Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 13 Years

NCT ID: NCT00372255

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-17
• Study Completion Date: 2006-03-28

Brief Summary

The study will evaluate the immune response and the tolerability of the influenza vaccine administered in children aged 6-13 years old.

Conditions

Influenza

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Influsplit SSW® 2005/2006 6-9 years Group

Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW® 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).

Group Type: EXPERIMENTAL

Influsplit SSW® 2005/2006

Intervention Type: BIOLOGICAL

Study influenza vaccine was administered intramuscularly in the non-dominant arm

Influsplit SSW® 2005/2006 10-13 years Group

Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW® 2005/2006 vaccine at Day 0.

Group Type: ACTIVE_COMPARATOR

Influsplit SSW® 2005/2006

Intervention Type: BIOLOGICAL

Study influenza vaccine was administered intramuscularly in the non-dominant arm

Interventions

Influsplit SSW® 2005/2006

Study influenza vaccine was administered intramuscularly in the non-dominant arm

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy children or children with an increased health risk due to an underlying chronic disease-such as chronic airways diseases (including asthma), chronic cardiovascular, hepatic and renal diseases as well as diabetes and other metabolic diseases-aged between 6 and 13 years.
• All subjects must not have received a prior influenza vaccination.
• All subjects must not have had a prior influenza disease.

Exclusion Criteria

• Use of any study or unlicensed medications/ vaccine other than the study vaccine within 30 days of the vaccination and/or during the study period.
• Acute illness at the start of the study.
• Acute, clinically significant pulmonary, cardiovascular abnormalities or abnormalities of the hepatic or renal function.
• Known allergic reactions which might be caused by the ingredients of the vaccine.
• Girls post-menarche: pregnancy or positive pregnancy-test
• Multiple sclerosis or congenital or acquired immunodeficiencies.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Würzburg, Bavaria, Germany

GSK Investigational Site

Bützow, Mecklenburg-Vorpommern, Germany

GSK Investigational Site

Rostock, Mecklenburg-Vorpommern, Germany

GSK Investigational Site

Rostock, Mecklenburg-Vorpommern, Germany

GSK Investigational Site

Bischofswerda, Saxony, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Wurzen, Saxony, Germany

GSK Investigational Site

Bredstedt, Schleswig-Holstein, Germany

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

GSK Investigational Site

Husum, Schleswig-Holstein, Germany

GSK Investigational Site

Niebüll, Schleswig-Holstein, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

Countries

Germany

References

Schmidt-Ott R, Schwarz T, Haase R, Sander H, Walther U, Fourneau M, Htun-Myint L, Sanger R, Schuster V. Immunogenicity and reactogenicity of a trivalent influenza split vaccine in previously unvaccinated children aged 6-9 and 10-13 years. Vaccine. 2007 Dec 21;26(1):32-40. doi: 10.1016/j.vaccine.2007.10.049. Epub 2007 Nov 9.

Reference Type: BACKGROUND

PMID: 18022736 (View on PubMed)

Study Documents

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

2005-004517-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

106252

Identifier Type: -

Identifier Source: org_study_id