Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' IPV Vaccine (PoliorixTM) in Toddlers
20 december 2017 uppdaterad av: GlaxoSmithKline
An Open-label Study to Assess the Safety and Reactogenicity of GlaxoSmithKline Biologicals' Inactivated Poliomyelitis Vaccine Poliorix Administered as a Booster Dose at 18-24 Months of Age in Healthy Toddlers in China.
The study will evaluate the safety and reactogenicity of PoliorixTM given as a single booster dose to Chinese children at 18-24 months of age.
Studieöversikt
Studietyp
Interventionell
Inskrivning (Faktisk)
26
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Guangxi
-
Wuzhou, Guangxi, Kina, 543002
- GSK Investigational Site
-
-
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
1 år till 2 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- A male or female toddler between, and including, 18 and 24 months of age at the time of the booster vaccination.
- Subjects who received three doses of OPV as primary vaccination in the first year of life as per Chinese recommendations.
- Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with exception of DTP and/or Hib vaccine(s).
- Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination, or planned administration during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
- Previous booster vaccination against poliomyelitis since the end of the primary vaccination series.
- History of poliomyelitis disease.
- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Major congenital defects or serious chronic illness.
The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
• Current febrile illness or axillary temperature > 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
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: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: POLIORIX GROUP
Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix™ vaccine that was administrated into the upper right thigh by intramuscular injection (IM).
|
Single dose, intramuscular administration.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Tidsram: During the 4-day (Days 0-3) post-vaccination period
|
Assessed solicited local symptoms were pain, redness and swelling.
Any = all reports of the specified symptom irrespective of intensity grade.
Grade 3 pain = cried when limb was moved/spontaneously painful.
Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
|
During the 4-day (Days 0-3) post-vaccination period
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Tidsram: During the 4-day (Days 0-3) post-vaccination period
|
Assessed solicited general symptoms were temperature [defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)], drowsiness, irritability and loss of appetite.
Any = all reports of the specified symptom irrespective of intensity grade and relationship to vaccination.
Grade 3 drowsiness= drowsiness that prevented normal activity.
Grade 3 irritability= crying that could not be comforted/ prevented normal activity.
Grade 3 loss of appetite= subject did not eat at all.
Grade 3 fever = fever above (>) 39.0 °C.
Related = symptom assessed by the investigator as related to the vaccination.
|
During the 4-day (Days 0-3) post-vaccination period
|
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Tidsram: During the 31-day (Days 0-30) post-vaccination period
|
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Grade 3 AE = an AE which prevented normal, everyday activities.
Related = AE assessed by the investigator as related to the vaccination.
|
During the 31-day (Days 0-30) post-vaccination period
|
|
Number of Subjects With Serious Adverse Events (SAEs)
Tidsram: During the entire study period (from Day 0 to Month 1)
|
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
|
During the entire study period (from Day 0 to Month 1)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
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 (Faktisk)
1 juni 2009
Primärt slutförande (Faktisk)
3 augusti 2009
Avslutad studie (Faktisk)
3 augusti 2009
Studieregistreringsdatum
Först inskickad
12 juni 2009
Först inskickad som uppfyllde QC-kriterierna
12 juni 2009
Första postat (Uppskatta)
15 juni 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 januari 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 december 2017
Senast verifierad
1 maj 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 112683
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Ja
IPD-planbeskrivning
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokument
-
Klinisk studierapport
Informationsidentifierare: 112683Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Datauppsättning för individuella deltagare
Informationsidentifierare: 112683Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Informerat samtycke
Informationsidentifierare: 112683Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistisk analysplan
Informationsidentifierare: 112683Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Studieprotokoll
Informationsidentifierare: 112683Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
-
Datauppsättningsspecifikation
Informationsidentifierare: 112683Informationskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
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 .