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Vaqta

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Vaqta

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice.

The safety of VAQTA has been evaluated in over 10,000 subjects 1 year to 85 years of age. Subjects were given one or two doses of the vaccine. The second (booster dose) was given 6 months or more after the first dose.

The most common local adverse reactions and systemic adverse events ( ≥ 15%) reported in different clinical trials across different age groups when VAQTA was administered alone or concomitantly were:

  • Children — 12 through 23 months of age: injection-site pain/tenderness (37.0%), injection-site erythema (21.2%), fever (16.4% when administered alone, and 27.0% when administered concomitantly).
  • Children/Adolescents — 2 through 18 years of age: injection-site pain (18.7%)
  • Adults — 19 years of age and older: injection-site pain, tenderness, or soreness (67.0%), injectionsite warmth (18.2%) and headache (16.1%)
Allergic Reactions

Local and/or systemic allergic reactions that occurred in < 1% of over 10,000 children/adolescents or adults in clinical trials regardless of causality included: injection-site pruritus and/or rash; bronchial constriction; asthma; wheezing; edema/swelling; rash; generalized erythema; urticaria; pruritus; eye irritation/itching; dermatitis [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Children — 12 through 23 Months of Age

Across five clinical trials, 4374 children 12 to 23 months of age received one or two 25U doses of VAQTA, including 3885 children who received 2 doses of VAQTA and 1250 children who received VAQTA concomitantly with one or more other vaccines, including Measles, Mumps, and Rubella Virus Vaccine, Live (M-M-R II®), Varicella Vaccine, Live (VARIVAX®), Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine, Adsorbed (Tripedia or INFANRIX), Measles, Mumps, Rubella, and Varicella Vaccine, Live (ProQuad®), Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197, Prevnar), or

Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate, PedvaxHIB®). Overall, the race distribution of study subjects was as follows: 64.7% Caucasian; 15.7% Hispanic-American; 12.3% Black; 4.8% other; 1.4% Asian; and 1.1% Native American. The distribution of subjects by gender was 51.8% male and 48.2% female.

In an open-label clinical trial, 653 children 12 to 23 months of age were randomized to receive a first dose of VAQTA with ProQuad and Prevnar concomitantly (N=330) or a first dose of ProQuad and pneumococcal 7-valent conjugate vaccine concomitantly, followed by a first dose of VAQTA 6 weeks later (N=323). Approximately 6 months later, subjects received either the second doses of ProQuad and VAQTA concomitantly or the second doses of ProQuad and VAQTA separately. The race distribution of the study subjects was as follows: 60.3% Caucasian; 21.6% African-American; 9.5% Hispanic-American; 7.2% other; 1.1% Asian; and 0.3% Native American. The distribution of subjects by gender was 50.7% male and 49.3% female.

Table 1 presents rates of solicited local reactions at the VAQTA injection site and rates of elevated temperatures ( ≥ 100.4°F and ≥ 102.2°F) that occurred within 5 days following each dose of VAQTA and elevated temperatures > 98.6°F for a total of 14 days after vaccination; occurrences of these events were recorded daily on diary cards. Table 2 presents rates of unsolicited systemic adverse events that occurred within 14 days at ≥ 5% in any group following each dose of VAQTA.

Table 1: Incidences of Solicited Local Adverse Reactions at the VAQTA Injection Site and Elevated Temperatures Following Each Dose of VAQTA in Healthy Children 12-23 Months of Age Receiving VAQTA Alone or Concomitantly With ProQuad and PREVNAR*

Adverse reaction: Days 1-5 unless noted Dose 1 Dose 2
VAQTA alone VAQTA + ProQuad + Prevnar concomitantly VAQTA alone VAQTA + ProQuad concomitantly
Injection site adverse reactions N=274 N=311 N=251 N=263
  Injection site erythema 11.7% 9.6% 12.7% 9.5%
  Injection site pain/tenderness 15.3% 20.9% 20.3% 17.5%
  Injection site swelling 9.5% 6.8% 7.6% 6.1%
  Temperature > 98.6°F or feverish (Days 1-14) 12.4% 35.7% 10.8% 10.3%
  N=243 N=285 N=221 N=237
  Temperature ≥ 100.4°F 10.3% 16.8% 10% 4.2%
  Temperature ≥ 102.2 °F 2.1% 3.5% 2.3% 2.5%
*Pneumococcal 7-valent Conjugate Vaccine
N=number of subjects for whom data are available.

Table 2: Incidences of Unsolicited Systemic Adverse Events ≥ 5% in Any Group Following Each Dose of VAQTA in Healthy Children 12-23 Months of Age Receiving VAQTA Alone or Concomitantly With ProQuad and PREVNAR*

Adverse Event: Days 1-14 Dose 1 Dose 2  
VAQTA alone VAQTA + ProQuad + PREVNAR concomitantly VAQTA alone VAQTA + ProQuad concomitantly
  N=274 N=311 N=251 N=263
General Disorders and Administration Site Conditions
  Irritability 3.6% 6.1% 2.8% 2.7%
Infections and Infestations
  Upper respiratory tract infection 3.3% 6.1% 4.8% 5.7%
Skin and Subcutaneous Tissue Disorders
  Dermatitis diaper 1.1% 6.1% 2.4% 3.4%
*Pneumococcal 7-valent Conjugate Vaccine

In Stage I of an open, multicenter, randomized study, children 15 months of age were randomized to receive the first dose of VAQTA alone (N=151) or concomitantly with PedvaxHIB and INFANRIX (N=155); another group of children 15 months of age were randomized to receive the first dose of VAQTA alone (N=152) or concomitantly with PedvaxHIB (N=159). All groups received the second dose of VAQTA alone at least 6 months following the first dose. The race distribution of Stage I study subjects was: 63.9% Caucasian; 17.5% Hispanic-American; 14.7% Black; 2.6% other; and 1.3% Asian. The distribution of subjects by gender was 54.0% male and 46.0% female. In Stage II of this study, an additional 654 children 12-17 months of age received the first dose of VAQTA alone followed by the second dose of VAQTA 6 months later. The race distribution of Stage II of the study subjects was: 66.1% Caucasian; 10.6% Hispanic-American; 16.8% Black; 4.7% other; and 1.5% Asian. The distribution of subjects by gender was 51.2% male and 48.8% female.

Table 3 presents rates of solicited local reactions at the VAQTA injection-site and rates of elevated temperatures ( ≥ 100.4°F and ≥ 102.2°F) that occurred within 5 days following each dose of VAQTA and elevated temperatures > 98.6°F for a total of 14 days following each dose of VAQTA. Occurrences of these events were recorded daily on diary cards. Table 4 presents rates of unsolicited systemic adverse events that occurred within 14 days at ≥ 5% following each dose of VAQTA.

Table 3: Incidences of Solicited Local Adverse Reactions at the VAQTA Injection Site and Elevated Temperatures Following Each Dose of VAQTA in Healthy Children 12-23 Months of Age Receiving VAQTA Alone or Concomitantly with PedvaxHIB With or Without INFANRIX (Stage I) and those Receiving VAQTA Alone at Both Doses (Stage II)

Adverse Reaction: Days 1-5 unless noted Stage I Stage II
Dose 1 Dose 2 Dose 1 Dose 2
VAQTA alone VAQTA + PedvaxHIB and Infanrix or VAQTA + PedvaxHIB concomitantly VAQTA alone VAQTA alone VAQTA alone
Injection site adverse reactions N=256 N=302 N=503 N=647 N=599
  Injection site erythema 18.0% 19.9% 21.5% 11.7% 16.2%
  Injection site pain/tenderness 21.9% 36.4% 27.4% 20.1% 22.9%
  Injection site swelling 10.2% 14.2% 10.1% 7.1% 7.0%
  Temperature > 98.6°F or feverish (Days 114) 10.2% 17.2% 10.7% 10.0% 8.2%
  N=234 N=290 N=473 N=631 N=591
  Temperature ≥ 100.4°F 9.0% 16.9% 9.1% 9.4% 8.6%
  Temperature ≥ 102.2 °F 3.8% 3.1% 3.2% 2.9% 2.4%
N= number of subjects for whom data is available

Table 4: Incidences of Unsolicited Systemic Adverse Events ≥ 5% in Any Group Following Each Dose of VAQTA in Healthy Children 12-23 Months of Age Receiving VAQTA Alone or Concomitantly with PedvaxHIB With or Without INFANRIX (Stage and Those Receiving VAQTA Alone at Both Doses (Stage II)

Adverse Event: Days 1-14 Stage I Stage II
Dose 1 Dose 2 Dose 1 Dose 2
VAQTA alone VAQTA +PedvaxHIB and Infanrix or VAQTA + PedvaxHIB concomitantly VAQTA alone VAQTA alone VAQTA alone
  N=256 N=302 N=503 N=647 N=599
Gastrointestinal Disorders
  Diarrhea 3.9% 8.3% 3.8% 4.6% 3.8%
  Teething 3.1% 2.3% 1.4% 5.7% 4.3%
General Disorders and Administration Site Conditions
  Irritability 6.3% 9.6% 4.0% 8.8% 6.5%
Infections and Infestations
  Upper respiratory tract infection 2.3% 3.3% 3.0% 4.9% 5.2%
Respiratory, Thoracic and Mediastinal Disorders
  Rhinorrhea 2.0% 4.0% 3.8% 6.2% 3.8%

Data presented in Tables 1 through 4 on solicited local reactions, and solicited and unsolicited systemic adverse events with incidence ≥ 5% following each dose of VAQTA are representative of other clinical trials of VAQTA in children 12 through 23 months of age. Across the five studies conducted in children 12-23 months of age, ≥ 39.9% of subjects experienced local adverse reactions and ≥ 55.7% of subjects experienced systemic adverse events. The majority of local and systemic adverse events were mild to moderate in intensity.

The following additional unsolicited local adverse reactions and systemic adverse events were observed at a common frequency of ≥ 1% to < 10% in any individual clinical study. This listing includes only the adverse reactions not reported elsewhere in the label. These local adverse reactions and systemic adverse events occurred among recipients of VAQTA alone or VAQTA given concomitantly within 14 days following any dose of VAQTA across four clinical studies.

Eye disorders: Conjunctivitis

Gastrointestinal disorders: Constipation; vomiting

General disorders and administration site conditions: Injection-site bruising; injection-site ecchymosis

Infections and infestations: Otitis media; nasopharyngitis; rhinitis; viral infection; croup; pharyngitis streptococcal; laryngotracheobronchitis; viral exanthema; gastroenteritis viral; roseola

Metabolism and nutrition disorders: Anorexia

Psychiatric disorders: Insomnia; crying

Respiratory, thoracic and mediastinal disorders: Cough; nasal congestion; respiratory congestion

Skin and subcutaneous tissue disorders: Rash vesicular; measles-like/rubella-like rash; varicellalike rash; rash morbilliform

Serious Adverse Events (Children 12 through 23 Months of Age)

Across the five studies conducted in subjects 12-23 months of age, 0.7% (32/4374) of subjects reported a serious adverse event following any dose of VAQTA, and 0.1% (5/4374) of subjects reported a serious adverse event judged to be vaccine related by the study investigator. The serious adverse events were collected over the period defined in each protocol (14, 28, or 42 days). Vaccine-related serious adverse events which occurred following any dose of VAQTA with or without concomitant vaccines included febrile seizure (0.05%), dehydration (0.02%), gastroenteritis (0.02%), and cellulitis (0.02%).

Children/Adolescents — 2 Years through 18 Years of Age

In 11 clinical trials, 2615 healthy children 2 years through 18 years of age received at least one dose of VAQTA. These studies included administration of VAQTA in varying doses and regimens (1377 children received one or more 25U doses). The race distribution of the study subjects who received at least one dose of VAQTA in these studies was as follows: 84.7% Caucasian; 10.6% American Indian; 2.3% African- American; 1.5% Hispanic-American; 0.6% other; 0.2% Oriental. The distribution of subjects by gender was 51.2% male and 48.8% female.

In a double-blind, placebo-controlled efficacy trial (i.e. The Monroe Efficacy Study), 1037 healthy children and adolescents 2 through 16 years of age were randomized to receive a primary dose of 25U of VAQTA and a booster dose of VAQTA 6, 12, or 18 months later, or placebo (alum diluent). All study subjects were Caucasian: 51.5% were male and 48.5% were female. Subjects were followed days 1 to 5 postvaccination for fever and local adverse reactions and days 1 to 14 for systemic adverse events. The most common adverse events/reactions were injection-site reactions, reported by 6.4% of subjects. Table 5 summarizes local adverse reactions and systemic adverse events reported in ≥ 1% of subjects. There were no significant differences in the rates of any adverse events or adverse reactions between vaccine and placebo recipients after Dose 1.

Table 5: Local Adverse Reactions and Systemic Adverse Events ( ≥ 1%) in Healthy Children and Adolescents from the Monroe Efficacy Study

Adverse Event VAQTA (N=519) Placebo (Alum Diluent)*†,‡
(N=518)
Rate (Percent)
Dose 1* Rate (Percent) Booster Rate (Percent)
 
Injection Site§ n=515 n=475 n=510
Pain 6.4% 3.4% 6.3%
Tenderness 4.9% 1.7% 6.1%
Erythema 1.9% 0.8% 1.8%
Swelling 1.7% 1.5% 1.6%
Warmth 1.7% 0.6% 1.6%
Systemic1 n=519 n=475 n=518
Abdominal pain 1.2% 1.1% 1.0%
Pharyngitis 1.2% 0% 0.8%
Headache 0.4% 0.8% 1.0%
N=Number of subjects enrolled/randomized.
Percent=percentage of subjects for whom data are available with adverse event
n=number of subjects for whom adverse events available
* No statistically significant differences between the two groups.
† Second injection of placebo not administered because code for the trial was broken.
‡ Placebo (Alum diluent) = amorphous aluminum hydroxyphosphate sulfate.
§ Adverse Reactions at the injection site (VAQTA) Days 1-5 after vaccination with VAQTA
para; Systemic adverse events reported Days 1-15 after vaccination, regardless of causality.

Adults — 19 Years of Age and Older

In an open-label clinical trial, 240 healthy adults 18 to 54 years of age were randomized to receive either VAQTA (50U/1-mL) with Typhim Vi (Typhoid Vi polysaccharide vaccine) and YF-Vax (yellow fever vaccine) concomitantly (N=80), typhoid Vi polysaccharide and yellow fever vaccines concomitantly (N=80), or VAQTA alone (N=80). Approximately 6 months later, subjects who received VAQTA were administered a second dose of VAQTA. The race distribution of the study subjects who received VAQTA with or without typhoid Vi polysaccharide and yellow fever vaccine was as follows: 78.3% Caucasian; 14.2% Oriental; 3.3% other; 2.1% African-American; 1.7% Indian; 0.4% Hispanic-American. The distribution of subjects by gender was 40.8% male and 59.2% female. Subjects were monitored for local adverse reactions and fever for 5 days and systemic adverse events for 14 days after each vaccination. In the 14 days after the first dose of VAQTA, the proportion of subjects with adverse events was similar between recipients of VAQTA given concomitantly with typhoid Vi polysaccharide and yellow fever vaccines compared to recipients of typhoid Vi polysaccharide and yellow fever vaccines without VAQTA. Table 6 summarizes solicited local adverse reactions and Table 7 summarizes unsolicited systemic adverse events reported in ≥ 5% in adults who received one or two doses of VAQTA alone and for subjects who received VAQTA concomitantly with typhoid Vi polysaccharide and yellow fever vaccines. There were no solicited systemic complaints reported at a rate ≥ 5%. Fever ≥ 101°F occurred in 1.3% of subjects in each group.

Table 6: Incidences of Solicited Local Adverse Reactions in Healthy Adults ≥ 19 Years of Age Occurring at ≥ 5% After Any Dose

Adverse Event VAQTA administered alone
(N=80)
VAQTA + ViCPS* and Yellow Fever vaccines administered concomitantly†
(N=80)
Rate Percent)
Injection-site*
Pain/tenderness/soreness 78.8% 70.3%
Warmth 23.7% 23.7%
Swelling 16.2% 8.8%
Erythema 17.5% 6.3%
N=Number of subjects enrolled/randomized.
Percent=percentage of subjects with adverse event.
*ViCPS=Typhoid Vi polysaccharide vaccine.
†VAQTA administered concomitantly with typhoid Vi polysaccharide (ViCPS) and yellow fever vaccines.
‡ Adverse Reactions at the injection site (VAQTA) Days 1-5 after vaccination

Table 7: Incidences of Unsolicited Systemic Adverse Events in Adults ≥ 19 Years of Age Occurring at ≥ 5% After Any Dose

Body System
Adverse Event
VAQTA administered alone
(N=80)
VAQTA + ViCPS* and Yellow Fever vaccines administered concomitantly†,
(N=80)
Rate (Percent)
General disorders and administration site reactions‡
  Asthenia/fatigue 7.5% 11.3%
  Chills 1.3% 7.5%
Gastrointestinal disorders‡
  Nausea 7.5% 12.5%
Musculoskeletal and connective tissue disorders‡
  Myalgia 5.0% 10.0%
  Arm pain 0.0% 6.3%
Nervous system disorders‡
  Headache 23.8% 26.3%
Infections and infestations‡
  Upper respiratory infection 7.5% 3.8%
  Pharyngitis 2.5% 6.3%
N=Number of subjects enrolled/randomized with data available.
Percent=percentage of subjects with adverse event for whom data are available.
*ViCPS=Typhoid Vi polysaccharide vaccine.
†VAQTA administered concomitantly with typhoid Vi polysaccharide (ViCPS) and yellow fever vaccines.
‡Systemic Adverse Events reported Days 1-15 after vaccination, regardless of causality.

In four clinical trials involving 1645 healthy adults 19 years of age and older who received one or more 50U doses of hepatitis A vaccine, subjects were followed for fever and local adverse reactions 1 to 5 days postvaccination and for systemic adverse events 1 to 14 days postvaccination. One single-blind study evaluated doses of VAQTA with varying amounts of viral antigen and/or alum content in healthy adults ≥ 170 pounds and ≥ 30 years of age (N=210 adults administered 50U/1-mL dose). One open-label study evaluated VAQTA given with immune globulin (IG) or alone (N=164 adults who received VAQTA alone). A third study was single-blind and evaluated 3 different lots of VAQTA (N=1112). The fourth study that was also single-blind evaluated doses of VAQTA with varying amounts of viral antigen in healthy adults ≥ 170 pounds and ≥ 30 years of age (N=159 adults administered the 50U/1-mL dose). Overall, the race distribution of the study subjects who received at least one dose of VAQTA was as follows: 94.2% Caucasian; 2.2% Black; 1.5% Hispanic; 1.5% Oriental; 0.4% other; 0.2% American Indian. 47.6% of subjects were male and 52.4% were female. The most common adverse event/reaction was injection-site pain/soreness/tenderness reported by 67.0% of subjects. Of all reported injection-site reactions 99.8% were mild (i.e., easily tolerated with no medical intervention) or moderate (i.e., minimally interfered with usual activity possibly requiring little medical intervention). Listed below in Table 8 are the local adverse reactions and systemic adverse events reported by ≥ 5% of subjects, in decreasing order of frequency within each body system.

Table 8: Incidences of Local Adverse Reactions and Systemic Adverse Events ≥ 5% in Adults 19 Years of Age and Older

Body System
Adverse Events
VAQTA (Any Dose)
(N=1645)
Rate (n/total n)
Nervous system disorders* n=1641
  Headache 16.1%
General disorders and administration site reactions† n=1640
  Injection-site pain/tenderness/soreness 67.0%
  Injection-site warmth 18.2%
  Injection-site swelling 14.7%
  Injection-site erythema 13.7%
N=Number of subjects enrolled/randomized.
n=Number of subjects in each category with data available.
Percent=percentage of subjects for whom data are available with adverse event.
*Systemic Adverse Events reported Days 1 to 14 after vaccination, regardless of causality.
†Adverse Reactions at the injection site (VAQTA) and measured fever Days 1 to 5 after vaccination.

The following additional unsolicited systemic adverse events were observed among recipients of VAQTA that occurred within 14 days at a common frequency of ≥ 1% to < 10% following any dose not reported elsewhere in the label. These adverse reactions have been reported across 4 clinical studies.

Musculoskeletal and connective tissue disorders: Back pain; stiffness

Reproductive system and breast disorders: Menstruation disorders

Post-Marketing Experience

The following additional adverse events have been reported with use of the marketed vaccine. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to a vaccine exposure.

Blood and lymphatic disorders: Thrombocytopenia.

Nervous system disorders: Guillain-Barré syndrome; cerebellar ataxia; encephalitis.

Post-Marketing Observational Safety Study

In a post-marketing, 60-day safety surveillance study, conducted at a large health maintenance organization in the United States, a total of 42,110 individuals ≥ 2 years of age received 1 or 2 doses of VAQTA (13,735 children/adolescents and 28,375 adult subjects). Safety was passively monitored by electronic search of the automated medical records database for emergency room and outpatient visits, hospitalizations, and deaths. Medical charts were reviewed when an event was considered to be possibly vaccine-related by the investigator. None of the serious adverse events identified were assessed as being related to vaccine by the investigator. Diarrhea/gastroenteritis, resulting in outpatient visits, was determined by the investigator to be the only vaccine-related nonserious adverse reaction in the study. There was no vaccine-related adverse reaction identified that had not been reported in earlier clinical trials with VAQTA.

Read the Vaqta (hepatitis a vaccine, inactivated) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Use With Other Vaccines

Do not mix VAQTA with any other vaccine in the same syringe or vial. Use separate injection sites and syringes for each vaccine. Please refer to package inserts of coadministered vaccines.

In clinical trials in children, VAQTA was concomitantly administered with one or more of the following US licensed vaccines: Measles, Mumps, and Rubella Virus Vaccine, Live; Varicella Vaccine, Live; Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine, Adsorbed; Measles, Mumps, Rubella, and Varicella Vaccine, Live; Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197); and Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate). Safety and immunogenicity were similar for concomitantly administered vaccines compared to separately administered vaccines. In clinical trials in adults, VAQTA was concomitantly administered with typhoid Vi polysaccharide and yellow fever vaccines [see ADVERSE REACTIONS and Clinical Studies]. Safety and immunogenicity were similar for concomitantly administered vaccines compared to separately administered vaccines.

Use With Immune Globulin

VAQTA may be administered concomitantly with Immune Globulin, human, using separate sites and syringes. The recommended vaccination regimen for VAQTA should be followed. Consult the manufacturer's product circular for the appropriate dosage of Immune Globulin. A booster dose of VAQTA should be administered at the appropriate time as outlined in the recommended regimen for VAQTA [see Clinical Studies].

Immunosuppressive Therapy

If VAQTA is administered to a person receiving immunosuppressive therapy, an adequate immunologic response may not be obtained.

Read the Vaqta Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 8/29/2014
This monograph has been modified to include the generic and brand name in many instances.

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