Prevenar Post-Licensure Safety Study in Russia: Frequency Of Fever Post Vaccination
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- Percentage of Participants With Febrile Reactions Post-dose 1
Study Overview
Brief Summary
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 3 Months to 23 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Percentage of Participants With Febrile Reactions Post-dose 1
Time Frame: 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.
Percentage of Participants With Febrile Reactions Post-dose 2
Time Frame: 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.
Percentage of Participants With Febrile Reactions Post-dose 3
Time Frame: 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.
Percentage of Participants With Febrile Reactions Post-dose 4
Time Frame: 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.
Secondary Outcomes
- Percentage of Participants With Pre-Specified Local Reactions Post-dose 1(Day 1 to Day 3 post-dose 1)
- Percentage of Participants With Pre-Specified Local Reactions Post-dose 2(Day 1 to Day 3 post-dose 2)
- Percentage of Participants With Pre-Specified Local Reactions Post-dose 3(Day 1 to Day 3 post-dose 3)
- Percentage of Participants With Pre-Specified Local Reactions Post-dose 4(Day 1 to Day 3 post-dose 4)
- Percentage of Participants With Pre-Specified Systemic Events Post-dose 1(Day 1 to Day 3 post-dose 1)
- Percentage of Participants With Pre-Specified Systemic Events Post-dose 2(Day 1 to Day 3 post-dose 2)
- Percentage of Participants With Pre-Specified Systemic Events Post-dose 3(Day 1 to Day 3 post-dose 3)
- Percentage of Participants With Pre-Specified Systemic Events Post-dose 4(Day 1 to Day 3 post-dose 4)