Conceptio › Archive › ClinicalTrials.gov
ClinicalTrials.gov public full text Public Domain

Study of a Booster Dose of a Tetravalent Dengue Vaccine in Subjects Who Previously Completed the 3-dose Schedule

Sanofi Pasteur, a Sanofi Company · 2016
ClinicalTrials.gov · Datasets · License: Public Domain · 2016
Open Source ↗
dengue-feverdengue-virus
The aim of the study was to assess and describe the booster effect of a CYD dengue vaccine dose administered 4 to 5 years after the completion of a 3-dose vaccination schedule. Primary Objective \- To demonstrate the non-inferiority, in terms of geometric mean of titer ratios (GMTRs), of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD13 - NCT00993447 and CYD30 - NCT01187433 trials (participants from Group 1 only). Secondary Objectives: * If the primary objective of non-inferiority was achieved: To demonstrate the superiority, in terms of GMTRs, of a CYD dengue vaccine booster compared to the third CYD dengue vaccine injection in participants from CYD13 and CYD30 trials. * To describe the immune responses elicited by a CYD dengue vaccine booster and placebo injection in participants who received 3 doses of the CYD dengue vaccine in the CYD13 and CYD30 trials in all participants. * To describe the neutralizing antibody levels of each dengue serotype post-dose 3 (CYD13 and CYD30 participants) and immediately prior to booster or placebo injection in all participants. * To describe the neutralizing antibody persistence 6 months, 1 year, and 2 years post booster or placebo injection in all participants. * To evaluate the safety of booster vaccination with the CYD dengue vaccine in all participants.
Conceptio Open Archive

Analyze & explore related research in Conceptio

Connect this record directly into your research workflow or AI agent. Explore citations across open repositories, query full text, and export structured proof bundles.

This document is indexed with metadata only: full text is not available in the archive for this record. Open the official source ↗

Related documents

Record · ID 910923
Retrieved via Conceptio: every document is proof-bundled with source, license, and retrieval metadata.
Bring this data into your agent: Connect via MCP or API · 20 free credits to start · no card required
Read the Docs → · View CLI source on GitHub · Conceptio Open Knowledge Archive