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Completed

NCT Number: NCT01035749

Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children Aged 10 to Less Than 18 Years

The purpose of this study is to show that vaccination with a single dose of GSK Biologicals' pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) guidance criteria for a pandemic influenza vaccine.

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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

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Tartu, Estonia

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female children 10 to < 18 years of age at the time of the first vaccination. "Less than 18 years of age" implies inclusion of adolescents who have not reached their 18th birthday as of Day 0, the day of the first vaccine dose under this protocol.
  • Written informed consent obtained from the subject's parent/legally acceptable representative (LAR); written informed assent obtained from the subject if appropriate.
  • Good general health as established by medical history and clinical examination before entering into the study.
  • Parent/LAR access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
  • Subjects who the investigator believes that they and/or their parent(s)/LAR can and will comply with the requirements of the protocol.

Exclusion criteria

  • Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
  • Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus vaccine.
  • Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject or parent(s)/ LAR(s) unable/unlikely to provide accurate safety reports.
  • Presence of a temperature >= 38.0ºC by any route or method, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
  • Diagnosed with cancer, or treatment for cancer, within 3 years.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • Receipt of systemic glucocorticoids within 1 month prior to study enrollment (first dose of study vaccine), or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
  • Receipt of any immunoglobulins and/or any blood products within 6 months of study enrollment or planned administration of any of these products during the study period.
  • Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
  • An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
  • Administration of any licensed vaccine within 30 days before the first dose of study vaccine, with the exception of seasonal influenza vaccine (which may be given within 2 weeks before the first dose of study vaccine).
  • Planned administration of any A/California H1N1v-like vaccine other than the study vaccine between Day 0 and the Day 189 phlebotomy.
  • Planned administration of any other vaccine not foreseen by the study protocol between Day 0 and Day 42 after the first vaccine dose, including seasonal influenza vaccine. Routine childhood vaccinations are exempted if they cannot be delayed, but they must not be administered on the same day as the H1N1 vaccine candidate.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
  • Child in care.

Treatment and study plan

GSK Biologicals' Influenza investigational vaccine GSK2340274A

Biological

One or two doses administered intramuscularly

GSK Biologicals' Influenza investigational vaccine GSK2340273A

Biological

Two doses intramuscularly

Placebo (Saline)

Biological

One dose intramuscularly

Primary outcomes

  1. Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain

    Time frame: At Day 21

    Seroconversion defined as: - For initially seronegative subjects, antibody titre ≥ 1:40 after vaccination - For initially seropositive subjects, antibody titre after vaccination ≥ 4 fold the pre-vaccination antibody titre

  2. Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain

    Time frame: At Day 0 and Day 21

    A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.

  3. HI Antibody Seroconversion Factors Against Flu A/CAL/7/09 H1N1 Strain

    Time frame: At Day 21

    Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.

Secondary outcomes

  1. HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain

    Time frame: At Day 0 and Day 42

    Antibody titres were expressed as Geometric mean titers (GMTs).

  2. HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain

    Time frame: At Day 0 and Day 182

    Antibody titres were expressed as GMTs.

  3. HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain

    Time frame: At Days 0, 182 and 189

    Antibody titres were expressed as Geometric mean titers (GMTs).

  4. Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain

    Time frame: At Day 42

    A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre.

  5. HI Antibody Titres Against Flu A/CAL/7/09 H1N1 Strain

    Time frame: At Day 0 and Day 21

    Antibody titers were expressed as GMTs.

  6. Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain

    Time frame: At Day 182

    A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre.

  7. Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain

    Time frame: At Day 189

    A seroconverted subject was defined as a subject who had either a pre-vaccination titre below 1:10 and a post-vaccination titre greater than or equal to 1:40 or a pre-vaccination titre greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titre. Day 0 was used as reference activity.

  8. Number of Subjects Seroconverted for HI Antibodies Against Flu A/CAL/7/09 H1N1 Strain

    Time frame: At Day 189

    A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. Day 182 was used as reference activity.

  9. The Number of Subjects Seroprotected for HI Antibodies Against Flu A/CAL/7/09 H1N1

    Time frame: At Day 0 and Day 42

    A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection.

  10. Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1

    Time frame: At Day 0 and Day 182

    A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection.

  11. Number of Subjects Seroprotected to HI Antibodies Against Flu A/CAL/7/09 H1N1

    Time frame: At Day 0, Day 182 and Day 189

    A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.

  12. Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 H1N1

    Time frame: At Day 42

    GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

  13. GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1

    Time frame: At Day 182

    GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

  14. GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 0 as Reference Activity

    Time frame: At Day 189

    GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

  15. GMFR for HI Antibodies Against Flu A/CAL/7/09 H1N1 Using Day 182 as Reference Activity

    Time frame: At Day 189

    GMFR (also known as the seroconversion factor, SCF) was defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.

  16. Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)

    Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose

    Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was > 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity.

  17. Number of Subjects Reporting Any and Grade 3 Solicited Local AEs

    Time frame: During the 7-day (Days 0-6) post-vaccination period following booster dose

    Any was defined as occurrence of any local symptom regardless of their intensity grade.Grade 3 redness and swelling was > 100 millimeter (mm) and grade 3 pain was defined as pain that prevented normal activity

  18. Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs

    Time frame: During the 7-day (Days 0-6) post-vaccination period following each dose

    Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature equal to or above (≥) 39.0°C.

  19. Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs

    Time frame: During the 7-day (Days 0-6) post-vaccination period following booster dose

    Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering, sweating and fever (Fever = axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature equal to or above (≥) 39.0°C.

  20. Number of Subjects Reporting Any Medically Attended Events (MAEs)

    Time frame: During the entire study period (Days 0-364) following the first vaccination

    MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.

  21. Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)

    Time frame: During the entire study period (Days 0-364) following first vaccination

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

  22. Number of Subjects With Normal and Abnormal Hematological and Biochemical Parameters Assessed With Respect to Normal Laboratory Ranges

    Time frame: At Days 0, 21, 42, 182 and 189

    Subjects were categorized according to their results at pre-vaccination (PRE), Day 21, Day 42, Day 182 and Day 189 which were within normal, above normal, below the normal ranges or unknown. The laboratory parameters assessed were Alanine aminotransferase (ALAT), Aspartate aminotransferase (ASAT), Total Bilirubin, Creatinine, Hematocrit, Hemoglobin, Platelets, Blood urea nitrogen (BUN) and White blood cells (WBCs).

  23. Number of Subjects Reporting Any Unsolicited AEs

    Time frame: During the 42-day (Days 0-41) follow up period after first vaccination.

    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 was defined as any symptom regardless of intensity or relationship to vaccination.

  24. Number of Subjects Reporting Any Unsolicited AEs

    Time frame: During the 21-day (Days 0-20) follow-up period after booster vaccination.

    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 was defined as any symptom regardless of intensity or relationship to vaccination.

  25. Number of Subjects Reporting Serious Adverse Events (SAEs)

    Time frame: During the entire study period (Day 0 to Day 364)

    SAEs: 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine (GSK2340274A) in Children Aged 10 to Less Than 18 Years

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Dec 21, 2009
Registry last updated
Aug 17, 2018

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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