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Evaluation of Antibody Persistence Following 4 MenACWY Vaccinations

13. Juni 2019 aktualisiert von: GlaxoSmithKline

A Phase IV, Open-Label, Multi-Center Study to Evaluate the Safety and the 1-year Persistence of Antibody Response Among Children Who Received 4 Doses of the GSK MenACWY Conjugate Vaccine at 2, 4, 6 and 12 Months of Age in South Korea

This is Phase IV, Open label, Multicenter study. Subject's parents and/or legal guardian will be provided information about the trial. If interested and if eligible, they will then be asked to provide signed informed consent. The initial study visit can occur immediately after signed informed consent has been obtained. Approximately 135 subjects will be enrolled to receive 4 doses of intramuscular MenACWY vaccine at 2, 4, 6 and 12 months of age.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

128

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Korea, Republik von
      • Ansan si, Korea, Republik von, 425 707
        • GSK Investigational Site
      • Incheon, Korea, Republik von, 400 711
        • GSK Investigational Site
      • Jeonju, Korea, Republik von, 561 712
        • GSK Investigational Site
      • Seongnam si, Korea, Republik von, 463 707
        • GSK Investigational Site
      • Seoul, Korea, Republik von, 110 744
        • GSK Investigational Site
      • Seoul, Korea, Republik von, 158 710
        • GSK Investigational Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

2 Monate bis 2 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  1. Healthy male and female 2 month-old infants (55 - 89 days) on the day of consent.
  2. Infants whose parents or legal guardians have voluntary given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
  3. Infants whose parents or legal guardians can comply with study procedures including follow-up

Exclusion Criteria:

  1. Previously received any meningococcal A, C, W and Y vaccines.
  2. Previous confirmed or suspected disease caused by N. meningitidis or who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection at any time since birth.
  3. Progressive, unstable or uncontrolled clinical conditions.
  4. A history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component, such as latex allergy.
  5. Experienced significant acute or chronic infection within the previous 7 days or have experienced fever (temperature ≥ 38.0°C [100.4°F]) within the previous 3 days.
  6. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  7. Received treatment with systemic administration corticosteroids (PO/IV/IM) for more than 14 consecutive days from birth
  8. Ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin) at any time since birth and for the full length of the study.
  9. Any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw.
  10. Any condition which, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
  11. Received or are planning to receive any investigational or non-registered medicinal product from birth and throughout the study.
  12. Received oral or parenteral antibiotic treatment in the 3 days prior to the scheduled blood draw (topical antibiotics are acceptable, including antibiotic eye drops).
  13. Relatives of site research staff working on this study.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: MenACWY Group
Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who will receive 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly at 2,4,6 ad 12 months of age.
Biologisch: MenACWY
Four Intramuscular doses of MenACWY vaccine at 2, 4, 6 and 12 months of age followed by two blood samples at 13 and 24 months of age.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination.
Zeitfenster: Within 30 minutes of each vaccination
Solicited signs and symptoms occurring within 30 minutes following each vaccination, include solicited local events (e.g. injection site erythema, induration and tenderness -threshold for Erythema and Induration: Type II- None [<10mm], Any[>=10 mm]), solicited systemic events (e.g. change in eating habits, sleepiness, irritability, vomiting, diarrhea, fever[ body temperature >=38°C measured preferably via tympanic route]), and any other solicited event like use of analgesic/antipyretics for treatment or for prophylaxis
Within 30 minutes of each vaccination
Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination
Zeitfenster: From Day 1 to Day 7 after each vaccination
Solicited local AEs reported from day 1 to day 7 after each vaccination were assessed. Assessed local symptoms include injection site erythema, injection site induration and injection site tenderness. Any = incidence of a particular symptom regardless of intensity grade.Threshold for Erythema and Induration: Type II None (<10 mm), Any (>=10 mm)
From Day 1 to Day 7 after each vaccination
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination.
Zeitfenster: From Day 1 to Day 7 after each vaccination
Solicited systemic AEs reported from day 1 to day 7 after each vaccination were assessed. Assessed systemic symptoms include change in eating habits, sleepiness, irritability, vomiting, diarrhea and fever (body temperature ≥ 38°C (100.4°F)).
From Day 1 to Day 7 after each vaccination
Number of Subjects With Any Medically Attended Unsolicited AEs and AEs Leading to Premature Withdrawal
Zeitfenster: From Day 1 to Visit 6 (at 24 Months of age)
An unsolicited adverse event is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject parent(s)/legal guardian(s)] who has signed the informed consent. All medically attended unsolicited AEs were collected from Day 1 to Visit 6.
From Day 1 to Visit 6 (at 24 Months of age)
Number of Subjects With Serious AEs (SAEs)
Zeitfenster: From Day 1 to Visit 6 (At 24 months of age)
Subjects reporting SAEs from day 1 to visit 6 (at 24 months of age) were assessed. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in one or more of the following: death, is life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.
From Day 1 to Visit 6 (At 24 months of age)
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 8 Against Each N.Meningitidis Serogroup A,C,W and Y at 24 Months of Age.
Zeitfenster: At 24 months of age (Visit 6)
To assess antibody persistence against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using human serum complement.
At 24 months of age (Visit 6)
Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 8, Against Each N.Meningitidis Serogroup at 24 Months of Age
Zeitfenster: At 24 months of age (Visit 6)
To assess antibody persistence against N. Meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement
At 24 months of age (Visit 6)
Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 128 Against Each N.Meningitidis Serogroup at 24 Months of Age
Zeitfenster: At 24 months of age (Visit 6)
To assess antibody persistence against N. Meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement
At 24 months of age (Visit 6)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Subjects With hSBA ≥8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age
Zeitfenster: At 13 months of age (Visit 5)
To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using human serum complement.
At 13 months of age (Visit 5)
Percentage of Subjects With rSBA Titers ≥ 8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age
Zeitfenster: At 13 months of age (Visit 5)
To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement.
At 13 months of age (Visit 5)
Percentage of Subjects With rSBA Titers ≥ 128 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age
Zeitfenster: At 13 months of age (Visit 5)
To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement.
At 13 months of age (Visit 5)
hSBA Geometric Mean Titers (GMTs) Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age
Zeitfenster: At 24 months of age (Visit 6)
To assess persistence of antibody response in terms of GMTs using hSBA assay against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.
At 24 months of age (Visit 6)
rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age
Zeitfenster: At 24 months of age (Visit 6)
To assess persistence of antibody response in terms of GMTs using rSBA assay against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.
At 24 months of age (Visit 6)
hSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age
Zeitfenster: At 13 months of age (Visit 5)
To assess antibody response in terms of GMTs using hSBA assay against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.
At 13 months of age (Visit 5)
rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age.
Zeitfenster: At 13 months of age (Visit 5)
To assess antibody response in terms of GMTs using rSBA assay against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.
At 13 months of age (Visit 5)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

GlaxoSmithKline

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

13. Juli 2015

Primärer Abschluss (Tatsächlich)

28. Dezember 2017

Studienabschluss (Tatsächlich)

28. Dezember 2017

Studienanmeldedaten

Zuerst eingereicht

13. Mai 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Mai 2015

Zuerst gepostet (Schätzen)

18. Mai 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

27. Juni 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Juni 2019

Zuletzt verifiziert

1. Juni 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 205336
  • V59_75 (Andere Kennung: Novartis)
  • 2014-005392-90 (EudraCT-Nummer)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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