Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Children

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00502593
First received: July 16, 2007
Last updated: March 9, 2012
Last verified: March 2012
  Purpose

The present study is designed to evaluate in children (aged between 3 and 9 years) the immunogenicity and safety of different antigen doses of the candidate vaccine (GSK1562902A) administered following a two-administration schedule (21 days apart). Subjects in the control group will receive Fluarix. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
Influenza
Biological: Pandemic Influenza Vaccine (GSK1562902A)
Biological: Fluarix
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Controlled Study of Safety & Immunogenicity of Diff. Antigen Doses of a Pandemic Influenza Vaccine Candidate (GSK1562902A) Given as 2 Doses in Children Between 3 & 9 Yrs of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Geometric mean titers of serum antibodies [ Time Frame: At day 0 ] [ Designated as safety issue: No ]
  • Seroconversion rates [ Time Frame: At day 21 ] [ Designated as safety issue: No ]
  • Seroconversion factors [ Time Frame: At day 21 ] [ Designated as safety issue: No ]
  • Seroprotection rates [ Time Frame: At day 0 ] [ Designated as safety issue: No ]
  • Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms [ Time Frame: During a 7 day follow-up period after each vaccination ] [ Designated as safety issue: No ]
  • Percentage, intensity and relationship to vaccination of solicited local and general signs and symptoms [ Time Frame: During a 21 day follow-up period after the first vaccination, during a 30-day follow-up period after the second vaccination ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: During the entire study (Day 0 to Day Month 24) ] [ Designated as safety issue: No ]
  • Descriptive statistics (mean, median, minimum, maximum) of selected biochemistry parameters [ Time Frame: At each scheduled time point ] [ Designated as safety issue: No ]
  • Number and percentage of subjects with normal or abnormal values for each selected biochemistry parameter [ Time Frame: At each scheduled time point ] [ Designated as safety issue: No ]
  • Geometric mean titers of serum antibodies - day 21 [ Time Frame: At day 21 ] [ Designated as safety issue: No ]
  • Geometric mean titers of serum antibodies - day 42 [ Time Frame: At day 42 ] [ Designated as safety issue: No ]
  • Geometric mean titers of serum antibodies - 6 months [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Geometric mean titers of serum antibodies - 12 months [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
  • Geometric mean titers of serum antibodies - 24 months [ Time Frame: At 24 months ] [ Designated as safety issue: No ]
  • Seroconversion rates - day 42 [ Time Frame: At day 42 ] [ Designated as safety issue: No ]
  • Seroconversion rates - 6 months [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Seroconversion rates - 12 months [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
  • Seroconversion rates - 24 months [ Time Frame: At 24 months ] [ Designated as safety issue: No ]
  • Seroconversion factors - day 42 [ Time Frame: At day 42 ] [ Designated as safety issue: No ]
  • Seroconversion factors - 6 months [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Seroconversion factors - 12 months [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
  • Seroconversion factors - 24 months [ Time Frame: At 24 months ] [ Designated as safety issue: No ]
  • Seroprotection rates - day 21 [ Time Frame: At day 21 ] [ Designated as safety issue: No ]
  • Seroprotection rates - day 42 [ Time Frame: At day 42 ] [ Designated as safety issue: No ]
  • Seroprotection rates - 6 months [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
  • Seroprotection rates - 12 months [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
  • Seroprotection rates - 24 months [ Time Frame: At 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum neutralizing antibody titers tested [ Time Frame: At days 0, 21, 42, Month 6, Month 12 and Month 24 ] [ Designated as safety issue: No ]
  • GMTs of serum neutralizing antibodies [ Time Frame: At days 0, 21, 42, Month 6, Month 12 and Month 24 ] [ Designated as safety issue: No ]
  • Seroconversion rates [ Time Frame: At days 21, 42, Month 6, Month 12 and Month 24 ] [ Designated as safety issue: No ]
  • Seroprotection rates [ Time Frame: At 6 months, 12 months and 24 months ] [ Designated as safety issue: No ]

Enrollment: 138
Study Start Date: July 2007
Study Completion Date: April 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: Pandemic Influenza Vaccine (GSK1562902A)
2 doses, intramuscular injection, 3 different formulations are tested
Experimental: Group B Biological: Pandemic Influenza Vaccine (GSK1562902A)
2 doses, intramuscular injection, 3 different formulations are tested
Experimental: Group C Biological: Pandemic Influenza Vaccine (GSK1562902A)
2 doses, intramuscular injection, 3 different formulations are tested
Active Comparator: Group D Biological: Fluarix
2 doses, intramuscular injection

  Eligibility

Ages Eligible for Study:   3 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
  • Children aged between and including 3 and 9 years of age at the time of first vaccination.
  • Written informed consent obtained from the parent(s) or guardian of the subject.
  • Healthy children as established by medical history and clinical examination before entering the study.
  • Subjects who are likely to reside in the vicinity of the study center for the duration of the study.

Exclusion criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the investigational vaccine within 30 days prior to the enrolment in this study, or planned use during the study period.
  • Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after the second vaccination, with the exception of routine childhood inoculations which cannot be delayed, but which must not be administered on the same day as the investigational vaccine candidate.
  • Administration of the interpandemic influenza vaccine 21 days prior to Day 0 or up to Day 51.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the enrolment in this study.
  • Any chronic drug therapy to be continued during the study period, with the exception of inhalative treatment for seasonal allergies or asthma.
  • 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 used in this study.
  • History of any neurological disorders or seizures.
  • Acute disease 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00502593

Locations
Spain
GSK Investigational Site
Blanes (Girona), Spain, 17300
GSK Investigational Site
L'Eliana, Valencia, Spain, 46183
GSK Investigational Site
Paiporta, Valencia, Spain, 46200
GSK Investigational Site
Quart de Poblet, Valencia, Spain, 46930
GSK Investigational Site
Valencia, Spain, 46011
GSK Investigational Site
Valencia, Spain, 46008
GSK Investigational Site
Valencia, Spain, 46024
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Domingo JD et al. (2010) Immunogenicity and safety of H5N1 A/Vietnam/1194/2004 (Clade 1) AS03-adjuvanted prepandemic candidate influenza vaccines in children aged 3 to 9 years. a phase II, randomized, open, controlled study. Pediatr Infect Dis J. 29(6): e35-e46.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00502593     History of Changes
Other Study ID Numbers: 107066, 108498, 108500
Study First Received: July 16, 2007
Last Updated: March 9, 2012
Health Authority: Spain: Dr. Mr. Elías Ruiz Rojo, Secretary of the Clínical Research Ethics Committee (EC) of the VA-DGSP and CSISP (Directorate General of Public Health of Valencia)

Keywords provided by GlaxoSmithKline:
Influenza
Pandemic Influenza Vaccine (GSK1562902A)

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014