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Prevenar (PCV-7) Post-Licensure Safety Study In Russia

26. Juli 2012 aktualisiert von: Pfizer

Prevenar Post-Licensure Safety Study in Russia: Frequency Of Fever Post Vaccination

This study is planned to monitor the local and/or systemic reactions and compatibility of PCV-7 with routine vaccines in the Russian National immunization schedule. Consistent with the observational nature of this protocol, Prevenar will be administered as standard of care.

The aim of this study is to estimate the incidence of febrile reactions more than 38.0 degrees Celsius, specifically (≥38 to < 39 degrees C; > 39 to < 40 degrees C and > 40 degrees C, and the frequency of other local or systemic reactions following vaccination with Prevenar (PCV-7) co-administered with other routine childhood vaccines under the conditions of routine daily use in the Russian Federation.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

100

Kontakte und Standorte

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

Studienorte

  • Russische Föderation
      • Moscow, Russische Föderation, 119049
        • Russian State Medical University
      • Moscow, Russische Föderation, 119296
        • Russian Academy of Medical Sciences
      • Saint Petersburg, Russische Föderation, 197022
        • Research Institute of Childhood Infections
      • Yekaterinburg, Russische Föderation, 620085
        • City Children's Clinical Hospital #8

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

3 Monate bis 1 Jahr (Kind)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Infants and Children from 3 months to 23 months at enrollment

Beschreibung

Inclusion Criteria:

  • Infants eligible for Prevenar vaccination according to the Regulatory approved terms of the marketing authorization in the Russian Federation:
  • Infants from 3 months up to 23 months of age who may benefit from active immunization against disease caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media).
  • Parents or legal guardians willing and able to complete the diary cards.

Exclusion Criteria:

  • Hypersensitivity to the active substances or to any of the excipients;
  • Hypersensitivity to diphtheria toxoid;
  • Age less than 3 months or greater than or equal to 2 years at enrollment;
  • Contraindications as listed in the Package Insert / Russian SmPC for either Prevenar or for any concomitantly used other vaccines;
  • Previously vaccinated with 23-valent pneumococcal polysaccharide vaccine;
  • Prophylactic use of non-steroidal anti-inflammatory medications and/or acetaminophen (e.g., paracetamol). However, acetaminophen/paracetamol may be administered for treatment of fever, pain, etc.

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
healthy children after vaccination
Sonstiges: Non-interventional observational study
Non-interventional observational study

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With Febrile Reactions Post-dose 1
Zeitfenster: Day 1 to Day 3 post-dose 1
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of greater than or equal to (>=) 38 degrees Celsius (C). Percentage of participants with febrile reaction of >=38 degrees C to less than or equal to (<=) 39 degrees C, >39 degrees C to <=40 degrees C and >40 degrees C were observed.
Day 1 to Day 3 post-dose 1
Percentage of Participants With Febrile Reactions Post-dose 2
Zeitfenster: Day 1 to Day 3 post-dose 2
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed.
Day 1 to Day 3 post-dose 2
Percentage of Participants With Febrile Reactions Post-dose 3
Zeitfenster: Day 1 to Day 3 post-dose 3
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C to <=39 degrees C was observed.
Day 1 to Day 3 post-dose 3
Percentage of Participants With Febrile Reactions Post-dose 4
Zeitfenster: Day 1 to Day 3 post-dose 4
Febrile reactions were defined as reactions which causes a rise in body temperature following vaccination in children. Fever was defined as a temperature of >=38 degrees C. Percentage of participants with febrile reaction of >=38 degrees C was observed.
Day 1 to Day 3 post-dose 4

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With Pre-Specified Local Reactions Post-dose 1
Zeitfenster: Day 1 to Day 3 post-dose 1
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 centimeters [cm]); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
Day 1 to Day 3 post-dose 1
Percentage of Participants With Pre-Specified Local Reactions Post-dose 2
Zeitfenster: Day 1 to Day 3 post-dose 2
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
Day 1 to Day 3 post-dose 2
Percentage of Participants With Pre-Specified Local Reactions Post-dose 3
Zeitfenster: Day 1 to Day 3 post-dose 3
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
Day 1 to Day 3 post-dose 3
Percentage of Participants With Pre-Specified Local Reactions Post-dose 4
Zeitfenster: Day 1 to Day 3 post-dose 4
Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Induration and redness were scaled as Any (induration or redness present); Mild (<2.5 cm); Moderate (>=2.5 cm to <5.0 cm); Severe (>=5.0 cm). Participants may be represented in more than 1 category. Solicited local reactions included redness, swelling and tenderness while unsolicited local reactions included injection site hematoma, injection site hemorrhage, injection site induration and injection site warmth.
Day 1 to Day 3 post-dose 4
Percentage of Participants With Pre-Specified Systemic Events Post-dose 1
Zeitfenster: Day 1 to Day 3 post-dose 1
Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.
Day 1 to Day 3 post-dose 1
Percentage of Participants With Pre-Specified Systemic Events Post-dose 2
Zeitfenster: Day 1 to Day 3 post-dose 2
Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.
Day 1 to Day 3 post-dose 2
Percentage of Participants With Pre-Specified Systemic Events Post-dose 3
Zeitfenster: Day 1 to Day 3 post-dose 3
Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.
Day 1 to Day 3 post-dose 3
Percentage of Participants With Pre-Specified Systemic Events Post-dose 4
Zeitfenster: Day 1 to Day 3 post-dose 4
Systemic events (any fever >=38 degrees C, decreased appetite, diarrhea, restless sleep, unusual crying, unusual fussiness, unusual irritability, and vomiting) were reported using an electronic diary. Participants may be represented in more than 1 category.
Day 1 to Day 3 post-dose 4

Mitarbeiter und Ermittler

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

Sponsor

Pfizer

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.

Nützliche Links

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

1. Dezember 2009

Primärer Abschluss (Tatsächlich)

1. August 2011

Studienabschluss (Tatsächlich)

1. August 2011

Studienanmeldedaten

Zuerst eingereicht

21. September 2010

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. September 2010

Zuerst gepostet (Schätzen)

23. September 2010

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

31. August 2012

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. Juli 2012

Zuletzt verifiziert

1. Juli 2012

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 0887X1-4596
  • B1841011

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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