Maternal Immunization Study
Participants needed: Pregnant women between 18-45 years, and have had an uncomplicated pregnancy. You must not have received a tetanus-diphtheria immunization at any time during this pregnancy.
GSK Biologicals’ Boostrix is a reduced-antigen-content dTpa vaccine, a combination booster vaccine (a vaccine against more than one disease combined into one shot) for individuals from the age of four years onward, to protect against diphtheria, tetanus and pertussis diseases. A number of studies have shown that dTpa is safe and effective. However, the effect of dTpa has not been studied during pregnancy. 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 newborn against these diseases as the antibodies (protection) produced by the mother are passed to the baby through the placenta (a temporary organ that joins the mother and baby and feeds the 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. In Canada, the National Advisory Committee on Immunisation (NACI) recommends vaccinating pregnant women over 26 weeks gestation if they have not already had their pertussis vaccine as an adult.
The purpose of the study is to find out if dTpa is safe and effective in pregnant women. The study will last about five months for each participant. About 680 pregnant women will take part in the study with approximately 70 here at the IWK
This study is sponsored by GSK; a group of companies that makes and sells vaccines, medicines, and health products.
Participation in the study involves up to five visits. The visits will occur at the IWK Health Centre.
Participants will be compensated for their time and for out-of-pocket expenses such as travel costs to and from study visits. Participants will receive $50 per visit for visits with a vaccination and blood sample and $25 per visit for visits with only a blood sample or return of a diary card, and a parking pass at the end of each visit if required.
Contact Pam MacIntyre