Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children
13 mars 2019 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
184
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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-
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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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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
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
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: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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.
|
At 2, 3, 4, 5, 6 years after booster vaccination.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
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
Tidsram: 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
Tidsram: 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
Tidsram: 48 months after booster Vaccination
|
Serogroups included MenA, MenC, MenW-135 and MenY.
|
48 months after booster Vaccination
|
|
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 60 Months After Booster Vaccination
Tidsram: 60 months after booster Vaccination
|
Serogroups included MenA, MenC, MenW-135 and MenY.
|
60 months after booster Vaccination
|
|
Percentage of Participants With rSBA-Antibody Titers >=1:8 For Each of the 4 Serogroups at 72 Months After Booster Vaccination
Tidsram: 72 months after booster Vaccination
|
Serogroups included MenA, MenC, MenW-135 and MenY.
|
72 months after booster Vaccination
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants With Serum Bactericidal Assay Using rSBA-Antibody Titers >=1:128 for Each of the 4 Serogroups
Tidsram: 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 rSBA Geometric Mean Titers (GMTs) for Each of the 4 Serogroups
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
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Användbara länkar
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 juli 2013
Primärt slutförande (Faktisk)
1 november 2017
Avslutad studie (Faktisk)
1 november 2017
Studieregistreringsdatum
Först inskickad
27 juni 2013
Först inskickad som uppfyllde QC-kriterierna
12 juli 2013
Första postat (Uppskatta)
17 juli 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juni 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 mars 2019
Senast verifierad
1 mars 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MENACWY-TT-102
- C0921001 (Annan identifierare: Alias Study Number)
- 2012-005816-25 (EudraCT-nummer)
- 200088 (Alias Study Number)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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