A Study to Learn How Safe, Tolerable and Capable of Producing an Immune Response is, a Modified RNA Vaccine Against Pandemic Influenza : A PHASE 1, RANDOMIZED, OBSERVER-BLIND, DOSE-RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINE CANDIDATES AGAINST PANDEMIC INFLUENZA IN HEALTHY INDIVIDUALS 18 THROUGH 49 YEARS OF AGE
The purpose of this study is to learn about the safety and effects of the study vaccine for the possible prevention of influenza. Influenza is a disease that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. The study vaccine is called Pandemic Influenza modRNA (pdmFlu) Vaccine.This study is seeking for participants who are:between the age of 18 to 49 years old.willing and able to follow with all scheduled visits, treatment plan, laboratory tests, lifestyle changes, and other study procedures.healthy as confirmed by medical history, physical examinations, and the study doctor.capable of signing informed consent.Participants will receive either:the pdmFlu Vaccine,a licensed Influenza Vaccine (QIV)a placebo. A placebo does not have any medicine in it but looks just like the study medicine.Participants will not know which vaccine they receive. Participants will receive the study vaccines as a single shot in the arm at day 1 and at day 21. The study will compare participant experiences to help understand if the pdmFlu Vaccine is safe and effective. Participants will take part in this study for up to 8 months. During this time, the participants will receive the study vaccine and take part in follow-up visits..
| Medienart: |
|
|---|
Klinische Studie| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 11. Apr. Zur Gesamtaufnahme - year:2024 |
|---|
| Sprache: |
Englisch |
|---|
| Links: |
Volltext [kostenfrei] |
|---|
| Themen: |
610 |
|---|
| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: December 21, 2023, Last downloaded: ClinicalTrials.gov processed this data on April 17, 2024, Last updated: April 17, 2024 |
|---|
| Study ID: |
NCT06179446 |
|---|---|
| Veröffentlichungen zur Studie: |
|
| fisyears: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
CTG009538178 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | CTG009538178 | ||
| 003 | DE-627 | ||
| 005 | 20240417010430.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 231227s2024 xx |||||o 00| ||eng c | ||
| 035 | |a (DE-627)CTG009538178 | ||
| 035 | |a (UBBS_Klinische_Studien)NCT06179446 | ||
| 035 | |a (UBBS_Klinische_Studien)C5561001 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 245 | 1 | 0 | |a A Study to Learn How Safe, Tolerable and Capable of Producing an Immune Response is, a Modified RNA Vaccine Against Pandemic Influenza |b A PHASE 1, RANDOMIZED, OBSERVER-BLIND, DOSE-RANGING STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MODIFIED RNA VACCINE CANDIDATES AGAINST PANDEMIC INFLUENZA IN HEALTHY INDIVIDUALS 18 THROUGH 49 YEARS OF AGE |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: December 21, 2023, Last downloaded: ClinicalTrials.gov processed this data on April 17, 2024, Last updated: April 17, 2024 | ||
| 520 | |a The purpose of this study is to learn about the safety and effects of the study vaccine for the possible prevention of influenza. Influenza is a disease that can spread easily from one person to another and cause body aches, fever, cough, and other symptoms. The study vaccine is called Pandemic Influenza modRNA (pdmFlu) Vaccine.This study is seeking for participants who are:between the age of 18 to 49 years old.willing and able to follow with all scheduled visits, treatment plan, laboratory tests, lifestyle changes, and other study procedures.healthy as confirmed by medical history, physical examinations, and the study doctor.capable of signing informed consent.Participants will receive either:the pdmFlu Vaccine,a licensed Influenza Vaccine (QIV)a placebo. A placebo does not have any medicine in it but looks just like the study medicine.Participants will not know which vaccine they receive. Participants will receive the study vaccines as a single shot in the arm at day 1 and at day 21. The study will compare participant experiences to help understand if the pdmFlu Vaccine is safe and effective. Participants will take part in this study for up to 8 months. During this time, the participants will receive the study vaccine and take part in follow-up visits. | ||
| 650 | 2 | |a Influenza, Human | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Recruiting | |
| 650 | 4 | |a Phase: Phase 1 | |
| 650 | 4 | |a 610 | |
| 773 | 0 | 8 | |i Enthalten in |t ClinicalTrials.gov |g (2024) vom: 11. Apr. |
| 773 | 1 | 8 | |g year:2024 |g day:11 |g month:04 |
| 856 | 4 | 0 | |u https://clinicaltrials.gov/show/NCT06179446 |m X:VERLAG |x 0 |z kostenfrei |3 Volltext |
| 912 | |a GBV_CTG | ||
| 951 | |a AR | ||
| 952 | |j 2024 |b 11 |c 04 | ||