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
2 other identifiers
interventional
240
1 country
18
Brief Summary
The study will evaluate the immune response and the tolerability of the influenza vaccine administered in children aged 6-13 years old.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Nov 2005
Shorter than P25 for phase_4
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 17, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2006
CompletedFirst Submitted
Initial submission to the registry
September 5, 2006
CompletedFirst Posted
Study publicly available on registry
September 6, 2006
CompletedResults Posted
Study results publicly available
May 6, 2019
CompletedMay 6, 2019
February 1, 2019
4 months
September 5, 2006
February 4, 2019
February 4, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (9)
Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
21 days post-vaccination (Day 21)
SCF for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
21 days post-vaccination (Day 21)
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
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
21 days post-vaccination (Day 21)
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
21 days post-vaccination (Day 21)
- +4 more secondary outcomes
Study Arms (2)
Influsplit SSW® 2005/2006 6-9 years Group
EXPERIMENTALSubjects 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).
Influsplit SSW® 2005/2006 10-13 years Group
ACTIVE COMPARATORSubjects aged 10 to 13 years who received 1 dose of Influsplit SSW® 2005/2006 vaccine at Day 0.
Interventions
Study influenza vaccine was administered intramuscularly in the non-dominant arm
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (18)
GSK Investigational Site
Würzburg, Bavaria, 97070, Germany
GSK Investigational Site
Bützow, Mecklenburg-Vorpommern, 18246, Germany
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18106, Germany
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18109, Germany
GSK Investigational Site
Bischofswerda, Saxony, 01877, Germany
GSK Investigational Site
Dresden, Saxony, 01067, Germany
GSK Investigational Site
Dresden, Saxony, 01159, Germany
GSK Investigational Site
Dresden, Saxony, 01169, Germany
GSK Investigational Site
Leipzig, Saxony, 04178, Germany
GSK Investigational Site
Leipzig, Saxony, 04317, Germany
GSK Investigational Site
Wurzen, Saxony, 04808, Germany
GSK Investigational Site
Bredstedt, Schleswig-Holstein, 25821, Germany
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937, Germany
GSK Investigational Site
Husum, Schleswig-Holstein, 25813, Germany
GSK Investigational Site
Niebüll, Schleswig-Holstein, 25899, Germany
GSK Investigational Site
Berlin, 10315, Germany
GSK Investigational Site
Berlin, 10999, Germany
GSK Investigational Site
Berlin, 13055, Germany
Related Publications (1)
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.
PMID: 18022736BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2006
First Posted
September 6, 2006
Study Start
November 17, 2005
Primary Completion
March 28, 2006
Study Completion
March 28, 2006
Last Updated
May 6, 2019
Results First Posted
May 6, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.