Download Adacel Quadra - SA Pharmaceutical Journal

Adacel Quadra™ –
A new combination vaccine for use as booster in
children from 6 years of age, adolescents and adults
There has been a resurgence in the incidence of pertussis in
several countries. There has also been a shift in the age
distribution of pertussis, with dramatic increases being
reported among adolescents and adults. It appears, therefore, that immunity to pertussis, whether acquired from
natural infection during childhood or whether acquired from
routine infant immunisation, may not be lifelong. Indeed, it
has been shown that the duration of protection from both
whole cell and acellular pertussis vaccine is six years, while
natural infection may provide protection for up to 15 years.
There is clearly a need for a pertussis booster to be
added to the low-dose diphtheria, tetanus and poliomyelitis
(e.g. TdPolio®) booster currently recommended for adults,
adolescents and children over six years of age. Td Polio® is
no longer available, and therefore Adacel Quadra™ can be
used in place of Td Polio®.
Approved indication
Adacel Quadra™is a component pertussis vaccine, with
diphtheria and tetanus toxoids adsorbed, and inactivated
poliomyelitis vaccine. It is indicated for use as a booster in
children from six years of age, adolescents and adults.
Adacel Quadra™ is not intended for primary immunisation or
as a booster in children less than three years of age.
Mode of action
The combination vaccine is an active immunising agent
against diphtheria, pertussis, tetanus and poliomyelitis.
Dosage
One dose (0.5 ml) administered by intramuscular injection,
usually into the deltoid region. The deep subcutaneous route
can also be used.
Evidence of efficacy
Immunogenicity studies in children from the age of 6 years,
adolescents and adults have shown that Adacel Quadra™
induces high antibody response rates to all components of the
vaccine. The immunogenicity profile has been shown to be
comparable to that observed with single dose boosters of
diphtheria-tetanus vaccine or with diphtheria-tetanus-inactivated polio vaccine containing similar amounts of tetanus and
diphtheria toxoids and inactivated polio virus type 1, 2 and 3.1
Serological correlates for protection against pertussis
have not yet been established. However, based on two
studies with acellular pertussis (i.e. infant DTaP), which
conferred a protective efficacy of 85% against pertussis
disease, Adacel Quadra™ is considered to elicit a protective
immune response against pertussis (seroprotection rates
three years post-vaccination of > 96%).1
Reference: 1. Adacel TM Quadra package insert.
44
Precautions
o General
Hypersensitivity to the active substances or to any of the
other excipients of the vaccine.
Anaphylactic reaction to a previous dose of vaccine containing
any of the active substances contained in Adacel Quadra™.
Evolving encephalopathy – Adacel Quadra™ should not be
given to patients who previously experienced an encephalopathy of unknown origin within 7 days of previous
immunisation with a pertussis-containing vaccine. Adacel
Quadra™ should not be given to patients with progressive or
unstable neurological disorder or uncontrolled epilepsy until
the condition has stabilised.
Vaccination should be deferred in the presence of acute
illness, including febrile illness.
o Pregnancy and lactation
There is no data on the use of acellular pertussis vaccines in
pregnancy. The use of this vaccine is not recommended
during pregnancy or lactation.
Major adverse effects
In order to minimise the risk of adverse reactions, the interval
between a booster dose of Adacel Quadra™ and preceding
booster doses of diphtheria and tetanus-containing vaccines
should be at least five years.
Most commonly reported adverse reactions include local
reactions at the injection site (pain, redness and swelling).
These signs and symptoms are usually mild and resolve
without sequelae. Other common adverse effects reported
include headache, nausea, vomiting, diarrhoea, joint or
muscle pain, weakness, chills, fatigue and fever.
Drug interactions
Adacel Quadra™ is an inactivated vaccine and theoretically
there is no reason why it should not be administered at the same
time as other vaccines or immunoglobulins, at different sites.
Cost: SEP (Excl. VAT) R185.00
Presentation
Adacel QuadraTM is presented as a suspension, single dose
(0.5ml) pre-filled syringe, co-packed with two needles.
Patient information
In order to minimise the risk of adverse reactions, the interval
between a booster dose of Adacel Quadra™ and preceding
booster doses of diphtheria and tetanus-containing vaccines
should be at least five years.
Conclusion
Immunity acquired through childhood vaccination or natural
exposure wanes over time. Therefore, there is a need for a
single-dose booster of pertussis, diphtheria, tetanus and
poliomyelitis vaccine, which may be administered to children
from six years of age, adolescents and adults.
Manufactured by Sanofi-Pasteur.Distributed by UTI Pharma, also available in other wholesalers.
SA Pharmaceutical Journal – November/December 2009