Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children
13. mars 2019 oppdatert av: Pfizer
A PHASE III, OPEN, MULTI-CENTRE, CONTROLLED STUDY TO EVALUATE THE LONG-TERM ANTIBODY PERSISTENCE AT 2, 3, 4, 5 AND 6 YEARS AFTER A BOOSTER DOSE OF MENINGOCOCCAL SEROGROUP A, C, W-135, Y- TETANUS TOXOID CONJUGATE VACCINE (MENACWY-TT) OR MENINGITEC (REGISTERED) ADMINISTERED IN HEALTHY 5-YEAR-OLD CHILDREN IN STUDY MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), WHO WERE PRIMED WITH THE SAME VACCINE IN STUDY MENACWY-TT-039 (109670) AT 12 THROUGH 23 MONTHS OF AGE.
The purpose of this study is to evaluate the long-term antibody persistence as well as safety of GSK Biologicals' MenACWY-TT vaccine versus Meningitec up to 6 years after booster vaccination administered in healthy 5 year old children in the study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (NCT00955682), who were primed with the same vaccine in the study MENACWY-TT-039 (NCT00474266) at 12 through 23 months of age.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The subjects in this study will be allocated to the same groups as in study MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (NCT00955682).
No vaccine will be administered during this long-term persistence study.
Studietype
Intervensjonell
Registrering (Faktiske)
184
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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Espoo, Finland, 02230
- Espoo Vaccine Research Clinic
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Helsinki, Finland, 00930
- Helsinki East Vaccine Research Clinic
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Helsinki, Finland, 00100
- Tampereen yliopisto/ Etela-Helsingin rokotetutkimusklinikka
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Jarvenpaa, Finland, 60100
- Tampereen Yliopisto/ Jarvenpaan rokotetutkimusklinikka
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Oulu, Finland, 90220
- Tampereen yliopisto/ Oulun rokotetutkimusklinikka
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Pori, Finland, 28100
- Tampereen yliopisto/ Porin rokotetutkimusklinikka
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Seinajoki, Finland, 60100
- Seinäjoki Vaccine Research Clinic
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Tampere, Finland, 33100
- Tampere Vaccine Research Clinic
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Turku, Finland, 20520
- Tampereen yliopisto/ Turun rokotetutkimusklinikka
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Vantaa, Finland, 01300
- Tampereen yliopisto/ Ita-Vantaan rokotetutkimusklinikka
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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
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
All subjects must satisfy ALL the following criteria at study entry:
- Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- A male or female who has received primary and booster vaccination with the MenACWY-TT or Meningitec vaccines in studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036), respectively.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- Child in care.
- History of meningococcal disease.
- Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine outside of studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039 Y2, 3, 4, 5 (112036).
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
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: Randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: ACWY-TT group
Subjects primed and boosted with the MenACWY-TT vaccine.
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At 2, 3, 4, 5, 6 years after booster vaccination.
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Aktiv komparator: MenCCRM group
Subjects primed and boosted with the Meningitec vaccine.
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At 2, 3, 4, 5, 6 years after booster vaccination.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants With rSBA-Antibody Titers Greater Than or Equal to (>=) 1:8 For Each of the 4 Serogroups at 24 Months After Booster Vaccination
Tidsramme: 24 months after booster Vaccination
|
Serogroups included MenA, MenC, MenW-135 and MenY.
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24 months after booster Vaccination
|
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Percentage of Participants With rSBA-Antibody Titers >= 1:8 For Each of the 4 Serogroups at 36 Months After Booster Vaccination
Tidsramme: 36 months after booster Vaccination
|
Serogroups included MenA, MenC, MenW-135 and MenY.
|
36 months after booster Vaccination
|
|
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 48 Months After Booster Vaccination
Tidsramme: 48 months after booster Vaccination
|
Serogroups included MenA, MenC, MenW-135 and MenY.
|
48 months after booster Vaccination
|
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Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination
Tidsramme: 60 months after booster Vaccination
|
Serogroups included MenA, MenC, MenW-135 and MenY.
|
60 months after booster Vaccination
|
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Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination
Tidsramme: 72 months after booster Vaccination
|
Serogroups included MenA, MenC, MenW-135 and MenY.
|
72 months after booster Vaccination
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Tidsramme: 24, 36, 48, 60 and 72 months after booster Vaccination
|
Serogroups included MenA, MenC, MenW-135 and MenY.
|
24, 36, 48, 60 and 72 months after booster Vaccination
|
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Serum Bactericidal Assay Using rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Tidsramme: 24, 36, 48, 60 and 72 months after booster Vaccination
|
Serogroups included MenA, MenC, MenW-135 and MenY.
|
24, 36, 48, 60 and 72 months after booster Vaccination
|
|
Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)
Tidsramme: Baseline up to the Month 72 after booster vaccination (up to 6 years)
|
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between first dose of study drug and up to 72 months after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.
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Baseline up to the Month 72 after booster vaccination (up to 6 years)
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Percentage of Participants With Serum Bactericidal Assay Using hSBA-Antibody Titers >=1:4 and >=1:8 for Each of the 4 Serogroups
Tidsramme: 24, 36, 48, 60 and 72 months after booster Vaccination
|
Serogroups included MenA, MenC, MenW-135 and MenY.
|
24, 36, 48, 60 and 72 months after booster Vaccination
|
|
Serum Bactericidal Assay Using hSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Tidsramme: 24, 36, 48, 60 and 72 months after booster Vaccination
|
Serogroups included MenA, MenC, MenW-135 and MenY.
|
24, 36, 48, 60 and 72 months after booster Vaccination
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
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Hjelpsomme linker
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. juli 2013
Primær fullføring (Faktiske)
1. november 2017
Studiet fullført (Faktiske)
1. november 2017
Datoer for studieregistrering
Først innsendt
27. juni 2013
Først innsendt som oppfylte QC-kriteriene
12. juli 2013
Først lagt ut (Anslag)
17. juli 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. juni 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
13. mars 2019
Sist bekreftet
1. mars 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MENACWY-TT-102
- C0921001 (Annen identifikator: Alias Study Number)
- 2012-005816-25 (EudraCT-nummer)
- 200088 (Alias Study Number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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