Booster Vaccination Study With a Pneumococcal Vaccine in Children Primed With the Same Vaccine
21. August 2018 aktualisiert von: GlaxoSmithKline
Booster Vaccination With Pneumococcal Vaccine GSK1024850A or Prevenar™ Co-administered With Hiberix™ in Children Primed With the Same Vaccines
The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix at 12-18 months of age, in children primed with the same vaccines in primary study NCT00680914.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Interventionell
Einschreibung (Tatsächlich)
450
Phase
- Phase 3
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Ansan, Korea, Republik von, 425-707
- GSK Investigational Site
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Bucheon-Si, GyeongGi-do,, Korea, Republik von, 420-767
- GSK Investigational Site
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Daejeon, Korea, Republik von, 301-723
- GSK Investigational Site
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GyeongSangNam-do, Korea, Republik von, 641-560
- GSK Investigational Site
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Gyeonggi-do, Korea, Republik von, 411-706
- GSK Investigational Site
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Iksan, Korea, Republik von, 570-711
- GSK Investigational Site
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Jeju City, Korea, Republik von, 690-121
- GSK Investigational Site
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Jeonju Jeonbuk, Korea, Republik von, 561-712
- GSK Investigational Site
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Pusan, Korea, Republik von, 602-739
- GSK Investigational Site
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Seoul, Korea, Republik von, 150-719
- GSK Investigational Site
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Seoul, Korea, Republik von, 130-702
- GSK Investigational Site
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Seoul, Korea, Republik von, 158-710
- GSK Investigational Site
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Suwon City, Gyeonggi-do, Korea, Republik von, 442-723
- GSK Investigational Site
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Wonju-si Kangwon-do, Korea, Republik von, 220-701
- GSK Investigational Site
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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
1 Jahr bis 1 Jahr (Kind)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- A male or female between, and including, 12-18 months of age at the time of booster vaccination.
- Subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
- Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00680914.
- Written informed consent obtained from the parent(s)/guardian(s) of the child/ward.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the vaccination, or planned use during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
- Administration of any pneumococcal and/or Hib vaccine since the end of study NCT00680914.
- Planned administration/administration of a vaccine not allowed by the study protocol during the period starting 1 month (30 days) before the administration of the booster dose of the study vaccines (Visit 1) and up to the follow-up visit (Visit 2) with the exception of vaccines included in the Korean routine immunization which can be given at least one week before the administration of the study vaccines or after study end.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of reactions or allergic disease likely to be exacerbated by any component of the study vaccines.
- Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Tympanic or axillary/ oral temperature >= 37.5°C or rectal temperature >= 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
- Acute disease at the time of enrolment.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Synflorix Group
Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
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Intramuscular injection, administered as a single dose
Andere Namen:
Intramuscular injection, administered as a single dose
Andere Namen:
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Aktiver Komparator: Prevenar Group
Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
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Intramuscular injection, administered as a single dose
Andere Namen:
Intramuscular injection, administered as a single dose
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Number of Subjects Reporting Grade 3 Adverse Events
Zeitfenster: Within 31 days (Day 0 - Day 30) after booster vaccination.
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Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.
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Within 31 days (Day 0 - Day 30) after booster vaccination.
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Number of Subjects Reporting Solicited Symptoms
Zeitfenster: Within 4 days (Days 0 to 3) after booster vaccination
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Solicited local symptoms assessed include pain, redness and swelling at the injection site.
Solicited general symptoms assessed include drowsiness, fever (equal to or above 37.5 degrees Celsius), irritability and loss of appetite.
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Within 4 days (Days 0 to 3) after booster vaccination
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Number of Subjects Reporting Unsolicited Adverse Events
Zeitfenster: Within 31 days (Days 0 to 30) after booster vaccination
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An unsolicited adverse event is any adverse event (i.e.
any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study.
Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
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Within 31 days (Days 0 to 30) after booster vaccination
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Number of Subjects Reporting Serious Adverse Events
Zeitfenster: After booster vaccination up to study end (Month 0 to Month 1)
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Serious adverse events are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
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After booster vaccination up to study end (Month 0 to Month 1)
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Concentration of Antibodies Against Vaccine Pneumococcal Serotypes
Zeitfenster: One month after booster vaccination (Month 1)
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Concentrations of antibodies are measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations expressed as microgram per milliliter (ug/mL). Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. |
One month after booster vaccination (Month 1)
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Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Zeitfenster: One month after booster vaccination (Month 1)
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Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. |
One month after booster vaccination (Month 1)
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Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Zeitfenster: One month after booster vaccination (Month 1)
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Concentrations of antibodies are measured by 22F-inhibition ELISA and are presented as geometric mean concentrations expressed as microgram per milliliter.
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One month after booster vaccination (Month 1)
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Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Zeitfenster: One month after booster vaccination (Month 1)
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Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line.
The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.
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One month after booster vaccination (Month 1)
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Concentration of Antibodies Against Protein D (PD)
Zeitfenster: One month after booster vaccination (Month 1)
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Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per milliliter (EU/mL).
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One month after booster vaccination (Month 1)
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Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP)
Zeitfenster: One month after booster vaccination (Month 1)
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Concentrations of antibodies are presented as geometric mean concentrations expressed as microgram per milliliter.
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One month after booster vaccination (Month 1)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Kim CH, Kim JS, Cha SH, Kim KN, Kim JD, Lee KY, Kim HM, Kim JH, Hyuk S, Hong JY, Park SE, Kim YK, Kim NH, Fanic A, Borys D, Ruiz-Guinazu J, Moreira M, Schuerman L, Kim KH. Response to primary and booster vaccination with 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in Korean infants. Pediatr Infect Dis J. 2011 Dec;30(12):e235-43. doi: 10.1097/INF.0b013e31822a8541.
- Kim CH et al. Immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the Korean Society of Pediatric Infectious Diseases - 2011 Spring Conference. Seoul, South Korea, 7-11 June 2011.
- Kim JS et al. Safety and reactogenicity of booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein d conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the 8th International Symposium on Antimicrobial Agents and Resistance (ISAAR). Seoul, Republic of Korea, 6-8 April 2011.
- Kim KH et al. Immunogenicity of booster vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein d conjugate vaccine (PHiD-CV) in Korean children. Abstract presented at the 8th International Symposium on Antimicrobial Agents and Resistance (ISAAR). Seoul, Republic of Korea, 6-8 April 2011.
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
11. Juni 2009
Primärer Abschluss (Tatsächlich)
11. Januar 2010
Studienabschluss (Tatsächlich)
11. Januar 2010
Studienanmeldedaten
Zuerst eingereicht
28. Mai 2009
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
28. Mai 2009
Zuerst gepostet (Schätzen)
1. Juni 2009
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
20. September 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
21. August 2018
Zuletzt verifiziert
1. Oktober 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 112933
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiendaten/Dokumente
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Einwilligungserklärung
Informationskennung: 112933Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Datensatzspezifikation
Informationskennung: 112933Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Einzelner Teilnehmerdatensatz
Informationskennung: 112933Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Kommentiertes Fallberichtsformular
Informationskennung: 112933Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Studienprotokoll
Informationskennung: 112933Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Statistischer Analyseplan
Informationskennung: 112933Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Klinischer Studienbericht
Informationskennung: 112933Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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 .