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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00964158
First received: August 20, 2009
Last updated: September 13, 2012
Last verified: September 2012
  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 3 and 17 years.


Condition Intervention Phase
Influenza A Virus, H1N1 Subtype
Influenza Infection
Biological: Pandemic influenza vaccine GSK2340272A
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 17 Years

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: Day 0, Day 21, Day 42 and Month 6+7 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Humoral immune response in terms of H1N1 HI antibodies [ Time Frame: Day 0, 21, 42, Month 6, Month 6+7 Days, Month 12 and Month 18 ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of neutralizing antibodies (in a subset of subjects) [ Time Frame: Day 0, 21, 42, Month 6, Month 6+7 Days, Month 12 and Month 18 ] [ Designated as safety issue: No ]
  • Occurrence of local and general symptoms [ Time Frame: During a 7-day follow-up period after each vaccination ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: During a 21-day follow-up period after the first vaccination, during a 62-day follow-up period after the second vaccination, and during a 30 day follow up period after the booster 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 visits [ Time Frame: From the beginning up to the study end (i.e. Day 0 up to Month 12) ] [ Designated as safety issue: No ]
  • Safety evaluation in terms of biochemical parameters [ Time Frame: Day 0, 21, 42, Month 6 and Month 6 + 7 Days ] [ Designated as safety issue: No ]

Enrollment: 210
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
Not Applicable
Biological: Pandemic influenza vaccine GSK2340272A
Two primary intramuscular (IM) injections and a booster IM injection

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
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 3 and 17 years at the time of the first study vaccination.
  • Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
  • Healthy children as established by medical history and clinical examination when entering into 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.

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.
  • Acute disease and/or fever at the time of enrolment
  • 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.
  • Previous administration of any H1N1 A/California-like vaccine.
  • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
  • If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
  • Any known or suspected allergy to any constituent of influenza vaccines;a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
  • Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.
  • 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: NCT00964158

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:
Carmona A et al. Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents. Abstract presented at the 49th Annual Meeting of Infectious Diseases Society of America (IDSA). Boston, USA, 20-23 October 2011.
Juan GS et al. (2011) Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents. Vaccine. 29(26):4353-4361.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00964158     History of Changes
Other Study ID Numbers: 113528
Study First Received: August 20, 2009
Last Updated: September 13, 2012
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:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014