ActHIB

Name: ActHIB

Descriptions

Haemophilus b conjugate vaccine is an active immunizing agent that is used to prevent infection caused by the Haemophilus influenza type b (Hib) bacteria. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

Haemophilus b conjugate vaccine is prepared by adding a diphtheria, meningococcal, or tetanus-related substance to the process. However, this vaccine does not take the place of the regular vaccines for diphtheria, tetanus, or meningococcus that children and adults should receive. All of the haemophilus b conjugate vaccines work the same way, but they may be given at different ages or using a different schedule.

Infections with Haemophilus influenza type b (Hib) bacteria can cause life-threatening illnesses, such as meningitis (a brain disease), epiglottitis (a throat disease that can cause suffocation), pericarditis (a heart disease), pneumonia (a lung disease), and septic arthritis (a bone and joint disease). Hib meningitis may cause death or leave the child with serious and permanent damage, such as mental retardation, deafness, epilepsy, or partial blindness.

Haemophilus b conjugate vaccine is recommended for all children 2 months to 5 years of age (i.e., up to the 6th birthday).

The Hiberix® vaccine is used as a booster dose for children who have already received the primary series with a haemophilus b conjugate vaccine. The vaccine will "boost" or increase the protection that the child had from an earlier dose.

This vaccine is to be administered only by or under the direct supervision of your doctor.

This product is available in the following dosage forms:

  • Solution
  • Powder for Solution
  • Powder for Suspension

What is the most important information I should know about this vaccine?

Your child should not receive this vaccine if he or she has ever had an allergic reaction to a haemophilus B or a tetanus vaccine.

Proper Use of haemophilus b conjugate vaccine

This section provides information on the proper use of a number of products that contain haemophilus b conjugate vaccine. It may not be specific to ActHIB. Please read with care.

A nurse or other trained health professional will give your child this vaccine. This vaccine is given as a shot into a muscle.

The exact schedule for your child's vaccines will vary depending on the brand of medicine used and your child's age at the time of the first dose. In general, your child will receive the first dose at 2 to 6 months of age, followed by 2 more doses at least 8 weeks apart. Your child will usually receive a booster dose at 15 to 18 months of age, although he or she can receive this medicine up until the age of 5 years.

It is important that your child receive all of the doses of vaccine in this series. Try to keep all of your scheduled appointments. If your child does miss a dose of this vaccine, make another appointment as soon as possible.

Your child may receive other vaccines at the same time as this one, but in a different body area. You should receive information sheets about all of the vaccines your child receives. Make sure you understand all of the information that is given to you.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take ActHIB or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ActHIB. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Indications

ActHIB vaccine is indicated for the active immunization of infants and children 2 months through 5 years of age for the prevention of invasive disease caused by H influenzae type b.

TriHIBit vaccine, ActHIB vaccine combined with Tripedia vaccine by reconstitution, is indicated for the active immunization of children 15 through 18 months of age for prevention of invasive disease caused by H influenzae type b and diphtheria, tetanus and pertussis.

Vaccination with ActHIB vaccine reconstituted with saline diluent (0.4% Sodium Chloride) or Tripedia vaccine (TriHIBit vaccine) may not protect 100% of individuals.

Clinical pharmacology

H influenzae type b was the leading cause of invasive bacterial disease among children in the United States prior to licensing of Haemophilus b conjugate vaccines.

The response to ActHIB vaccine is typical of a T-dependent immune response to antigen. The prominent isotype of anti-capsular PRP antibody induced by ActHIB vaccine is IgG.3 A booster response for IgG has been demonstrated in children 12 months of age or older who previously received two or three doses of ActHIB vaccine. Bactericidal activity against H influenzae type b was demonstrated in serum after immunization and correlated with the anti-PRP antibody response induced by ActHIB vaccine.4

Antibody to H influenzae capsular polysaccharide (anti-PRP) titers of > 1.0 mcg/mL following vaccination with unconjugated PRP vaccine correlated with long-term protection against invasive H influenzae type b disease in children older than 24 months of age.5 Although the relevance of this threshold to clinical protection after immunization with conjugate vaccines is not known, particularly in light of the induced, immunologic memory, this level continues to be considered as indicative of long-term protection.6 In clinical studies, ActHIB vaccine induced, on average, anti-PRP levels ≥ 1.0 mcg/mL in 90% of infants after the primary series (2, 4, and 6 months) and in more than 98% of infants following a booster dose given at 15 to 19 months of age.4

Two clinical trials supported by the National Institutes of Health (NIH) have compared the anti- PRP antibody responses to three Haemophilus b conjugate vaccines in racially mixed populations of children. These studies were done in Tennessee7 (TABLE 1) and in Minnesota, Missouri, and Texas (8) (TABLE 2) in infants immunized with ActHIB vaccine and other Haemophilus b conjugate vaccines at 2, 4, and 6 months of age. All Haemophilus b conjugate vaccines were administered concomitantly with Poliovirus Vaccine Live Oral and whole cell DTP vaccines at separate sites. Neither Poliovirus Vaccine Live Oral nor whole cell DTP vaccines are licensed or distributed in the US.

TABLE 1: Anti-PRP Antibody Responses Following a Two or Three Dose Series of a Haemophilus b Vaccine at 2, 4, and 6 Months of Age - Tennessee7

VACCINE Na GEOMETRIC MEAN CONCENTRATION (GMC) (mcg/mL) Post Third Immunization % ≥ 1.0 mcg/mL
PreImmunization at 2 months Post Second Immunization at 6 months Post Third Immunization at 7 months
PRP-Tb (ActHIB vaccine) 65 0.10 0.30 3.64 83%
PRP-OMPc (PedvaxHIB®) 64 0.11 0.84 N/A 50%d
HbOCe (HibTITER®) 61 0.07 0.13 3.08 75%
a N = Number of Children
b Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
c Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)
d Seroconversion after the recommended 2-dose primary immunization series is shown
e Haemophilus b Conjugate Vaccine (Diphtheria CRMW7 Protein Conjugate)
N/A Not applicable in this comparison trial although third dose data have been published7

TABLE 2: Anti-PRP Antibody Responses Following a Two or Three Dose Series of a Haemophilus b Vaccine at 2, 4, and 6 Months of Age - Minnesota, Missouri, and Texas8

VACCINE Na GEOMETRIC MEAN CONCENTRATION (GMC) (mcg/mL) Post Thirdb Immunization % ≥ 1.0 mcg/mL
Pre Immunization at 2 months Post Second Immunization At 6 months Post Thirdb Immunization At 7 months
PRP-Tc (ActHIB vaccine) 142 0.25 1.25 6.37 97%
PRP-OMPd (PedvaxHIB) 149 0.18 4.00 N/A 85%e
HbOCf (HibTITER) 167 0.17 0.45 6.31 90%
a N = Number of Children
b Sera were obtained after the third dose from 86 and 110 infants, in PRP-T and HbOC vaccine groups, respectively
c Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
d Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)
e Seroconversion after the recommended 2-dose primary immunization series is shown
f Haemophilus b Conjugate Vaccine (Diphtheria CRM197 Protein Conjugate)
N/A Not applicable in this comparison trial although third dose data have been published8

Native American populations have had high rates of H influenzae type b disease and have been observed to have low immune responses to Haemophilus b conjugate vaccines. In a clinical study enrolling Alaskan Native Americans, following the administration of a three dose series of ActHIB at 6 weeks, 4 months, and 6 months of age, 75% of subjects achieved an anti-PRP antibody titer of ≥ 1.0 mcg/mL at 7 months of age (1 month after the last vaccination).9

In four separate studies, children 12 to 24 months of age who had not previously received Haemophilus b conjugate vaccination were immunized with a single dose of ActHIB vaccine (TABLE 3). GMC anti-PRP antibody responses were 5.12 mcg/mL (90% responding with ≥ 1.0 mcg/mL) for children 12 to 15 months of age and 4.4 mcg/mL (82% responding with ≥ 1.0 mcg/mL) for children 17 to 24 months of age.10

TABLE 3: Anti-PRP Antibody Responses in 12- to 24-month-old Children Immunized with a Single Dose of ActHIB10

AGE GROUP Na GEOMETRIC MEAN CONCENTRATION (GMC) (mcg/mL) % SUBJECTS WITH ≥ 1.0 mcg/mL
Pre Immunization Post Immunizationb Pre Immunization Post Immunizationb
12 to 15 months 256 0.06 5.12 1.6 90.2
17 to 24 months 81 0.10 4.40 3.7 81.5
a N = Number of Children
b Post immunization responses measured at approximately 1 month after vaccination

ActHIB vaccine has been found to be immunogenic in children with sickle cell anemia, a condition which may cause increased susceptibility to Haemophilus b disease. Following two doses of ActHIB vaccine given at two-month intervals, 89% of these children (mean age 11 months) had anti-PRP antibody titers of ≥ 1.0 mcg/mL. This is comparable to anti-PRP antibody levels demonstrated in normal children of similar age following two doses of ActHIB vaccine.11

TriHIBit Vaccine (ActHIB vaccine combined with Tripedia vaccine by reconstitution)

Randomized comparative clinical trials demonstrated that the anti-PRP response achieved in 15- to 20-month-old children 1 month after one dose of TriHIBit vaccine (ActHIB vaccine reconstituted with Tripedia vaccine) was similar to that achieved when the ActHIB and Tripedia vaccines were given concomitantly at different sites with separate needles and syringes (TABLE 4).10 All children had received three doses of a Haemophilus b conjugate vaccine (HibTITER or ActHIB vaccine) and three doses of a whole-cell DTP vaccine prior to entry into this clinical trial.

TABLE 4: Anti-PRP Responses in 15- to 20-month-old Children Following Immunization with TriHIBit Vaccine Compared to ActHIB Vaccine and Tripedia Vaccine Given Concomitantly at Separate Sites10

  IMMUNOGENICITY
Pre-Dose Post-Dose (1 month post-vaccination)
TriHIBit vaccine Separate Injectionsa TriHIBit vaccine Separate Injectionsa
Nb 88 94 93 98
Anti-PRP (mcg/mL) 0.89 1.15 90.30 80.90
% > 1 mcg/mL 45.50 53.20 100.00 100.00
a ActHIB and Tripedia administered concomitantly at separate sites
b N= Number of Children

For data on the antibody responses to diphtheria, tetanus and pertussis (PT and FHA) antigens in this study, refer to the Tripedia vaccine product insert.

REFERENCES

3 Holmes SJ, et al. Immunogenicity of four Haemophilus influenzae type b conjugate vaccines in 17- to 19-month-old children. J Pediatr 118:364-371, 1991.

4 Data on file, Sanofi Pasteur SA.

5 Peltola H, et al. Prevention of Haemophilus influenzae type b bacteremic infections with the capsular polysaccharide vaccine. N Engl J Med 310:1561-1566, 1984.

6 Recommendations of the Immunization Practices Advisory Committee (ACIP). Haemophilus b conjugate vaccines for prevention of Haemophilus influenzae type b disease among infants and children two months of age and older. MMWR 40:No. RR-1, 1991.

7 Decker MD, et al. Comparative trial in infants of four conjugate Haemophilus influenza type b vaccines. J Pediatr 120:184-189, 1992.

8 Granoff DM, et al. Differences in the immunogenicityof three Haemophilus influenzae type b conjugate vaccines in infants. J Pediatr 121:187-194, 1992.

9 Bulkow LR, et al. Comparative immunogenicity of four Haemophilus influenzae type b conjugate vaccines in Alaska Native infants. Pediatr Infect Dis J 12:484-92, 1993.

10 Data on file, Sanofi Pasteur Inc.

11 Kaplan SL, et al. Immunogenicity of Haemophilus influenzae type b polysaccharide-tetanus protein conjugate vaccine in children with sickle hemoglobinopathy or malignancies, and after systemic Haemophilus influenzae type b infection. J Pediatr 120:367-370, 1992.

Geriatric

The haemophilus b conjugate vaccine is not recommended for adult or geriatric patients.

  • Vaccination and Immunization Safety Information

Usual Pediatric Dose for Haemophilus influenzae Prophylaxis

2 months to 5 years:

4 dose series:
3 primary doses of 0.5 mL, IM, at 2, 4 and 6 months of age
1 booster dose of 0.5 mL, IM, at 15 to 18 months of age

Precautions

Safety and efficacy have not been established in patients younger than 6 weeks.

To report suspected adverse reactions, contact the Vaccine Adverse Event Reporting System (VAERS) at: https://vaers.hhs.gov

Consult WARNINGS section for additional precautions.

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