Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT00404651
Brief Summary:
The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP\~T vaccine is consistent.
The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP\~T vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after the three-dose primary series.
The secondary objectives are:
* To describe in each group, the immunogenicity parameters for all antigens one month after the third dose of the primary series
* To assess the overall safety in each group one month after the third dose of the primary series.
Study:
NCT00404651
Study Brief:
Protocol Section:
NCT00404651