Clinical trial NCT00372255: Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 13 Years
Official title: An Open, Phase IV Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 13 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-09-06
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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.

Primary outcomes:
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
timeFrame: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
measure: Seroconversion Factor (SCF) for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
timeFrame: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
measure: Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
timeFrame: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
Secondary outcomes:
measure: Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
timeFrame: 21 days post-vaccination (Day 21)
measure: SCF for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
timeFrame: 21 days post-vaccination (Day 21)
measure: Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
timeFrame: 21 days post-vaccination (Day 21)
measure: Number of Seroprotected Subjects Who Were Unprotected at Pre-vaccination Against 3 Influenza Strains in Children Aged Between 10 and 13 Years
timeFrame: 21 days post-vaccination (Day 21)
measure: Number of Seroprotected Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
timeFrame: 21 days post-vaccination (Day 21)
measure: Number of Subjects With Solicited Local Symptoms
timeFrame: During the 4-day (Day 0-3) post-vaccination period following each dose and across doses
measure: Number of Subjects With Solicited General Symptoms
timeFrame: During the 4-day (Day 0-3) post-vaccination period following each dose and across doses
measure: Number of Subjects With Unsolicited Adverse Events.
timeFrame: During 31 days after the study vaccine dose (Day 0-30)
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Buetzow
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Rostock
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Rostock
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Bischofswerda
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Wurzen
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Bredstedt
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Flensburg
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Husum
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Niebuell
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.