Boostrix Vaccine (Pregnant Women)

GSK Biologicals’ reduced-antigen-content dTpa vaccine, Boostrix, is a combination booster vaccine (a vaccine against more than one disease combined into one shot) indicated for individuals from the age of four years onwards against diphtheria, tetanus and pertussis diseases. It was first licensed for use in Germany in 1999. A number of studies have shown that Boostrix is safe and effective, in fact it has already been given to women in the UK. However, the effect of Boostrix has not been studied during pregnancy. The study staff can provide you with more details about these diseases.

Some of the effects of these diseases are explained below:

    • Diphtheria is a serious disease that affects the nose, throat and tonsils. It usually begins with a sore throat and can quickly develop to cause breathing problems. If untreated, this could lead to nerve damage, heart problems, and even death.
    • Tetanus (lockjaw) is an infection of the blood. It causes strong cramps that prevent breathing and can lead to death.
    • Pertussis (whooping cough) is a disease that can cause long spells of coughing and choking making it hard to breathe.

Whooping cough can last for up to 12 weeks. It is not usually serious in older children, but it can be very serious or even fatal in babies under one year of age.Vaccinating women during pregnancy may help in protecting the child against these diseases as the antibodies (proteins produced in response to an antigen) produced by the mother are passed to the unborn baby through the placenta (a temporary organ that joins the mother and unborn baby and feeds the unborn baby in the womb). Around 18 countries including United States of America, New Zealand and United Kingdom recommend vaccination against these diseases for pregnant women.This study will find out if Boostrix is safe and effective during pregnancy. The study will last about five months for each participant. About 680 pregnant women will take part in the study.

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Trial Information

StatusIn Recruitment
Start DateSeptember 2016
End DateTBD
Trial Duration6 months
Number of Visits4
Lead CRCJessica Richer

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