Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Children Aged 10 to Less Than 18 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01035749
First received: December 17, 2009
Last updated: July 23, 2012
Last verified: May 2011
  Purpose

The purpose of this study is to show that vaccination with a single dose of GSK Biologicals' pandemic H1N1 vaccine results in an immune response that meets or exceeds European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) guidance criteria for a pandemic influenza vaccine.


Condition Intervention Phase
H1N1 Subtype
Influenza A
Biological: GSK Biologicals' Influenza investigational vaccine GSK2340274A
Biological: GSK Biologicals' Influenza investigational vaccine GSK2340273A
Biological: Placebo (saline)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine (GSK2340274A) in Children Aged 10 to Less Than 18 Years

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Humoral immune response in terms of HI antibodies [ Time Frame: 21 days after the first dose of H1N1 vaccine (Day 21) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Humoral immune response in terms of homologous HI antibodies [ Time Frame: At Day 0, Day 21, Day 42, Day 182 and Day 189 ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of heterologous HI antibodies [ Time Frame: at Day 0, Day 21, Day 42, Day 182 and Day 189 ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of MN antibodies [ Time Frame: at Day 0, Day 21, Day 42, Day 182 and Day 189 ] [ Designated as safety issue: No ]
  • Solicited local and general symptoms [ Time Frame: during a 7-day follow up period after each dose ] [ Designated as safety issue: No ]
  • Unsolicited adverse events [ Time Frame: during a 21-day follow-up period after each dose ] [ Designated as safety issue: No ]
  • Occurrence of medically-attended events (MAEs), serious adverse events(SAEs), potential immune-mediated disease (pIMDs) [ Time Frame: throughout the study period (from Day 0 until Day 364) ] [ Designated as safety issue: No ]
  • Clinical laboratory abnormalities [ Time Frame: at Day 0, Day 21, Day 42, Day 182 and Day 189 ] [ Designated as safety issue: No ]

Enrollment: 310
Study Start Date: February 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects will receive two doses of the investigational vaccine GSK2340274A (standard formulation) and one dose of placebo according to a protocol defined schedule.
Biological: GSK Biologicals' Influenza investigational vaccine GSK2340274A
One or two doses administered intramuscularly
Biological: Placebo (saline)
One dose intramuscularly
Experimental: Group B
Subjects will receive two doses of the investigational vaccine GSK2340274A (alternative formulation) and one dose of placebo according to a protocol defined schedule
Biological: GSK Biologicals' Influenza investigational vaccine GSK2340274A
One or two doses administered intramuscularly
Biological: Placebo (saline)
One dose intramuscularly
Experimental: Group C
Subjects will receive three doses of the investigational vaccine GSK2340274A (alternative formulation) according to a protocol defined schedule
Biological: GSK Biologicals' Influenza investigational vaccine GSK2340274A
One or two doses administered intramuscularly
Experimental: Group D
Subjects will receive two doses of the investigational vaccine GSK2340273A and one dose of placebo according to a protocol defined schedule
Biological: GSK Biologicals' Influenza investigational vaccine GSK2340273A
Two doses intramuscularly
Biological: Placebo (saline)
One dose intramuscularly

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female children 10 to < 18 years of age at the time of the first vaccination. "Less than 18 years of age" implies inclusion of adolescents who have not reached their 18th birthday as of Day 0, the day of the first vaccine dose under this protocol.
  • Written informed consent obtained from the subject's parent/legally acceptable representative (LAR); written informed assent obtained from the subject if appropriate.
  • Good general health as established by medical history and clinical examination before entering into 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 the investigator believes that they and/or their parent(s)/LAR can and will comply with the requirements of the protocol.

Exclusion Criteria:

  • Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-like virus.
  • Previous vaccination at any time with an A/California/7/2009 (H1N1)v-like virus vaccine.
  • Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, even if stable, are deemed by the investigator to render the potential subject or parent(s)/ LAR(s) unable/unlikely to provide accurate safety reports.
  • Presence of a temperature >= 38.0ºC by any route or method, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination. NOTE: The subject may be vaccinated at a later date, provided symptoms have resolved, vaccination occurs within the window specified by the protocol, and all other eligibility criteria continue to be satisfied.
  • Diagnosed with cancer, or treatment for cancer, within 3 years.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • Receipt of systemic glucocorticoids within 1 month prior to study enrollment (first dose of study vaccine), or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
  • Receipt of any immunoglobulins and/or any blood products within 6 months of study enrollment or planned administration of any of these products during the study period.
  • Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin are eligible if no such doses are given in the 24 hours before a study vaccination. Persons receiving prophylactic antiplatelet medications, e.g., low-dose acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
  • An acute evolving neurological disorder or history of Guillain-Barré syndrome within 6 weeks of receipt of seasonal influenza vaccine.
  • Administration of any licensed vaccine within 30 days before the first dose of study vaccine, with the exception of seasonal influenza vaccine (which may be given within 2 weeks before the first dose of study vaccine).
  • Planned administration of any A/California H1N1v-like vaccine other than the study vaccine between Day 0 and the Day 189 phlebotomy.
  • Planned administration of any other vaccine not foreseen by the study protocol between Day 0 and Day 42 after the first vaccine dose, including seasonal influenza vaccine. Routine childhood vaccinations are exempted if they cannot be delayed, but they must not be administered on the same day as the H1N1 vaccine candidate.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza vaccine.
  • 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: NCT01035749

Locations
Estonia
GSK Investigational Site
Tartu, Estonia, 50106
Slovakia
GSK Investigational Site
Cifer, Slovakia, 919 43
GSK Investigational Site
Dolny Kubin, Slovakia, 026 01
GSK Investigational Site
Nova Dubnica, Slovakia, 018 51
GSK Investigational Site
Puchov, Slovakia, 020 01
GSK Investigational Site
Ruzomberok, Slovakia, 034 01
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01035749     History of Changes
Other Study ID Numbers: 113883
Study First Received: December 17, 2009
Last Updated: July 23, 2012
Health Authority: Slovakia: State Institute for Drug Control
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
pandemic influenza
Clinical trial
H1N1
children

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 27, 2014