Ngubani oxhase lolu cwaningo?

Yi-GlaxoSmithKline

Ideski Losizo Lokusekelwa Kwezokwelashwa

• http://www.clinicalsupporthd.gsk.com
• GSKClinicalSupportHD@gsk.com
• Ucingo: +1-438-899-8201

Ucwaningo lokuphepha kanye nokusabela kokuzivikela komzimba

komgomo we-RSV komama abakhulelwe nezingane zabo

I-GSK ithanda ukubonga bonke ababambe iqhaza kulolu cwaningo

lwezokwelapha. Sicabanga ukuthi kubalulekile ukuthi wazi imiphumela
yocwaningo. Siyethemba ukuthi izokusiza ukuthi uqonde futhi uzizwe
uziqhenya ngendima yakho ebalulekile ocwaningweni lwezokwelapha.

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Ulwazi olujwayelekile mayelana nocwaningo lokuphenya
Lwenziwe nini ucwaningo?
Ucwaningo lwaqala ngoNovemba 2019 futhi
lwaphela ngoMeyi 2021.
Kungani kwakwenziwa lolu cwaningo?
I-RSV (igciwane lemigudu yokuphefumula)
lingathelela imigudu yomoya namaphaphu.
Izinsana, izingane ezincane kanye nabantu
abadala banamathuba amaningi okuthi babe
nokutheleleka okunzima kwe-RSV. Ngaphezu
kukahhafu wazo zonke izinsana utheleleke
nge-RSV phakathi nonyaka wokuqala wazo
wokuphila. Cishe zonke izingane zisuke
sezitheleleke nge-RSV ngosuku lwazo lokuzalwa
lwesibili. I-RSV isabalala ngokukhwehlela kanye
nokuthimula isuka kumuntu iye komunye. Iholela
ekubeni nekhala eligxiza amafinyila, imfiva,
ukukhwehlela, nokungathandi ukudla. Imithi
yokugoma ingasiza ekuvikeleni ku-RSV. Iqukethe
izingxenye ze-RSV ezingakwazi ukubangela
ukutheleleka. Lezi zingxenye zisiza umzimba
ukuthi wenze izivikelo, ezaziwa ngokuthi
amasosha omzimba, ku-RSV.
Izingane ezisanda kuzalwa nezinsana zisengozini
enkulu yokuba nesifo esibi kakhulu se-RSV. Enye
indlela yokuvikela izingane wukuthi omama bazo
Ngubani obambe iqhaza kulolu cwaningo?
Ngomama abakhulelwe abangu-213
kanye nezinsana zabo abazitetile
ezingu-206 abasuka emazweni angu-9
Omama abaneminyaka engu-18 kuya
ku- 40 ubudala abakhulelwe
Izinsana ezingu-111 zesilisa (u-54%)
Izinsana ezingu-95 zesifazane (u-46%)
bagomele i-RSV ngesikhathi bekhulelwe.
Amasosha omzimba kamama angase adlulele
enganeni ngaphambi kokuzalwa, anikeze isivikelo
esithile phakathi nezinyanga zokuqala zokuphila.
Izinjongo ezinkulu zocwaningo bekungu:
• Bheka ukuphepha komgomo we-RSV uma
unikezwa omama abakhulelwe - kubo bobabili
umama nengane.
• Hlola amazinga ezinhlobo ezimbili ezihlukene
zamasosha omzimba e-RSV komama
abakhulelwe
• Hlola ukuthi omama abakhulelwe
abawutholile umgomo we-RSV bawadluliselile
yini amasosha omzimba we-RSV ezinganeni
zabo ezisanda kuzalwa futhi luhlole amazinga
alawa masosha omzimba kubantwana.
Odokotela bocwaningo baqoqe ulwazi mayelana
nemiphumela engemihle engaba khona emithini
yokugoma enikezwe kulolu cwaningo. Imiphumela
ingatholakala esigabeni esithi “Kwakuyimiphi
imiphumela emibi?”.
Lo mbiko ugxile emiphumeleni yezinjongo
eziyinhloko zocwaningo. Yonke imiphumela
ingatholakala esifinyezweni semiphumela
yezempilo.
 Omama abakhulelwe Omama abakhulelwe bebengeke balibambe
bebengalibamba iqhaza iqhaza ocwaningweni uma:
ocwaningweni uma:
• bephila kahle • baba nezinkinga ezinkulu ekukhulelweni kwamanje
• bevumele izingane zabo ukuthi zibambe • babekhulelwe ingane engaphezu kweyodwa
iqhaza kulolu cwaningo
• babenokutheleleka kwe-HIV, i-hepatitis B noma
• bevumele ukuthi kuqoqwe igazi i-hepatitis C
lamzanyana kuzona
• baba nanoma yikuphi ukuphambana kofuzo noma
kokuzalwa kombungu okutholwe ngesikhathi
bekhulelwe
• babe nomlando wokuzala ingane eshonile,
ukuzalwa ngaphambi kwesikhathi noma
ukuphuphunyelwa yizisu okuningi

Yimiphi imigomo eyacwaningwa?

Umgomo we-RSV: umuthi wokugoma Umuthi-mbumbulu: inhlanganisela engasebenzi.
owenzelwe ukuvikela ezifweni ze-RSV. Lo mgomo Umuthi mbumbulu wanikezwa ngomjovo
wanikezwa ngomjovo engalweni. engalweni.

Lwenziwa kanjani ucwaningo?

Umfanekiso 1a uchaza ukuthi yimiphi imigomo Umfanekiso 1a no-1b uphinde ubonise ukuthi
omama abakhulelwe eqenjini ngalinye amasampula egazi athathwa nini. Igazi eliphuma
locwaningo abayithola nokuthi bayithola nini. enkabeni (okuthiwa igazi lamzanyana)
lalithathwa ngesikhathi sokubeletha. Lawa
Kwakalwa amazinga omthamo amabili omgomo
masampula athathelwa ukukala amasosha
we-RSV: U-60 microgremu no-120 microgremu.
omzimba. Odokotela bocwaningo baphinde
Omama abakhulelwe eqenjini Lokulawula
baqoqa ulwazi ngokuphepha komgomo.
bathole umuthi mbumbulu.
Omama abakhulelwe babelandelelwa izinyanga
Omama abakhulelwe bafakwa eqenjini
ezingu-6 ngemva kokubeletha. Izinsana zabo
locwaningo ngenhlanhla (njengokuphonsa
zalandelelwa unyaka owodwa ngemva
uhlamvu lwemali). Abasebenzi bocwaningo
kokuzalwa.
babazi ukuthi yikuphi ukwelashwa omama
abakhulelwe abakuthola; nokho omama
abakhulelwe kanye nodokotela bocwaningo
babengazi ukuthi yikuphi ukwelashwa
abakuthola.
Umfanekiso 1a: Idizayni yocwaningo yomama

Umfanekiso 1b: Idizayni yocwaningo lwezingane

Yayimiphi imiphumela eyinhloko yocwaningo?
Lo mbiko unikeza imiphumela yezinjongo eziyinhloko zocwaningo. Yonke imiphumela ingatholakala
esifinyezweni semiphumela yezempilo.

Amasosha omzimba e-RSV komama Amazinga azo zombili izinhlobo zamasosha

omzimba anyuswa komama abagonyiwe.
nezingane
Amasosha omzimba adluliselwa ngempumelelo
esuka komama aya kuzo zonke izingane.
Kwahlolwa amazinga aphakathi ezinhlobo
ezimbili ezihlukene zamasosha omzimba e-RSV
komama abakhulelwe nezingane.

Yayiyini imiphumela engemihle?

Izehlakalo zezokwelapha ezingafuneki (izehlakalo
ezibucayi) zingenzeka kubantu lapho bethola
umgomo. Odokotela bocwaningo bayaziqopha
lezi zehlakalo. Isifinyezo sazo zonke izehlakalo
ingatholakala esifinyezweni semiphumela
yezempilo.
Uma udokotela wocwaningo ecabanga ukuthi
isehlakalo sidalwe wumgomo, urekhoda lokhu
njengokungase kube wumphumela wokusabela
obucayi).
Kulesi sifinyezo, "imiphumela engemihle*"
ibhekisa kulezo zehlakalo udokotela wocwaningo
acabanga ukuthi kungenzeka ukuthi zidalwe
wumgomo wocwaningo.
Akekho umbambiqhaza owahoxa ocwaningweni
ngenxa yemiphumela engemihle yomgomo.
Ubuhlungu endaweni ejoviwe yimiphumela
emibi eyabikwa kaningi ngomama abakhulelwe
ezinsukwini zokuqala ezingu-7 ngemva
kokugoma (Umfanekiso 2a).
Omama abakhulelwe babika ubuhlungu
bomphimbo njengesehlakalo sezokwelapha
esenzeka kakhulu phakathi nenyanga eyodwa
ngemva komgomo we-RSV (Umfanekiso 2b).
Izehlakalo zezokwelapha ezibucayi kufika emavikini
angu-6 ngemva kokubeletha zabikwa ngu-:
• 30% womama abakhulelwe eqenjini le-RSV 60,
• 27% womama abakhulelwe eqenjini
le-RSV 120, kanye no-
• 22% womama abakhulelwe eqenjini
Lokulawula.
Izehlakalo zezokwelapha ezibucayi kufika
enyakeni owodwa ngemva kokubeletha
zabikelwa u-:
• 25% wezingane eziseqenjini le-RSV 60,
• 29% wezingane eziseqenjini le-RSV 120,
kanye no-
• 32% wezingane eziseqenjini Lokulawula.
Azikho izehlakalo ezibucayi zezokwelapha
ezithathwe njengezidalwa umgomo wocwaningo.
Lolu cwaningo aluzange luveze ukukhathazeka
ngokuphepha ngomgomo we-RSV. Imiphumela
emibi ebikwe kulolu cwaningo iwukusabela
okulindelekile emuthini wokugoma we-RSV.
Imiphumela yokuphepha eyengeziwe
ingatholakala esifinyezweni semiphumela
yezempilo.
Umfanekiso 2a: Imiphumela emibi ebikwe omama phakathi nezinsuku ezingu-7 ngemva kokugoma

Umfanekiso 2b: Izehlakalo zezokwelapha ezabikwa omama kungakapheli inyanga eyodwa bagonywa

Lolu cwaningo luzisize kanjani iziguli nabacwaningi?

Imiphumela yalolu cwaningo ikhombisa ukuthi
amasosha omzimba akhiqizwa womama ngemva
kokugonywa ngomgomo we-RSV. Lamasosha
omzimba adluliselwa ngempumelelo esuka
komama eya ezinganeni zabo. Lolu cwaningo
aluzange luveze ukukhathazeka ngokuphepha
ngomgomo we-RSV.
Lesi sifinyezo sibonisa imiphumela yocwaningo
olulodwa kuphela. Ezinye izingcwaningo
zingathola imiphumela ehlukile. Kuhlanganiswe
nemiphumela evela kwezinye izingcwaningo
zokuphenya, okutholwe kulolu cwaningo
kungasiza ekuthuthukiseni ukuqonda komgomo
we-RSV kanye nokutheleleka kwe-RSV.
Ingabe zikhona izinhlelo zokuqhubeka nezingcwaningo?
Ngesikhathi sokulungiselela lesi sifinyezo, ezinye e-European Medicines Agency kanye/noma
izingcwaningo beziqhubeka ukuze kuqhutshekwe e-United States National Institutes of Health.
nokuhlola umgomo we-RSV. Amalinki anikezwe ekugcineni kwedokhumenti.
Imiphumela yanoma yiziphi izingcwaningo
zesikhathi esizayo izotholakala kumawebhusayithi

Ngingalutholaphi ulwazi olwengeziwe mayelana nalolu cwaningo?

Isihloko esinemininingwane yalolu cwaningo lokuhlola sithi:
Ucwaningo lweSigaba II, olungahleliwe, olungakhethi, lapho umcwaningo engazi ukuthi unikeze muphi
umuthi, olulawulwa ngumuthi mbumbulu lwamazwe amaningi ukuze kuhlolwe ukuphepha, ukuphendula
kanye nokuvikeleka komthamo owodwa womgomo osaphenywayo onikezwa ngokufakwa emsipheni
we-GSK komama (GSK3888550A), kwabesifazane abanempilo abakhulelwe abaneminyaka engu-18 kuya
ku-40 iminyaka kanye nezinsana ezizalwa omama abagonyiwe.
Izingcwaningo zezempilo zinezinombolo zocwaningo eziyingqayizivele. Ngezansi yizinombolo zocwaningo
ezihlukile ezihlotshaniswa nalolu cwaningo.

Isikhungo Iwebhusayithi Inombolo Yocwaningo

I-European Medicines Agency www.clinicaltrialsregister.eu 2019-001991-12

United States National Institutes www.clinicaltrials.gov NCT04126213

of Health (NIH)

Udokotela wakho angakusiza uqonde kabanzi mayelana nalolu cwaningo kanye nemiphumela.
Akufanele wenze izinguquko ekunakekelweni kwakho ngokusekelwe emiphumeleni yalokhu nanoma
yiluphi ucwaningo olulodwa.

Inguqulo 1.1 yale dokhumenti yathuthukiswa futhi yagunyazwa yi-GSK ngomhla ka-2 Disemba 2021.
Imininingwane ekulesi sifinyezo ayifaki ulwazi olwengeziwe olutholakala ngemva kwalolu suku.
Ukusetshenziswa kwedatha nolwazi oluqukethwe kule dokhumenti akunamingcele, inqobo nje uma kungeke kusetshenziswe
ezicelweni zabanye zokugunyazwa komkhiqizo ngokusemthethweni. Nakuba kungadingekile, lapho sisebenzisa le datha, sicela
ukuthi ikhredithi efanele noma ukuchasiswa kwe-GSK njengomthombo wedatha inikezwe. I-GSK iyasilahla isibopho sakho
konke ukusetshenziswa kwedatha ngabasebenzisi bale dokhumenti, ngokwezinga eligcwele elivunyelwe umthetho
osebenzayo. Alukho uphawu lokuhweba, ilungelo lobunikazi, noma amalungelo okulawula/ukuhluka kwedatha aphethwe
yi-GSK ayekwa, anelayisensi noma athintekayo.

Le dokhumenti ikunikeza isifinyezo esifushane salolu cwaningo sezithameli ezivamile. Ungathola ulwazi olwengeziwe
ezifingqweni zesayensi zocwaningo. Amalinki alezo zifinyezo anikezwe ngezansi.
Kubafundi bale dokhumenti ngendlela yombhalo, amawebhusayithi ahlotshaniswa namalinki
yilawa:
Isifinyezo se-EudraCT:
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-001991-12US
NIH/clinicaltrials.gov:
https://clinicaltrials.gov/ct2/show/NCT04126213?term=209544&cond=RSV&draw=2&rank=1