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

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ClinicalTrials.gov Identifier: NCT00372255
Recruitment Status : Completed
First Posted : September 6, 2006
Results First Posted : May 6, 2019
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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

Condition or disease Intervention/treatment Phase
Influenza Biological: Influsplit SSW® 2005/2006 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open, Phase IV Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 13 Years
Actual Study Start Date : November 17, 2005
Actual Primary Completion Date : March 28, 2006
Actual Study Completion Date : March 28, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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




Primary Outcome Measures :
  1. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years [ Time Frame: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2) ]
    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.

  2. Seroconversion Factor (SCF) for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years [ Time Frame: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2) ]
    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.

  3. Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years [ Time Frame: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2) ]
    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.


Secondary Outcome Measures :
  1. Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years [ Time Frame: 21 days post-vaccination (Day 21) ]
    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.

  2. SCF for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years [ Time Frame: 21 days post-vaccination (Day 21) ]
    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.

  3. Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years [ Time Frame: 21 days post-vaccination (Day 21) ]
    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.

  4. Number of Seroprotected Subjects Who Were Unprotected at Pre-vaccination Against 3 Influenza Strains in Children Aged Between 10 and 13 Years [ Time Frame: 21 days post-vaccination (Day 21) ]
    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.

  5. Number of Seroprotected Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years [ Time Frame: 21 days post-vaccination (Day 21) ]
    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.

  6. Number of Subjects With Solicited Local Symptoms [ Time Frame: During the 4-day (Day 0-3) post-vaccination period following each dose and across doses ]
    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.

  7. Number of Subjects With Solicited General Symptoms [ Time Frame: During the 4-day (Day 0-3) post-vaccination period following each dose and across doses ]
    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.

  8. Number of Subjects With Unsolicited Adverse Events. [ Time Frame: During 31 days after the study vaccine dose (Day 0-30) ]
    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.

  9. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: 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 ]
    SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.



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Ages Eligible for Study:   6 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00372255


Locations
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Germany
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Buetzow, Mecklenburg-Vorpommern, Germany, 18246
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18106
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18109
GSK Investigational Site
Bischofswerda, Sachsen, Germany, 01877
GSK Investigational Site
Dresden, Sachsen, Germany, 01067
GSK Investigational Site
Dresden, Sachsen, Germany, 01159
GSK Investigational Site
Dresden, Sachsen, Germany, 01169
GSK Investigational Site
Leipzig, Sachsen, Germany, 04178
GSK Investigational Site
Leipzig, Sachsen, Germany, 04317
GSK Investigational Site
Wurzen, Sachsen, Germany, 04808
GSK Investigational Site
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
Berlin, Germany, 10315
GSK Investigational Site
Berlin, Germany, 10999
GSK Investigational Site
Berlin, Germany, 13055
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 106252
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 106252
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 106252
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 106252
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 106252
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 106252
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00372255     History of Changes
Other Study ID Numbers: 106252
2005-004517-14 ( EudraCT Number )
First Posted: September 6, 2006    Key Record Dates
Results First Posted: May 6, 2019
Last Update Posted: May 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs