The nature and frequency of adverse events identified in the studies differed depending on the age of the vaccinated.
In clinical trials in children aged 9 to 18 months, within 7 days after vaccination, the most frequently observed sensitivity at the injection site and tenderness. In clinical trials in children aged 2 to 10 years the most frequent signs of pain and redness at the injection site, irritability, diarrhea, drowsiness, anorexia; in adolescents aged 11-18 years and in adults between 18 and 55 years of age the most frequent symptoms were soreness at the injection site, headache and fatigue.
The incidence of the following side effects is classified according to recommendations of the World Health Organization (WHO) and includes the following categories:
- Very often: ≥ 10%
- Frequently: ≥ 1% and <10%
- Uncommon: ≥ 0.1% and <1%
- Rarely: ≥ 0.01% and <0.1%
- Very rarely: <0.01%
- The frequency is unknown: it can not be determined according to the available data.
Children aged 9 to 18 months
Most of the recorded local and general reactions observed within 7 days after vaccination were mild and lasted less than 3 days. In addition, the following side effects are noted:
From the side of metabolism and nutrition
Often: loss of appetite.
From the nervous system
Often: drowsiness.
From the gastrointestinal tract
Very often or often: vomiting.
General disorders and disorders at the site of administration
Often: soreness, erythema at the injection site, edema at the injection site, irritability, abnormal crying, fever.
Children from 2 to 10 years old
Most of the recorded local and general reactions observed within 7 days after vaccination were mild. In addition, the following violations were noted:
From the side of metabolism and nutrition
Very often or often: decreased appetite.
From the nervous system
Very often or often: drowsiness.
Co cmopgastrointestinal tract
Often: diarrhea.
Often: vomiting.
From the skin and subcutaneous tissues
Often: rash, hives.
From the musculoskeletal and connective tissue
Often: arthralgia.
General disorders and disorders at the site of administration
Often: soreness and compaction at the injection site.
Very often or often: irritability, redness at the injection site, edema at the injection site, fever.
Persons in age 11-55 years
Most of the recorded local and general reactions observed within 7 days after vaccination were mild. In addition, the following violations were noted:
From the side of metabolism and nutrition
Very often or often: decreased appetite.
From the nervous system
Often: headache.
From the gastrointestinal tract
Very often or often: diarrhea.
Often: vomiting.
From the skin and subcutaneous tissues
Often: rash.
From the musculoskeletal and connective tissue
Often: arthralgia.
General disorders and disorders at the site of administration
Often: Pain, tightness, redness and swelling at the injection site, increased fatigue, general malaise.
Often: chills, fever.
In the postmarketing period In addition, information was received on the following undesirable phenomenaafter the administration of the drug (currently the frequency of development of these phenomena and their cause-and-effect relationship with the use of the vaccine Menacretra can not be determined):
From the immune system
Hypersensitivity reactions, such as anaphylactic shock, anaphylactoid reactions, stridor breathing, difficulty breathing, swelling of the upper respiratory tract, urticaria, redness of the skin, skin itching, lowering of blood pressure.
From the nervous system
Guillain-Barre syndrome (GBS), paresthesia, loss of consciousness (due to impaired regulation of the autonomic nervous system), dizziness, convulsions, facial nerve paralysis, acute disseminated encephalomyelitis, transverse myelitis.
From the musculoskeletal and jointissue
Myalgia.
Post-marketing research
The risk of GBS following the introduction of the Menactra vaccine was evaluated in a US retrospective cohort study that used an electronic medical care database of 9 578 688 patients aged 11-18 years, of whom 1,431,906 (15%) received the Menacinth vaccine.None of the patients described in 72 reports of medically confirmed cases of GBS did not receive the Menacinth vaccine within 42 days before the onset of symptoms. Another 129 potential cases of SGB were not medically confirmed or were excluded from the analysis due to the lack or insufficiency of medical information. In an analysis that took into account the missing data, the estimated additional risk of GBS ranged from 0 to 5 additional cases of GBS per 1,000,000 vaccinated within 6 weeks after vaccination.