Surveillance of Influenza Virus Among Children With Febrile Respiratory Complaints Attending the Pediatric Clinic of the First Affiliated Hospital, Shantou University Medical College, Shantou, Guangdong, Mainland China

Influenza Type B Clinical Trial

Official title:

Surveillance of Influenza Virus Among Children With Febrile Respiratory Complaints Attending the Pediatric Clinic of the First Affiliated Hospital, Shantou University Medical College, Shantou, Guangdong, Mainland China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00760500
• Other study ID #: SIVFRC
• Secondary ID: N01AI70005
• Status: Completed
• Phase: N/A
• First received: September 25, 2008
• Last updated: February 16, 2015
• Start date: January 2004
• Est. completion date: March 2014

Study information

• Verified date: February 2015
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The surveillance of influenza virus among children with febrile reparatory complaints attending the pediatric clinic in Shantou is an epidemiologic study to identify the type (influenza A or B) and the subtype of Influenza A of the isolates from children with febrile respiratory complaints who attend the pediatric clinic of the first Affiliated Hospital, Shantou University Medical College, Shantou Guangdong, China. Also this study investigates the genetic composition of all segments of isolated strains using standard molecular techniques and to make available the new strains of influenza viruses isolated from such children for the formulation of influenza vaccines. Clinical manifestation of the respiratory illness is recorded and single nasopharyngeal swab is obtained from eligible children. Viral culture is performed on the nasopharyngeal secretions. If influenza is isolated, this is characterized if it belongs to influenza A or B. If the virus is characterized as influenza A, further antigenic studies is done to determine subtype of influenza. Viral isolates is further studied to determine the genetic composition of the virus. Information obtained from the viral isolates is shared with the WHO and the CDC.

Description:

OBJECTIVES

Primary objective:

• To identify the type (Influenza A or B) and the subtype of Influenza A of the isolates from children with febrile respiratory complaints who attend the pediatric clinic of the First Affiliated Hospital, Shantou University Medical College, Shantou, Guangdong, China.

Secondary objectives

• To investigate the genetic composition of all segments of isolated strains using standard molecular techniques.

• To make available the new strains of influenza viruses isolated from such children for the formulation of influenza vaccines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13201
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• Age: 0 day to 18 years.

• Patient was seen at the pediatric clinic of the First Affiliated Hospital within 7 days of the onset of signs and symptoms of febrile respiratory illness suspected to be of viral origin (temperature > 37.7ºC or reliable history of fever before being examined, and respiratory symptoms and signs such as cough, sore throat, and coryza).

• Parents agree to a nasopharyngeal specimen being taken by swab from their child.

Exclusion Criteria:

• Patient is too ill to tolerate a nasopharyngeal specimen swab.

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Influenza Type A
• Influenza Type B
• Influenza, Human

Intervention

Other:
• Nasopharyngeal Swab
Nasopharyngeal Swab

Locations

Country	Name	City	State
China	First Affiliated Hospital	Shantou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	National Institute of Allergy and Infectious Diseases (NIAID), The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify Influenza A or B and the subtype of Influenza A of the isolates from children with febrile respiratory complaints who attend the pediatric clinic of the First Affiliated Hospital, Shantou University Medical College.		This is an epidemiologic study, there is no time frame.	No

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital