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Completed

NCT Number: NCT00372255

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

6 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GSK Investigational Site, Würzburg, Bavaria, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Influsplit SSW® 2005/2006

Biological

Study influenza vaccine was administered intramuscularly in the non-dominant arm

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 6, 2006
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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