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

NCT01207583 | Completed Results

• 2 other identifiers: 0887X1-4596B1841011
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Healthy Children After Vaccination

Keywords

vaccine; infant; healthy subjects

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• 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

Study Arms (1)

healthy children after vaccination

healthy children after vaccination

Other: Non-interventional observational study

Interventions

Non-interventional observational study OTHER

Non-interventional observational study

healthy children after vaccination

Eligibility Criteria

• Age: 3 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants and Children from 3 months to 23 months at enrollment

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Russian State Medical University

Moscow, 119049, Russia

Location

Russian Academy of Medical Sciences

Moscow, 119296, Russia

Location

Research Institute of Childhood Infections

Saint Petersburg, 197022, Russia

Location

City Children's Clinical Hospital #8

Yekaterinburg, 620085, Russia

Location

Related Links

• To obtain contact information for a study center near you, click here.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2010
• First Posted: September 23, 2010
• Study Start: December 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 31, 2012
• Results First Posted: August 31, 2012

Record last verified: 2012-07

Locations

RU (4)