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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01323946
First received: March 24, 2011
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Influenza
Biological: GSK Biologicals' investigational vaccine GSK1562902A
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to components of the investigational vaccine GSK1562902A [ Time Frame: On Day 192 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to components of the investigational vaccine GSK1562902A [ Time Frame: On Day 0, Day 42, Day 182, Day 192 and Day 364 ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to components of the investigational vaccine GSK1562902A in terms of neutralising antibodies [ Time Frame: On Day 0, Day 42, Day 182, Day 192 and Day 364 ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general adverse events (AEs) [ Time Frame: During a 7-day (Day 0-6) follow-up period after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited AEs [ Time Frame: During a 21-day (Day 0-20) follow-up period after each vaccination and from Day 0 to Day 84 overall ] [ Designated as safety issue: No ]
  • Occurrence of medically-attended adverse events (MAEs), potential Immune-Mediated Diseases (pIMDs) and serious adverse events (SAEs) [ Time Frame: During the entire study period (Day 0-364) ] [ Designated as safety issue: No ]

Enrollment: 113
Study Start Date: April 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Not Applicable
Biological: GSK Biologicals' investigational vaccine GSK1562902A
Three intramuscular injections

Detailed Description:

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

  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 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.
  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: NCT01323946

Locations
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
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01323946     History of Changes
Other Study ID Numbers: 109825
Study First Received: March 24, 2011
Last Updated: December 19, 2013
Health Authority: Singapore: Health Sciences Authority
Australia: Therapeutic Goods Administration

Keywords provided by GlaxoSmithKline:
H5N1
influenza infection
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 August 28, 2014