AzTrials
AzTrials

InfluenzaPhase 3NCT01196988

Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine When Administered in Children

A Phase 3 study testing Influenza vaccine GSK2321138A, FluarixTM and Influenza vaccine GSK2604409A in people with Influenza, run by GlaxoSmithKline at 59 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational vaccine GSK2321138A in children aged 3 to 17 years, and to describe safety and immunogenicity of the GSK Biologicals' investigational vaccine GSK2321138A in children aged 6 to 35 months. Read more about this study

Who is it for?
Ages 6 months to 17 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Influenza vaccine GSK2321138A, FluarixTM and Influenza vaccine GSK2604409A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,027 participants
Where
59 sitesin 5 countries
Study dates
4 Oct 2010to 15 Jun 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
  • For non US countries:
  • - Children, male or female, aged between 6 months and 17 years at the time of the first study vaccination.
  • For US :
  • Children, male or female, aged between 3 and 17 years at the time of the first study vaccination
  • Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
Show all 13Show fewer
  • Subjects in stable health as determined by investigator's clinical examination and assessment of subjects' medical history.
  • Written informed assent obtained from the subject if/as required by local regulations.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
  • - has practiced adequate contraception for 30 days prior to vaccination,
  • - and has a negative urine pregnancy test on the day of vaccination,
  • - and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series

Who cannot join

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. Routine registered childhood vaccinations are permitted.
  • Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
  • Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
  • Prior receipt of any seasonal or pandemic influenza vaccine (registered or investigational) within 6 months preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
  • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
Show all 17Show fewer
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • History of seizures or progressive neurological disease.
  • History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
  • Concurrently participating in another clinical study, at any time during the study period in which the subject has been or will be exposed to an investigational or a non-investigational product .
  • History of hypersensitivity to a previous dose of influenza vaccine, history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines
  • Acute disease and/or fever at the time of enrolment
  • Ongoing aspirin therapy
  • Pregnant or lactating female
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study
  • Child in Care.

Trial locations and contacts

59 sites in 5 countries.

59 sites in 5 countries

Germany24 sites

  • GSK Investigational Site

    Berlin, 10315

  • GSK Investigational Site

    Berlin, 10967

  • GSK Investigational Site

    Berlin, 13055

  • GSK Investigational Site

    Eschwege, Hesse, 37269

  • GSK Investigational Site

    Ettenheim, Baden-Wurttemberg, 77955

  • GSK Investigational Site

    Flensburg, Schleswig-Holstein, 24937

  • GSK Investigational Site

    Gilching, Bavaria, 82205

  • GSK Investigational Site

    Hamburg, 22307

  • GSK Investigational Site

    Heiligenhaus, North Rhine-Westphalia, 42579

  • GSK Investigational Site

    Kehl, Baden-Wurttemberg, 77694

  • GSK Investigational Site

    Kirchheim, Bavaria, 85551

  • GSK Investigational Site

    Kleve-Materborn, North Rhine-Westphalia, 47533

  • GSK Investigational Site

    Leipzig, Saxony, 04178

  • GSK Investigational Site

    Munich, Bavaria, 81735

  • GSK Investigational Site

    Nördlingen, Bavaria, 86720

  • GSK Investigational Site

    Schwäbisch Hall, Baden-Wurttemberg, 74523

  • GSK Investigational Site

    Solingen, North Rhine-Westphalia, 42719

  • GSK Investigational Site

    Stuttgart, Baden-Wurttemberg, 70469

  • GSK Investigational Site

    Tauberbischofsheim, Baden-Wurttemberg, 97941

  • GSK Investigational Site

    Trier, Rhineland-Palatinate, 54290

  • GSK Investigational Site

    Tuttlingen, Baden-Wurttemberg, 78532

  • GSK Investigational Site

    Weimar, Thuringia, 99425

  • GSK Investigational Site

    Willich, North Rhine-Westphalia, 47877

  • GSK Investigational Site

    Wolfenbüttel, Lower Saxony, 38302

Other trials in Germany

United States14 sites

  • GSK Investigational Site

    Binghamton, New York, 13901

  • GSK Investigational Site

    Boca Raton, Florida, 33432

  • GSK Investigational Site

    Boston, Massachusetts, 02130

  • GSK Investigational Site

    Elmira, New York, 14901

  • GSK Investigational Site

    Houston, Texas, 77055

  • GSK Investigational Site

    Lexington, Kentucky, 40509

  • GSK Investigational Site

    Metairie, Louisiana, 70006

  • GSK Investigational Site

    Omaha, Nebraska, 68134

  • GSK Investigational Site

    Raleigh, North Carolina, 27609

  • GSK Investigational Site

    Sacramento, California, 95816

  • GSK Investigational Site

    San Angelo, Texas, 76904

  • GSK Investigational Site

    Syracuse, New York, 13210

  • GSK Investigational Site

    Wichita, Kansas, 67205

  • GSK Investigational Site

    Wichita, Kansas, 67207

Other trials in United States

Czechia10 sites

  • GSK Investigational Site

    Děčín, 405 01

  • GSK Investigational Site

    Humpolec, 396 01

  • GSK Investigational Site

    Jindřichův Hradec, 37701

  • GSK Investigational Site

    Kolín, 28002

  • GSK Investigational Site

    Náchod, 547 01

  • GSK Investigational Site

    Odolena Voda, 25070

  • GSK Investigational Site

    Pardubice, 532 03

  • GSK Investigational Site

    Pilsen, 305 99

  • GSK Investigational Site

    Prague, 1600

  • GSK Investigational Site

    Tábor, 390 02

Other trials in Czechia

France9 sites

  • GSK Investigational Site

    Aix-en-Provence, 13100

  • GSK Investigational Site

    Draguignan, 83300

  • GSK Investigational Site

    Essey-lès-Nancy, 54270

  • GSK Investigational Site

    La Bouëxière, 35340

  • GSK Investigational Site

    Le Havre, 76600

  • GSK Investigational Site

    Nantes, 44300

  • GSK Investigational Site

    Nice, 06300

  • GSK Investigational Site

    Seysses, 31600

  • GSK Investigational Site

    Tours, 37100

Other trials in France

Philippines2 sites

  • GSK Investigational Site

    Dasmariñas, Cavite, 4114

  • GSK Investigational Site

    Quezon City, 1113

Other trials in Philippines

About this study

Official title: Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine GSK2321138A When Administered in Children

This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' investigational vaccine GSK2321138A in children aged 3 to 17 years, and to describe safety and immunogenicity of the GSK Biologicals' investigational vaccine GSK2321138A in children aged 6 to 35 months.

Conditions
Influenza
Being tested
Influenza vaccine GSK2321138A, FluarixTM, Influenza vaccine GSK2604409A
Keywords
GSK Biologicals influenza vaccine GSK2321138A, influenza infection
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Influenza vaccine GSK2321138ABiological

    intramuscular injections

  • FluarixTMBiological

    intramuscular injections

  • Influenza vaccine GSK2604409ABiological

    intramuscular injections

Study groups in NCT01196988
Study groupRoleWhat they receive
GSK2321138A 1 GroupExperimentalSubjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
Receives: Biological: Influenza vaccine GSK2321138A
Fluarix GroupActive comparatorSubjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
Receives: Biological: FluarixTM
GSK2604409A GroupActive comparatorSubjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
Receives: Biological: Influenza vaccine GSK2604409A
GSK2321138A 2 GroupExperimentalSubjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
Receives: Biological: Influenza vaccine GSK2321138A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

    Measured: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  2. Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.

    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

    Measured: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

Secondary outcomes (25)

  1. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

    Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.

    Measured: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  2. Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.

    Titers are presented as geometric mean titers (GMTs). The reference cut-off value was 1:10. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

    Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.

    Measured: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  3. Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.

    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.

    Measured: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

  4. Number of Seroconverted Subjects Against 4 Strains of Influenza Disease by Age Strata.

    A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.

    Measured: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

  5. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease

    A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

    Measured: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  6. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.

    A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.

    Measured: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  7. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.

    A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.

    Measured: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  8. Number of Seroprotected Subjects Against 4 Strains of Influenza.

    A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

    Measured: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  9. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.

    A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.

    Measured: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  10. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.

    A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:80. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6-17 months and 18-35 months.

    Measured: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  11. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.

    A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

    Measured: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  12. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.

    A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.

    Measured: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  13. Number of Seroprotected Subjects Against 4 Strains of Influenza Disease by Age Strata.

    A seroprotected subject was defined as as a vaccinated subject who had a serum HI titer ≥ 1:120. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6 -17 months and 18-35 months.

    Measured: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]

  14. Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.

    MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata).

    Measured: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

  15. Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.

    MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 3-8 years and 9-17 years.

    Measured: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

  16. Mean Geometric Increase (MGI) Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease by Age Strata.

    MGI is defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The 4 influenza strains assessed were the FLU A/California/7/09 (H1N1), FLU A/Victoria/210/09 (H3N2), FLU B/Brisbane/60/08 (Victoria) and FLU B/Brisbane/3/07 (Yamagata). Subjects were assessed according to 2 age strata: 6 -17 months and 18-35 months.

    Measured: At Day 28 (for primed subjects) and Day 56 (for unprimed subjects)

  17. Number of Subjects With Any and Grade 3 Solicited Local Symptoms.

    Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful (Child <6 years) or pain that prevented normal activity (Child >6 years). Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of the injection site.

    Measured: During the 7-day (Days 0-6) follow-up period after any vaccination.

  18. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Younger Than 6 Years Old.

    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature >39.0°C.

    Measured: During the 7-day (Days 0-6) follow-up period after any vaccination.

  19. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms in Subjects Aged 6 Years or Older.

    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = temperature >39.0°C.

    Measured: During the 7-day (Days 0-6) follow-up period after any vaccination.

  20. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).

    Unsolicited AE covers any AE 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 = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination.

    Measured: During the 28-day (Days 0-27) follow-up period after any vaccination.

  21. Number of Subjects With Any, Grade 3 and Related Medically Attended Adverse Events (MAEs).

    MAEs were defined as AEs that resulted in medical attention (defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason). Any = any MAE regardless of intensity or relationship to vaccination. Grade 3 MAE = MAE which prevented normal, everyday activities. Related = MAE assessed by the investigator as related to the vaccination. Assessment of intensity for MAEs was not performed.

    Measured: During the entire study period (Day 0 - Day 180)

  22. Number of Subjects With Any and Related Potential Immune-Mediated Diseases (pIMDs).

    pIMDs were defined as a subset of AEs that included both clearly autoimmune diseases (AID) and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.

    Measured: During the entire study period (Day 0 - Day 180)

  23. Number of Subjects With Any and Related Serious Adverse Events (SAEs).

    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

    Measured: During the entire study period (Day 0 - Day 180)

  24. Number of Days With Solicited Local Symptoms.

    The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited local symptoms for duration were pain, redness and swelling at the injection site.

    Measured: During the 7-day (Days 0-6) follow-up period after vaccination.

  25. Number of Days With Solicited General Symptoms

    The number of days with any grade of local symptoms after Dose 1 and Dose 2 vaccination respectively was tabulated. Assessed solicited general symptoms for duration were drowsiness, fatigue, gastrointestinal symptoms (Gastro.), headache, irritability, loss of appetite, muscle aches, shivering and temperature [axillary temperature equal to or above 37.5 degrees Celsius (°C)].

    Measured: During the 7-day (Days 0-6) follow-up period after vaccination.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2010 (estimated)
  2. Study start4 Oct 2010
  3. Primary completion15 Jun 2011
  4. Study completion15 Jun 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
3,027 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01196988
Sponsor's protocol ID
113275
Status last verified
Mar 2017
First submitted
7 Sep 2010
Last updated
21 Sep 2018
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Domachowske JB, Pankow-Culot H, Bautista M, Feng Y, Claeys C, Peeters M, Innis BL, Jain V. A randomized trial of candidate inactivated quadrivalent influenza vaccine versus trivalent influenza vaccines in children aged 3-17 years. J Infect Dis. 2013 Jun 15;207(12):1878-87. doi: 10.1093/infdis/jit091. Epub 2013 Mar 7.

    PubMed 23470848

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Influenza vaccine GSK2321138A, FluarixTM and Influenza vaccine GSK2604409A in people with Influenza, run by GlaxoSmithKline at 59 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 59 sites in Germany, United States, Czechia, France, Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. (time frame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01196988, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in