Protective antitoxin levels (≥ 0.01 lU/mL) against diphtheria and tetanus toxoids were achieved in 100% of recipients. Pertussis agglutinins were detected in 99.6% of participants. Over 96% had titres ≥ 1:64. The combination of Act-HIB with DPT Adsorbed resulted in lower litres to pertussis when compared to administration at separate sites; GMT's differed by 11.5 to 32%. However, 95% of recipients receiving the vaccine at the same site still had titres ≥ 1:64.
Indications: Routine: For the routine immunization of all children between 2 and 59 months of age. In infants, 3 injections are to be given i.m. at 2, 4 and 6 months of age, followed by a booster at 18* months of age.
Infants starting their primary immunization series between the age of 3 and 6 months should receive 3 doses at 2 month intervals with a booster dose at 18* months of age.
For infants between the age of 7 and 11 months, 2 doses should be given at an interval of 2 months, followed by a booster at 18* months of age.
Children between 12 and 17 months of age who have not previously received any Haemophilus b vaccine should receive 1 dose of the vaccine followed by a booster at or after 18* months of age.
Unvaccinated children between 18 and 59 months of age should receive a single dose of vaccine.
*The booster dose may be given as early as 15 months of age provided that at least 2 months have elapsed since the previous dose.
Older children or adults with chronic conditions associated with increased risk of invasive Hib disease such as persons with splenic dysfunction (e.g., sickle cell disease, asplenia), antibody deficiency, HIV infection or certain malignancies may be immunized with a single dose of the vaccine.
Connaught's DPT Adsorbed may be used for the reconstitution of lyophilized Act-HIB in place of the saline diluent normally supplied. This provides an efficient means of administering routine immunization against diphtheria, tetanus, pertussis and H. influenzae type b in a single injection at a single visit.
Act-HIB may be administered simultaneously with DPT, DPT-Polio and IPV at separate sites with separate syringes.
As immunization does not prevent acquisition and carriage of Hib, children who have been vaccinated should receive rifampin prophylaxis as recommended for prevention of secondary cases in families and day-care centres.
At the present time, haemophilus b conjugate vaccines are not recommended for infants younger than 2 months of age.
Contraindications: Immunization should be deferred during the course of any febrile illness or acute infection. Hypersensitivity to any component of this vaccine, including tetanus protein, is a contraindication for use of this vaccine. Elective immunization of individuals should be deferred during an outbreak of poliomyelitis.
Warnings: Immunization should be deferred during the course of any febrile illness or acute infection. Hypersensitivity to any component of this vaccine, including tetanus protein, is a contraindication for use of this vaccine. Elective immunization of individuals should be deferred during an outbreak of poliomyelitis.
As with any vaccine, vaccination with Act-HIB may not protect 100% of susceptible individuals.
Capsular polysaccharide antigen can be detected in the urine of vaccinees (or up to 2 weeks following immunization with conjugate vaccines. This phenomenon should not be confused with invasive Hib infections.
Precautions: General: Epinephrine Hydrochloride Solution (1:1 000) must be immediately available to combat unexpected anaphylactic or allergic reactions.
Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the patient's history with respect to possible hypersensitivity to the vaccine or similar vaccine.
Any febrile illness or acute infection is reason to delay the use of Act-HIB.
Special care should be taken to ensure that the injection does not enter a blood vessel.
A separate sterile syringe and needle should be used for each individual patient to prevent transmission of hepatitis or other infectious agents from one person to another.
Act-HIB may be of benefit in preventing the occurrence of secondary cases. However, epidemiological studies have not been done and rifampin prophylaxis is still recommended. Because the vaccine will not protect against non-typeable strains of H. influenzae which cause recurrent upper respiratory disease, otitis media and sinusitis, the vaccine is not recommended for these conditions.
Although some immune response to the tetanus protein component may occur, immunization with this vaccine does not substitute for routine tetanus immunization. Individuals who have received multiple doses of products containing tetanus toxoid show no differences in reaction rates when immunized with this vaccine.
Pregnancy: Animal reproduction studies have not been conducted with Act-HIB. It is also not known whether Act-HIB can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Act-HIB is not recommended for use in pregnant women.
Children with Symptomatic HIV Infection: Available data suggest that routine childhood immunizations are not hazardous to HIV-infected children. Furthermore, there is no evidence that immunization with routine vaccines leads to deterioration of the clinical condition of HIV-infected persons. Immunization with DPT (Diphtheria, Pertussis and Tetanus), IPV (Inactivated Poliomyelitis Vaccine) and Act-HIB is recommended, although immunization may be less effective than it would be for immune-competent children.
Adverse Effects: Health care providers should report any occurrences temporally related to the administration of the product in accordance with provincial and federal statutory requirements.
Local reactions including pain, redness, swelling and induration may occur at the injection site. These reactions are more common following the first dose of the vaccine. In a placebo controlled clinical trial, local reactions following the vaccine were no different from placebo except for an increase in redness at 24 hours following the third dose.
Systemic reactions including fever, irritability, drowsiness, prolonged or abnormal crying, anorexia and vomiting have occurred after immunization with Act-HIB in conjunction with DPT. The rates of reactions observed were generally comparable to those usually reported following DPT with the exception that there were slightly more febrile reactions reported among PRP-T recipients within 6 to 24 hours of vaccination.
Table IV shows systemic reactions reported in a controlled clinical trial.
Table IV
Systemic Reactions (r/o) Within 24 Hours of Vaccination
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