Decennial Administration of a Reduced Antigen Content Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine in Young Adults

Abstract

ClinicalTrials.gov identifier: NCT00610168 .

Evaluation of a new syringe presentation of reduced-antigen content diphtheria, tetanus, and acellular pertussis vaccine in healthy adolescents - A single blind randomized trial

“…The results were consistent with previous reports in adolescents 4,6,14,18 and non-inferiority of the new presentation compared to the old presentation was demonstrated. dTpa administered using the new dTpa syringe presentation was also well tolerated and the incidence and nature of adverse events were similar irrespective of the syringe presentation and comparable with previous studies.…”

“…dTpa administered using the new dTpa syringe presentation was also well tolerated and the incidence and nature of adverse events were similar irrespective of the syringe presentation and comparable with previous studies. 4,11,12,15 Large swelling reactions, which can be associated with repeated booster doses of dTpa vaccines, 6,14 were not observed in either study group.…”

“…4,5 Boostrix TM , which was first licensed in 1999, is currently available in over 70 countries and has a well-established immunogenicity and tolerability profile in populations ranging from school age to the elderly. [6][7][8][9][10][11][12][13][14][15][16][17][18][19] Traditionally, Boostrix TM has been available as a single-dose vial or a prefilled disposable syringe where the tip-cap and plunger stopper contained methylester W1883. However, following the discontinuation of W1883 production by the manufacturer (West), the syringe presentation has recently been replaced using prefilled syringes from a different manufacturer, wherein the tip-cap component contains FM27 (a latex-free non-cytotoxic rubber compound) and the plunger stopper component contains FM457 (an ultra-low extractable bromobutyl compound).…”

“…[6][7][8][9][10][11][12][13][14][15][16][17][18][19][20] Owing to a recent technical change in the Boostrix TM syringe presentation, this study was undertaken to compare the immunogenicity and safety of the new and previous syringe presentations, which differed in the nature of the compounds present in the tipcaps and plunger stoppers.…”

Is adding maternal vaccination to prevent whooping cough cost-effective in Australia?

“…Maximum vaccine efficacy of dTpa in mothers (92%) was estimated from the APERT study 43 waning over five years. While the literature supports antibody protection for at least 10 years, 44 a five-year duration of protection was selected to account for mothers who are re-vaccinated with subsequent pregnancies. Passive vaccine protection in infants due to maternal vaccination was estimated from UK observational data showing high levels of protection (91%) in infants up to three months old.…”