Haemophilus influenzae type b conjugate vaccine

This product is used to prevent invasive infections caused by Haemophilus influenzae type b. Its main capsular polysaccharide PRP (polyribosylribitol phosphate) can produce anti-PRP IgG antibody response in the human body and form immune memory. Activity studies have shown that the specific antibodies induced by the Haemophilus influenzae type b conjugate vaccine in newborns and children have bactericidal and opsonization functions. Immunogenicity studies have shown that after the second targeted vaccination of infants aged 2 months and above, an average of 90% of anti-PRP antibody titers are 0.15mg/ml. After the third injection, almost all of them are positive, and about 90% of them exceed 1mg/ml. After 3-4 month old infants are vaccinated with 3 injections of this product, a booster injection is given 8-12 months later. Regardless of whether it is a conjugated polysaccharide vaccine or a non-conjugated polysaccharide vaccine, the titer of PRP antibodies is significantly increased, 10 times higher than the average. This confirms that the initial vaccination of this product established immune memory, and suggests that when the vaccinated children are naturally infected, the surface capsule of the pathogenic bacteria should stimulate a considerable recall response. After one injection of this product was given to children aged 12-24 months, more than 80% of them converted to positive (anti-PRP antibody 1mg/ml).

Haemophilus influenzae type b capsular polysaccharide conjugated with tetanus toxoid protein. One dose unit of this vaccine contains: 10 mu g of Haemophilus influenzae type b polysaccharide conjugated with tetanus toxoid; 0.6 mg of tromethamine (hydroxymethylaminomethane); 42.5 mg of sucrose; diluent: 2.0 mg of sodium chloride, added to 0.5 mL of water for injection.

This vaccine is used to prevent infectious diseases caused by Haemophilus influenzae type b in children between 2 months and 5 years old, such as meningitis, pneumonia, sepsis, epiglottitis, etc. This vaccine cannot prevent infections caused by other bacteria, nor can it prevent meningitis and pneumonia caused by other reasons.

The basic immunization program is three doses of injection within 6 months after birth, and vaccination can be started 6 weeks after birth. To ensure long-term protection, a booster dose is recommended in the second year after birth. Infants and young children aged 6-12 months who have not been vaccinated should receive two doses, one month apart, and a booster dose in the second year after birth. Children aged 1-5 years who have not been vaccinated should receive one dose. Since the immunization program of each country is different, vaccination should be carried out according to the immunization program recommended by the country. Usage: The vaccine is used for intramuscular injection after reconstitution. However, for patients with thrombocytopenia and hemorrhagic diseases, it should be injected subcutaneously. Before vaccination, the diluent and the reconstituted vaccine should be carefully observed for foreign particulate matter and/or changes in physical properties. If any of these are observed, it should be discarded. All the diluent in the provided container must be added to the vaccine bottle to reconstitute the vaccine. After adding the diluent, the mixture should be shaken thoroughly until the freeze-dried vaccine is completely dissolved. When using multiple-dose vaccines, a single dose should be drawn from the glass bottle containing the multiple-dose vaccine using a sterile needle and syringe. As with other vaccines, single doses of vaccine should be carefully aspirated under strict aseptic conditions to avoid contamination of the contents. Haemophilus influenzae type b conjugate vaccine is absolutely prohibited from intravenous injection under any circumstances.

In controlled clinical studies, symptoms and signs after vaccination were actively monitored and recorded daily. Within 48 hours after vaccination, local symptoms collected commonly included mild redness at the injection site, which was mild and resolved on its own. Other local symptoms collected included mild swelling and pain at the injection site. Within 48 hours of vaccination, systemic symptoms collected and reported were mild and resolved on their own. These symptoms included fever, loss of appetite, irritability, vomiting, diarrhea, and abnormal crying. As with all Haemophilus influenzae type b conjugate vaccines, there have been reports of the above systemic symptoms when this product was administered simultaneously with other vaccines. Very rare allergic reactions, including anaphylaxis, have been reported.

People with a known history of allergy to any component of the vaccine and those who have had allergic symptoms after previous vaccination with Haemophilus influenzae type b vaccine should not receive Haemophilus influenzae type b conjugate vaccine. As with other vaccines, people with acute severe febrile illness should postpone vaccination with Haemophilus influenzae type b conjugate vaccine, but mild infections are not contraindications to vaccination.

Haemophilus influenzae type b conjugate vaccine can be administered at any time before, during or after other inactivated or live vaccines. Haemophilus influenzae type b conjugate vaccine can be mixed with SmithKline Beecham's Infanrix (acellular DTP vaccine) or Tritanrix HB (whole-cell DTP-HB vaccine) in the same syringe. Other injectable vaccines should be administered at different sites. Haemophilus influenzae type b conjugate vaccine can be mixed with Tritanrix HB or Infanrix, and Haemophilus influenzae type b conjugate vaccine can be reconstituted with Tritanrix HB or Infanrix and administered simultaneously. Tritanrix HB or Infanrix exists in the form of a suspension. During storage, a white precipitate and a clear supernatant can be observed. The vaccine is shaken thoroughly to a uniform white suspension. Before use, observe for any foreign particulate matter and/or physical changes. If any of these are observed, discard them. The entire contents of a single dose of Tritanrix HB or Infanrix must be added to the single-dose glass bottle containing the white pellets of Haemophilus influenzae type b conjugate vaccine to reconstitute the whole-cell DTPw-HB-Hib combination vaccine or acellular DTPw-HB-Hib combination vaccine. Then shake the mixture thoroughly until all the Haemophilus influenzae type b conjugate vaccine pellets are dissolved in the Tritanrix HB or Infanrix suspension. Discard the sterile diluent that comes with the Haemophilus influenzae type b conjugate vaccine. As with other vaccines, patients receiving immunosuppressive therapy and immunocompromised patients may not be able to produce an adequate immune response after vaccination.

Store in a refrigerator at 2-8°C away from light. Do not freeze.

Each bottle contains 0.5 ml. Each human dose is 0.5 ml, containing 10 micrograms of Haemophilus influenzae type b capsular oligosaccharide bound to CRM197 protein.

36 months.