HibTITER

MIMS Abbreviated Prescribing Information
haemophilus B conjugate vaccine
Lederle
Section: 10(a) Vaccines - Immunology
Permitted in sport

Use: Active immunisation against Haemophilus influenzae type B infections in
children 2 months-5 years
Contraindications: IV admin.
Precautions: Immunosuppression; fever, acute illness; pregnancy, lactation,
infants < 6 weeks
Adverse Reactions: Irritability; sleepiness; prolonged crying; appetite
loss; vomiting, diarrhoea; rash; fever; local erythema, warmth, swelling,
tenderness

HibTITER (Injection) Rx CMI
Eagan Haemophilus influenza type B (purified capsular polysaccharide); bound
to Diphtheria protein conjugate 25 mcg; NaCl 0.9%; thiomersal (multidose
vial)
Pack 10 mcg/0.5 mL [1] : $33.96
Pack 10 mcg/0.5 mL [20]
Dose 2-6 months: 3 x 2 monthly 0.5 mL IM doses. 7-11 months (previously
unvaccinated): 2 x 2 monthly 0.5 mL IM doses. 12-14 months (previously
unvaccinated): 1 x 0.5 mL IM dose. All vaccinated children to receive a 0.5
mL IM booster at greater than or equal to 15 months (but not 2 months after
previous dose). 15-60 months (previously unvaccinated): 1 x 0.5 mL IM dose;
no booster required
Refer: MIMS Annual 1998 p. 10-838


HibTITERMIMS Full Prescribing Information
Lederle Laboratories
MIMS revision date: 1/05/1999
 Composition Haemophilus B conjugate vaccine (Diphtheria CRM197 protein
conjugate).
 Description HibTITER is a sterile solution of a conjugate of
oligosaccharides of the capsular antigen of Haemophilus influenzae type B
(Haemophilus B) and Diphtheria CRM197 protein dissolved in sodium chloride
0.9%. The oligosaccharides are derived from highly purified capsular
polysaccharide, polyribosylribitol phosphate, isolated from Haemophilus B
strain Eagan grown in a chemically defined medium, and coupled by reductive
amination directly to highly purified CRM197. CRM197 is a nontoxic variant
of diphtheria toxin isolated from cultures of Corynebacterium diphtheria C7
(beta197) grown in a casamino acids and yeast extract based medium which is
ultrafiltered before use. The conjugate is purified to remove unreacted
protein, oligosaccharides and reagents; sterilised by filtration; and filled
into vials.
The vaccine is a clear, colourless solution. Each single 0.5 mL dose is
formulated to contain purified Haemophilus B saccharide 10 microgram and
approximately CRM197 protein 25 microgram. Thiomersal is included in the
multidose presentation as a preservative.
 Actions Pharmacology. Immunogenicity. Linkage of Haemophilus B saccharides
to a protein such as CRM197 results in an enhanced antibody response
(predominantly IgG) to the saccharide and immunological memory. Laboratory
evidence indicates that the native state of the CRM197 protein and the use
of oligosaccharides in the formulation of HibTITER enhances its T helper
potential and thus its immunogenicity.
The vaccine generated an immune response characteristic of a protein
antigen; IgG anti-PRP antibodies of IgG1 subclass predominated and the
immune system was primed for a booster response to HibTITER, and there is
some evidence suggesting natural increases in antibody levels over time
after vaccination. Data from passive antibody studies indicate that a
pre-existing level of antibody to PRP of 0.15 microgram/mL correlates with
protection.
Antibody generated by HibTITER has been found to have high avidity, a
measure of the functional affinity of antibody to bind to antigen. High
avidity antibody is more potent than low avidity antibody in serum
bactericidal assays. The contribution to clinical protection is unknown.
In infants vaccinated initially at one to six months of age in ten centres
in the United States and who received three doses at approximately two month
intervals, anti-PRP antibody levels greater than or equal to 1 microgram/mL
were attained by more than 90% of infants of all ages after two doses and by
more than 98% after three doses. One month after the third vaccination, the
geometric mean antibody levels were 16.8, 26.8, and 30.0 microgram/mL in
infants initially vaccinated at one to two, three to four, and five to six
months of age respectively. In infants vaccinated initially at one to six
months of age, the percentage with levels greater than or equal to 1
microgram/mL were 27.9, 90.3, and 99.2% after the first, second and third
dose of vaccine respectively (see Table 1). Long-term persistence of the
antibody response was observed. More than 80% of the 235 infants who
received three doses of vaccine had an anti-PRP antibody level greater than
or equal to 1 microgram/mL at two years of age. Data from field trials
indicate that a level of greater than or equal to 1.0 microgram/mL three
weeks after vaccination is associated with long-term protection.
One month after the second dose, 99.5% of the infants vaccinated at 7 to 11
months of age and 100% of the infants vaccinated at 12 to 14 months of age
responded with anti-PRP antibody levels greater than or equal to 1
microgram/mL and the geometric mean antibody levels were 27.93 and 32.66
microgram/mL, respectively (see Table 1); 100% of the infants' sera had
bactericidal activity.
A single dose of HibTITER administered to 377 children 15 to 23 months of
age resulted in a geometric mean antibody level of 11.35 microgram/mL and
more than 97% had anti-PRP antibody levels greater than or equal to 1
microgram/mL (see Table 1); 92.2% of the infants' sera had bactericidal
activity.
When evaluated in an in vitro complement mediated bactericidal assay, none
of the prevaccinated sera of the one to six month old infants killed H.
influenzae type B. Two months after the second dose of vaccine, 95% of the
infants' sera had bactericidal activity, and one month after the third dose,
98% of the sera had bactericidal activity.
Immunogenicity has been reported in a total of 422 infants in six
postlicensure studies in the United States. After three doses, titres ranged
from 2.37 to 8.45 microgram/mL with 67 to 94% attaining greater than or
equal to 1 microgram/mL. Please refer to table 1.


Immunogenicity of HibTITER was evaluated in 26 children 22 months to 5 years
of age who had not responded to earlier vaccination with Haemophilus B
polysaccharide vaccine. One dose of HibTITER was immunogenic in all 26
children and generated antibody levels of greater than or equal to 1
microgram/mL in 25 of the 26 infants. HibTITER has been found to be
immunogenic in children with sickle-cell disease, a condition which may
cause increased susceptibility to Haemophilus B disease. In 20 of these
infants aged two to six months, three doses of HibTITER given at two month
intervals generated a geometric mean anti-PRP antibody level of 22.1
microgram/mL and 100% of the subjects had a level greater than or equal to 1
microgram/mL one month after the third dose. 90% of the infants had a level
greater than or equal to 1 microgram/mL 18 months after the initial
vaccination.
In one immunogenicity study involving 124 subjects, no impairment of the
antibody response to the individual antigens occurred when HibTITER was
given at the same time as Diphtheria Tetanus Pertussis Vaccine, (DTP)
(separate sites) plus Oral Polio Vaccine (OPV) to children 18 months of age
or Measles, Mumps and Rubella Vaccine (MMR) to children 15 months of age.
Protective efficacy. HibTITER was shown to be effective in a large scale
controlled trial in a multi ethnic population in northern California carried
out between February 1988 and June 1990. There were no vaccine failures in
infants who received three doses of HibTITER and 12 cases of Haemophilus B
disease (six cases of meningitis) in the control group. The estimate of
efficacy is 100% (p = 0.0002) with 95% confidence intervals 68 to 100%.
Overall, in the northern California population immunised from February 1988
through to January 1992, including prelicensure study population and the
children immunised postlicensure, there were no cases of Haemophilus B
disease in fully vaccinated infants less than two years of age. Five cases
of disease occurred in children who only received one dose of HibTITER and
one case occurred in a 31/2 year old child who did not receive a booster
dose as recommended.
A comparative clinical trial was performed in Finland where approximately
53,000 infants received HibTITER at four and six months of age and a booster
dose at 14 months in a trial conducted from January 1988 through to December
1990. Only two children developed Haemophilus B disease after receiving the
two dose primary vaccination schedule. One child became ill at 15 months of
age and the other at 18 months of age; neither child received the scheduled
booster at 14 months of age. No vaccine failure has been reported in
children who received the two dose primary series and the booster dose at 14
months of age. Based on more than 32,000 person years of follow up time, the
estimate of efficacy is about 95% when compared to historical control groups
followed between 1985 and 1988. Historical controls were used since all
infants received one of two Haemophilus B conjugate vaccines during the
period of the trial.
Evidence of efficacy postmarketing includes significant reductions in
Haemophilus B disease that are closely associated with increases in the net
doses of Haemophilius B conjugate vaccine distributed in the United States.
In the Northern California Kaiser Permanente there has been a 94% decrease
in Haemophilus disease incidence in 1991 for children younger than 18 months
of age, compared to 1984 to 1988, when HibTITER was not available for this
age group. Furthermore, active surveillance by the Centers for Disease
Control and Prevention (CDC) has shown a 71% decrease in Haemophilus B
disease in children less than 15 months old, between 1989 and 1991, which
corresponds temporally and geographically with increases in net doses of
Haemophilus B conjugate vaccine distributed in the United States. As with
all vaccines, this conjugate vaccine cannot be expected to be 100%
effective. There have been rare reports to the Vaccine Event Reporting
System (VAERS) of Haemophilus B disease following full primary immunisation.
 Indications Immunisation of children two months to five years of age
against invasive diseases caused by Haemophilus influenzae type B.
 Contraindications Hypersensitivity to any component of the vaccine,
including Diphtheria toxoid (or thiomersal in the multidose presentation).
 Warnings If the vaccine is used in persons deficient in producing antibody,
whether due to genetic defect or to immunosuppressive therapy, the expected
immune response may not be obtained.
Deferral of administration of vaccine may be considered in individuals
receiving immunosuppressive therapy.
As with any vaccine, HibTITER may not protect 100% of individuals receiving
the vaccine. Also, as reported with other vaccines, cases of Haemophilus B
disease may occur prior to the onset of the protective effects of the
vaccine.
HibTITER will not protect against H. influenzae other than type B strains or
other microorganisms that cause meningitis or septic disease.
Carcinogenesis, mutagenesis, impairment of fertility. HibTITER has not been
evaluated for its carcinogenic or mutagenic potential or impairment of
fertility.
Use in pregnancy. (Category B2)
HibTITER is not recommended for use in a pregnant woman.
 Precautions General. Prior to an injection of any vaccine, all reasonable
precautions should be taken to prevent adverse reactions. Any significant
acute illness or temperature over 38 deg. C is reason for delaying use of
HibTITER until the child has recovered except when, in the opinion of the
doctor, withholding the vaccine entails a greater risk. A minor afebrile
illness such as a mild upper respiratory infection is not usually reason to
defer immunisation.
As with the injection of any biological material, adrenaline should be
available for immediate use should an anaphylactic or other allergic
reaction occur.
Antigenuria has been detected following administration of Haemophilus B
conjugate vaccine, and therefore antigen detection may not have diagnostic
value in suspected Haemophilus B disease within two weeks of immunisation.
The vaccine should not be injected intradermally or intravenously since the
safety and immunogenicity of these routes have not been evaluated. The
vaccine should be given intramuscularly. Special care should be taken to
ensure that the injection does not enter a blood vessel.
A separate, sterile syringe and needle or a sterile disposable unit should
be used for each patient to prevent transmission of infectious agents from
one person to another.
It should be noted that immunisation with HibTITER does not substitute for
routine diphtheria immunisation.
 Adverse Reactions In clinical studies involving healthy children, HibTITER
was generally well tolerated.
The adverse reactions shown in Table 2 were seen with HibTITER up to 48
hours postvaccination in 401 infants initially vaccinated at 1 to 6 months
of age. All these side effects were infrequent, mild and transient with no
serious sequelae. No differences in the rates of these complaints were
reported after dose 1, 2 or 3. The side effects associated with a single
vaccination of HibTITER given to 354 infants of 15 to 23 months of age are
also detailed in Table 2. Please refer to table 2.


One hyporesponsive episode with a single seizure was observed when HibTITER
was given with DTP and inactivated polio vaccine (IPV) at a separate site.
In addition to the reactions shown in Table 2, rash, hives (urticaria),
erythema multiforme, convulsions, vomiting and diarrhoea, and Guillain-Barre
syndrome have been observed in postmarketing studies. However, a cause and
effect relationship among any of these events and the vaccination has not
been established.
 Interactions HibTITER may be administered simultaneously but at different
sites to other routine paediatric vaccines, e.g. DTP, OPV and MMR.
 Dosage and Administration HibTITER is for intramuscular use only.
HibTITER should be inspected visually for extraneous particulate matter
and/or discolouration prior to administration. If these anomalies exist,
HibTITER should not be administered.
Children. HibTITER is indicated for children two months to five years of age
for the prevention of invasive Haemophilus B disease. For infants two to six
months of age, the immunising dose is three separate injections of 0.5 mL
given at approximately two month intervals intramuscularly, preferably in
the outer aspect of the vastus lateralis (mid thigh). Previously
unvaccinated infants from seven to eleven months of age should receive two
separate intramuscular injections as described, approximately two months
apart. Children from 12 to 14 months of age who have not been vaccinated
previously should receive one intramuscular injection. All vaccinated
children should receive a single booster dose at 15 months of age or older,
but not less than two months after the previous dose. Previously
unvaccinated children 15 to 60 months of age should receive a single
intramuscular injection of HibTITER as described. Children older than 15
months of age can, alternatively, be vaccinated in the deltoid muscle.
Preterm infants should be vaccinated with HibTITER according to their
chronological age, from birth. Please refer to table 3.


Interruption of the recommended schedules with a delay between doses does
not necessitate starting the series over again, regardless of the length of
time elapsed between doses.
No data are available to support the interchangeability of HibTITER or other
Haemophilus B conjugate vaccines with one another. Therefore, it is
recommended that the same conjugate vaccine be used throughout each
immunisation schedule.
Each dose of 0.5 mL is formulated to contain purified Haemophilus B
saccharide 10 microgram and CRM197 protein approximately 25 microgram.
Before injection, the skin over the site to be injected should be cleansed
with a suitable antiseptic. After insertion of the needle, aspirate to
ensure that the needle has not entered a blood vessel.
Use in neonates. The safety and effectiveness of HibTITER in infants below
the age of 6 weeks have not been established.
Concomitant use with other vaccines. Limited studies have been conducted
where HibTITER was administered concomitantly with the primary vaccination
series of DTP and OPV, or concomitantly with MMR, in which individual
antigen responses were measured. While no impairment of immune response to
HibTITER or other individual tested antigens was demonstrated in these
studies, there is a suggestion that some Haemophilus influenzae type B
conjugated vaccines may impair antibody response to DTP antigens, although
protective levels are still achieved.
 Presentation Vial, 0.5 mL; 1 dose: 1's, 20's; 10 dose, multidose.
 Storage Store at 2 to 8 deg. C. (Refrigerate. Do not freeze.)
 Poison Schedule S4.
 Date of TGA approval or last amendment 23/07/1998
Jump To Top

**********************************************************

MIMS Abbreviated Prescribing Information
haemophilus B conjugate vaccine
Merck Sharp & Dohme
Section: 10(a) Vaccines - Immunology
Permitted in sport

Use: Active immunisation against Haemophilus influenzae type B infections in
children 2 to 71 months
Contraindications: IV admin.
Precautions: Immunosuppression; febrile illness, acute infection; pregnancy,
lactation, infants < 2 months
Adverse Reactions: Local erythema, pain, induration, tenderness;
irritability, sleepiness, diarrhoea, fever, vomiting; rash; seizures;
tracheitis; others, see MIMS Annual

PedvaxHIB (Injection) Rx
Ross Haemophilus influenza type B (purified capsular polysaccharide); bound
to Meningococcal protein conjugate 250 mcg; lyophilised powder + solv. (NaCl
0.9%, aluminium (hydroxide) 225 mcg, thiomersal 1:20,000)
Pack 15 mcg/0.5 mL (+ solv.) [1] : $35.01
Dose Infants 2-14 months: 0.5 mL IMI at 2 months, booster 2 months later. If
2 doses given before 12 months of age, 0.5 mL booster dose should be given
at 12 to 15 months of age but not earlier than 2 months after 2nd dose.
Infants > 15 months: single 0.5 mL IMI inj.
Refer: MIMS Annual 1998 p. 10-844


PedvaxHIBMIMS Full Prescribing Information
Merck Sharp & Dohme (Aust.) Pty Ltd
MIMS revision date: 1/11/1997
 Composition Haemophilus B conjugate vaccine (Meningococcal protein
conjugate).
 Description PedvaxHIB is a polysaccharide protein conjugate vaccine
prepared from the highly purified capsular polysaccharide
(polyribosylribitol phosphate or PRP) of Haemophilus influenzae type B (Hib,
Ross strain). The capsular polysaccharide of Hib is bound covalently to an
outer membrane protein complex (OMPC) of the B11 strain of Neisseria
meningitidis serogroup B.
PedvaxHIB is a lyophilised preparation containing lactose as a stabiliser
and, when reconstituted, is a sterile suspension for intramuscular use. Each
0.5 mL dose, when reconstituted as directed, is formulated to contain Hib
PRP 15 microgram, Neisseria meningitidis OMPC 250 microgram, aluminium 225
microgram (as aluminium hydroxide), thiomersal (a mercury derivative) at
1:20,000 as a preservative, and lactose 2 mg in saline 0.9%.
 Actions Pharmacology. Immunogenicity. PedvaxHIB is a PRP conjugate vaccine
in which the conjugation of a carbohydrate to a protein carrier enhances
antibody responses to the carbohydrate, a process that is thought to convert
the T independent antigen (PRP alone) into a T dependent antigen which
results in both an enhanced antibody response and immunological memory.
The anti-PRP titre considered to confer long-term protection is 1.0
microgram/mL. In children 12 to 17 months of age vaccinated with one dose of
PedvaxHIB, the geometric mean anti-PRP titre (GMT) was 3.38 microgram/mL and
82% responded with > 1.0 microgram/mL anti-PRP. The GMT achieved in children
aged 18 to 23 months vaccinated with one dose of PedvaxHIB was 7.16
microgram/mL and 97% responded with > 1.0 microgram/mL anti-PRP, and in
children 24 to 71 months of age the GMT was 10.29 microgram/mL and 93%
responded with > 1.0 microgram/mL anti-PRP.
In children two to eleven months of age vaccinated with two doses of
PedvaxHIB, the GMT was 5.69 and 89% responded with > 1.0 microgram/mL
anti-PRP. The titres were progressively higher in children aged two to
three, four to six and seven to eleven months.
87% of children two months of age who received two doses of PedvaxHIB (at
two to three months and four to five months) achieved antibody titres > 1.0
microgram/mL (GMT 3.9).
These data were derived by evaluating the sera in one laboratory using a
radioimmunoassay which correlated with both the Finland National Public
Health Institute assay and that recommended by the Centre for Biologics
Evaluation and Research of the FDA. Currently, very limited information is
available concerning the persistence of antibody response following
vaccination with PedvaxHIB. Antibody levels fall rapidly during the first
eight months following vaccination but levels above 0.15 microgram/mL which
confer protective immunity may be expected to persist for at least 12
months.
Protective efficacy. PedvaxHIB has been shown to be protective against
invasive Haemophilus influenzae B disease in Native American (Navajo)
infants, a population known to be relatively hyporesponsive to Haemophilus B
conjugate vaccines. A two dose regimen in infants 2 to 14 months of age
provided protection against invasive disease due to H. influenzae type B.
 Indications Active immunisation against invasive disease caused by
Haemophilus influenzae type B in infants and children two to 71 months of
age.
As with other vaccines, approximately 30 days following administration of
PedvaxHIB are required for protective levels of antibody to be achieved.
PedvaxHIB will not protect against Haemophilus influenzae other than type B
or against other microorganisms that cause meningitis or sepsis.
 Contraindications Hypersensitivity to any component of the vaccine or
diluent.
 Warnings There is insufficient evidence showing that PedvaxHIB given
immediately after exposure to natural Haemophilus influenzae type B will
prevent illness.
 Precautions Adequate treatment facilities, including adrenaline, should be
available for immediate use should an anaphylactoid or anaphylactic reaction
occur.
As with any vaccine, vaccination with PedvaxHIB may not result in a
protective antibody response in 100% of susceptible persons given the
vaccine.
Cases of Haemophilus B disease may occur in the weeks after vaccination,
prior to the onset of the protective effects of the vaccine.
The expected immune response may not be obtained when PedvaxHIB is used in
persons with malignancies or those receiving immunosuppressive therapy or
who are otherwise immunocompromised.
Any acute infection or febrile illness is reason for delaying use of
PedvaxHIB except when, in the opinion of the doctor, withholding the vaccine
entails a greater risk.
An antibody response to the carrier protein (N. meningitidis) has been
demonstrated but its clinical benefits or disadvantages have not been
established. See also Dosage and Administration, Use with other vaccines.
Carcinogenesis, mutagenesis, impairment of fertility. PedvaxHIB has not been
evaluated for its carcinogenic or mutagenic potential, or its potential to
impair fertility.
Use in pregnancy. (Category B2)
It is not known whether PedvaxHIB can cause fetal harm when administered to
a pregnant woman or can affect reproductive capacity. PedvaxHIB is not
recommended, therefore, for use in a pregnant woman.
Use in lactation. It is not known whether PedvaxHIB is excreted in human
milk. Because many drugs are excreted in human milk, caution should be
exercised when PedvaxHIB is administered to a breastfeeding mother.
 Adverse Reactions In clinical studies involving healthy children two months
of age and older, PedvaxHIB was generally well tolerated. Parental
observations reported over a 48 hour period following vaccination with
PedvaxHIB included the following.
Local. Swelling less than or equal to 2.5 cm (12.1%), swelling/ induration >
2.5 cm (3.1%), pain/ soreness (12.6%), erythema less than or equal to 2.5 cm
(16.5%), erythema > 2.5 cm (1.1%).
General. Irritability (24.4%), lethargy/ sleepiness (16.9%), crying (4.5%),
diarrhoea (6.1%), fever greater than or equal to 38.3 deg. C (3.3%),
vomiting (3.2%), rash (2.0%), anorexia (0.9%), nausea (0.8%) and urticaria
(0.1%). A causal relationship between these observations and vaccination has
not been established.
Rarely, severe crying episodes may occur.
In later clinical studies with Pedvax HIB, one additional serious adverse
reaction (tracheitis, possibly related to the vaccine) was reported.
As with any vaccine, there is the possibility that broad use of PedvaxHIB
could reveal adverse reactions not observed in clinical trials. The
following additional adverse reactions have been reported with use of the
marketed vaccine.
Haematological. Lymphadenopathy.
Hypersensitivity. Rarely angioedema.
Central nervous system. Seizures (including febrile seizures).
Dermatological. Sterile injection site abscess; pain at injection site.
Currently, information on the incidence and severity of adverse effects
following a booster dose is not available. Based on experience with some
other polysaccharide vaccines, the possibility of increased incidence/
severity of adverse reactions cannot be excluded.
Potential side effects. During studies with Haemophilus influenzae type B
polysaccharide vaccines, convulsions, early onset Haemophilus B disease and
Guillain-Barre syndrome have occurred rarely. However, a cause and effect
relationship between these side effects and the vaccination was not
established.
 Interactions Laboratory tests. Sensitive tests, e.g. latex agglutination
kits, may detect PRP derived from the vaccine in the urine of some vaccinees
for up to seven days following vaccination with PedvaxHIB.
 Dosage and Administration Dosage. Children. Infants 2 to 14 months. Ideally
infants should receive a 0.5 mL dose of vaccine beginning at two months of
age followed by a 0.5 mL dose two months later. When the primary two dose
regimen is completed before 12 months of age, a booster dose is required
(see below).
15 months and over. A single 0.5 mL dose of vaccine.
Booster dose. In infants completing the primary two dose regimen before 12
months of age, a booster dose (0.5 mL) should be administered at 12 to 15
months of age but not earlier than two months after the second dose.
Administration. For intramuscular administration, do not inject
intravenously.
Reconstitute only with the aluminium hydroxide diluent supplied.
Firstly, agitate the diluent vial, then, using sterile technique, withdraw
the entire volume of aluminium hydroxide diluent into the syringe to be used
for reconstitution. Inject all the aluminium hydroxide diluent in the
syringe into the vial of lyophilised vaccine, and agitate to mix thoroughly.
Withdraw the entire contents into a syringe and inject the total volume
(about 0.5 mL) of reconstituted vaccine intramuscularly, preferably into the
anterolateral thigh or the outer aspect of the upper arm.
It is recommended that the vaccine be used as soon as possible after
reconstitution. Store reconstituted vaccine in the vaccine vial at 2 to 8
deg. C and discard if not used within 24 hours. Agitate prior to injection.
Parenteral drug products should be inspected visually for extraneous
particulate matter and discolouration prior to administration. Aluminium
hydroxide diluent and PedvaxHIB when reconstituted are slightly opaque white
suspensions.
Special care should be taken to ensure that the injection does not enter a
blood vessel.
It is important to use a separate sterile syringe and needle for each
patient to prevent transmission of hepatitis B or other infectious agents
from one person to another.
Revaccination. Infants completing the primary two dose regimen before 12
months of age should receive a booster dose (see above).
Use with other vaccines. Limited studies have been conducted in which
PedvaxHIB was administered concomitantly with the primary vaccination series
of diphtheria, tetanus, pertussis (DTP) and oral polio vaccine (OPV), or
concomitantly with M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live)
(using separate sites and syringes) or with a booster dose of OPV plus DTP
(using separate sites and syringes for PedvaxHIB and DTP). While no
impairment of immune response to PedvaxHIB or other individual tested
antigens was demonstrated in these studies, there is a suggestion that
Haemophilus influenzae type B conjugated vaccines may impair antibody
response to DTP antigens, although protective levels are still achieved. The
type, frequency and severity of adverse experiences observed in these
studies were similar to those seen when the individual vaccines were given
alone.
 Presentation Injection, 0.5 mL: 1's.
 Storage The vaccine must be maintained at 2 to 8 deg. C during shipment to
ensure that there is no loss of potency.
Before reconstitution, store PedvaxHIB at 2 to 8 deg. C.
Store reconstituted vaccine in the vaccine vial at 2 to 8 deg. C and discard
if not used within 24 hours.
Do not freeze the aluminium hydroxide diluent or the reconstituted vaccine.
 Poison Schedule S4.
 Date of TGA approval or last amendment 06/05/1997