Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)

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: NCT00971321
Recruitment Status : Completed
First Posted : September 3, 2009
Results First Posted : February 25, 2019
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 6 and 35 months.

This protocol posting has been updated following protocol amendment 4, March 2010. The protocol posting sections impacted are number of subjects, primary and secondary endpoints and intervention.


Condition or disease Intervention/treatment Phase
Influenza Biological: Pandemic influenza vaccine GSK2340272A Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 6 to 35 Months
Study Start Date : September 10, 2009
Actual Primary Completion Date : November 24, 2010
Actual Study Completion Date : November 24, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: GSK 2340272A F1 Group
Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (<) 12 months at study entry.
Biological: Pandemic influenza vaccine GSK2340272A
Two primary intramuscular (IM) injections

Experimental: GSK 2340272A F2 Group
Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (<) 12 months at study entry.
Biological: Pandemic influenza vaccine GSK2340272A
Two primary intramuscular (IM) injections




Primary Outcome Measures :
  1. Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies [ Time Frame: At Day 0 ]
    Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

  2. Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies [ Time Frame: At Day 42 ]
    Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

  3. Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies [ Time Frame: At Day 0 ]
    Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

  4. Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies [ Time Frame: At Day 42 ]
    Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

  5. Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibodies [ Time Frame: At Day 42 ]
    Seroconversion (SCR) was defined as the percentage of vaccinees that have 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 4-fold increase in post-vaccination titer. The strain assessed was Flu A/California/7/2009 (H1N1).

  6. Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies [ Time Frame: At Day 42 ]
    Seroprotection (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The strain assessed was Flu A/California/7/2009 (H1N1).

  7. Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers [ Time Frame: At Day 42 ]
    Seroconversion factor was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The strain assessed was Flu A/California/7/2009 (H1N1).


Secondary Outcome Measures :
  1. Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies [ Time Frame: At Days 0, 21, 42, and at Month 11-12 ]
    Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

  2. Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies [ Time Frame: At Days 0, 21, 42 and at Month 11-12 ]
    Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

  3. Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibody Titers [ Time Frame: At Days 21, 42 and at Month 11-12 ]
    Seroconversion (SCR) was defined as the percentage of vaccinees that have 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 4-fold increase in post-vaccination titer. The strain assessed was Flu A/California/7/2009 (H1N1).

  4. Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies [ Time Frame: At Days 0, 21, 42 and at Month 11-12 ]
    Seroprotection (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The strain assessed was Flu A/California/7/2009 (H1N1).

  5. Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers [ Time Frame: At Days 21, 42 and at Month 11-12 ]
    Seroconversion factor was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The strain assessed was Flu A/California/7/2009 (H1N1).

  6. Titers for Serum Neutralising Antibodies [ Time Frame: At Days 0, 21 and 42 ]
    Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:8. The strain assessed was Flu A/Neth/602/09.

  7. Titers for Serum Neutralising Antibodies [ Time Frame: At Days 0, 21, 42 and at Month 11-12 ]
    Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:8. The strain assessed was Flu A/Neth/602/09.

  8. Number of Subjects With Vaccine Response for Serum Neutralising Antibodies [ Time Frame: At Days 21 and 42 ]
    Vaccine response rate was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination for neutralising antibody response. For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The strain assessed was Flu A/Neth/602/2009.

  9. Number of Subjects With Vaccine Response for Serum Neutralising Antibodies [ Time Frame: At Days 21, 42 and at Month 11-12 ]
    Vaccine response rate was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination for neutralising antibody response. For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The strain assessed was Flu A/Neth/602/2009.

  10. Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period after 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 = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.

  11. Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 7-day (Days 0-6) post-vaccination period after each dose and across doses ]
    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

  12. Number of Subjects With Any Medically-attended Events (MAEs) [ Time Frame: During the entire study period (Day 0 up to Month 7 and Day 0 up to Month 11-12) ]
    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.

  13. Number of Subjects With Any Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Disease (pIMDs) [ Time Frame: During the entire study period (Day 0 up to Month 11-12) ]
    An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. 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.

  14. Number of Subjects With Normal/Abnormal Biochemical Levels [ Time Frame: At Days 0, 21 and 42 ]
    Among biochemical parameters assessed were: alanine aminotrasferase [ALAT], aspartate aminotransferase [ASAT], bilirubin total [BIL/T], bilirubin direct [BIL/D], creatinine [CREA] and blood urea nitrogen [BUN]. Levels of biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above.

  15. Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: During a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84) ]
    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. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.

  16. Number of Subjects With Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (Day 0 up to Month 11-12) ]
    Serious adverse events (SAEs) assessed include 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 their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
  • Children, male or female, aged between 6 and 35 months at the time of first study vaccination.
  • Written informed consent obtained from the parent(s) or LAR(s) of the subject.
  • Healthy children, as established by medical history and clinical examination when entering the study.
  • Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.

Exclusion Criteria:

  • 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.
  • Clinically or virologically confirmed influenza infection within six months preceding the study start.
  • Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
  • 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.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
  • History of hypersensitivity to vaccines.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines
  • History of any neurological disorders or seizures.
  • Acute disease and/or fever at the time of enrolment
  • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
  • Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
  • Child in Care.

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): NCT00971321


Locations
Layout table for location information
Spain
GSK Investigational Site
Bilbao, Spain, 48013
GSK Investigational Site
Burgos, Spain, 09005
GSK Investigational Site
Madrid, Spain, 28046
GSK Investigational Site
Móstoles/Madrid, Spain, 28935
GSK Investigational Site
Sevilla, Spain, 41013
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline
Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 113462
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: 113462
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 113462
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: 113462
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: 113462
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 113462
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: 113462
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00971321    
Other Study ID Numbers: 113462
First Posted: September 3, 2009    Key Record Dates
Results First Posted: February 25, 2019
Last Update Posted: February 25, 2019
Last Verified: August 2018
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:
influenza infection
GSK Bio's influenza vaccine GSK2340272A
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases