Comparison of the morbidity of tetanus toxoid boosters with tetanus-diphtheria toxoid boosters

Macko, Michael B.; Powell, Candace E

doi:10.1016/s0196-0644(85)80732-0

Cited by 34 publications

(11 citation statements)

References 4 publications

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“…or s.c.) and method of injection, (3) tetanus antitoxin levels prior to vaccination, (4) the presence (and perhaps quantity) of adjuvants, (5) age of the subjects, and (6) method used to assess reactogenicity (e.g., personal or telephone interviews with or without open or closed questions, diary cards to be filled in by vaccinees, etc.). In any case, the overall incidence of reactions observed (50%) was lower than of that described in some controlled trials (ranging between 70% and 82%) 11,13,14,18 but higher than the incidence reported in another (31%) 15 and somewhat similar to that reported by Middaugh during a mass Td campaign (58%). 17 The reactogenicity profile of Td vaccine observed in this study is consistent with that reported in the literature, 5,11,13,18 except for malaise, which is usually reported less frequently.…”

Section: Discussionsupporting

confidence: 52%

“…In any case, the overall incidence of reactions observed (50%) was lower than of that described in some controlled trials (ranging between 70% and 82%) 11,13,14,18 but higher than the incidence reported in another (31%) 15 and somewhat similar to that reported by Middaugh during a mass Td campaign (58%). 17 The reactogenicity profile of Td vaccine observed in this study is consistent with that reported in the literature, 5,11,13,18 except for malaise, which is usually reported less frequently. 5 However, it should be borne in mind that four (pain, swelling, malaise, fever) out of the five adverse reactions most commonly reported were those mentioned as examples in the diary card.…”

Section: Discussionsupporting

confidence: 52%

“…On the other hand, discomfort with arm movement was reported in 14% of diary cards, a high incidence considering that it was not mentioned in the card, although it was always mentioned by the investigators when instructing the subjects on how to record the adverse reactions. Furthermore, edema, a typical adverse local reaction commonly reported in clinical trials (incidence: 5%-32%) 5,13,18 was not reported by any vaccinee of this study, perhaps because edema was regarded as swelling by the vaccinees.…”

Section: Discussionmentioning

confidence: 61%

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Reactogenicity Profile of Tetanus‐Diphtheria (Adult‐Type) Vaccine: Results of a Naturalistic Study Performed at an Adult Vaccination Center

Vilella

Dal‐Ré²,

Simó

et al. 2000

The Journal of Clinical Pharma

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A prospective observational naturalistic study was conducted at a vaccination center to assess the reactogenicity of tetanus‐diphtheria (adult‐type) (Td) vaccine. In 1 year, 3072 adult subjects were invited to participate, of whom 1977 (62% women, mean age [± SD]: 39 [± 14.5] years [range: 18–85 years]) actively did so. A follow‐up diary card was provided to all subjects to record all local and general symptoms experienced during the following 4 days after vaccination. Of the study population (n = 1977), 280 received a second Td dose, and 30 received a third dose: the total number of diary cards collected was 2287. Td was always administered (i.m. route) in the left arm. The study population was grouped by age: 52%, 41%, and 7% were ages 18 to 35, 36 to 65, and > 65 years, respectively, most of them beingtravelers to developing countries. Close to two‐thirds of subjects received up to nine different vaccines (mainly hepatitis B, hepatitis A, and typhoid) in addition to Td. Adverse reactions were classified as mild, moderate, and severe. Overall, 50% of subjects reported some type of adverse reaction. Pain, discomfort with arm movement, swelling, malaise, and fever (axillary temperature ≥ 38°C) were recorded in 43%, 14%, 3.8%, 5.1%, and 1.7% of all diary cards, respectively. Local and general reactions were considered as mild by almost two‐thirds of vaccinees and lasted ≤ 48 hours in about three‐fourths of them. The incidence of moderate plus severe local reactions was significantly (p < 0.01) more commonly reported in the 18‐ to 35‐year‐old group than in the 36‐ to 65‐year‐old group. No statistically significant differences were observed when comparing the incidence of general adverse reactions of those receiving Td alone with those receiving additional vaccines or when comparing the duration and intensity by age groups. Only 5.2% of subjects required analgesic/antipyretic treatment. In conclusion, this study shows that Td vaccine is reasonably well tolerated when given alone or with other vaccines. Similar studies should be conducted with other vaccines routinely recommended to adults to assess how they are administered in usual clinical practice and the reactogenicity profile perceived by the vaccinees.

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Section: Discussionsupporting

confidence: 52%

Section: Discussionsupporting

confidence: 52%

Section: Discussionmentioning

confidence: 61%

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Reactogenicity Profile of Tetanus‐Diphtheria (Adult‐Type) Vaccine: Results of a Naturalistic Study Performed at an Adult Vaccination Center

Vilella

Dal‐Ré²,

Simó

et al. 2000

The Journal of Clinical Pharma

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“…Current mix of studies have come a long way of testing use of combination vaccines like Td(tetanus diphtheria), DTap (Diphtheria Tetanus and a cellular Pertussis), Tdap (Tetanus diphtheria and acellular Pertussis) and typhoid tetanus conjugate vaccines in the adolescent age groups and not tetanus toxoid; and many countries are recommending the use of conjugate vaccines. 10 However, in our country given the cost restraints of the conjugate vaccines and the declining incidence of Diphtheria and Pertussis in the country, tetanus vaccine gains importance and preference to be offered under the programmatic banner.…”

Section: Discussionmentioning

confidence: 99%

An Open-Label, Single-Treatment, Single-Period, Single Dose, Clinical Phase 1 Study to Assess the Safety and Tolerability of Tetanus Vaccine in Healthy, Adult Subjects in India

Kar¹,

Singh²,

Samantaray³

et al. 2019

jebmh

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BACKGROUNDTetanus toxoid vaccine has always been an indelible constituent of the Universal Immunization Programme in India. Besides being given to pregnant women in two doses, it used to be given in children at the ages of ten and sixteen. Gradually with the coming down of the burden of communicable diseases, the vaccine is now even recommended in five years age besides as a prophylactic vaccine for any injury of moderate to severe degree in the tropical situations. With India achieving Neonatal Tetanus Elimination in 2015, the pressures to ensure the availability of cost-effective vaccine has gone up. To cope with the increased demand of this vaccine in India, a bio similar tetanus vaccine vial for the Indian market is proposed and hence the Phase 1 study to validate the dose and the safety of the interventional product was planned at Kalinga Institute of Medical Sciences, Bhubaneswar in the eastern part of India under stringent regulatory guidelines of Central Drug Standards Control Organization (CDSCO), and adhering to the good clinical practice guidelines. MATERIALS AND METHODS24 recruits (healthy adults aged 18-45 years) were taken up for the study with lab screening for blood parameters both preand seven days post vaccination. 23 subjects completed the study as per the protocol and were included in the Efficacy Analysis. Only solicited local adverse events were reported in the trial. Total number of solicited adverse events reported in the trial was 15 (62.5%) The maximal incidence of any local reaction after immunizations within 7 days of vaccination was 58.3% (Pain/Tenderness) followed by swelling/induration in 1 (4.2) subject. RESULTSIgG antibody response after single dose of vaccine was optimal in study population. There is a statistically significant difference between pre-vaccination and post-vaccination values for IgG response against Tetanus antibodies, after single dose. Prevaccination GMT of study changed from 2.24 IU/ml to 12.81 IU/ml, indicating significant results. CONCLUSIONIn our study, in a mixed age and gender group, the seroconversion was nearly 76% and the AEs were 62.5% all of which subsided on their own without medication, which suggests that the vaccine is effective and can proceed onto Phase 2 and 3 trials for further in-depth assessments of the safety and primarily immunogenicity of the vaccine.

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“…Td immunization is generally safe and well tolerated 7 , 10 , 13 – 16 although sore arms were reported in as many as 75% in a telephone survey of 100 emergency room patients 16 . In another study, 0.5% of almost 700 responders reported seeing a physician because of side effects 13 .…”

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confidence: 99%

Tetanus‐Diphtheria Vaccinations in a Veterans Nursing Home

Hagen‐Coenen¹,

Drinka²,

Siewert³

1992

J American Geriatrics Society

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Comparison of the morbidity of tetanus toxoid boosters with tetanus-diphtheria toxoid boosters

Cited by 34 publications

References 4 publications

Reactogenicity Profile of Tetanus‐Diphtheria (Adult‐Type) Vaccine: Results of a Naturalistic Study Performed at an Adult Vaccination Center

Reactogenicity Profile of Tetanus‐Diphtheria (Adult‐Type) Vaccine: Results of a Naturalistic Study Performed at an Adult Vaccination Center

An Open-Label, Single-Treatment, Single-Period, Single Dose, Clinical Phase 1 Study to Assess the Safety and Tolerability of Tetanus Vaccine in Healthy, Adult Subjects in India

Tetanus‐Diphtheria Vaccinations in a Veterans Nursing Home

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