertussis-tetanus Combined Vaccine)
INN of investigational material : -
Therapeutic category code : 636 Mixed biological preparations
Dosage and Administration for Investigational material : Primary immunization: In general, 0.5 mL of the product is injected subcutaneously 3 times, at an interval of 3 to 8 weeks.

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

safety
safety:Rate of vaccine-related adverse event, Factors that may influence safety, Rate of serious vaccine-related adverse event

other
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