The purpose of this study is to look at the safety and immunogenicity of a combination vaccine that includes tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap). The study will be conducted in 48 pregnant women and 32 non-pregnant women. Safety of the newborn infant and the effect of the mother's vaccination on the infants' immune responses prior to vaccinating infants with another combination vaccine to protect against diphtheria, tetanus, and pertussis will be evaluated. Participants will be 18-45 years old. Pregnant volunteers will be 30-32 weeks pregnant and at a low risk for pregnancy complications. Pregnant volunteers will receive 2 injections (1 vaccine and 1 placebo, inactive substance); non-pregnant volunteers will receive 1 injection of vaccine. Blood samples will be collected from the mother and infant, along with the baby's growth measurements. Participation for mother infant pairs is about 15 months and about 7 months for non-pregnant women.
Age range
45 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Incidence of injection site and systemic reactions following injections.
Timeframe: Recorded 0 to 7 days after injection.
Frequency of vaccine-associated adverse events (AEs).
Timeframe: 30 minutes post-injection, Day 0, 1-2, 7, 4 weeks post-injection, delivery, Day 1-2, 7, and 2 and 4 months post-delivery. Infant AEs: Delivery, 2, 4, 7, and 13 months. Non-pregnant: Day 0, 1-2, 7, 4 weeks and 6 months.
Frequency of vaccine-associated serious adverse events (SAEs).
Timeframe: Maternal SAEs through 4 months post delivery and infant SAEs from delivery to 13 months. Non-pregnant SAEs: Day 0 through to 6 months post-injection.
Infant growth measurements (fronto-occipital circumference [FOC], length and weight).
Timeframe: At delivery and at 2, 7 and 13 months of age.
Bayley III developmental screening of infants.
Timeframe: At age 13 months.
Incidence of pertussis infection captured by surveillance for adverse events (AEs) and serious adverse events (SAEs).
Timeframe: Duration of study, captured by surveillance for AEs and SAEs. Antepartum: Day 1-2 and 7; 4 weeks; delivery. Postpartum: Day 1-2 and 7; Month 2, 4,7, and 13.