Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Summary of the safety profile
The safety of Nimenrix presented in the table below is based on two clinical study datasets as follows: • A pooled analysis of data from 9,621 subjects administered a single dose of Nimenrix. This total included 3,079 toddlers (12 months to 23 months), 909 children between 2 and 5 years of age, 990 children between 6 and 10 years of age, 2,317 adolescents (11 to 17 years) and 2,326 adults (18 to 55 years).
• Data from a study in infants aged 6 to 12 weeks at the time of the first dose (Study MenACWY-TT- 083), 1,052 subjects received at least one dose of a primary series of 2 or 3 doses of Nimenrix and 1,008 received a booster dose at approximately 12 months of age.

Safety data have also been evaluated in a separate study, in which a single dose of Nimenrix was administered to 274 individuals aged 56 years and older.

Local and general adverse reactions
In the 6-12 weeks and in the 12-14 months age groups who received 2 doses of Nimenrix given 2 months apart, the first and second doses were associated with similar local and systemic reactogenicity.

The local and general adverse reaction profile of a booster dose of Nimenrix given to subjects from 12 months through 30 years of age after primary vaccination with Nimenrix or other conjugated or plain polysaccharide meningococcal vaccines, was similar to the local and general adverse reaction profile observed after primary vaccination with Nimenrix, except for gastrointestinal symptoms (including diarrhoea, vomiting, and nausea), which were very common among subjects 6 years of age and older.

Tabulated list of adverse reactions

Adverse reactions reported are listed according to the following frequency categories: 
Very common: (≥1/10)
Common:        (≥1/100 to <1/10)
Uncommon:      (≥1/1,000 to <1/100)
Rare:          (≥1/10,000 to <1/1,000)
Very rare:     (<1/10,000)
Not known (cannot be estimated from available data)

Table 1 shows the adverse reactions reported from the studies in subjects aged from 6 weeks up to 55 years of age and post-marketing experience. Adverse reactions reported in subjects aged >55 years were similar to those observed in younger adults.

Table 1: Tabulated summary of adverse reactions by system organ class System Organ Class             Frequency         Adverse reactions
Blood and lymphatic system     Not known***      Lymphadenopathy disorders
Metabolism and nutrition       Very common       Appetite lost disorders
Psychiatric disorders          Very common       Irritability
Uncommon          Insomnia
Crying
Nervous system disorders       Very common       Drowsiness
Headache
Uncommon          Hypoaesthesia
Dizziness
Rare              Febrile convulsion
Gastrointestinal disorders     Common            Diarrhoea
Vomiting
Nausea*
Skin and subcutaneous tissue   Uncommon          Pruritus disorders                                        Urticaria
Rash**
Musculoskeletal and            Uncommon          Myalgia connective tissue disorders                      Pain in extremity
General disorders and          Very common       Fever administration site conditions                   Swelling at injection site Pain at injection site
Redness at injection site
Fatigue
Common            Injection site haematoma*
Uncommon          Malaise
Injection site induration
Injection site pruritus
Injection site warmth
Injection site anaesthesia
Not known***      Extensive limb swelling at the injection site,
frequently associated with erythema,
sometimes involving the adjacent joint or swelling of the entire injected limb
*Nausea and Injection site haematoma occurred at a frequency of Uncommon in infants **Rash occurred at a frequency of Common in infants
***ADR identified post-marketing

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/ 34TU                              U34T