Conjugated vaccine (adsorbed) against diphtheria, tetanus, pertussis (acellular component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b
What is Vaxiles - Vaccine and what is it used for?
Vaxelis is a vaccine containing active ingredients derived from diphtheria, tetanus, pertussis and Haemophilus influenzae type b bacteria, hepatitis B virus and inactivated poliovirus. It is used in infants and young children over six weeks of age to protect them from the following infectious diseases:
- diphtheria (a highly contagious disease affecting the throat and skin and can cause damage to the heart and other organs);
- tetanus (trismus, usually caused by a wound infection);
- whooping cough (whooping cough);
- hepatitis B (a "viral infection of the liver);
- poliomyelitis (polio, a disease that affects the nervous system and can lead to muscle weakness or paralysis);
- invasive diseases (such as pneumonia and meningitis) caused by the bacterium H. influenzae type b (Hib).
How is Vaxiles - Vaccine used?
Vaxelis is available as a suspension for injection in pre-filled syringes. The medicine can only be obtained with a prescription. Vaxelis vaccination should be carried out in accordance with official recommendations.
The recommended initial vaccination schedule consists of two or three doses, given at least one month apart, to infants over six weeks of age. A booster dose should be given at least six months after the last initial dose. Both Vaxelis and a suitable combination of other vaccines can be used for the booster dose. Vaxelis is given by injection into a muscle, usually in the upper thigh or shoulder.
For more information, see the Summary of Product Characteristics (included in the "EPAR)
How does Vaxiles - Vaccine work?
Vaxelis is a vaccine. Vaccines work by “teaching” the immune system (the body's natural defenses) to defend itself against disease. Vaxelis contains small amounts of materials derived from viruses and bacteria against which it protects.
When a child is vaccinated, the immune system recognizes the parts of bacteria and viruses as 'foreign' and produces the corresponding antibodies. Later, if the person naturally comes into contact with the bacteria or viruses, their immune system will be able to produce the antibodies quickly. This will help the body protect itself from the diseases caused by these bacteria and viruses.
The vaccine is "adsorbed" on aluminum compounds. This means that some of the active ingredients are fixed on tiny particles of aluminum compounds, increasing the ability to produce antibodies.
What benefits of Vaxiles - Vaccine have been shown in studies?
Vaxelis has been studied in two main studies involving more than 2,500 infants and young children over six weeks of age who received two or three doses of the vaccine during the first six months of life. Subsequently, they received a booster dose shortly after they turned one year old. The effects of Vaxelis were compared with those of another vaccine, Infanrix hexa, which was formulated to confer protection against the same six diseases as Vaxelis. In these studies, the children were also given other vaccines, in accordance with local vaccination schedules, to protect them from other childhood diseases such as rotavirus gastroenteritis, measles, mumps, rubella and chickenpox. The main measure of effectiveness was the production of antibody levels that confer known protection against infections caused by diphtheria, tetanus, polio, hepatitis B and H. influenzae type b and expected protection against pertussis.
Both studies found that Vaxelis produced satisfactory antibody levels to confer protection against all six diseases in 90% -100% of children who completed the Vaxelis vaccination program.
What are the risks associated with Vaxiles - Vaccine?
The most common side effects of Vaxelis are pain, swelling and redness at the injection site, irritability, crying, sleepiness, fever, reduced appetite and vomiting. For the full list of side effects reported with Vaxelis, see the package leaflet.
Vaxelis should not be used in children who have had an allergic reaction to Vaxelis or a vaccine containing the same components, including substances used in the manufacture of the vaccine and which may be present in extremely low concentrations (such as the antibiotics neomycin and streptomycin). Vaxelis must not be used in children who have experienced encephalopathy (brain disease) of unknown origin within seven days of receiving a vaccine containing pertussis components. It must not be given to children with severe or uncontrolled disorders of the brain or nervous system, such as uncontrolled epilepsy (seizure), unless the condition has stabilized with treatment and the benefit of vaccination is clearly greater than the risk. For the full list of restrictions, see the package leaflet.
Why has Vaxiles - Vaccine been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vaxelis's benefits are greater than its risks and recommended that it be approved for use in the EU. The Committee considered that Vaxelis has been shown to produce levels satisfactory protective antibodies against diphtheria, tetanus, pertussis, hepatitis B virus, poliovirus and H. influenzae type b. Previously, such antibody levels have been shown to confer protection against these diseases. Regarding safety, the CHMP considered that overall the profile of this vaccine is similar to that of other vaccines.
What measures are being taken to ensure the safe and effective use of Vaxiles - Vaccine?
A risk management plan has been developed to ensure that Vaxelis is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Vaxelis, including the appropriate precautions to be followed by healthcare professionals and patients. Further information can be found in the summary of the risk management plan.
Other information about Vaxiles - Vaccine
For more information about Vaxelis therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The information on Vaxiles - Vaccine published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
