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

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

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

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Influsplit SSW® 2005/2006

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10315
    • GSK Investigational Site
  • Berlin, Germany, 13055
    • GSK Investigational Site
  • Berlin, Germany, 10999
    • GSK Investigational Site
  • Bayern
    • Wuerzburg, Bayern, Germany, 97070
      • GSK Investigational Site
  • Mecklenburg-Vorpommern
    • Buetzow, Mecklenburg-Vorpommern, Germany, 18246
      • GSK Investigational Site
    • Rostock, Mecklenburg-Vorpommern, Germany, 18109
      • GSK Investigational Site
    • Rostock, Mecklenburg-Vorpommern, Germany, 18106
      • GSK Investigational Site
  • Sachsen
    • Bischofswerda, Sachsen, Germany, 01877
      • GSK Investigational Site
    • Dresden, Sachsen, Germany, 01067
      • GSK Investigational Site
    • Dresden, Sachsen, Germany, 01169
      • GSK Investigational Site
    • Dresden, Sachsen, Germany, 01159
      • GSK Investigational Site
    • Leipzig, Sachsen, Germany, 04178
      • GSK Investigational Site
    • Leipzig, Sachsen, Germany, 04317
      • GSK Investigational Site
    • Wurzen, Sachsen, Germany, 04808
      • GSK Investigational Site
  • Schleswig-Holstein
    • Bredstedt, Schleswig-Holstein, Germany, 25821
      • GSK Investigational Site
    • Flensburg, Schleswig-Holstein, Germany, 24937
      • GSK Investigational Site
    • Husum, Schleswig-Holstein, Germany, 25813
      • GSK Investigational Site
    • Niebuell, Schleswig-Holstein, Germany, 25899
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 13 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	Biological: Influsplit SSW® 2005/2006; Study influenza vaccine was administered intramuscularly in the non-dominant arm
ACTIVE_COMPARATOR: 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.	Biological: Influsplit SSW® 2005/2006; Study influenza vaccine was administered intramuscularly in the non-dominant arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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
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
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)
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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 17, 2005
• Primary Completion (ACTUAL): March 28, 2006
• Study Completion (ACTUAL): March 28, 2006

Study Registration Dates

• First Submitted: September 5, 2006
• First Submitted That Met QC Criteria: September 5, 2006
• First Posted (ESTIMATE): September 6, 2006

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 106252; 2005-004517-14 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Dataset Specification
   Information identifier: 106252
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Study Protocol
   Information identifier: 106252
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Annotated Case Report Form
   Information identifier: 106252
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Individual Participant Data Set
   Information identifier: 106252
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Informed Consent Form
   Information identifier: 106252
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Clinical Study Report
   Information identifier: 106252
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register