Safety and Immunogenicity of H1N1 Vaccines in Children Aged 6 Months to Less Than 9 Years of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00976820
First received: September 11, 2009
Last updated: June 14, 2012
Last verified: January 2012
  Purpose

The purpose of this study is to characterize the safety and immune response of the H1N1 (swine) flu vaccines GSK2340274A and GSK2340273A in children 6 months to less than 9 years of age.

This Protocol Posting has been updated following the Protocol amendment 1 & 2, September and October 2009. The sections impacted are study design, objectives and analysis methods.


Condition Intervention Phase
Influenza Infection
Biological: GSK2340274A
Biological: GSK2340273A
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Safety and Immunogenicity of A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340273A in Children 6 Months to Less Than 9 Years of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Vaccine virus-homologous HI antibody response of subjects in Groups A - D [ Time Frame: At screening visit prior to day 0 and days 21 or 42 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vaccine-virus homologous HI antibody response of subjects in Groups A - D [ Time Frame: At screening visit prior to day 0, at day 21, day 42, and day 182 ] [ Designated as safety issue: No ]
  • Vaccine virus heterologous HI antibody response in a subcohort of subjects in each group (A - D) [ Time Frame: At screening visit prior to day 0, at day 21, day 42, and day 182 ] [ Designated as safety issue: No ]
  • Vaccine virus-homologous and heterologous microneutralization antibody response for subjects in all groups (A - D) [ Time Frame: At screening visit prior to day 0, at day 21, day 42, and day 182 ] [ Designated as safety issue: No ]
  • Occurrence of specifically-solicited local and general signs and symptoms [ Time Frame: During a 7-day (Day 0-6) follow-up period after each dose of vaccine ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: During a 21-day (Day 0-20) follow-up period after each dose and from Days 0 -to 84 ] [ Designated as safety issue: No ]
  • Clinical laboratory abnormalities [ Time Frame: At screening visit prior to day 0, days 7, 21, 42, and 182 ] [ Designated as safety issue: No ]
  • Occurrence of medically attended and/or serious adverse events, and of potential immune-mediated diseases [ Time Frame: Days 0 to 385 ] [ Designated as safety issue: No ]

Enrollment: 323
Study Start Date: October 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects in this group will receive investigational vaccine regimen according to a protocol specified schedule different from Group B, Group C and Group D
Biological: GSK2340274A
Two intramuscular injections
Experimental: Group B
Subjects in this group will receive investigational vaccine regimen according to a protocol specified schedule different from Group A, Group C and Group D
Biological: GSK2340274A
Two intramuscular injections
Experimental: Group C
Subjects in this group will receive investigational vaccine regimen according to a protocol specified schedule different from Group A, Group B and Group D
Biological: GSK2340273A
Two intramuscular injections
Experimental: Group D
Subjects in this group will receive investigational vaccine regimen according to a protocol specified schedule different from Group A, Group B and Group C
Biological: GSK2340273A
Two intramuscular injections

Detailed Description:

Collaborators: United States Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority

  Eligibility

Ages Eligible for Study:   6 Months to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female children 6 months to less than 9 years of age at the time of the first vaccination.
  • 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.
  • Safety laboratory test results within the parameters specified in the protocol.
  • 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 their parent(s)/ LAR can and will comply with the requirements of the protocol.
  • Female subjects of non-childbearing potential (pre-menarche) may be enrolled in the study.

Exclusion Criteria:

  • Previous vaccination with an H1N1v-like virus vaccine or a medical history of physician-confirmed infection with an H1N1v-like virus.
  • 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 (>=100.4ºF) by any route or method, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
  • 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
  • Receipt of systemic glucocorticoids within 1 month prior to study enrollment, 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 3 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 4 weeks before the first dose of study vaccine, with the exception of seasonal influenza vaccine.
  • Planned administration of any vaccine not foreseen by the study protocol between Day 0 and the Day 42 phlebotomy, 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 any constituent of influenza vaccines; 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: NCT00976820

Locations
Canada, British Columbia
GSK Investigational Site
Coquitlam, British Columbia, Canada, V3K 3P4
Canada, Manitoba
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3A 1M3
Canada, Newfoundland and Labrador
GSK Investigational Site
Saint John's, Newfoundland and Labrador, Canada, A1A 3R5
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
GSK Investigational Site
Brampton, Ontario, Canada, L6T 0G1
GSK Investigational Site
Hamilton, Ontario, Canada, L8L 5G8
GSK Investigational Site
Newmarket, Ontario, Canada, L3Y 5G8
GSK Investigational Site
Sudbury, Ontario, Canada, P3E 1H5
GSK Investigational Site
Toronto, Ontario, Canada, M5G 1N8
GSK Investigational Site
Toronto, Ontario, Canada, M9V 4B4
Canada, Quebec
GSK Investigational Site
Montreal, Quebec, Canada, H3T 1C5
GSK Investigational Site
Quebec City, Quebec, Canada, G1V 4T3
GSK Investigational Site
Sherbrooke, Quebec, Canada, J1H 1Z1
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Langley J et al. Immunogenicity and safety of an H1N1 2009 pandemic influenza vaccine formulated with and without AS03 adjuvant in children aged 6 months to less than 9 years. Abstract presented at the Options for the Control of Influenza VII Conference. Hong Kong SAR, China, 3-7 September 2010.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00976820     History of Changes
Other Study ID Numbers: 113482
Study First Received: September 11, 2009
Last Updated: June 14, 2012
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
influenza infection
Influenza Vaccines
GSK Bio's influenza vaccine GSK2340273A
GSK Bio's influenza vaccine GSK2340274A

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 31, 2014