Hepatitis A, inactivated vaccine interacts in the following cases:
For individuals requiring either post-exposure prophylaxis or combined immediate and longer term protection (e.g., travellers departing on short notice to endemic areas), in countries where IG is available the hepatitis A vaccine may be administered concomitantly with IG using separate sites and syringes. Although the antibody titre obtained is likely to be lower than when the vaccine is given alone. The clinical relevance of this observation has not been established.
If hepatitis A vaccine is used in individuals with malignancies or those receiving immunosuppressive therapy or who are otherwise immunocompromised, the expected immune response may not be obtained.
HIV-infected adults should receive a single dose of 1.0mL (50U) of the hepatitis A vaccine at an elected date followed by a booster dose of 1.0mL (50U) 6 months later.
It is not known whether the hepatitis A vaccine can cause foetal harm when administered to a pregnant woman, or can affect reproduction capacity. It is not recommended in pregnancy unless there is a high risk of hepatitis A infection, and the attending physician judges that the possible benefits of vaccination outweigh the risks to the foetus.
It is not known whether the hepatitis A vaccine is excreted in human milk, and the effect on breastfed infants following administration of it to mothers has not been studied. Hence, it should be used with caution in women who are breastfeeding.
It has not been evaluated in fertility studies.
Animal reproduction studies have not been conducted.
No studies on the effects on the ability to drive and use machines have been performed. However, is expected to have no or negligible influence on the ability to drive and use machines.
In clinical trials with 1,529 healthy adults who received one or more doses of hepatitis A vaccine, subjects were followed for elevated temperature and local reactions during a 5-day period postvaccination and systemic adverse events including fever during a 14-day period postvaccination. Injection-site reactions, generally mild and transient, were the most frequently reported adverse events.
In a post-marketing safety study, a total of 29,587 individuals ≥18 years of age received 1 or 2 doses of hepatitis A vaccine. There was no serious, vaccine-related, adverse event identified. There was no nonserious, vaccine-related, adverse event resulting in outpatient visits, with the exception of diarrhoea/gastroenteritis in adults at a rate of 0.5%.
The table presents adverse reactions reported as vaccine related observed in clinical trials, and in a post-authorisation safety study and adverse reactions spontaneously reported after use of the marketed vaccine.
Adverse reactions are ranked under headings of frequency using the following convention: [Very Common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10,000 to <1/1000); Very Rare (<1/10,000); Not Known (cannot be estimated from the available data)].
| System Organ Class | Frequency | Adverse reactions |
|---|---|---|
| Infections and infestations | Uncommon | Pharyngitis, Upper respiratory infection |
| Rare | Bronchitis, Infectious gastroenteritis | |
| Blood and lymphatic system disorders | Uncommon | Lymphadenopathy |
| Not Known | Thrombocytopenia1 | |
| Metabolism and nutrition disorders | Rare | Anorexia |
| Psychiatric disorders | Rare | Apathy, Insomnia |
| Nervous system disorders | Common | Headache |
| Uncommon | Dizziness, Paresthesia | |
| Rare | Somnolence, Migraine, Tremor | |
| Not Known | Guillain-Barré syndrome1 | |
| Eye disorders | Rare | Itching eye, Photophobia, Tearing |
| Ear and labyrinth disorders | Uncommon | Ear pain |
| Rare | Vertigo | |
| Vascular disorders | Uncommon | Hot flashes |
| Respiratory, thoracic and mediastinal disorders | Uncommon | Respiratory congestion, Nasal congestion, Cough |
| Rare | Pharyngeal edema, Sinus disorder | |
| Gastrointestinal disorders | Uncommon | Nausea, Diarrhoea/ Gastroenteritis2, Flatulence, Vomiting |
| Rare | Dry mouth, Mouth ulcer | |
| Skin and subcutaneous tissue disorders | Uncommon | Pruritus, Urticaria, Erythema |
| Rare | Night sweats, Rash, Skin disorder | |
| Musculoskeletal and connective tissue disorders | Common | Arm pain (in the injected arm) |
| Uncommon | Myalgia, Stiffness, Shoulder pain, Musculoskeletal pain, Back pain, Arthralgia, Leg pain, Neck pain, Muscle weakness | |
| Rare | Muscle cramp, Elbow pain, Hip pain, Jaw pain, Spasm | |
| Reproductive system and breast disorders | Rare | Menstruation disorder |
| General disorders and administrative site conditions | Very Common | Injection-site tenderness, Pain, Warmth, Swelling, Erythema |
| Common | Asthenia/Fatigue, Fever (≥38.3°C, Oral) Injection-site ecchymosis, Pain/Soreness | |
| Uncommon | Injection-site pruritus, Stiffness/Tightness, Pain, Injection-site hematoma, Chills, Abdominal pain, Malaise, Injection-site induration and numbness, Cold sensation, Flu-like illness | |
| Rare | Injection-site burning, Induration (≤2.5 centimeters), Muscle twitching, Rash, Abdominal distention, Chest pain, Flank pain, Irritability |
1 Post-authorisation safety study
2 Spontaneous reporting after use of marketed vaccine
As with all vaccines, allergic reactions, in rare cases leading to shock, may occur.
In 5 combined clinical trials, 4,374 children 12 through 23 months of age received one or two 25 U doses of hepatitis A vaccine. Out of the 4,374 children who received the vaccine, 3,885 (88.8%) children received 2 doses of it and 1,250 (28.6%) children received the hepatitis A vaccine concomitantly with other vaccines. Children were followed for elevated temperature and injection-site adverse reactions during a 5-day period postvaccination and systemic adverse events including fever during a 14-day period postvaccination.
In three of the five protocols which specifically prompted for injection-site erythema, pain/tenderness, and swelling daily for Day 1 through Day 5 postvaccination, the most frequently reported injection-site adverse reaction after any dose of the vaccine was injection-site pain/tenderness.
The most common systemic adverse events among recipients of the hepatitis A vaccine alone were fever and irritability. The data from the five protocols were combined as similar methods for collecting systemic adverse events were used.
In clinical trials with 2,595 healthy children (≥2 years of age) and adolescents who received one or more doses of hepatitis A vaccine, subjects were followed for elevated temperature and local reactions during a 5-day period postvaccination and systemic adverse events including fever during a 14-day period postvaccination. Injection-site reactions, generally mild and transient, were the most frequently reported adverse events.
Adverse reactions reported as vaccine related are listed below in decreasing order of frequency within each system organ classification.
In a post-marketing safety study, a total of 12,523 individuals 2 through 17 years of age received 1 or 2 doses of the hepatitis A vaccine. There was no serious, vaccine-related, adverse event identified. There was no non-serious, vaccine-related, adverse event resulting in outpatient visits.
The tables below present adverse reactions reported as vaccine related observed in clinical trials, and in a post-authorisation safety study and adverse reactions spontaneously reported after use of the marketed vaccine.
Adverse reactions are ranked under headings of frequency using the following convention:
[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)].
Children 12 months through 23 months of age:
| System Organ Class | Frequency | Adverse Reactions |
|---|---|---|
| Blood and lymphatic system disorders | Not Known | Thrombocytopenia1 |
| Immune system disorders | Rare | Multiple allergies |
| Metabolism and nutrition disorders | Uncommon | Decreased appetite, Anorexia |
| Rare | Dehydration | |
| Psychiatric disorders | Uncommon | Insomnia, Restlessness |
| Rare | Agitation, Nervousness, Phobia, Screaming, Sleep disorder | |
| Nervous system disorders | Uncommon | Somnolence, Crying, Lethargy, Hypersomnia, Poor quality sleep |
| Rare | Dizziness, Headache, Ataxia | |
| Not Known | Guillain-Barré syndrome1 | |
| Eye disorders | Rare | Eyelid margin crusting |
| Respiratory, thoracic and mediastinal disorders | Uncommon | Rhinorrhea, Cough, Nasal congestion |
| Rare | Respiratory tract congestion, Sneezing, Asthma, Allergic rhinitis, Oropharyngeal pain | |
| Gastrointestinal disorders | Common | Diarrhoea |
| Uncommon | Vomiting | |
| Rare | Flatulence, Abdominal distension, Upper abdominal pain, Faeces discolored, Frequent bowel movements, Nausea, Stomach discomfort, Constipation, Eructation, Infantile spitting up | |
| Skin and subcutaneous tissue disorders | Uncommon | Rash, Dermatitis diaper |
| Rare | Urticaria, Cold sweat, Eczema, Generalized erythema, Papular rash, Blister, Erythema, Generalized rash, Heat rash, Hyperhidrosis, Skin warm | |
| Musculoskeletal, connective tissue disorders | Rare | Synovitis |
| General disorders and administrative site conditions | Very Common | Injection-site pain/ tenderness, Injection-site erythema |
| Common | Injection-site swelling, Fever, Irritability, Injection-site warmth, Injection-site bruising | |
| Uncommon | Injection-site hematoma, Injection -site nodule, Malaise, Injection-site rash | |
| Rare | Pain, Injection-site haemorrhage, Injection-site pruritus, Discomfort, Fatigue, Gait disturbance, Injection -site discoloration, Injection-site papule, Injection-site urticaria, Feeling hot |
1 Spontaneous reporting after use of marketed vaccine
Children/adolescents (2 years through 17 years of age):
| System Organ Class | Frequency | Adverse Events |
|---|---|---|
| Blood and lymphatic system disorders | Not Known | Thrombocytopenia1 |
| Metabolism and nutrition disorders | Rare | Anorexia |
| Psychiatric disorders | Uncommon | Irritability |
| Rare | Nervousness | |
| Nervous system disorders | Common | Headache |
| Uncommon | Dizziness | |
| Rare | Somnolence, Paraesthesia | |
| Not Known | Guillain-Barré syndrome1 | |
| Ear and labyrinth disorders | Rare | Ear pain |
| Vascular disorders | Rare | Flushing |
| Respiratory, thoracic and mediastinal disorders | Rare | Nasal congestion, Cough; Rhinorrhea |
| Gastrointestinal disorders | Uncommon | Abdominal pain, Vomiting, Diarrhoea, Nausea |
| Skin and subcutaneous tissue disorders | Uncommon | Rash, Pruritus |
| Rare | Urticaria, Sweating | |
| Musculoskeletal, connective tissue disorders | Uncommon | Arm pain (in the injected limb), Arthralgia, Myalgia |
| Rare | Stiffness | |
| General disorders and administrative site conditions | Very Common | Injection-site pain and Tenderness |
| Common | Injection-site warmth, Erythema and Swelling, Fever, Injection-site ecchymosis | |
| Uncommon | Asthenia/fatigue, Injection-site pruritus and Pain/soreness | |
| Rare | Injection-site induration, Flu-like illness, Chest pain, Pain, Warm sensation, Injection-site scab, Stiffness/tightness and Stinging |
1 Spontaneous reporting after use of marketed vaccine
As with all vaccines, allergic reactions, in rare cases leading to shock, may occur.
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