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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372255
• Other study ID #: 106252
• Secondary ID: 2005-004517-14
• Status: Completed
• Phase: Phase 4
• Start date: November 17, 2005
• Est. completion date: March 28, 2006

Study information

• Verified date: February 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: March 28, 2006
• Est. primary completion date: March 28, 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza

Intervention

Biological:
• Influsplit SSW® 2005/2006
Study influenza vaccine was administered intramuscularly in the non-dominant arm

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Bischofswerda	Sachsen
Germany	GSK Investigational Site	Bredstedt	Schleswig-Holstein
Germany	GSK Investigational Site	Buetzow	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Flensburg	Schleswig-Holstein
Germany	GSK Investigational Site	Husum	Schleswig-Holstein
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Niebuell	Schleswig-Holstein
Germany	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Rostock	Mecklenburg-Vorpommern
Germany	GSK Investigational Site	Wuerzburg	Bayern
Germany	GSK Investigational Site	Wurzen	Sachsen

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Schmidt-Ott R, Schwarz T, Haase R, Sander H, Walther U, Fourneau M, Htun-Myint L, Sänger 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. Epub 2007 Nov 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years	Titers of serum HI antibodies are presented as geometric mean titers (GMTs) against the three influenza strains contained in the trivalent influenza vaccine Influsplit SSW 2005/2006 (GlaxoSmithKline/SSW) after a single versus after two vaccine doses of Influsplit SSW 2005/2006. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.	28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
Primary	Seroconversion Factor (SCF) for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years	Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.	28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
Primary	Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years	A seroconverted subject was defined as a subject who was either seronegative prior to the vaccination and had a protective post-vaccination titer of greater than or equal to (=) 1:40 or who was seropositive prior to the vaccination and had at least a 4-fold increase in the titer as the outcome of the vaccination. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.	28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
Secondary	Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years	Titers of serum HI antibodies are presented as geometric mean titers (GMTs) against the three influenza strains contained in the trivalent influenza vaccine Influsplit SSW 2005/2006 (GlaxoSmithKline/SSW) after a single versus after two vaccine doses of Influsplit SSW 2005/2006. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.	21 days post-vaccination (Day 21)
Secondary	SCF for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years	Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.	21 days post-vaccination (Day 21)
Secondary	Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years	A seroconverted subject was defined as a subject who was either seronegative prior to the vaccination and had a protective post-vaccination titer of greater than or equal to (=) 1:40 or who was seropositive prior to the vaccination and had at least a 4-fold increase in the titer as the outcome of the vaccination. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.	21 days post-vaccination (Day 21)
Secondary	Number of Seroprotected Subjects Who Were Unprotected at Pre-vaccination Against 3 Influenza Strains in Children Aged Between 10 and 13 Years	Seroprotection power (SPP) was defined as the proportion of the subjects unprotected before vaccination (titre < 40) who were protected after vaccination (titer = 40). The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.	21 days post-vaccination (Day 21)
Secondary	Number of Seroprotected Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years	A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer = 1:40. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.	21 days post-vaccination (Day 21)
Secondary	Number of Subjects With Solicited Local Symptoms	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.	During the 4-day (Day 0-3) post-vaccination period following each dose and across doses
Secondary	Number of Subjects With Solicited General Symptoms	Assessed solicited general symptoms were Arthralgia, Fatigue, Fever, Headache, Myalgia, Shivering and Sweating. Any= occurrence of the symptom regardless of intensity grade. Grade 3 fever = Grade 3 symptoms greater than (>) 39.0 °C. Related = symptoms considered by the investigator to have a causal relationship to study vaccination.	During the 4-day (Day 0-3) post-vaccination period following each dose and across doses
Secondary	Number of Subjects With Unsolicited Adverse Events.	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.	During 31 days after the study vaccine dose (Day 0-30)
Secondary	Number of Subjects With Serious Adverse Events (SAEs)	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	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

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