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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Children After Vaccination

Intervention / Treatment
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* Other: Non-interventional observational study


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 23 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| healthy children after vaccination<br>healthy children after vaccination | Other: Non-interventional observational study<br>* Non-interventional observational study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Day 1 to Day 3 post-dose 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Day 1 to Day 3 post-dose 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine, infant, healthy subjects