Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' IPV Vaccine (PoliorixTM) in Toddlers
20. desember 2017 oppdatert 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
26
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Guangxi
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Wuzhou, Guangxi, Kina, 543002
- GSK Investigational Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
1 år til 2 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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).
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Single dose, intramuscular administration.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Tidsramme: During the 4-day (Days 0-3) post-vaccination period
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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.
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During the 4-day (Days 0-3) post-vaccination period
|
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Tidsramme: 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.
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During the 4-day (Days 0-3) post-vaccination period
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Tidsramme: During the 31-day (Days 0-30) post-vaccination period
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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.
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During the 31-day (Days 0-30) post-vaccination period
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Number of Subjects With Serious Adverse Events (SAEs)
Tidsramme: During the entire study period (from Day 0 to Month 1)
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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.
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During the entire study period (from Day 0 to Month 1)
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2009
Primær fullføring (Faktiske)
3. august 2009
Studiet fullført (Faktiske)
3. august 2009
Datoer for studieregistrering
Først innsendt
12. juni 2009
Først innsendt som oppfylte QC-kriteriene
12. juni 2009
Først lagt ut (Anslag)
15. juni 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. januar 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. desember 2017
Sist bekreftet
1. mai 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 112683
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Ja
IPD-planbeskrivelse
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiedata/dokumenter
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Klinisk studierapport
Informasjonsidentifikator: 112683Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datasett for individuell deltaker
Informasjonsidentifikator: 112683Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Skjema for informert samtykke
Informasjonsidentifikator: 112683Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Statistisk analyseplan
Informasjonsidentifikator: 112683Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokoll
Informasjonsidentifikator: 112683Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datasettspesifikasjon
Informasjonsidentifikator: 112683Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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