|
|
|
|
| LEADER |
01000caa a22002652 4500 |
| 001 |
CTG008627762 |
| 003 |
DE-627 |
| 005 |
20230425180155.0 |
| 007 |
cr uuu---uuuuu |
| 008 |
220826s2023 xx |||||o 00| ||eng c |
| 035 |
|
|
|a (DE-627)CTG008627762
|
| 035 |
|
|
|a (UBBS_Klinische_Studien_WHO)EUCTR2021-004889-35-DE
|
| 035 |
|
|
|a (UBBS_Klinische_Studien_WHO)UCDCRC/21/10
|
| 035 |
|
|
|a (UBBS_Klinische_Studien_WHO)2021-004889-35-IE
|
| 040 |
|
|
|a DE-627
|b ger
|c DE-627
|e rakwb
|
| 041 |
|
|
|a eng
|
| 245 |
1 |
0 |
|a This is a multicentre Phase II trial evaluating different booster strategies in individuals already vaccinated against SARS-CoV-2. This trial allows testing of different booster strategies for comparative assessment of their immune responses and safety against SARS-CoV-2 and its variants. This study tests whether a 4th vaccination dose is needed and determines the optimal booster vaccination schedule for further evaluation in a phase III trial.
|b An International Multicentre, Phase 2, Randomised, Adaptive Protocol to determine the need for, optimal timing of and immunogenicity of administering a 4th homologous mRNA vaccination dose against SARS-CoV-2 in the general population (18+ years) already vaccinated against SARS-CoV-2 (EU-COVAT-2 BOOSTAVAC) - EU-COVAT-2 BOOSTAVAC
|
| 264 |
|
1 |
|c 2023
|
| 336 |
|
|
|a Text
|b txt
|2 rdacontent
|
| 337 |
|
|
|a Computermedien
|b c
|2 rdamedia
|
| 338 |
|
|
|a Online-Ressource
|b cr
|2 rdacarrier
|
| 500 |
|
|
|a WHO International Clinical Trials Registry Platform (https://www.who.int/ictrp/en/), First posted: 03-05-2022, Last updated: 2023-01-13
|
| 650 |
|
4 |
|a Medical Condition: Severe Acute Respiratory Syndrome Coronavirus 19 (COVID-19/SARS-CoV-2) MedDRA version: 23.1Level: PTClassification code 10084457Term: COVID-19 immunisationSystem Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 23.0Level: LLTClassification code 10084462Term: SARS-CoV-2 vaccinationSystem Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
|
| 650 |
|
4 |
|a Study Type: Interventional
|
| 650 |
|
4 |
|a Phase: Phase 2
|
| 650 |
|
4 |
|a Recruitment Status: Authorised-recruitment may be ongoing or finished
|
| 650 |
|
4 |
|a 610
|
| 773 |
0 |
8 |
|i Enthalten in
|t WHO International Clinical Trials Registry Platform
|g (2023) vom: 09. Jan.
|
| 773 |
1 |
8 |
|g year:2023
|g day:09
|g month:01
|
| 856 |
4 |
0 |
|u https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-004889-35
|z kostenfrei
|3 Volltext
|
| 912 |
|
|
|a GBV_CTG
|
| 912 |
|
|
|a SSG-OLC-PHA
|
| 951 |
|
|
|a AR
|
| 952 |
|
|
|j 2023
|b 09
|c 01
|
Klinische Studie