Vaccines for Human Use

Diphtheria vaccine

Validation of a serological method using Vero cells

Study code: BSP006 / Study type: Refinement, Reduction

Validation of a serological method combined with Tetanus vaccines

Study code: BSP034 Phase 1 / Study type: Refinement, Reduction

Validation of a serological method combined with Tetanus vaccines

Study code: BSP034 Phase 1 Ext / Study type: Refinement, Reduction

Validation of a serological method combined with Tetanus vaccines

Study code: BSP034 Phase 2 / Study type: Refinement, Reduction

Tetanus vaccine

Validation of a serological method

Study code: BSP019 Phases 1 & 2 / Study type: Refinement, Reduction

Validation of a serological method combined with Diphtheria vaccines

Study code: BSP035 : Phase 3 / Study type: Refinement, Reduction

Establishment of a reference preparation for use in a new serological assay

Study code: BSP045 / Study type: Refinement, Reduction

In vitro detection of tetanus toxicity (BINACLE assay) – Part 1 and Part 2

Study code: BSP136 / Study type: Replacement

Pertussis vaccine

Standardisation of an in vivo assay for detection of residual pertussis toxin

 Study code: BSP076 / Study type: Refinement, Reduction

Validation of a serological assay for acellular pertussis vaccines

 Study code: BSP083 / Study type: Refinement, Reduction

Validation of a serological assay (Kendrick test)

 Study code: ECVAM-BSP (pre-BSP104) / Study type: Refinement, Reduction

Hepatitis A vaccine

Validation of an in vitro method and establishment of the corresponding reference preparation

Study code: BSP016 / Study type: Replacement

Inactivated Poliovirus vaccine (IPV)

Standardisation of the rat bioassay

Study code: BSP021 / Study type: Refinement

Standardisation of an in vitro assay

Study code: BSP023 / Study type: Replacement

Vaccines for Veterinary Use

Veterinary Clostridial vaccine

Collaborative study for the validation of cell line assays for in-process toxicity and antigenicity testing of Clostridium septicum vaccine antigens - Part 2: Optimisation of cell line assays

Study code: BSP130 / Study type: Replacement

Establishment of a reference antiserum (multicomponent) for serological and immunochemical assays

Study code: BSP022 / Study type: Refinement, Replacement

Collaborative study for the validation of cell line assays for in-process toxicity and antigenicity testing of Clostridium septicum vaccine antigens – Part 1

Study code: BSP130 / Study type: Replacement

Establishment of 2 reference preparations for use in a new serological assay

Study code: BSP024 / Study type: Refinement, Reduction

Validation of a new serological assay & establishment of a reference preparation

Study code: BSP038 / Study type: Refinement, Reduction

Swine erysipelas vaccine

Validation of a new serological assay & establishment of a reference preparation

Study code: BSP038 / Study type: Refinement, Reduction

Newcastle disease vaccine

Validation of an in vitro assay & establishment of a reference preparation Phase 1

Study code: BSP055 / Study type: Replacement

Validation of an in vitro assay & establishment of a reference preparation Phase 2

Study code: BSP055 / Study type: Replacement

Rabies vaccine

Validation of a serological assay

Study code: BSP105 / Study type: Refinement

Tetanus vaccine

In vitro detection of tetanus toxicity (BINACLE assay) – Part 1 and Part 2

Study code: BSP136 / Study type: Replacement

Blood Products

Tetanus Immunoglobulin

Validation of 2 in vitro alternative assays

Study code: BSP079 / Study type: Replacement

Biologicals

Somatropin

Establishment of a CRS for the use of physico-chemical methods

Study code: BSP004 / Study type: Replacement