|
|
|
|
LEADER |
01000caa a22002652 4500 |
001 |
CTG008063052 |
003 |
DE-627 |
005 |
20230425183156.0 |
007 |
cr uuu---uuuuu |
008 |
211221s2023 xx |||||o 00| ||eng c |
035 |
|
|
|a (DE-627)CTG008063052
|
035 |
|
|
|a (UBBS_Klinische_Studien_WHO)EUCTR2021-005226-26-ES
|
035 |
|
|
|a (UBBS_Klinische_Studien_WHO)HIPRA-HH-2
|
040 |
|
|
|a DE-627
|b ger
|c DE-627
|e rakwb
|
041 |
|
|
|a eng
|
245 |
1 |
0 |
|a A phase II study to evaluate safety and immunogenicity of recombinant proteincandidate vaccine against SARS-CoV-2 in adults fully vaccinated against COVID-19 with extension period to evaluate a fourth dose
|b A Phase IIb, double-blind, randomized, active controlled, multi-centre, non-inferiority trial followed by a Phase III, single arm, open label trial, to assess immunogenicity and safety of a booster vaccination with a recombinant protein RBD fusion dimer candidate (PHH-1V) against SARS-CoV-2, in adults fully vaccinated against COVID-19 followed with an extension period to study a fourth dose administration of PHH-1V.
|
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: 02-11-2021, Last updated: 2023-01-13
|
650 |
|
4 |
|a Medical Condition: SARS-CoV-2 MedDRA version: 23.0Level: LLTClassification code 10084272Term: SARS-CoV-2 infectionSystem Organ Class: 100000004862;Therapeutic area: Diseases [C] - Virus Diseases [C02]
|
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:2021-005226-26
|z kostenfrei
|3 Volltext
|
912 |
|
|
|a GBV_CTG
|
912 |
|
|
|a SSG-OLC-PHA
|
951 |
|
|
|a AR
|
952 |
|
|
|j 2023
|b 09
|c 01
|