Tetanus — Immunogenicity and Safety of Boostrix Polio Vaccine as a Booster Dose in 5 to 6-year-old Children.
Citation(s)
Ferrera G et al A comparison of the immunogenicity and safety of a booster dose of reduced-antigen-content with full-strength DTPa-IPV vaccines administered with MMRV to children 5-6 years of age. Abstract presented at the 44th Congresso Nazionale Societa Italiana di Igiene, Medicina Preventiva e Sanita Pubblica (SITI). Venezia, Italia, 3-6 October, 2010.
Ferrera G et al Immunogenicity and safety of Booster vaccination with reduced-antigen-content or full-strength Diphtheria-Tetanus-Acellular-Pertussis-IPV vaccines in pre-school children, primed with a 2+1 schedule. Abstract presented at the 29th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). The Hague, The Netherlands, 7-11 June 2011.
Ferrera G, Cuccia M, Mereu G, Icardi G, Bona G, Esposito S, Marchetti F, Messier M, Kuriyakose S, Hardt K Booster vaccination of pre-school children with reduced-antigen-content diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine co-administered with measles-mumps-rubella-varicella vaccine: a randomized, controlled trial in children primed according to a 2 + 1 schedule in infancy. Hum Vaccin Immunother. 2012 Mar;8(3):355-62. doi: 10.4161/hv.18650. Epub 2012 Feb 13.
Immunogenicity and Safety of GSK Biologicals' dTpa-IPV Vaccine (Boostrix Polio) as a Booster Dose in 5 to 6-year-old Children.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
