Vaccines
> Pediarix
FAQs on Pediarix
Vaccine
Clinical questions
& answers
Pediarix
is a combination product containing DTaP, hepatitis B, and inactivated
polio vaccines. It is produced by GlaxoSmithKline, and was licensed
on December 13, 2002.
Related
MMWR Article
Categories
of questions answered on this page: |
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General
questions: |
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Vaccine
use, recommendations & schedule: |
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- If
a child gets a birth dose of monovalent hepatitis B vaccine,
can he/she get Pediarix for subsequent doses?
- Can
a child who received a birth dose of monovalent hepatitis
B vaccine still receive a 3-dose series of Pediarix, even
if would mean getting an extra dose of hepatitis B?
- Are
CDC and AAP relaxing their recommendations regarding the
birth dose of hepatitis B vaccine to encourage use of Pediarix?
- May
an infant born to a HBsAg-positive mother or a mother whose
HBsAg status is unknown be given Pediarix after a birth
dose of monovalent hepatitis B vaccine?
- Why
does CDC recommend Pediarix for infants of HBsAg positive
mothers or mothers whose HBsAg status is unknown when the
FDA did not license the vaccine for these children?
- May
Pediarix be given simultaneously with other vaccines?
- Does
use of Pediarix affect the total number of doses required
of the three component vaccines?
- What
are the minimum intervals & ages for doses of Pediarix?
- Can
Pediarix be used to complete a primary series begun with
individual DTaP, hepatitis B, and IPV vaccines?
- Can
a child who starts the series with Pediarix switch to individual
DTaP, hepatitis B, and IPV vaccines?
- Can
a child who has received one or more doses of DTaP from
another manufacturer complete the primary series with Pediarix,
or can a child who began the series with Pediarix switch
to another manufacturer's DTaP?
- May
Pediarix be used to complete a primary series begun using
other manufacturers' IPV or hepatitis B vaccines (or vice
versa)?
- If
a dose of Pediarix is inadvertently administered at less
than 6 weeks of age, should it be repeated at the appropriate
age?
- If
a dose of Pediarix is inadvertently given to a patient 7
years of age or older, would the DTaP component count as
a dose of Td, or would it have to be repeated?
- If
Pediarix is inadvertently given as a 4th dose or school
booster (4-6 years), may it be counted, or should any vaccines
be repeated?
- If
Pediarix is used for 3-dose primary series, may TriHIBit
be used for the 4th dose of DTaP?
- May
COMVAX be used after Pediarix has been used for one or more
doses of hepatitis B vaccine; or may Pediarix be used after
COMVAX has been used for one or more doses?
- May
Pediarix be used as part of an accelerated DTaP schedule
(e.g., during a pertussis outbreak) when the third dose
is given at under 6 months of age or less than 8 weeks after
dose two?
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Safety
and contraindications: |
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Administration,
storage and handling: |
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Programmatic
issues: |
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- Who is eligible
to get Pediarix?
Pediarix
is approved as a 3-dose primary series, at 2, 4, and 6 months
of ages. It is licensed for children 6 weeks through 6 years of
age.
- Who
should NOT get Pediarix?
Pediarix
should not be given to infants less than 6 weeks of age or to
anyone 7 years of age or older. (Also see "Contraindications,"
below.)
- Can
providers use Pediarix for booster doses of DTaP and IPV after
the 3-dose primary series?
No. Pediarix is licensed only for the primary series. It should
be followed with 4th and 5th doses of DTaP and a 4th dose of IPV
at appropriate ages.
- Are
the individual components of Pediarix identical to vaccines already
available in the U.S.?
Pediarix
contains the same DTaP and hepatitis B antigens used in existing
U.S. vaccines (Infanrix and Engerix-B, respectively). The IPV
component is derived from a vaccine that has been used in other
countries since 1996. It has not been used previously in the
U.S., but contains the same three poliovirus types, strains,
and antigen content as the currently-licensed U.S. vaccine.
- Is
Pediarix as immunogenic as the three component vaccines given
separately?
Yes.
Clinical studies have shown the immune response to Pediarix
to be comparable to that of the separate vaccines.
- Is
the hepatitis B immune response to Pediarix given at 2, 4, and
6 months comparable to that of monovalent hepatitis B vaccine
given at birth, 1 month and 6 months?
Yes.
The concentration of antibody to hepatitis B surface antigen
is higher in groups of children given monovalent hepatitis B
vaccine at birth, 1 and 6 months, but the percentage of children
achieving protective antibody titers is the same.
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Vaccine
use, recommendations & schedule: |
- If
a child gets a birth dose of monovalent hepatitis B vaccine, can
he/she get Pediarix for subsequent doses?
Yes.
No.
CDC and AAP still encourage parents to get their children the
first dose of hepatitis B vaccine at birth.
- May
an infant born to a HBsAg-positive mother or a mother whose HBsAg
status is unknown be given Pediarix after a birth dose of monovalent
hepatitis B vaccine?
Yes. The ACIP has approved the use of Pediarix to complete the
series regardless of the mother's HBsAg status.
- Why
does CDC recommend Pediarix for infants of HBsAg positive mothers
or mothers whose HBsAg status is unknown when the FDA did not
license the vaccine for these children?
The
Advisory Committee on Immunization Practices is constituted by
the Department of Health and Human Services to make recommendations
about the appropriate use of vaccines and other biologic products
in the United States. Before making these recommendations, the
Committee examines all available data on the topic. There are
times when the data clearly support the use of a vaccine in a
manner not specifically approved by the FDA. The reason for this
is that the FDA requires specific data, in the form of a clinical
trial, to support each licensed indication.
Neither Merck (Comvax) nor GSK (Pediarix) have
tested their combination vaccines in a blinded manner among
infants born to HBsAg positive women. However, the data are
very clear that the response to the hepatitis B component of
the combinations is at least as good, and may be better, than
the response to the vaccine given alone. There is no biologic
evidence or reason to believe that infants born to HBsAg positive
women respond any differently to hepatitis B vaccine (alone
or in combination) than infants born to HBsAg negative women.
This is not experimentation. This is rational extrapolation
of established vaccine response data. If there were any reason
whatsoever to believe that the response to hepatitis B vaccine
in a combination was different in these children than to monovalent
vaccine, ACIP would not have made the recommendation they made.
- May
Pediarix be given simultaneously with other vaccines?
Yes.
Pediarix may be given with any other vaccines at separate injection
sites.
- What
are the minimum intervals and minimum ages for each dose of Pediarix?
The
minimum age and interval for each dose are equivalent to the longest
interval or oldest age recommended for any of the individual components
for that dose. (For example, the minimum age for dose 1 is 6 weeks,
the same as DTaP and IPV, while the minimum age for dose 3 is
6 months, the same as hepatitis B.)
Dose |
Minimum
Age |
Minimum
Interval From Previous Dose |
1 |
6
weeks |
N/A |
2 |
10
weeks |
4
weeks |
3 |
6
months |
8
weeks |
- Can
Pediarix be used to complete a primary series begun with individual
DTaP, hepatitis B and IPV vaccines?
Yes,
if the child received Infanrix as the DTaP vaccine. It is preferable
to use the same manufacturer's DTaP vaccine for all doses in the
primary series. But if you do not know whether a child received
Infanrix for prior doses, or if Pediarix is the only DTaP-containing
vaccine available, Pediarix may still be used to complete the
series.
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- Can
a child who starts the series with Pediarix switch to individual
DTaP, hepatitis B and IPV vaccines?
Yes.
- Can
a child who has received one or more doses of DTaP from another
manufacturer complete the primary series with Pediarix, or can
a child who began the series with Pediarix switch to another manufacturer's
DTaP?
Whenever
feasible, the same brand of DTaP should be used for all doses
of the primary series. However, if this isn't possible, use
a different manufacturer's product rather than defer vaccination.
- May
Pediarix be used to complete a primary series begun using other
manufacturers' IPV or hepatitis B vaccines (or vice versa)?
Yes
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- If
a dose of Pediarix is inadvertently given to a patient 7 years
of age or older, would the DTaP component count as a dose of Td,
or would it have to be repeated?
In
this situation count the DTaP dose as if it were Td. Do not repeat.
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- If
Pediarix is used for 3-dose primary series, may TriHIBit be used
for the 4th dose of DTaP?
Yes,
as long as the Hib component of TriHIBit represents the final
dose of the Hib series, and the child has received at least
one prior dose of Hib vaccine.
- May
COMVAX be used after Pediarix has been used for one or more doses
of hepatitis B vaccine; or may Pediarix be used after COMVAX has
been used for one or more doses?
Yes.
Either use is acceptable.
- May
Pediarix be used as part of an accelerated DTaP schedule (e.g.,
during a pertussis outbreak) when the third dose is given at under
6 months of age or less than 8 weeks after dose two?
Pediarix may be used to begin such an accelerated schedule, using
the minimum interval of 4 weeks between doses 1 and 2. DTaP, rather
than Pediarix, would normally be recommended for the third dose
in this situation. However, Pediarix may be used as long as an
additional dose of hepatitis B vaccine is given at the appropriate
age and interval to ensure proper boosting.
Safety
and contraindications: |
- Is
the safety profile of Pediarix similar to that of the three component
vaccines?
Overall
the rates of other adverse events were comparable in clinical
trials, although infants who received Pediarix had somewhat higher
rates of fever >100.4°F than infants who received
the component vaccines injected at separate sites.
- Is
it safe to give Pediarix with Hib and PCV at the same visit?
These
vaccines may be given at the same visit. However, safety information
is not yet available for all doses in the primary series when
Pediarix, Hib and PCV are given at the same visit. After the first
dose of Pediarix with Hib and PCV, the rate of fever >100.4°F
was higher than when hepatitis B vaccine (Engerix™), DTaP
(Infanrix™), Hib, and PCV were administered separately at
the same visit.
- Does
Pediarix contain thimerosal?
Pediarix
does not contain thimerosal as a preservative. Thimerosal is
used during the early stages of production, and subsequently
removed, leaving only a clinically insignificant trace.
- What
conditions contraindicate Pediarix?
(1)
Hypersensitivity to any component of the vaccine, including
yeast, neomycin, and polymyxin B.
(2) A history of anaphylaxis after a previous dose of Pediarix
or any of its components.
(3) A history of encephalopathy within 7 days of a previous
dose of any pertussis-containing vaccine.
(4) Progressive neurologic disorder, including infantile spasms,
uncontrolled epilepsy, or progressive encephalopathy.
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Are
there other warnings or precautions regarding the use of Pediarix?
Warnings
and precautions for the individual components also apply to Pediarix.
Conditions for which Pediarix, or one of its components, should
be deferred, or the risks weighed against the benefits include:
temperature of >105°F within 48 hours of a prior
dose, collapse or shock-like state within 48 hours of a prior
dose, persistent inconsolable crying for 3 or more hours occuring
within 48 hours of a prior dose, seizures with or without fever
within 3 days of a prior dose, Guillain-Barré syndrome
within 6 weeks of a prior dose, or concurrent moderate or severe
acute illness. Immunosuppressive therapies may reduce the immune
response to the vaccine. See the package insert for details.
- Can
Pediarix be given to children with HIV infection?
Yes.
- Can
children with latex allergies get Pediarix?
While
the vial stopper is latex-free, the tip cap and rubber plunger
of the needleless prefilled syringes contain dry natural latex.
This may cause an allergic reaction in a child with a severe
latex allergy.
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Administration,
storage and handling: |
- What
are the recommended route and site for administering Pediarix?
Pediarix should be given intramuscularly, using a 7/8-1 inch,
22-25 gauge needle. The anterolateral thigh is the preferred site,
although the deltoid is acceptable when there is adequate muscle
mass.
- How
should Pediarix be stored?
Pediarix should be refrigerated between 36° and 46°F (2°
and 8°C).
- May
Pediarix be frozen?
No. Pediarix that has been subjected to freezing temperatures
should be discarded.
- How
is Pediarix supplied?
Pediarix is supplied in single-dose vials; and pre-filled disposable
syringes, with or without needles.
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- Will
Pediarix be available through VFC? And if so, when?
Pediarix has been approved for VFC, and is available in limited
quantities through CDC contracts. State projects must carefully
evaluate their Pediarix need before ordering to determine how
it will impact their previously projected usage of DTaP, Hepatitis
B and IPV.
- How
do I record administration of Pediarix on a shot record that doesn't
have spot designated for it?
Record the date under each separate component.
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