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

Purpose

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.

Condition	Intervention
Healthy Children After Vaccination	Other: Non-interventional observational study

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Prevenar Post-Licensure Safety Study in Russia: Frequency Of Fever Post Vaccination

Resource links provided by NLM:

MedlinePlus related topics: Fever

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Percentage of Participants With Febrile Reactions Post-dose 1 [ Time Frame: Day 1 to Day 3 post-dose 1 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 Outcome Measures:

Percentage of Participants With Pre-Specified Local Reactions Post-dose 1 [ Time Frame: Day 1 to Day 3 post-dose 1 ] [ Designated as safety issue: Yes ]
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.
Percentage of Participants With Pre-Specified Local Reactions Post-dose 2 [ Time Frame: Day 1 to Day 3 post-dose 2 ] [ Designated as safety issue: Yes ]
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.
Percentage of Participants With Pre-Specified Local Reactions Post-dose 3 [ Time Frame: Day 1 to Day 3 post-dose 3 ] [ Designated as safety issue: Yes ]
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.
Percentage of Participants With Pre-Specified Local Reactions Post-dose 4 [ Time Frame: Day 1 to Day 3 post-dose 4 ] [ Designated as safety issue: Yes ]
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.
Percentage of Participants With Pre-Specified Systemic Events Post-dose 1 [ Time Frame: Day 1 to Day 3 post-dose 1 ] [ Designated as safety issue: Yes ]
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.
Percentage of Participants With Pre-Specified Systemic Events Post-dose 2 [ Time Frame: Day 1 to Day 3 post-dose 2 ] [ Designated as safety issue: Yes ]
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.
Percentage of Participants With Pre-Specified Systemic Events Post-dose 3 [ Time Frame: Day 1 to Day 3 post-dose 3 ] [ Designated as safety issue: Yes ]
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.
Percentage of Participants With Pre-Specified Systemic Events Post-dose 4 [ Time Frame: Day 1 to Day 3 post-dose 4 ] [ Designated as safety issue: Yes ]
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.

Enrollment:	100
Study Start Date:	December 2009
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
healthy children after vaccination healthy children after vaccination	Other: Non-interventional observational study Non-interventional observational study

Eligibility

Ages Eligible for Study:	3 Months to 23 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Infants and Children from 3 months to 23 months at enrollment

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207583

Locations

Russian Federation
Russian Academy of Medical Sciences
Moscow, Russian Federation, 119296
Russian State Medical University
Moscow, Russian Federation, 119049
Research Institute of Childhood Infections
Saint Petersburg, Russian Federation, 197022
City Children's Clinical Hospital #8
Yekaterinburg, Russian Federation, 620085

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01207583 History of Changes
Other Study ID Numbers:	0887X1-4596, B1841011
Study First Received:	September 21, 2010
Results First Received:	July 26, 2012
Last Updated:	July 26, 2012
Health Authority:	Russia: Ministry of Health of the Russian Federation

Keywords provided by Pfizer:

vaccine
infant
healthy subjects

ClinicalTrials.gov processed this record on May 22, 2013