Prevenar (PCV-7) Post-Licensure Safety Study In Russia
26 juli 2012 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Faktisk)
100
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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Moscow, Ryska Federationen, 119049
- Russian State Medical University
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Moscow, Ryska Federationen, 119296
- Russian Academy of Medical Sciences
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Saint Petersburg, Ryska Federationen, 197022
- Research Institute of Childhood Infections
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Yekaterinburg, Ryska Federationen, 620085
- City Children's Clinical Hospital #8
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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
3 månader till 1 år (Barn)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Infants and Children from 3 months to 23 months at enrollment
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
healthy children after vaccination
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Non-interventional observational study
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants With Febrile Reactions Post-dose 1
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of Participants With Pre-Specified Local Reactions Post-dose 1
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
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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
1 december 2009
Primärt slutförande (Faktisk)
1 augusti 2011
Avslutad studie (Faktisk)
1 augusti 2011
Studieregistreringsdatum
Först inskickad
21 september 2010
Först inskickad som uppfyllde QC-kriterierna
21 september 2010
Första postat (Uppskatta)
23 september 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
31 augusti 2012
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 juli 2012
Senast verifierad
1 juli 2012
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 0887X1-4596
- B1841011
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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