- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02867319
Safety Study of ACYW135 Meningococcal Polysaccharide Vaccine Aged 2-50 Years Old
15 augusti 2016 uppdaterad av: Beijing Chaoyang District Centre for Disease Control and Prevention
This phase I clinical study evaluates the safety of ACYW135 meningococcal polysaccharide vaccine in population aged 2-6, 7-17, 18-50 years old by the method of both passive and active surveillance.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
60
Fas
- Fas 1
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
2 år till 50 år (Barn, Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- With the subject (or his guardian's) informed consent and signed the informed consent;
- The history, physical examination and clinical judgement were determined to be healthy and in accordance with the vaccination age of the product;
- The Subject or his guardian could comply with the clinical study protocol;
- Have not been inoculated with Meningococcal vaccine in the past six months and A + C meningococcal polysaccharide vaccine in the past two years;
- Have not been inoculated with other preventive biological products;
- Axillary temperature≤37.0 ℃.
Exclusion Criteria:
- Children with the history of Neisseria meningitis;
- Had allergies or serious adverse reactions of previous vaccination, such as allergies, urticaria, dyspnea, edema, abdominal pain, etc;
- Had immune inhibitor therapy and cytotoxic therapy, inhaled corticosteroids in the past 6 months (not including allergic rhinitis corticosteroid aerosol therapy, patients with acute non concurrent dermatitis surface corticosteroid therapy);
- Have been accepted blood products in the past 3 months;
- Have been inoculated with other research drugs or vaccines in the past month;
- Have been inoculated with attenuated live vaccine in the past 14 days;
- Have been inoculated with subunit or inactivated vaccine in the past 7 days;
- Had any acute illness, the need for systemic application of antibiotics or antiviral treatment in the past 7 days;
- Had fever in the past 3 days (axillary temperature≥38.0℃) ;
- Have been diagnosed with abnormal coagulation function (such as the lack of coagulation factors, coagulation disorders and abnormal blood platelet), obvious bruises or coagulation disorders by physician diagnosis;
- Had the history of thyroid resection or the need for treatment of thyroid diseases in the past 12 months;
- Asplenia, functional asplenia and asplenia or splenectomy of any situation;
- Had epilepsy, convulsions, encephalopathy, mental illness or family history;
- Suffering from serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia, neurological disorders or Guillain-Barre syndrome);
- Suffering from known or suspected concurrent diseases including: respiratory diseases, acute or chronic infection of the activities, children's mother or the subject had HIV infection, cardiovascular disease, high blood pressure, during cancer treatment period, skin diseases;
- The female during her pregnant and lactation period or who plan to become pregnant during the trial.
- The subject of any other factors that are not suitable to participate in clinical trials according to the researcher's judgment.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: age of 18-50 years old
|
A dose of ACYW135 meningococcal polysaccharide vaccine will be given in certain arm.
|
|
Experimentell: age of 7-17 years old
|
A dose of ACYW135 meningococcal polysaccharide vaccine will be given in certain arm.
|
|
Experimentell: age of 2-6 years old
|
A dose of ACYW135 meningococcal polysaccharide vaccine will be given in certain arm.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The rate of adverse reactions of ACYW135 meningococcal polysaccharide vaccine
Tidsram: 28 days
|
Adverse reactions associated with vaccine will be observed in subjects after each vaccination.
Solicited local adverse events include Pain, Redness, Swelling, Induration, Rash, Pruritus at injection site.
solicited general adverse events include Fever, Nausea, Vomiting, Diarrhea, Decreased appetite, Be agitated (irritability, abnormal crying), fatigue, allergy
|
28 days
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2016
Primärt slutförande (Faktisk)
1 juli 2016
Studieregistreringsdatum
Först inskickad
11 augusti 2016
Först inskickad som uppfyllde QC-kriterierna
11 augusti 2016
Första postat (Uppskatta)
15 augusti 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
16 augusti 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
15 augusti 2016
Senast verifierad
1 augusti 2016
Mer information
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .