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:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 12:08 AM
NCT ID:
NCT06642558
Brief Summary:
The purpose of this study is to assess the safety and immunogenicity of two dose levels of the single dose Recombinant RSV vaccine(CHO cells), when administered intramuscularly (IM) in healthy adults aged 18 years and older.
Detailed Description:
A total of 522 subjects in the phase 1/2 study will be enrolled. The study will be conducted in 2 parts (phase 1 for dose escalation and phase 2 for expansion), with first evaluation of safety of 2 two dose levels of Recombinant RSV vaccine(CHO cells) in healthy participants aged 18-59 and ≥60 in phase 1 before preceding with vaccination of the participants aged 50-59 and ≥60 in phase 2. To ensure the safety of the study participants, phase 1 will follow a staggered enrolment with 3 steps. All subjects in each age group in phase 1 will be randomly receive the investigational vaccine(half or full dose) and the placebo in a 2:1 ratio, while all subjects in each age group in phase 2 will be randomly receive the half dose vaccine, the full dose vaccine and the placebo in a 1:1:1 ratio.
Study:
NCT06642558
Study Brief:
Protocol Section:
NCT06642558