Clinical trial NCT01207583: Prevenar (PCV-7) Post-Licensure Safety Study In Russia
Official title: Prevenar Post-Licensure Safety Study in Russia: Frequency Of Fever Post Vaccination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Children After Vaccination
Keywords: vaccine
infant
healthy subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-23
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants and Children from 3 months to 23 months at enrollment

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With Febrile Reactions Post-dose 1
timeFrame: Day 1 to Day 3 post-dose 1
measure: Percentage of Participants With Febrile Reactions Post-dose 2
timeFrame: Day 1 to Day 3 post-dose 2
measure: Percentage of Participants With Febrile Reactions Post-dose 3
timeFrame: Day 1 to Day 3 post-dose 3
measure: Percentage of Participants With Febrile Reactions Post-dose 4
timeFrame: Day 1 to Day 3 post-dose 4
Secondary outcomes:
measure: Percentage of Participants With Pre-Specified Local Reactions Post-dose 1
timeFrame: Day 1 to Day 3 post-dose 1
measure: Percentage of Participants With Pre-Specified Local Reactions Post-dose 2
timeFrame: Day 1 to Day 3 post-dose 2
measure: Percentage of Participants With Pre-Specified Local Reactions Post-dose 3
timeFrame: Day 1 to Day 3 post-dose 3
measure: Percentage of Participants With Pre-Specified Local Reactions Post-dose 4
timeFrame: Day 1 to Day 3 post-dose 4
measure: Percentage of Participants With Pre-Specified Systemic Events Post-dose 1
timeFrame: Day 1 to Day 3 post-dose 1
measure: Percentage of Participants With Pre-Specified Systemic Events Post-dose 2
timeFrame: Day 1 to Day 3 post-dose 2
measure: Percentage of Participants With Pre-Specified Systemic Events Post-dose 3
timeFrame: Day 1 to Day 3 post-dose 3
measure: Percentage of Participants With Pre-Specified Systemic Events Post-dose 4
timeFrame: Day 1 to Day 3 post-dose 4
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Russian State Medical University
city: Moscow
country: Russian Federation
facility: Russian Academy of Medical Sciences
city: Saint Petersburg
country: Russian Federation
facility: Research Institute of Childhood Infections
city: Yekaterinburg
country: Russian Federation
facility: City Children's Clinical Hospital #8
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: