- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04700618
A Clinical Trial to Evaluate the Safety and Immunogenicity of PPV23 Vaccine Revaccinated in 60-70 Years Old
A Phase Ⅳ Clinical Trial to Evaluate the Safety and Immunogenicity of 23 Valent Pneumococcal Polysaccharide Vaccine Revaccinated in 60-70 Years Old in Shanghai
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
- Antibody double growth rate in 28-40 days after immunization;
- Antibody GMC level in 28-40days after immunization;
- Incidence of adverse reactions in 0-30days.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
-
-
Shanghai
-
Shanghai, Shanghai, Kina
- Shanghai Municipal Center for Disease Control and Prevention
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- The age was 60-70 years old on the day of enrollment;
- The subjects have signed the informed consent and signed the date;
- The subjects are able to participate in all planned follow-up visits and were able to follow all trial procedures (e.g. complete diary card / contact card, return to visit);
- The subjects in the study group had been vaccinated with 23 valent pneumococcal polysaccharide vaccine made in China for more than 5 years;
- The control group had never been vaccinated with any pneumococcal vaccine; 6.Axillary temperature ≤37.0℃.
Exclusion Criteria:
- With a medical history with hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness;
- Allergic to any ingredient of vaccine or with allergy history to any vaccine; 3.Subjects with immunodeficency or suspected impairment of immunologic function (e.g. caused by HIV), or subjects are in the process of immunosuppressor therapy(Taking orally injecting of steroid hormone);
4.Administration of immunoglobulins within 30 days prior to this study; 5.Acute febrile disease(temperature ≥ 37.0°C) or infectious disease; 6.With a clearly diagnosed history of thrombocytopenia or other coagulopathy, may cause contraindications for subcutaneous injection; 7.With any serious chronic illness, acute infectious diseases, or respiratory diseases; 8.Suffering from serious cardiovascular diseases (pulmonary heart disease, pulmonary edema, hypertension can not be controlled to normal by drugs), liver and kidney diseases, diabetes with complications; 9.With any kind of infectious, purulent, or allergic skin diseases; 10.With any other factor that makes the investigator determines the subject is unsuitable for this study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Studiegruppe
Forsøgspersonerne i undersøgelsesgruppen var blevet vaccineret med 23 valent pneumokok polysaccharidvaccine fremstillet i Kina i mere end 5 år.
|
The study group and the control group were vaccinated with one dose of vaccine and blood was collected after 28-40 days.
|
Placebo komparator: Kontrolgruppe
Kontrolgruppen var aldrig blevet vaccineret med nogen pneumokokvaccine.
|
The study group and the control group were vaccinated with one dose of vaccine and blood was collected after 28-40 days.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Antibody doubling rate
Tidsramme: The blood collection time was 28-40 days after vaccination.
|
The difference of serum antibody double growth level between the two groups was compared.
|
The blood collection time was 28-40 days after vaccination.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Forekomst af bivirkninger
Tidsramme: Inden for 30 dage efter vaccination.
|
Bivirkninger blev indsamlet i løbet af observationsperioden.
|
Inden for 30 dage efter vaccination.
|
Antibody GMC level
Tidsramme: The blood collection time was 28-40 days after vaccination.
|
The difference of serum antibody GMC level between the two groups was compared.
|
The blood collection time was 28-40 days after vaccination.
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studiestol: Xiang Guo, Shanghai Municipal Center for Disease Control and Prevention
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PPV23-2021-2
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Vaccination
-
National Cancer Institute (NCI)AfsluttetHPV16-anitbody-niveauer efter vaccination | HPV18-antistofniveauer efter vaccinationUganda
-
Université de Reims Champagne-ArdenneRekruttering
-
China National Biotec Group Company LimitedPeking University; Beijing Institute of Biological Products Co Ltd.; Sichuan... og andre samarbejdspartnereAfsluttet
-
China National Biotec Group Company LimitedSichuan Center for Disease Control and PreventionAfsluttet
-
Emory UniversityMerck Sharp & Dohme LLCAfsluttetVaccinationForenede Stater
-
Columbia UniversityAfsluttet
-
Indiana UniversityNational Center for Advancing Translational Sciences (NCATS)Rekruttering
-
Columbia UniversitySeattle Children's Hospital; New York Presbyterian Hospital; Agency for Healthcare...Afsluttet
-
China National Biotec Group Company LimitedBeijing Institute of Biological Products Co Ltd.; Wuhan Institute of Biological... og andre samarbejdspartnereUkendt
-
Johns Hopkins UniversityNational Institute for Biomedical Imaging and Bioengineering (NIBIB); St... og andre samarbejdspartnereAfsluttet
Kliniske forsøg med 23-valent pneumococcal polysaccharide vaccine
-
Emory UniversityNational Institute of Allergy and Infectious Diseases (NIAID)Afsluttet
-
Cedars-Sinai Medical CenterAfsluttetCrohns sygdom | Colitis ulcerosa | Inflammatorisk tarmsygdomForenede Stater
-
Canadian Immunization Research NetworkAfsluttet
-
GlaxoSmithKlineAfsluttetHerpes zoster | Herpes zoster vaccineForenede Stater, Estland, Canada
-
Sinovac Biotech Co., LtdAfsluttet
-
Sinovac Biotech Co., LtdAfsluttet
-
CanSino Biologics Inc.Henan Center for Disease Control and PreventionAfsluttetPneumokokinfektioner | Bakterielle infektioner | StreptokokinfektionerKina
-
Beijing Zhifei Lvzhu Biopharmaceutical Co., LtdAktiv, ikke rekrutterende
-
Sinovac Biotech Co., LtdAfsluttet
-
CanSino Biologics Inc.Henan Center for Disease Control and PreventionAfsluttetPneumokokinfektioner | Bakterielle infektioner | StreptokokinfektionerKina