When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Individuals with an incomplete, or no, history of a primary series of diphtheria and tetanus toxoids should not be vaccinated with IPV-Boostrix. IPV-Boostrix is not precluded in subjects with an incomplete, or no, history of previous pertussis or polio vaccination. However a booster response will only be elicited in individuals who have been previously primed by vaccination or by natural infection.
with the following:
In subjects ³ 40 years of age that had not received any diphtheria or tetanus containing vaccine in the past 20 years (including those who have never been vaccinated or whose vaccination status was unknown), one dose of IPV-Boostrix induces an antibody response against pertussis and protects against tetanus and diphtheria in the majority of cases. Two additional doses of a diphtheria and tetanus containing vaccine will maximize the vaccine response against diphtheria and tetanus when administered one and six months after the first dose (see section 5.1).
Deleted the following:
There are no data on the duration of protection against pertussis following vaccination with IPV-Boostrix.
Added pertussis to the following sentence:
Repeat vaccination against diphtheria, tetanus, pertussis and poliomyelitis should be performed at intervals as per official recommendations.
Removed reference to ‘infant’ in the following sentence:
As for any vaccination, the risk-benefit of immunising with IPV-Boostrix or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder.
Updated the heading to include ‘fertility.
Corrected the spelling for ‘pruritus’
Under the subheading Post-marketing surveillance, replaced the statement
The reactogenicity of revaccination with IPV-Boostrix has not been evaluated.
with
Data suggest that in subjects with DTP in childhood a booster dose might give an increase of local reactogenicity.
Added data on seroprotection / seropositivity rates for five years following a first vaccination of children 4 to 8 years of age with IPV-Boostrix
Added data on seroprotection / seropositivity rates for three to 3.5 years, 5 and 10 years following a first vaccination with Boostrix (dTpa component of IPV-Boostrix)
Added the following statements regarding immunogenicity:
The immunogenicity of IPV-Boostrix, administered 5 years after a first booster dose of IPV-Boostrix at 4 to 8 years of age, has been evaluated. One month post vaccination, > 99 % of subjects were seropositive against pertussis and seroprotected against diphtheria, tetanus and all three polio types.
The immunogenicity of Boostrix (dTpa component of IPV-Boostrix), administered 10 years after a first booster dose with reduced-antigen content diphtheria, tetanus and acellular pertussis vaccine(s) has been evaluated. One month post vaccination, > 99 % of subjects were seroprotected against diphtheria and tetanus and seropositive against pertussis.
After administration of one dose of IPV-Boostrix to 140 adults ³ 40 years of age that had not received any diphtheria and tetanus containing vaccine in the past 20 years, more than 96.4% of adults were seropositive for all three pertussis antigens and 77.7% and 95.7% were seroprotected against diphtheria and tetanus respectively.
Deleted the following statement:
The immunogenicity of revaccination with IPV-Boostrix has not been evaluated.