Adverse reactions : תופעות לוואי

4.8    Undesirable effects

Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Frequencies are defined as follows:
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 the available data)

Adverse reactions from clinical trials

Children 2 to 10 years of age
Overall 3464 subjects aged 2 to10 years were exposed to Menveo in completed clinical trials. The characterization of the safety profile of Menveo in children 2 to 10 years of age is based on data from four clinical trials in which 3181 subjects received Menveo.


Menveo_DR V4.0_notification_13.06.2019_clean                             Page 4 of 16 The most common adverse reactions during the clinical trials generally persisted for one to two days and were not severe. These adverse reactions were:

Metabolism and nutrition disorders:

Common: eating disorder
Nervous system disorders:

Very common: sleepiness, headache

Gastrointestinal disorders:
Common: nausea, vomiting, diarrhea

Skin and subcutaneous tissue disorders:

Common: rash
Musculoskeletal and connective tissue disorders:

Common: myalgia, arthralgia

General disorders and administration site conditions:
Very common: irritability, malaise, injection site pain, injection site erythema (≤50 mm), injection site induration (≤50 mm)
Common: injection site erythema (>50mm), injection site induration (>50mm), chills, fever ≥38oC Uncommon: injection site pruritus

Individuals 11 to 65 years of age

The characterization of the safety profile of Menveo in adolescents and adults, is based on data from five randomised controlled clinical trials including 6401 participants (from 11-65 years of age) who received Menveo. Among Menveo recipients, 58.9%, 16.4%, 21.3% and 3.4% were in the 11-18 year, 19-34 year, 35-55 year and 56-65 year age groups, respectively. The two primary safety studies were randomised, active-controlled trials that enrolled participants aged 11 to 55 years (N=2663) and 19 to 55 years (N=1606), respectively.

The incidence and severity of any, local, systemic, and other reactions were generally similar in the Menveo groups across all studies and within the adolescent and adult age groups. The reactogenicity profile and rates of adverse events among subjects aged 56-65 years who received Menveo (N=216), were similar to that observed in Menveo recipient subjects aged 11-55.

The most common local and systemic adverse reactions observed in clinical trials were pain at the injection site and headache.

The list provided below presents adverse reactions reported in three pivotal and two supportive clinical trials per system organ class. The most common side effects reported during clinical trials usually lasted only one to two days and were not usually severe.


Nervous system disorders:
Very common: headache
Uncommon: dizziness

Menveo_DR V4.0_notification_13.06.2019_clean                             Page 5 of 16 Gastrointestinal disorders:
Very common: nausea

Skin and subcutaneous tissue disorders:
Common: rash

Musculoskeletal and connective tissue disorders:
Very common: myalgia
Common: arthralgia
General disorders and administration site conditions:
Very common: injection site pain, injection site erythema (≤50 mm), injection site induration (≤50 mm), malaise
Common: injection site erythema (>50 mm), injection site induration (>50 mm), fever ≥38°C, chills Uncommon: injection site pruritus

In the adolescent age group, the safety and tolerability of the vaccine was favourable relative to Tdap and did not substantially change with concomitant or sequential administration of other vaccines.

Post-marketing experience (all age groups)

Immune system disorders
Not known: hypersensitivity including anaphylaxis
Nervous system disorders
Not known: tonic convulsion, febrile convulsion, syncope

Ear and labyrinth disorders
Not known: vertigo

General disorders and administration site conditions
Not known: injection site cellulitis, injection site swelling, including extensive swelling of the injected limb 

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://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il Additionally, you should also report to GSK Israel (il.safety@gsk.com)