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

August 27, 2009
June 30, 2011
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: 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 ]
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 NCT00971321 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 (day 0-20) 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 ]
  • Humoral immune response in terms of HI 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 adverse events of specific interest, of serious adverse events, and of medically attended visits [ Time Frame: From the beginning up to the study end (day 0 - month 18) ] [ 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, 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 6 to 35 Months

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Influenza A Virus, H1N1 Subtype
  • Influenza Infection
Biological: Pandemic influenza vaccine GSK2340272A
Two primary intramuscular (IM) injections
  • Experimental: Group A
    Subjects in this group will receive investigational vaccine regimen according to a protocol specified schedule different from Group B
    Intervention: Biological: Pandemic influenza vaccine GSK2340272A
  • Experimental: Group B
    Subjects in this group will receive investigational vaccine regimen according to a protocol specified schedule different from Group A
    Intervention: Biological: Pandemic influenza vaccine GSK2340272A

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
157
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 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.
Both
6 Months to 35 Months
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00971321
113462
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2011

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