Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Immunogenicity and Safety of an Investigational Pandemic Influenza Vaccine in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01323946
Recruitment Status : Completed
First Posted : March 28, 2011
Results First Posted : February 4, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The objective of the study is to evaluate the immunogenicity and safety of prime-boost vaccination schedule of GSK Biologicals' investigational vaccine GSK1562902A.

Condition or disease Intervention/treatment Phase
Influenza Biological: GSK Biologicals' investigational vaccine GSK1562902A Phase 2

Detailed Description:
This protocol posting was modified according to the protocol amendment 2 (dated 16-June-2011). The impacted section is eligibility criteria.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects were to be stratified into three age strata (6 to 11 months, 12 to 23 months and 24 to 35 months) in the ratio of 2:1:1.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of GSK Biologicals' (Pre-) Pandemic Influenza Candidate Vaccine (GSK1562902A) in Children Aged 6 to 35 Months
Actual Study Start Date : April 18, 2011
Actual Primary Completion Date : June 22, 2012
Actual Study Completion Date : November 2, 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GSK1562902A 6 to 12 M Group
Subjects between 6 and 12 months of age (6 to 12 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
Biological: GSK Biologicals' investigational vaccine GSK1562902A
Three intramuscular injections

Experimental: GSK1562902A 12 to 24 M Group
Subjects between 12 and 24 months of age (12 to 24 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
Biological: GSK Biologicals' investigational vaccine GSK1562902A
Three intramuscular injections

Experimental: GSK1562902A 24 to 36 M Group
Subjects between 24 and 36 months of age (24 to 36 M), who received 2 primary doses of A/Indonesia/05/2005 GSK1562902A vaccine on Days 0 and 21 and 1 booster dose of the A/turkey/Turkey/1/2005 GSK1562902A vaccine on Day 182.
Biological: GSK Biologicals' investigational vaccine GSK1562902A
Three intramuscular injections




Primary Outcome Measures :
  1. Number of Seroconverted Subjects in Terms of H5N1 Hemagglutination Inhibition (HI) Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain [ Time Frame: At Day 192 ]
    A seroconverted subject is defined as a subject that had either a pre-vaccination (Day 0) titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer on Day 192.

  2. Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain [ Time Frame: At Day 192 ]
    Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination (Day 192) reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer).

  3. Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain [ Time Frame: At Day 192 ]
    A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.


Secondary Outcome Measures :
  1. Hemagglutination Inhibition (HI) Antibody Titers Against the A/Indonesia/05/2005 H5N1 Virus Strain [ Time Frame: At Day 0, Day 42, Day 182, Day 192 and Day 364 ]
    Titers were presented as geometric mean titers (GMTs). Analyses were done by age stratum and overall.

  2. Hemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/01/2005 H5N1 Virus Strain [ Time Frame: At Day 0, Day 182, Day 192 and Day 364 ]
    Titers were presented as geometric mean titers (GMTs). Analyses were done by age stratum and overall.

  3. Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 [ Time Frame: At Day 0, Day 42, Day 182, Day 192 and Day 364 ]
    A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10.

  4. Number of Seropositive Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain [ Time Frame: At Day 0, Day 182, Day 192 and Day 364 ]
    A seropositive subject is defined as a subject with a serum H5N1 HI antibody titer ≥ 1:10.

  5. Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain [ Time Frame: At Day 42, Day 182, Day 192 and Day 364 ]
    A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer <1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer.

  6. Number of Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain [ Time Frame: At Day 182 and Day 364 ]
    A seroconverted subjects is defined as a subject who had either a pre vaccination (Day 0) titer <1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a 4-fold increase in post-vaccination titer. Data for Day 192 are presented under Primary Outcome Measures.

  7. Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 Virus Strain [ Time Frame: At Day 0, Day 42, Day 182, Day 192 and Day 364 ]
    A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40.

  8. Number of Seroprotected Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain [ Time Frame: Day 0, Day 182 and Day 364 ]
    A seroprotected subject is defined as a subject with a serum H5N1 HI antibody titer ≥1:40. Data for Day 192 are presented under Primary Outcome Measures.

  9. Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain [ Time Frame: At Day 42, Day 182, Day 192 and Day 364 ]
    Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer).

  10. Mean Geometric Change in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/01/2005 H5N1 Virus Strain [ Time Frame: Day 182 and Day 364 ]
    Mean Geometric Change is defined as the geometric mean of the within-subject ratios of the post vaccination reciprocal HI titer to the pre-vaccination (Day 0) reciprocal HI titer (i.e. post-vaccination divided by pre-vaccination titer). Data for Day 192 are presented under Primary Outcome Measures.

  11. Number of Booster Seroconverted Subjects in Terms of H5N1 HI Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain [ Time Frame: At Day 192 and Day 364 ]
    Booster seroconversion is defined as follows: For seronegative subjects at pre-booster (Day 182), antibody titer ≥1:40 at post-booster time point(s). For seropositive subjects at pre-booster (Day 182), antibody titer at post-booster time point(s) ≥4-fold the pre-booster antibody titer.

  12. Booster Factor in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain [ Time Frame: At Day 192 and Day 364 ]
    Booster Factor was defined as the geometric mean of the within-subject ratios of the post-booster vaccination reciprocal HI titer to the pre-booster (Day 182) reciprocal titer.

  13. Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain [ Time Frame: Day 0, Day 42, Day 182, Day 192 and Day 364 ]
    A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28

  14. Number of Seropositive Subjects in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain [ Time Frame: Day 0, Day 182, Day 192 and Day 364 ]
    A seropositive subject is defined as a subject with serum neutralizing antibody titers ≥ 1:28.

  15. Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain [ Time Frame: Day 0, Day 42, Day 182, Day 192 and Day 364 ]
    Titers were presented as geometric mean titers (GMTs).

  16. Serum Neutralizing Antibody Titers in Terms of Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain [ Time Frame: Day 0, Day 182, Day 192 and Day 364 ]
    Titers were presented as geometric mean titers (GMTs).

  17. Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Indonesia/05/2005 H5N1 Virus Strain [ Time Frame: At Day 42, Day 182, Day 192 and Day 364 ]
    Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0)

  18. Number of Subjects With a Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain [ Time Frame: At Day 182, Day 192 and Day 364 ]
    Vaccine response is defined as: For initially seronegative subjects, neutralizing antibody titer ≥ 1:56 at the considered time point after vaccination For initially seropositive subjects, neutralizing antibody titer ≥ 4 fold from pre-vaccination (Day 0)

  19. Number of Subjects With a Booster Vaccine Response in Terms of Serum Neutralizing Antibodies Against A/Turkey/Turkey/1/2005 H5N1 Virus Strain [ Time Frame: At Day 192 and Day 364 ]
    Booster vaccine response is defined as: For seronegative subjects at Day 182, neutralizing antibody titers ≥ 1:56 at the considered time point after vaccination For seropositive subjects at Day 182, neutralizing antibody titers ≥ 4 fold from pre-vaccination (Day 182)

  20. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189) ]
    Solicited local symptoms assigned were pain, swelling and redness. Any was defined as occurrence of any local symptom regardless of intensity grade; Grade 3 pain was defined as cried when limb was moved spontaneously painful.

  21. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 7-day post-vaccination period following each dose and across doses (Day 0 - Day 7, Day 21 - Day 28, Day 182 - Day 189) ]
    Solicited general symptoms assessed were diarrhoea/ vomiting, drowsiness, irritability/ fussiness, loss of appetite, fever (axillary). Any= occurrence of any general symptom regardless of intensity grade and relationship to the vaccine. Irritability/ fussiness grade 3=crying that could not be comforted/ prevented normal activity; Drowsiness grade 3= drowsiness that prevented normal activity; Loss of appetite grade 3= did not eat at all; Diarrhoea/ vomiting grade 3= diarrhoea/ vomiting that prevented normal activity; Related= general symptom assessed by the investigator as causally related to the study vaccination.

  22. Number of Subjects With Medically-attended Events (MAEs) [ Time Frame: During the entire study period (from Day 0 to Day 364) ]
    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. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.

  23. Number of Subjects With Potential Immune-mediated Disease (pIMDs) [ Time Frame: During the entire study period (from day 0 to Day 364) ]
    Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.

  24. Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During a 21 day follow-up period after each vaccination (Day 0 - Day 21, Day 21 - Day 42, Day 182 - Day 203) ]
    An AE is 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. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. "Grade 3" was defined as an AE which prevented normal, everyday activities. "Related" was defined as an AE assessed by the investigator as causally related to the study vaccination.

  25. Number of Subjects With Unsolicited Adverse Events (AEs) [ Time Frame: During an 84 day follow-up period after each vaccination (Day 0 - Day 84, Day 21 - Day 105, Day 182 - Day 266) ]
    An AE is 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. "Any" was defined as an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. "Grade 3" was defined as an AE which prevented normal, everyday activities. "Related" was defined as an AE assessed by the investigator as causally related to the study vaccination.

  26. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (from Day 0 to 364) ]
    Serious adverse events (SAEs) assessed included medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/ incapacity.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Months to 35 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that parents/Legally Acceptable Representatives (LARs) can and will comply with the requirements of the protocol.
  • Children, male or female between, and including, 6 and 35 months of age at the time of first study vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Healthy children as established by medical history and clinical examination before entering 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 are likely to reside in the vicinity of the study centre for the duration of the study. In studies using the home-based model for vaccination and follow-up, subjects who are likely to remain in the vicinity of the area where they were recruited.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration of any vaccine 30 days prior and 21 days after any study vaccine administration.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines such as egg protein or thiomersal.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of any neurological disorders or seizures.
  • Acute disease at the time of enrolment.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
  • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned administration during the study period.
  • Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
  • Child in care.
  • Previous vaccination at any time with an H5N1 vaccine.
  • Medical history of physician-confirmed infection with a H5N1 virus.

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): NCT01323946


Locations
Layout table for location information
Australia, Australian Capital Territory
GSK Investigational Site
Garran, Australian Capital Territory, Australia, 2606
Australia, New South Wales
GSK Investigational Site
Westmead, New South Wales, Australia, 2145
Australia, South Australia
GSK Investigational Site
North Adelaide, South Australia, Australia, 5006
Australia, Victoria
GSK Investigational Site
Carlton, Victoria, Australia, 3053
Singapore
GSK Investigational Site
Singapore, Singapore, 119074
GSK Investigational Site
Singapore, Singapore, 228510
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline
Additional Information:
Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 109825
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: 109825
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: 109825
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 109825
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 109825
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: 109825
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 109825
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01323946    
Other Study ID Numbers: 109825
2011-004734-33 ( EudraCT Number )
First Posted: March 28, 2011    Key Record Dates
Results First Posted: February 4, 2019
Last Update Posted: May 7, 2019
Last Verified: April 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.
Keywords provided by GlaxoSmithKline:
H5N1
influenza infection
Influenza vaccine GSK1562902A
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases