NCT02946190 - Clinical Trial References

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.

Citation(s)

Buasri W, Impoolsup A, Boonchird C, Luengchaichawange A, Prompiboon P, Petre J, Panbangred W
Construction of Bordetella pertussis strains with enhanced production of genetically-inactivated Pertussis Toxin and Pertactin by unmarked allelic exchange. BMC Microbiol. 2012 Apr 23;12:61. doi: 10.1186/1471-2180-12-61.
Ibsen PH
The effect of formaldehyde, hydrogen peroxide and genetic detoxification of pertussis toxin on epitope recognition by murine monoclonal antibodies. Vaccine. 1996 Apr;14(5):359-68.
Podda A, Carapella De Luca E, Titone L, Casadei AM, Cascio A, Bartalini M, Volpini G, Peppoloni S, Marsili I, Nencioni L, et al
Immunogenicity of an acellular pertussis vaccine composed of genetically inactivated pertussis toxin combined with filamentous hemagglutinin and pertactin in infants and children. J Pediatr. 1993 Jul;123(1):81-4.
Rappuoli R
The vaccine containing recombinant pertussis toxin induces early and long-lasting protection. Biologicals. 1999 Jun;27(2):99-102. Review.
Salmaso S, Mastrantonio P, Tozzi AE, Stefanelli P, Anemona A, Ciofi degli Atti ML, Giammanco A; Stage III Working Group
. Sustained efficacy during the first 6 years of life of 3-component acellular pertussis vaccines administered in infancy: the Italian experience. Pediatrics. 2001 Nov;108(5):E81.

A Phase II Randomized, Observer-blind Controlled Pilot Study to Compare the Safety and Immunogenicity of Acellular Pertussis Vaccines Including Chemically or Genetically-detoxified Pertussis Toxin in Adolescents Aged 11-15 Years Previously Immunized With Acellular Pertussis Vaccines

Details for clinical trial NCT02946190

Clinical trial NCT02946190 - References