Vaqta威達

Vaqta

vaccine, hepatitis a

Manufacturer:

MSD

Distributor:

Zuellig
Full Prescribing Info
Contents
Hepatitis A vaccine, inactivated, adsorbed.
Description
One dose (0.5mL or 1mL) contains: Hepatitis A virus (inactivated) 1,2 25 U 3 or 50 U 3, respectively.
1 Produced on human diploid (MRC-5) fibroblast cells.
2 Adsorbed on amorphous aluminium hydroxyphosphate sulphate.
3 Units measured according to the in-house method of the manufacturer-Merck Sharp & Dohme Corp.
Excipients/Inactive Ingredients: Sodium borate, sodium chloride, and water for injection. (For adjuvant, see as previously mentioned.)
Action
Pharmacotherapeutic group: viral vaccines.
Pharmacology: Pharmacodynamics: 25 u/0.5 mL: VAQTA contains inactivated virus of a strain which was originally derived by further serial passage of a proven attenuated strain. The virus is grown, harvested, highly purified, formalin inactivated, and then adsorbed onto amorphous aluminum hydroxyphosphate sulfate.
Efficacy of VAQTA: The Monroe Clinical Study: Clinical studies showed that the seroconversion rate in children ~12 months of age was 96% within 6 weeks after the recommended primary dose and that the seroconversion rate was 97% in children (≥2 years of age) and adolescents within 4 weeks after the recommended primary dose. The onset of seroconversion following a single dose of VAQTA was shown to parallel the onset of protection against clinical hepatitis A disease.
Protective efficacy has been demonstrated after a single dose of VAQTA in 1037 children and adolescents 2 to 16 years of age in a US community with recurrent outbreaks of hepatitis A (The Monroe Efficacy Study). Seroconversion was achieved in more than 99% of vaccine recipients within 4 weeks of the vaccination. The pre-exposure protective efficacy of a single dose of VAQTA was observed to be 100% beginning 2 weeks after vaccination. A booster dose was administered to most vaccinees 6, 12, or 18 months after the primary dose. The effectiveness of VAQTA for use in this community has been demonstrated by the fact that after 9 years, since the trial ended, there has been no case of hepatitis A disease in any vaccinee.
Persistence of immunologic memory was demonstrated with an anamnestic antibody response to a booster dose given 6 to 18 months after the primary dose in children (≥2 years of age) and adolescents. To date, no cases of clinically confirmed hepatitis A disease ≥50 days after vaccination have occurred in these vaccinees from the Monroe Efficacy Study monitored for up to 9 years.
Immunogenicity Studies in Children 12 through 23 Months of Age: In three combined clinical studies that assessed immunogenicity, 1022 initially seronegative subjects received 2 doses of VAQTA alone or concomitantly with other vaccines (combined diphtheria toxoid-tetanus toxoid-acellular pertussis and/or Haemophilus influenzae b and/or combined measles-mumps-rubella-varicella and/or combined measles-mumps-rubella and/or varicella and/or pneumococcal 7-valent conjugate vaccine). Seroconversion was achieved in 99.9% of initially seronegative subjects. No significant differences were observed when vaccines were given individually or concomitantly.
Use in Children With Maternal Antibody to Hepatitis A: In a concomitant use study, children received VAQTA (25U) at ~12 months and ~18 months of age with or without other pediatric vaccines. After each dose of VAQTA (25U), the hepatitis A antibody titers were comparable between children who were initially seropositive to hepatitis A and children who were initially seronegative to hepatitis A. These data suggest that maternal antibody to hepatitis A in children ~12 months of age does not affect the immune response to VAQTA.
Antibody Persistence: In studies of healthy children (≥2 years of age) and adolescents who received an initial 25U dose of VAQTA at Day 0 and a subsequent 25U dose 6 to 18 months later, the hepatitis A antibody response to date has been shown to persist for at least 10 years. The GMTs tend to decline over time. The geometric mean titers (GMTs) declined over the first 5 to 6 years, but appeared to plateau through 10 years.
Data available from long-term studies up to 10 years on the persistence of HAV antibodies after 2 doses of VAQTA in healthy, immunocompetent subjects up to 41 years of age allows prediction that based on mathematical modeling at least 99% of subjects will remain seropositive (≥10 mlU anti-HAV/mL) at least 25 years after vaccination.
Based on this analysis, an additional vaccination following complete primary immunisation with 2 doses appears to be unnecessary. However, decisions regarding additional vaccination should be based on risk-benefit for the individual.
Post-marketing Safety: Study In a post-marketing safety study, conducted at a large health maintenance organization in the United States, a total of 12,523 individuals 2 through 17 years of age received 1 or 2 doses of VAQTA. Safety was monitored by reviewing medical records that tracked emergency room and outpatient visits, hospitalizations and deaths. There was no serious, vaccine-related, adverse event identified among the 12,523 individuals in this study. There was no nonserious, vaccine-related, adverse event resulting in outpatient visits. There was no vaccine-related, adverse event identified that had not been reported in earlier clinical trials with VAQTA.
50 u/mL: VAQTA contains inactivated virus of a strain which was originally derived by further serial passage of a proven attenuated strain. The virus is grown, harvested, highly purified, formalin inactivated, and then adsorbed onto amorphous aluminum hydroxyphosphate sulfate. Within the limits of current assay variability, the 50U dose of VAQTA contains less than 0.1 mcg of non-viral protein, less than 4 x 10-6 mcg of DNA, less than 10-4 mcg of bovine albumin, and less than 0.8 mcg of formaldehyde. Other process chemical residuals are less than 10 parts per billion (ppb).
Clinical studies showed seroconversion rates were 95% in adults within 4 weeks after the recommended primary dose. In a sub-set of these individuals ≥ 60 years of age, data indicate that 88% (n=64) seroconverted by week 4 after the primary dose.
In adults, seropositivity has been shown to persist up to 18 months after a single 50U dose. Persistence of immunologic memory was demonstrated with a substantial anamnestic antibody response to a booster dose of 50U given 6 to 18 months after the primary dose to adults. The data regarding the subjects more than 60 years of age are limited.
Antibody Persistence: In studies of healthy adults (18 to 41 years of age) who received an initial 50U dose of VAQTA at Day 0 and a subsequent 50U dose 6 months later, the hepatitis A antibody response to date has been shown to persist to at least 6 years. After an initial decline over 2 years, the GMTs appeared to plateau during the 2 to 6 year period.
Data available from long-term studies up to 10 years on the persistence of HAV antibodies after 2 doses of VAQTA in healthy, immunocompetent subjects up to 41 years of age allows prediction that based on mathematical modeling at least 99% of subjects will remain seropositive (≥10 mlU anti-HAV/ml) at least 25 years after vaccination.
Based on this analysis, an additional vaccination following complete primary immunisation with 2 doses appears to be unnecessary. However, decisions regarding additional vaccination should be based on risk-benefit for the individual.
Interchangeability of the booster dose: A clinical study in 537 healthy adults, 18 to 83 years of age, evaluated the immune response to a booster dose of VAQTA and a comparable licensed inactivated hepatitis A vaccine given at 6 or 12 months following initial dose of the comparator vaccine. When VAQTA was given as a booster dose in this case it produced an equivalent immune response and was generally well tolerated. (See Dosage & Administration.)
Concomitant use with Immunoglobulin: Concurrent administration to healthy adults (18-39 years of age) of 50 U/1.0 mL of VAQTA with immunoglobulin (IG, 0.06 mL/kg) was evaluated in a clinical study. The seroconversion rate at week 24 in the vaccine alone group (97%) was higher than in the vaccine plus IG group (92% p = 0.050) but rose to 100% in both groups one month post booster.
Concomitant use with other vaccines: A controlled clinical study was conducted with 240 healthy adults, 18 to 54 years of age, who were randomized to receive either: VAQTA, yellow fever and polysaccharide typhoid vaccines concomitantly at separate injection sites; or yellow fever and polysaccharide typhoid vaccines concomitantly at separate injection sites; or VAQTA alone.
The seropositivity rate (SPR) for hepatitis A when VAQTA, yellow fever and polysaccharide typhoid vaccines were administered concomitantly was generally similar to when VAQTA was given alone. However the GMTs for hepatitis A were reduced when the three vaccines were administered concomitantly. Clinically, this reduction in GMTs may be less relevant compared to the benefits of concomitant administration. The antibody response rates for yellow fever and typhoid were equivalent when yellow fever and polysaccharide typhoid vaccines were administered concomitantly with and without VAQTA. The concomitant administration of these three vaccines at separate injection sites was generally well tolerated. The addition of VAQTA to the standard practice of administering yellow fever and typhoid vaccines does not increase the rates of injection site and systemic adverse reactions. (See Dosage & Administration.)
Subcutaneous Administration: In a clinical study with 114 healthy seronegative adults who received subcutaneous administration of VAQTA (50U), at 4 weeks following the first dose, the SPR was 78%, and the GMT was 21 mIU/mL. At 24 weeks following the first dose and just prior to the second subcutaneous injection, the SPR was 95%, and the GMT was 153 mIU/mL. At 4 weeks following the second subcutaneous injection, the SPR was 100%, and the GMT was 1564 mIU/mL; the GMT was 2287 mlU/mL in subjects less than 30 years of age compared with a GMT of 1122 mlU/mL in subjects 30 years of age and older. The kinetics of seropositivity were slower for the first subcutaneous dose of VAQTA compared with historical data for intramuscular administration. At 24 weeks following the first subcutaneous dose, the SPR was similar to the historical data at 4 weeks after the initial intramuscular dose. However, at 4 weeks following the second subcutaneous dose, the SPR was similar to the historical data 4 weeks after the second dose with intramuscular administration. Subcutaneous administration of VAQTA was generally well tolerated.
Administration in HIV-Infected Adults: In a clinical study with 180 adults, 60 HIV-positive (20 to 45 years of age) and 90 HIV-negative adults (21 to 53 years of age) received VAQTA (50U) and 30 HIV-positive adults (22 to 45 years of age) received placebo. At 4 weeks following the first dose of VAQTA, the SPR was 61% for HIV-positive adults and 90% for HIV-negative adults. At 28 weeks following the first dose (4 weeks following the second dose) of VAQTA, the SPRs were satisfactory for all groups: 94% ( GMT of 1060 mIU/mL) in HIV-positive and 100% (GMT of 3602 mIU/mL) in HIV-negative adults. Furthermore, in the HIV-positive group receiving VAQTA, the SPR was 100% (GMT of 1959 mIU/mL) in subjects with CD4 cell counts ≥300 cell/mm3; however, the SPR was 87% (GMT of 517 mIU/mL) in subjects with CD4 cell counts <300 cell/mm3. Three HIV-positive adults with CD4 cell counts <100 cells/mm3 did not seroconvert after receipt of 2 doses of vaccine. The kinetics of the immune response were slower in the HIV-positive group compared with the HIV-negative group. There was an increased rate of local and systemic adverse effects reported in HIV-positive versus HIV-negative adults. In HIV-positive adults, administration of VAQTA did not appear to adversely affect the CD4 cell counts and HIV RNA burden.
Post-marketing Safety Study: In a post-marketing safety study, conducted at a large health maintenance organization in the United States, a total of 29,587 individuals ≥ 18 years of age received 1 or 2 doses of VAQTA. Safety was monitored by reviewing medical records that tracked emergency room and outpatient visits, hospitalizations and deaths. There was no serious, vaccine-related, adverse event identified among the 29,587 individuals in this study. There was no nonserious, vaccine-related, adverse event resulting in outpatient visits, with the exception of diarrhea/gastroenteritis in adults at a rate of 0.5%. There was no vaccine-related, adverse event identified that had not been reported in earlier clinical trials with VAQTA.
Pharmacokinetics: Since VAQTA is a vaccine, pharmacokinetic studies were not performed.
Toxicology: Preclinical safety: Preclinical safety revealed no specific hazard for humans.
Indications/Uses
The use of VAQTA should be based on official recommendations.
For optimal antibody response, primary immunization should be given at least 2, preferably 4, weeks prior to expected exposure to hepatitis A virus.
VAQTA will not prevent hepatitis caused by infectious agents other than hepatitis A virus.
25 u/0.5 mL: VAQTA (25U/0.5mL) is indicated for active pre-exposure prophylaxis against disease caused by hepatitis A virus. VAQTA (25U/0.5mL) is recommended for healthy individuals from 12 months of age to 17 years of age who are at risk of contracting or spreading infection or who are at risk of life-threatening disease if infected (e.g., hepatitis C with diagnosed liver disease).
50 u/mL: VAQTA (50U/1mL) is indicated for active pre-exposure prophylaxis against disease caused by hepatitis A virus. VAQTA (50U/1mL) is recommended for healthy adults 18 years of age and older who are at risk of contracting or spreading infection or who are at risk of life-threatening disease if infected (e.g., those with Human Immunodeficiency Virus [HIV] or hepatitis C with diagnosed liver disease).
Dosage/Direction for Use
Posology: The vaccination series consists of one primary dose and one booster dose given according to the following schedule: Primary dose: 25 u/0.5 mL: Individuals 12 months through 17 years of age should receive a single 0.5 mL (25U) dose of vaccine at an elected date.
Safety and effectiveness in infants <12 months of age have not been established.
50 u/mL: Adults 18 years of age and older should receive a single 1.0 mL (50U) dose of vaccine at an elected date.
Booster dose: 25 u/0.5 mL: Individuals who received a primary dose at 12 months through 17 years of age should receive a booster dose of 0.5 mL (25U) 6 to 18 months after the first dose.
Hepatitis A virus (HAV) antibodies persist for at least 10 years after the second dose (i.e. booster). Based on mathematic modeling duration of antibody persistence is predicted for at least 25 years (see Pharmacology: Pharmacodynamics under Actions).
50 u/mL: Adults 18 years of age and older who received a primary dose should receive a booster dose of 1.0 mL (50U) 6 to 18 months after the first dose.
HAV antibodies persist for at least 6 years after the second dose (i.e. booster). Based on mathematic modeling duration of antibody persistence is predicted for at least 25 years (see Pharmacology: Pharmacodynamics under Actions).
Interchangeability of the booster dose: 25 u/0.5 mL: A booster dose of VAQTA may be given at 6 to 12 months following the initial dose of other inactivated hepatitis A vaccines as shown by data for adults, 18 to 83 years of age; no such data are available for VAQTA (25U/0.5 mL) presentation.
50 u/mL: A booster dose of VAQTA may be given at 6 to 12 months following the initial dose of other inactivated hepatitis A vaccines. (See Pharmacology: Pharmacodynamics under Actions.)
Adults with HIV: 50 u/mL: HIV-infected adults should receive a single dose of 1.0 mL (50U) at elected date followed by a booster dose of 1.0 mL (50U) 6 months later.
Method of administration: VAQTA must not be administered into a blood vessel.
25 u/0.5 mL: VAQTA should be injected INTRAMUSCULARLY. The deltoid muscle is the preferred site for injection. The anterolateral thigh region may be used in infants if the deltoid muscle is not sufficiently developed. The vaccine should not be administered subcutaneously or intradermally since administration by these routes may result in a less than optimal response.
For individuals with bleeding disorders who are at risk of hemorrhage following intramuscular injection (e.g., hemophiliacs) other measures can be taken such as intramuscular administration of the vaccine after anti-hemophilia or other similar therapy, or applying pressure. This vaccine may be administered subcutaneously to these subjects.
50 u/mL: VAQTA should be injected INTRAMUSCULARLY in the deltoid region. The vaccine should not be administered intradermally since administration by this route may result in a less than optimal response.
For individuals with bleeding disorders who are at risk of hemorrhage following intramuscular injection (e.g., hemophiliacs), this vaccine may be administered subcutaneously (see Pharmacology: Pharmacodynamics under Actions).
Overdosage
There are no data with regard to overdose.
Contraindications
Hypersensitivity to any component of the vaccine.
Vaccination should be delayed in subjects with current severe febrile infections.
Special Precautions
Individuals who develop symptoms suggestive of hypersensitivity after an injection of VAQTA should not receive further injections of the vaccine (see Contraindications).
Use caution when vaccinating latex-sensitive individuals since the syringe plunger stopper and tip cap contain dry natural latex rubber that may cause allergic reactions.
Qualitative testing for antibodies to hepatitis A prior to immunization should be considered based on the probability of previous hepatitis A virus infection in patients who grew up in areas of high endemicity, and/or with a history of jaundice.
VAQTA does not cause immediate protection against hepatitis A, and there may be a period of 2 to 4 weeks before antibody becomes detectable.
VAQTA will not prevent hepatitis caused by infectious agents other than hepatitis A virus. Because of the long incubation period (approximately 20 to 50 days) for hepatitis A, it is possible for unrecognized hepatitis A infection to be present at the time the vaccine is given. The vaccine may not prevent hepatitis A in such individuals.
As with any vaccine, adequate treatment provisions, including epinephrine (adrenaline), should be available for immediate use should an anaphylactic or anaphylactoid reaction occur.
As with any vaccine, vaccination with VAQTA may not result in a protective response in all susceptible vaccinees.
This vaccine may contain traces of neomycin and formaldehyde which are used during the manufacturing process.
Effects on ability to drive and use machines: There are no data to suggest that VAQTA affects the ability to drive or operate machinery.
50 u/mL: VAQTA may be administered subcutaneously when clinically appropriate (e.g., people with bleeding disorders who are at risk of hemorrhage), although the kinetics of seroconversion are slower for the first subcutaneous dose of VAQTA compared with historical data for intramuscular administration.
Use In Pregnancy & Lactation
Animal reproduction studies have not been conducted with VAQTA.
It is not known whether VAQTA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. VAQTA 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 fetus.
It is not known whether VAQTA is excreted in human milk and the effect on breast-fed infants following administration of VAQTA to mothers has not been studied. Hence, VAQTA should be used with caution in women who are breast-feeding.
Adverse Reactions
Clinical Studies: 25 u/0.5 mL: Children 12 Months Through 23 Months of Age: In 5 combined clinical trials, 4374 children 12 through 23 months of age received one or two 25U doses of VAQTA. Out of the 4374 children who received VAQTA, 3885 (88.8%) children received 2 doses of VAQTA and 1250 (28.6%) children received VAQTA concomitantly with other vaccines. Children were followed for elevated temperature and injection-site adverse reactions during a 5-day period post-vaccination and systemic adverse events including fever during a 14-day period post-vaccination.
In three of the five protocols which specifically prompted for injection-site erythema, pain/tenderness, and swelling daily for Day 1 through Day 5 post-vaccination, the most frequently reported injection-site adverse reaction after any dose of VAQTA was injection-site pain/tenderness.
The most common systemic adverse events among recipients of VAQTA alone were fever and irritability. The data from the five protocols were combined as similar methods for collecting systemic adverse events were used.
The adverse events that were reported as vaccine-related when VAQTA was administered alone are listed as follows in decreasing order of frequency within each system organ classification.
[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).]
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.
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: diarrhea.
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 and 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.
Children/Adolescents (2 Through 17 Years of Age): In clinical trials with 2595 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 post-vaccination and systemic adverse experiences including fever during a 14-day period post-vaccination. Injection-site reactions, generally mild and transient, were the most frequently reported adverse experiences.
Adverse experiences reported as vaccine-related are listed as follows in decreasing order of frequency within each system organ classification.
[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).]
Metabolism and nutrition disorders: Rare: anorexia.
Psychiatric disorders: Uncommon: irritability.
Rare: nervousness.
Nervous system disorders: Common: headache.
Uncommon: dizziness.
Rare: somnolence; paraesthesia.
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; diarrhea; nausea.
Skin and subcutaneous tissue disorders: Uncommon: rash; pruritus.
Rare: urticaria; sweating.
Musculoskeletal, connective tissue and bone 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.
As with all vaccines, allergic reactions, in rare cases leading to shock, may occur (see Precautions).
50 u/mL: In clinical trials with 1529 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 post-vaccination and systemic adverse experiences including fever during a 14-day period post-vaccination. Injection-site reactions, generally mild and transient, were the most frequently reported adverse experiences.
Adverse experiences reported, as vaccine-related are listed as follows in decreasing order of frequency, within each system organ classification.
[Very Common: (≥1/10), Common: (≥1/100, <1/10), Uncommon: (≥1/1000, <1/100) and Rare: (≥1/10,000, <1/1000).]
Infections and infestations: Uncommon: pharyngitis; upper respiratory infection.
Rare: bronchitis; infectious gastroenteritis.
Blood and lymphatic system disorders: Uncommon: lymphadenopathy.
Metabolism and nutrition disorders: Rare: anorexia.
Psychiatric disorders: Rare: apathy; insomnia.
Nervous system disorders: Common: headache.
Uncommon: dizziness; paresthesia.
Rare: somnolence; migraine; tremor.
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; diarrhea; 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.
As with all vaccines, allergic reactions, in rare cases leading to shock, may occur (see Precautions).
Marketed experience: The following additional adverse reactions have been reported with use of the marketed vaccine.
Nervous system disorders: Very rarely, Guillain-Barré syndrome.
Blood and lymphatic system disorders: Very rarely, thrombocytopenia.
Post-marketing Safety Study: There was no serious, vaccine-related, adverse event identified.
25 u/0.5 mL: In a post-marketing safety study, a total of 12,523 individuals 2 through 17 years of age received 1 or 2 doses of VAQTA. There was no non-serious, vaccine-related, adverse event resulting in outpatient visits.
50 u/mL: In a post-marketing safety study, a total of 29,587 individuals ≥ 18 years of age received 1 or 2 doses of VAQTA. There was no non-serious, vaccine-related, adverse event resulting in outpatient visits, with the exception of diarrhea/gastroenteritis in adults at a rate of 0.5%.
Drug Interactions
If VAQTA is used in individuals with malignancies or those receiving immunosuppressive therapy or who are otherwise immunocompromised, the expected immune response may not be obtained.
Known or presumed exposure to HAV/travel to endemic areas: Use with immune globulin: For individuals requiring either post-exposure prophylaxis or combined immediate and longer term protection (e.g., travelers departing on short notice to endemic areas), in countries where IG is available VAQTA may be administered concomitantly with IG using separate sites and syringes. Although the antibody titer obtained is likely to be lower than when the vaccine is given alone. The clinical relevance of this observation has not been established.
25 u/0.5 mL: VAQTA Concomitant Use With Other Vaccines: Hepatitis A response has been shown to be similar when VAQTA was given alone or concomitantly with measles, mumps, rubella, varicella, pneumococcal 7-valent conjugate, inactivated polio, diphtheria toxoid, tetanus toxoid, acellular pertussis, or Haemophilus influenzae b vaccine. Responses to measles, mumps, rubella, varicella, pneumococcal 7-valent conjugate, inactivated polio, diphtheria toxoid, tetanus toxoid, acellular pertussis, and Haemophilus influenzae b were not affected by concomitant administration with VAQTA. Studies in adults 18 to 54 years of age have shown that VAQTA may be administered concomitantly with yellow fever and polysaccharide typhoid vaccines.
VAQTA must not be mixed with other vaccines in the same syringe. When concurrent administration is necessary, different injection sites and separate syringes must be used for each vaccine.
50 u/mL: Use with other vaccines: VAQTA may be given concomitantly at separate injection sites with yellow fever and polysaccharide typhoid vaccines (see Pharmacology: Pharmacodynamics under Actions). Though data in subjects 18 years of age and older are not available, studies in children 12 through 23 months of age have shown that VAQTA may be administered concomitantly with measles, mumps, rubella, varicella, pneumococcal 7-valent conjugate, and inactivated polio vaccines. Immunogenicity data are insufficient to support concomitant administration of VAQTA with DTaP (Diphtheria, Tetanus and acellular Pertussis).
Interaction studies other than with yellow fever and polysaccharide typhoid vaccines are not yet available; however, interactions with other vaccines are not anticipated when vaccines are administered at different injection sites. When concurrent administration is necessary, VAQTA must not be mixed with other vaccines in the same syringe, and other vaccines should be administered at different sites.
Caution For Usage
Special precautions for disposal and other handling: The vaccine should be used as supplied; no reconstitution is necessary.
Shake well before use. Thorough agitation is necessary to maintain suspension of the vaccine. For syringe without attached needle, hold the syringe barrel and attach the needle by twisting in clockwise direction until the needle fits securely on the syringe.
Parenteral drug products should be inspected visually for extraneous particulate matter and discoloration prior to administration. After thorough agitation, VAQTA is a slightly opaque white suspension.
It is important to use a separate sterile syringe and needle for each individual to prevent transmission of infections from one person to another.
Any unused product or waste material should be disposed of in accordance with local requirements.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Storage
Store in a refrigerator (2°C - 8°C).
DO NOT FREEZE since freezing destroys potency.
ATC Classification
J07BC02 - hepatitis A, inactivated, whole virus ; Belongs to the class of hepatitis viral vaccines.
Presentation/Packing
Inj (pre-filled syringe) 25 u/0.5 mL (paed) x 1's. 50 u/mL (adult) x 1's.
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