"The European Medicines Agency (EMA) has launched a review of the six direct-acting antivirals approved for use in the European Union for treating chronic hepatitis C virus infection, the agency said today.
They are daclatasvir (Dak"...
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 HAVRIX has been evaluated in 61 clinical trials involving more than 34,000 individuals receiving doses of 360 EL.U., 720 EL.U., or 1440 EL.U.
Of solicited adverse events in clinical trials of adults, who received HAVRIX 1440 EL.U., and children (2 years of age and older), who received either HAVRIX 360 EL.U. or 720 EL.U., the most frequently reported was injection-site soreness (56% of adults and 21% of children); less than 0.5% of soreness was reported as severe. Headache was reported by 14% of adults and less than 9% of children. Other solicited and unsolicited events occurring during clinical trials are listed below.
Incidence 1% to 10% of Injections
Metabolism and Nutrition Disorders: Anorexia.
Gastrointestinal Disorders: Nausea.
Incidence < 1% of Injections
Infections and Infestations: Pharyngitis, upper respiratory tract infections.
Blood and Lymphatic System Disorders: Lymphadenopathy.
Psychiatric Disorders: Insomnia.
Nervous System Disorders: Dysgeusia, hypertonia.
Eye Disorders: Photophobia.
Ear and Labyrinth Disorders: Vertigo.
Gastrointestinal Disorders: Abdominal pain, diarrhea, vomiting.
General Disorders and Administration Site Conditions: Injection site hematoma.
Investigations: Creatine phosphokinase increased.
Studies of HAVRIX 720 EL.U./0.5 mL in Children 11 to 25 Months of Age
In 4 studies, 3,152 children 11 to 25 months of age received at least one dose of HAVRIX 720 EL.U. administered alone or concomitantly with other routine childhood vaccinations [see Clinical Studies]. The studies included HAV 210 (N = 1,084), HAV 232 (N = 394), HAV 220 (N = 433), and HAV 231 (N = 1,241).
In the largest of these studies (HAV 231) conducted in the US, 1,241 children 15 months of age were randomized to receive: Group 1) HAVRIX alone; Group 2) HAVRIX concomitantly with measles, mumps, and rubella (MMR) vaccine (manufactured by Merck and Co.) and varicella vaccine (manufactured by Merck and Co.); or Group 3) MMR and varicella vaccines. Subjects in Group 3 who received MMR and varicella vaccines received the first dose of HAVRIX 42 days later. A second dose of HAVRIX was administered to all subjects 6 to 9 months after the first dose of HAVRIX. Solicited local adverse reactions and general events were recorded by parents/guardians on diary cards for 4 days (days 0 to 3) after vaccination. Unsolicited adverse events were recorded on the diary card for 31 days after vaccination. Telephone follow-up was conducted 6 months after the last vaccination to inquire about serious adverse events, new onset chronic illnesses and medically significant events. A total of 1,035 children completed the 6-month follow-up. Among subjects in all groups combined, 53% were male; 69% of subjects were white, 16% were Hispanic, 9% were black and 6% were other racial/ethnic groups.
Percentages of subjects with solicited local adverse reactions and general adverse events following HAVRIX administered alone (Group 1) or concomitantly with MMR and varicella vaccines (Group 2) are presented in Table 1. The solicited adverse events from the 3 additional coadministration studies conducted with HAVRIX were comparable to those from Study HAV 231.
Table 1: Solicited Local Adverse Reactions and General
Adverse Events Occurring Within 4 Days of Vaccinationa in Children 15 to 24
Months of Age With HAVRIX Administered Alone or Concomitantly With MMR and
Varicella Vaccines (TVC)
|Group 1 HAVRIX Dose 1 %||Group 2 HAVRIX+ MMR+Vb Dose 1 %||Group 1 HAVRIX Dose 2 %||Group 2 HAVRIX Dose 2 %|
|Local (at injection site for HAVRIX)|
|Irritability, grade 3||0.3||1.9||1.5||0.3|
|Drowsiness, grade 3||1.0||2.2||1.1||0.0|
|Loss of appetite, any||18.3||26.1||19.9||20.5|
|Loss of appetite, grade 3||1.0||1.4||0.4||0.3|
|Fever ≥ 100.6°F (38.1°C)||3.0||4.8||3.3||2.7|
|Fever ≥ 101.5°F (38.6°C)||2.0||2.6||1.8||1.6|
|Fever ≥ 102.4°F (39.1°C)||0.7||0.7||0.4||1.1|
|Total vaccinated cohort (TVC) = all subjects who received
at least one dose of vaccine.
N = number of subjects who received at least one dose of vaccine and for whom diary card information was available.
Grade 3: drowsiness defined as prevented normal daily activities; irritability/fussiness defined as crying that could not be comforted/prevented normal daily activities; loss of appetite defined as no eating at all.
a Within 4 days of vaccination defined as day of vaccination and the next 3 days.
b MMR = measles, mumps, and rubella vaccine; V = varicella vaccine.
Serious Adverse Events in Children 11 to 25 Months of Age
Among these 4 studies, 0.9% (29/3,152) of subjects reported a serious adverse event within the 31-day period following vaccination with HAVRIX. Among subjects administered HAVRIX alone 1.0% (13/1,332) reported a serious adverse event. Among subjects who received HAVRIX concomitantly with other childhood vaccines, 0.9% (8/909) reported a serious adverse event. In these 4 studies, there were 4 reports of seizure within 31 days post-vaccination: these occurred 2, 9, and 27 days following the first dose of HAVRIX administered alone and 12 days following the second dose of HAVRIX. In one subject who received INFANRIX and Hib conjugate vaccine followed by HAVRIX 6 weeks later, bronchial hyperreactivity and respiratory distress were reported on the day of administration of HAVRIX alone.
In addition to reports in clinical trials, worldwide voluntary reports of adverse events received for HAVRIX since market introduction of this vaccine are listed below. This list includes serious adverse events or events which have a suspected causal connection to components of HAVRIX or other vaccines or drugs. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the vaccine.
Infections and Infestations: Rhinitis.
Blood and Lymphatic System Disorders: Thrombocytopenia.
Immune System Disorders: Anaphylactic reaction, anaphylactoid reaction, serum sickness-like syndrome.
Vascular Disorders: Vasculitis.
Respiratory, Thoracic, and Mediastinal Disorders: Dyspnea.
Congenital, Familial, and Genetic Disorders: Congenital anomaly.
Musculoskeletal and Connective Tissue Disorders: Musculoskeletal stiffness.
General Disorders and Administration Site Conditions: Chills, influenza-like symptoms, injection site reaction, local swelling.
Read the Havrix (hepatitis a vaccine, inactivated) Side Effects Center for a complete guide to possible side effects
Concomitant Administration With Vaccines And Immune Globulin
In clinical studies HAVRIX was administered concomitantly with the following vaccines [see ADVERSE REACTIONS and Clinical Studies]:
- INFANRIX (DTaP);
- Hib conjugate vaccine;
- pneumococcal 7-valent conjugate vaccine;
- MMR vaccine;
- varicella vaccine.
HAVRIX may be administered concomitantly with immune globulin.
When concomitant administration of other vaccines or immune globulin is required, they should be given with different syringes and at different injection sites. Do not mix HAVRIX with any other vaccine or product in the same syringe or vial.
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to HAVRIX.
Read the Havrix Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 8/22/2014
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