Data from Clinical Studies Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates. Primary Immunization In a clinical study, 42 persons 6-58 years of age underwent primary immunization against tetanus and diphtheria. Eight of these participants (19%) noted local reactions consisting of pain and tenderness, induration, and erythema at the injection site; none reported systemic symptoms.4 Booster Immunization In a clinical study, 792 adolescents 11-17 years of age and 573 adults 18-64 years of age received a booster dose with DECAVAC vaccine. Study participants had not received tetanus or diphtheria toxoid-containing vaccines within the previous 5 years. Solicited local reactions and systemic adverse events were monitored daily for 14 days post-vaccination using subject diary cards. Serious adverse events were monitored through 6 months post-vaccination. Ninety-seven percent of participants who received DECAVAC vaccine completed the 6-month telephone follow-up. Solicited Adverse Events The frequency of selected solicited injection site reactions (pain, swelling, or erythema) occurring during Days 0-14 following booster vaccination with DECAVAC vaccine in adolescents 11 through 17 years of age, and adults 18 through 64 years of age are presented in Table 2. Pain at the injection site was the most common adverse reaction occurring in 71% of adolescents and 62.9% of adults. Table 2: Frequencies of Solicited Injection Site Reactions for Adolescents and Adults, Days 0-14 Following BoosterVaccination with DECAVAC Vaccine
Adverse Event Adolescents 11-17 years Adults 18-64 years Na = 783-787 (%) Na = 551-561 (%) Injection Site Any 71.0 62.9 Moderateb 15.6 10.2 Pain Severec 0.6 0.9 Any 18.3 17.3 Moderate Injection Site Swelling 1.0 to 3.4 cm 5.7 5.4 Severe ≥ 3.5 cm 5.5 5.5 ≥ 5 cm 3.6 2.7 Any 19.7 21.6 Moderate Injection Site Erythema 1.0 to 3.4 cm 4.6 8.4 Severe ≥ 3.5 cm 5.3 4.8 ≥ 5 cm 2.9 3.0 aN = number of participants who provided data (not all participants evaluated every event).
bInterfered with activities, but did not necessitate medical care or absenteeism.
cIncapacitating, prevented the performance of usual activities, may have/or did necessitate medical care or absenteeism. The frequency of solicited systemic adverse events occurring during Days 0-14 following booster vaccination with DECAVAC vaccine are presented in Table 3. Headache was the most frequent solicited systemic adverse event, and was usually of mild or moderate intensity. Table 3: Frequencies of Solicited Systemic Adverse Events for Adolescents and Adults, Days 0-14 Following Booster Vaccination with DECAVAC Vaccine
Adverse Event Adolescents 11-17 years Adults 18-64 years Na = 787 (%) Na = 560-561 (%) Headache Any 40.4 34.1 Moderateb 11.1 10.5 Severec 1.5 2.1 Body Ache or Muscle Weakness Any 29.9 18.8 Moderateb 6.9 5.7 Severec 0.9 0.9 Tiredness Any 27.3 20.7 Moderateb 7.5 6.1 Severec 1.0 0.5 Chills Any 12.6 6.6 Moderateb 2.5 1.6 Severec 0.1 0.5 Nausea Any 12.3 7.9 Moderateb 3.2 1.8 Severec 0.6 0.5 Sore and Swollen Joints Any 11.7 7.0 Moderateb 2.5 2.1 Severec 0.1 0.5 Diarrhea Any 10.2 11.3 Moderateb 2.0 2.7 Severec 0.0 0.5 Lymph Node Swelling Any 5.3 4.1 Moderateb 0.5 0.5 Severec 0.0 0.0 Vomiting Any 2.8 1.8 Moderateb 1.1 0.9 Severec 0.3 0.2 Fever Any ≥ 38.0°C ( ≥ 100.4°F) 2.7 1.1 ≥ 38.8°C to ≤ 39.4°C ( ≥ 102.0°F to ≤ 103.0°F) 0.6 0.2 ≤ 39.5°C ( ≤ 103.1°F) 0.1 0.2 Rash Any 2.0 2.3 aN = number of participants who provided data (not all participants evaluated every event).
bInterfered with activities, but did not necessitate medical care or absenteeism. incapacitating, prevented the performance of usual activities, may have/or did necessitate medical care or absenteeism. Serious Adverse Events Among 792 adolescents 11-17 years of age and 573 adults 18-64 years of age who received a booster dose with DECAVAC vaccine, 2 adolescents and 2 adults reported a serious adverse event that occurred within 30 days following vaccination. Events reported in adolescents were jaw fracture secondary to trauma and abdominal pain/appendectomy. Events reported in adults were atrial septal defect and elective surgical repair in one subject, and myocardial infarction in one subject with a history of coronary artery disease. Post-Marketing Experience The following adverse events have been spontaneously reported during the post-marketing use of Td manufactured by Sanofi Pasteur Inc. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccination. The following adverse events were included based on severity, frequency of reporting or the strength of causal association with DECAVAC vaccine. Blood and Lymphatic System Disorders Lymphadenopathy. Immune System Disorders Allergic reactions (such as rash, urticaria, pruritus, and angioedema), including anaphylactic reactions. Nervous System Disorders Headache, paresthesia, dizziness, syncope, and convulsions. Gastrointestinal Disorders Nausea, vomiting. Musculoskeletal, Connective Tissue and Bone Disorders Myalgia, arthralgia, pain in extremities, musculoskeletal stiffness. General Disorders and Administration Site Conditions Injection site reactions (including swelling, redness, warmth, induration, cellulitis, and nodules). Pyrexia, chills, pain, malaise, asthenia, fatigue, edema peripheral. Read the Decavac (tetanus and diphtheria toxoids adsorbed) Side Effects Center for a complete guide to possible side effectsLearn More »