Kliinilise uuringu otsus nr RKU-4/38

Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477

14.06.2024 nr RKU-4/38

OTSUS

Ravimi kliinilise uuringu loa andmiseks Euroopa Parlamendi ja nõukogu määruse (EL) nr

536/2014 (määrus (EL) 536/2014) alusel

Uuringu sponsor GlaxoSmithKline Biologicals esitas 23.02.2024 Ravimiametile taotluse

ravimi kliinilise uuringu teostamiseks määruse (EL) 536/2014 artikli 5 (1) ja ravimiseaduse

(RavS) § 991 lõikes 1 sätestatud tingimustel.

Tuginedes määruse (EL) 536/2014 artiklile 8, hindamisaruande I ja II osaga hõlmatud aspekte

hinnates, otsustab Ravimiamet ravimiseaduse § 996 lg 1 punkti 1 ja lõike 3 alusel

anda uuringu sponsorile GlaxoSmithKline Biologicals loa ravimi kliinilise uuringu

läbiviimiseks vastavalt esitatud uuringuplaanile nr 222090 järgmistel tingimustel:

uuringuplaani number: 222090 (versioon 1 kuupäevaga 5. detsember 2023)

uuringu referentsnumber: 24-004

uuringu nimetus: „A phase 3b, randomized, open label, multi-country, multi-center,

extension and crossover vaccination study to evaluate the immunogenicity and safety of

different revaccination schedules and persistence of a single dose of the RSVPreF3 OA

vaccine in adults aged 60 years and above who participated in the RSV OA=ADJ-006 study“

uuringu sponsor: GlaxoSmithKline Biologicals

uuritavate arv Eestis: 429

uuringu algus: august 2024

vastutavad uurijad ja uuringukeskused:

- Dr Ingrid Alt, Vee Perearstikeskus OÜ, Vee tn 6, 72713 Paide, Eesti

- Dr Ivo Valter, Center for Clinical and Basic Research AS, J. Pärna tn 4, 10128 Tallinn,

Eesti

- Dr Jaak Tälli, Innomedica OÜ, Narva mnt 7, 10117 Tallinn, Eesti

- Dr Riin Lanno, Merelahe TK OÜ, Paldiski mnt 68a, 10617 Tallinn, Eesti

- Dr Rain Jõgi, Tartu Ülikooli Kliinikum, L. Puusepa tn 8, 50406 Tartu, Eesti

Derek Moriarty

GlaxoSmithKline Biologicals

12 River Walk, Citywest Business Campus

D24 YK11 Dublin

IIRIMAA

2 (2)

- Dr Andres Siig, Aktsiaselts Medicum Tervishoiuteenused, Punane tn 61, 13619

Tallinn, Eesti

Vaide käesolevale otsusele saab esitada Ravimiametile 30 päeva jooksul arvates otsuse

teatavaks tegemisest vastavalt haldusmenetluse seaduse § 71 lõikele 1. Kui otsuse saaja soovib

otsust vaidlustada halduskohtus, võib ta vastavalt halduskohtumenetluse seadustiku § 7 lõikele

1 ja § 46 lõikele 1 esitada kaebuse otsuse peale Tartu Halduskohtule 30 päeva jooksul otsuse

teatavaks tegemisest arvates.

Lugupidamisega

(allkirjastatud digitaalselt)

Katrin Kiisk

Peadirektor

Nooruse 1 / 50411 Tartu / 737 4140 / [email protected] / www.ravimiamet.ee / Registrikood 70003477

14.06.2024 nr RKU-4/38

DECISION

to grant authorisation for clinical trial on the basis of Regulation (EU) No 536/2014 of the

European Parliament and of the council

State Agency of Medicines has received the application from sponsor GlaxoSmithKline

Biologicals on 23.02.2024 to conduct a clinical trial under the conditions stipulated in

Regulation (EU) No 536/2014 art 5 (1) and § 991 (1) of Estonian Medicinal Products Act

(MPA).

Based on art 8 of Regulation (EU) No 536/2014, considering the aspects covered by Part I and

Part II of the assessment report, on the basis of § 996 section 1 p 1 and (3) of Medicinal Product

Act

State Agency of Medicines has decided to give the approval to conduct the clinical study

protocol no 222090 under the following conditions:

protocol no: 222090 (Version 1, dated 05/12/2023)

full title of the trial: A phase 3b, randomized, open label, multi-country, multi-center,

extension and crossover vaccination study to evaluate the immunogenicity and safety of

different revaccination schedules and persistence of a single dose of the RSVPreF3 OA

vaccine in adults aged 60 years and above who participated in the RSV OA=ADJ-006 study

sponsor of the trial: GlaxoSmithKline Biologicals

number of subjects in Estonia: 429

starting date: August 2024

principal investigators and study locations:

- Dr Ingrid Alt, Vee Perearstikeskus OÜ, Vee tn 6, 72713 Paide, Estonia

- Dr Ivo Valter, Center for Clinical and Basic Research AS, J. Pärna tn 4, 10128 Tallinn,

Estonia

- Dr Jaak Tälli, Innomedica OÜ, Narva mnt 7, 10117 Tallinn, Estonia

- Dr Riin Lanno, Merelahe TK OÜ, Paldiski mnt 68a, 10617 Tallinn, Estonia

- Dr Rain Jõgi, Tartu University Hospital, L. Puusepa tn 8, 50406 Tartu, Estonia

Derek Moriarty

GlaxoSmithKline Biologicals

12 River Walk, Citywest Business Campus

D24 YK11 Dublin

IRELAND

2 (2)

- Dr Andres Siig, Aktsiaselts Medicum Tervishoiuteenused, Punane tn 61, 13619

Tallinn, Estonia

The addressee may file a challenge with State Agency of Medicines within 30 days as of the

day when the addressee became or should have become aware of the decision as prescribed in

Code of Administrative Procedure § 71(1). If the addressee wishes to have the decision to

annulled by the administrative court, he or she may submit a complaint to the Tartu

Administrative Court as prescribed in § 7(1) and § 46(1) of the Code of Administrative Court

Procedure within 30 days after the date on which the decision was notified to the applicant.

(digitally signed)

Katrin Kiisk

Director General