Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.
26. april 2018 opdateret af: GlaxoSmithKline
Phase IIIb, Multicentre Study to Assess Safety & Immunogenicity of GSK Biologicals' Combined DTPa/Hib (Infanrix/Hib) Vaccine vs Separate Administration of DTPa (Infanrix) & Hib (Hiberix) Vaccines in Healthy Infants 3,4,&5 Months of Age as Compared With the Separate Administration of DTPa and Hib Vaccines at Different Injection Sites.
This study will compare GSK Biologicals' DTPa/Hib vaccine to separately administered DTPa and Hib vaccines in Chinese infants 3, 4 & 5 months of age, in terms of safety and immunogenicity.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
660
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Mengshan, Kina
- GSK Investigational Site
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Wuzhou, Kina
- GSK Investigational Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
2 måneder til 3 måneder (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- A male or female between, and including, 90 and 120 days of age at the time of the first vaccination,
- written informed consent obtained from the parent or guardian of the subject
Exclusion Criteria:
- Subjects with known exposure to diphtheria, tetanus, pertussis and/or Haemophilus influenzae disease can not participate,
- Subjects who have received previous vaccination against diphtheria, tetanus, acellular pertussis and/or Haemophilus influenzae type b diseases can not participate.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Seroprotected Subjects Against Diphteria Toxoid (D) and Tetanus Toxoid (T)
Tidsramme: At Month 3
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A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations higher than or equal to (≥) 0.1 international units per milliliter (IU/mL).
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At Month 3
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Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP)
Tidsramme: At Month 3
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A seroprotected subject was defined as a vaccinated subject with an anti-PRP antibody concentration higher than or equal to (≥) 0.15 microgram/milliliter (µg/mL).
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At Month 3
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Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies
Tidsramme: At Month 3
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The vaccine response was defined as it follows:
|
At Month 3
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Subjects With Anti-PRP Antibody Concentrations ≥ 1.0 µg/mL
Tidsramme: At Month 3
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The number of subjects with anti-PRP antibody concentrations higher than or equal to (≥) 1.0 µg/mL post primary vaccination is reported.
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At Month 3
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Concentrations for Anti-D and Anti-T Antibodies
Tidsramme: At Month 0 and Month 3
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Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International units per milliliter (IU/mL).
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At Month 0 and Month 3
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Concentrations for Anti-PRP Antibodies
Tidsramme: At Month 0 and Month 3
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Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram/milliliter (µg/mL).
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At Month 0 and Month 3
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Concentrations for Anti-PT, Anti-FHA and Anti-PRN Antibodies
Tidsramme: At Month 3
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Anti-PT, anti-FHA and anti-PRN antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
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At Month 3
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Tidsramme: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses
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Assessed solicited local symptoms were pain, redness and swelling.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = pain that prevented normal activity.
Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
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During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Tidsramme: During the 4-day (Day 0-3) follow-up period after each vaccine dose and across doses
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Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)], irritability and loss of appetite.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
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 (Day 0-3) follow-up period after each vaccine dose and across doses
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Number of Subjects With Unsolicited Adverse Events (AEs)
Tidsramme: During the 31-day (Day 0-30) follow-up period after each vaccination
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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.
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During the 31-day (Day 0-30) follow-up period after each vaccination
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Number of Subjects With Serious Adverse Events (SAEs)
Tidsramme: From receipt of first dose of study vaccine (Day 0) to study end (Month 3)
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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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From receipt of first dose of study vaccine (Day 0) to study end (Month 3)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
3. januar 2007
Primær færdiggørelse (Faktiske)
1. juni 2007
Studieafslutning (Faktiske)
25. juni 2007
Datoer for studieregistrering
Først indsendt
18. december 2006
Først indsendt, der opfyldte QC-kriterier
18. december 2006
Først opslået (Skøn)
19. december 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. juni 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. april 2018
Sidst verificeret
1. december 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 104567
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (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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Statistisk analyseplan
Informations-id: 104567Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisk undersøgelsesrapport
Informations-id: 104567Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Individuelt deltagerdatasæt
Informations-id: 104567Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datasætspecifikation
Informations-id: 104567Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Formular til informeret samtykke
Informations-id: 104567Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokol
Informations-id: 104567Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Annoteret sagsbetænkningsformular
Informations-id: 104567Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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 .