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.
Study Type
OBSERVATIONAL
Enrollment
100
Non-interventional observational study
Russian State Medical University
Moscow, Russia
Russian Academy of Medical Sciences
Moscow, Russia
Research Institute of Childhood Infections
Saint Petersburg, Russia
City Children's Clinical Hospital #8
Yekaterinburg, Russia
Percentage of Participants With Febrile Reactions 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.
Time frame: Day 1 to Day 3 post-dose 1
Percentage of Participants With Febrile Reactions 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.
Time frame: Day 1 to Day 3 post-dose 2
Percentage of Participants With Febrile Reactions 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.
Time frame: Day 1 to Day 3 post-dose 3
Percentage of Participants With Febrile Reactions 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.
Time frame: Day 1 to Day 3 post-dose 4
Percentage of Participants With Pre-Specified Local Reactions 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.
Time frame: Day 1 to Day 3 post-dose 1
Percentage of Participants With Pre-Specified Local Reactions 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.
Time frame: Day 1 to Day 3 post-dose 2
Percentage of Participants With Pre-Specified Local Reactions 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.
Time frame: Day 1 to Day 3 post-dose 3
Percentage of Participants With Pre-Specified Local Reactions 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.
Time frame: Day 1 to Day 3 post-dose 4
Percentage of Participants With Pre-Specified Systemic Events 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.
Time frame: Day 1 to Day 3 post-dose 1
Percentage of Participants With Pre-Specified Systemic Events 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.
Time frame: Day 1 to Day 3 post-dose 2
Percentage of Participants With Pre-Specified Systemic Events 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.
Time frame: Day 1 to Day 3 post-dose 3
Percentage of Participants With Pre-Specified Systemic Events 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.
Time frame: Day 1 to Day 3 post-dose 4
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