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Pertussis batch PT FHA

Pío López, Adriano Arguedas Mohs, Arturo Abdelnour Vásquez, Maria Consuelo-Miranda, Emmanuel Feroldi, Fernando Noriega, Emilia Jordanov, Siham B Chir, Betzana Zambrano
BACKGROUND: Hexavalent diphtheria-tetanus-acellular pertussis-inactivated poliovirus-hepatitis B-Haemophilus influenzae type b (DTaP-IPV-HB-PRP-T)-containing vaccines are increasingly the standard of care. This study evaluated the primary series (NCT01177722) and booster (NCT01444781) of a fully liquid DTaP-IPV-HB-PRP-T vaccine in Latin America. METHODS: Infants (N = 1375) received hepatitis B vaccine at birth and were randomized to one of 3 batches of the investigational DTaP-IPV-HB-PRP-T or licensed control vaccine (DTaP-HB-IPV//PRP-T) at 2-4 to 6 months of age, coadministered with 7-valent pneumococcal conjugate vaccine (PCV7) (2-4-6 months) and rotavirus vaccine (2-4 months)...
November 2017: Pediatric Infectious Disease Journal
R Winsnes, D Sesardic, A Daas, E Terao, M-E Behr-Gross
An international collaborative study (coded BSP083) was performed under the aegis of the Biological Standardisation Programme supported by the Council of Europe and the European Commission, with the aim of replacing the in vivo challenge assays for potency determination of combined acellular pertussis (aP) vaccines by a refined procedure also allowing reduction of animal use. This study investigates whether the immunogenicity of aP vaccine components could be assayed in a guinea pig (gp) serology model, using the same vaccine immunising doses as for D and T components potency testing, instead of using separate animals as is currently done...
October 2009: Pharmeuropa Bio & Scientific Notes
Markus Knuf, Heinz-J Schmitt, Klaus Mohnike, Fred Zepp, Pirmin Habermehl, Christoph Kampmann, Peter Herden
PURPOSE: The objective of this study was to assess the local and systemic tolerability of two batches of the Biken acellular pertussis (Pa) vaccine following administration of a single vaccine dose to adults with or without a history of prior pertussis immunization. The results from this study were compared to data from published literature. PATIENTS AND METHODS: In a controlled, open-labeled double-blind trial, 518 healthy male and female adults with or without primary pertussis immunization were enrolled at three centers...
September 15, 2004: Medizinische Klinik
Bertrand Poirier, Nicole Bornstein, Murielle Andre, Denis Marmonier, Monique Pares, Gerard Vanhooren, Guy Rautmann, Marie-Emmanuelle Behr-Gross, Roland Dobbelaer, Florence Fuchs
A collaborative study was organised by the European Directorate For the Quality of Medicines (EDQM) to assess the suitability of a candidate mouse antiserum as a European Pharmacopoeia Biological reference preparation (BRP) for acellular pertussis vaccine potency testing. The candidate antiserum was obtained by immunising mice with a five-component acellular pertussis vaccine: pertussis toxin (PT), filamentous haemagglutinin (FHA), pertactin (PRN) and Fimbrial 2/Fimbrial 3 (Fim 2&3). The study has been divided into two separate phases...
March 2003: Biologicals: Journal of the International Association of Biological Standardization
E Miller
The evidence from pre-licensure studies does not suggest that there are clinically important differences in reactogenicity between acellular vaccines. The merits of different acellular products will therefore have to be compared on efficacy criteria. Ideally, acellular vaccines with the minimum antigen content necessary to ensure optimum protection should be used in order to avoid administration of superfluous antigens to children and to simplify licensing and batch release procedures. On the basis of the evidence so far available it seems unlikely that monocomponent pertussis toxin (PT) vaccines provide optimal protection and that multicomponent vaccines are needed to achieve a level of disease control that approaches that of a good whole-cell vaccine...
June 1999: Biologicals: Journal of the International Association of Biological Standardization
J Westdijk, J van den Ijssel, M Thalen, C Beuvery, W Jiskoot
In order to achieve batch-to-batch consistency of whole-cell pertussis vaccines, properties relevant for protection and safety should be characterised. Therefore, ELISAs to quantify pertussis toxin (PT), filamentous haemagglutinin (FHA), 92 kD outer membrane protein (92 kD-OMP) and pertactin (PRN) in Bordetella pertussis (B. pertussis) suspensions were developed. In this paper the influence of the bacterial growth stage on antigen production and antigen release into the supernatant was studied for pertussis strains 134, 509 and CS...
August 1997: Journal of Immunoassay
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