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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Influenza

Treatments: Biological: Influsplit SSW® 2005/2006

Study type: Interventional

Funder types: Industry

Identifiers

NCT00372255

106252

2005-004517-14 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 240 patients

Sex: All

Ages: 6 to 13 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Influsplit SSW® 2005/2006 6-9 years Group

Experimental group

Description:

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).

Treatment:

Biological: Influsplit SSW® 2005/2006

Influsplit SSW® 2005/2006 10-13 years Group

Active Comparator group

Description:

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

Treatment:

Biological: Influsplit SSW® 2005/2006