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

August 20, 2009
September 13, 2012
September 2009
November 2010   (final data collection date for primary outcome measure)
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 ]
Humoral immune response in terms of H1N1 haemagglutination inhibition (HI) antibodies [ Time Frame: Day 42 and Month 6+7 Days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00964158 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 [ 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, of serious adverse events, and of medically attended visits [ Time Frame: From the beginning up to the study end ] [ 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 ]
Not Provided
Not Provided
 
Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 17 Years

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Influenza A Virus, H1N1 Subtype
  • Influenza Infection
Biological: Pandemic influenza vaccine GSK2340272A
Two primary intramuscular (IM) injections and a booster IM injection
Experimental: Group A
Not Applicable
Intervention: Biological: Pandemic influenza vaccine GSK2340272A
Garcia-Sicilia J, Gillard P, Carmona A, Tejedor JC, Aristegui J, Merino JM, Behre U, Caplanusi A, Vaman T, Dieussaert I. Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents. Vaccine. 2011 Jun 10;29(26):4353-61. Epub 2011 Apr 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
3 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00964158
113528
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP