An Immunogenicity and Safety Study of Tetanus, Diphtheria and Acellular Pertussis Vaccine Booster (Tdap Booster)
Recruitment status was: Active, not recruiting
|Tetanus Diphtheria Pertussis||Biological: Td5ap Biological: Td1aP||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
|Official Title:||An Immunogenicity and Safety Study of Combined Adsorbed Tetanus, Low Dose Diphtheria and Acellular Pertussis Vaccine (Td5ap and Td1aP) Given as a School-leaving Booster to 14-15-year-old Children Primed With a Five Component Acellular Pertussis Vaccine at 3, 5 and 12 Months of Age, and a Booster Dose at 5½ Years of Age|
- to describe in each arm the immune response to diptheria toxin, tetanus toxoid, pertussis toxin, FHA, fimbriae 2/3 and pertactin four weeks after immunization with Td1aP and Td5ap [ Time Frame: 42 days ]
- safety of a fith dose of DTP vaccines [ Time Frame: 42 days ]
- pre-booster antibody levels [ Time Frame: 42 days ]
- pre-booster and post-booster IgG and IgA levels [ Time Frame: 42 days ]
- pre-booster and post-booster T cell immune responses [ Time Frame: 42 days ]
- pre-booster and post-booster B cell immune responses [ Time Frame: 42 days ]
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||June 2010|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Td5ap
Group 1 receiving Td5ap as a single intramuscular injection.
Intramuscular injection of 0.5 mL Td5ap (COVAXiS) on day 1.
Other Name: COVAXiS
Active Comparator: Td1aP
Group 2 receiving Td1aP as a single intramuscular injection
Intramuscular injection of 0.5 mL Td1aP (diTekiBooster) on day 1.
Other Name: diTekiBooster
The vaccines in the study are COVAXIS (Td5ap), Sanofi Pasteur Canada, and diTekiBooster (Td1aP), Statens Serum Institut, Denmark.
The primary objective of the study is to describe the immune response to diphtheria toxin, tetanus toxoid, pertussis toxin, filamentous haemagglutinin (FHA), fimbriae 2/3 and pertactin four weeks after immunization with Td1aP and Td5ap.
The secondary objectives include:
- describing the safety of a fith dose of DTP vaccines in 14-15 year-old children by observing systemic and local adverse reactions
- describing pre-booster antibody levels
- describing pre-booster and post-booster IgG and IgA levels in saliva
- describing in a subpopulation the pre-booster and post-booster T cell immune responses as determined by the production of cytokines
- describing in a subpopulation the pre-booster and post-booster B cell immune responses as determined by the number of effector and memory B-cells
The sample size is 400 subjects (200 in group 1 and 200 in group 2). It will be an open-label, randomized, multi-centre study in which group 1 will receive Td5ap as a single injection and group 2 will receive Td1aP as a single injection. DTP antibodies will be measured before and 28 days (+ 14 days) after Td5ap and Td1aP vaccination. The proportion of children with positive IgG antibody response will be measured in each study arm. Sera will be tested blindly by established ELISA methods and saliva samples will be analyzed by exploratory assays. In a subpopulation cellmediated immunity will be analyzed. The safety evaluation criteria will be the percentage of subjects with adverse events describing injection-site adverse reactions, systemic adverse events, daily temperatures and serious adverse events.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00870350
|Swedish Institute for Infectious Disease Control|
|Lund, Sweden, 221 85|
|Principal Investigator:||Leif Gothefors, Prof. em.||Swedish Institute for Infectious Disease Control|
|Study Director:||Eva Netterlid||Swedish Institute for Infectious Disease Control|