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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00971321
First received: August 27, 2009
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Influenza A Virus, H1N1 Subtype
Influenza Infection
Biological: Pandemic influenza vaccine GSK2340272A
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Humoral immune response in terms of H1N1 haemagglutination inhibition (HI) antibodies [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of H1N1 haemagglutination inhibition (HI) antibodies [ Time Frame: At Day 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Humoral immune response in terms of HI antibodies [ Time Frame: Day 0, 21, 42, and at Month 11-12 ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of neutralizing antibodies (in all subjects aged 6 to 11 months and a subset of subjects randomly selected using GSK SBIR) [ Time Frame: Day 0, 21, 42, Month 6, and at Month 11-12 ] [ Designated as safety issue: No ]
  • Occurrence of local and general symptoms [ Time Frame: During a 7-day (day 0-6) follow-up period after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: During a 21-day (day 0-20) follow-up period after the first vaccination, and during a 62-day follow-up period after the second vaccination ] [ Designated as safety issue: No ]
  • Occurrence of adverse events of specific interest / potential immune-mediated disorders, of serious adverse events, and of medically attended events [ Time Frame: From the beginning up to the study end (day 0 - month 12) ] [ Designated as safety issue: No ]
  • Safety evaluation in terms of biochemical parameters [ Time Frame: Day 0, 21 and 42 ] [ Designated as safety issue: No ]

Enrollment: 157
Study Start Date: September 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects in this group will receive investigational vaccine regimen according to a protocol specified schedule different from Group B
Biological: Pandemic influenza vaccine GSK2340272A
Two primary intramuscular (IM) injections
Experimental: Group B
Subjects in this group will receive investigational vaccine regimen according to a protocol specified schedule different from Group A
Biological: Pandemic influenza vaccine GSK2340272A
Two primary intramuscular (IM) injections

  Eligibility

Ages Eligible for Study:   6 Months to 35 Months
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971321

Locations
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
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
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: NCT00971321     History of Changes
Other Study ID Numbers: 113462
Study First Received: August 27, 2009
Last Updated: June 30, 2011
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios

Keywords provided by GlaxoSmithKline:
influenza infection
GSK Bio's influenza vaccine GSK2340272A

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

ClinicalTrials.gov processed this record on October 23, 2014