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Evaluation of Antibody Persistence Following 4 MenACWY Vaccinations

13 juni 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

128

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

2 maanden tot 2 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination.
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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.
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Subjects With hSBA ≥8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

GlaxoSmithKline

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

13 juli 2015

Primaire voltooiing (Werkelijk)

28 december 2017

Studie voltooiing (Werkelijk)

28 december 2017

Studieregistratiedata

Eerst ingediend

13 mei 2015

Eerst ingediend dat voldeed aan de QC-criteria

15 mei 2015

Eerst geplaatst (Schatting)

18 mei 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 juni 2019

Laatste update ingediend die voldeed aan QC-criteria

13 juni 2019

Laatst geverifieerd

1 juni 2019

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 205336
  • V59_75 (Andere identificatie: Novartis)
  • 2014-005392-90 (EudraCT-nummer)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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