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 : 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.

Medienart:

Klinische Studie

Erscheinungsjahr:

2023

Erschienen:

2023

Enthalten in:

WHO International Clinical Trials Registry Platform - (2023) vom: 09. Jan. Zur Gesamtaufnahme - year:2023

Sprache:

Englisch

Links:

Volltext [kostenfrei]

Themen:

610
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]
Phase: Phase 2
Recruitment Status: Authorised-recruitment may be ongoing or finished
Study Type: Interventional

Anmerkungen:

WHO International Clinical Trials Registry Platform (https://www.who.int/ictrp/en/), First posted: 02-11-2021, Last updated: 2023-01-13

ICTRP ID:

EUCTR2021-005226-26-ES
HIPRA-HH-2

Förderinstitution / Projekttitel:

PPN (Katalog-ID):

CTG008063052