Safety and Efficacy of H1N1 Vaccines in Children Aged 6 Months to Less Than 10 Years of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01051661
First received: January 14, 2010
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

The purpose of this study is to characterize the safety and efficacy of GSK Biologicals' H1N1 flu candidate vaccines GSK2340274A and GSK2340273A in children 6 months to less than 10 years of age.


Condition Intervention Phase
Pandemic H1N1 Influenza
Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)
Biological: GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations)
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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 Efficacy of A/California/7/2009 (H1N1)V-like Vaccines GSK2340274A and GSK2340273A in Children Aged 6 Months to Less Than 10 Years of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of reverse transcription-quantitative polymerase chain reaction (RT-qPCR)-confirmed cases of A/California influenza in Group A and Group C [ Time Frame: 14 days after first vaccination until study conclusion on Day 385 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of RT-qPCR-confirmed cases of A/California influenza in Group A, Group B, and Group C [ Time Frame: 14 days after first vaccination until study conclusion on Day 385 ] [ Designated as safety issue: No ]
  • Occurrence of RT-qPCR-confirmed influenza cases in Group A, Group B, and Group C [ Time Frame: Day 0 and Day 42 until study conclusion on Day 385 ] [ Designated as safety issue: No ]
  • Occurrence of culture-confirmed influenza cases in Group A, Group B, and Group C [ Time Frame: Days 0, 14, and 42 after the first vaccination until study conclusion on Day 385 ] [ Designated as safety issue: No ]
  • Occurrence of pneumonia cases, RT-qPCR-confirmed pneumonia cases, protocol specified influenza-like illness (ILI) symptoms in all reported ILI cases, & protocol specified (ILI) symptoms in RT-qPCR-confirmed influenza cases in Group A, B, C [ Time Frame: Days 0, 14, and 42 after the first vaccination until study conclusion on Day 385 ] [ Designated as safety issue: No ]
  • Vaccine virus-homologous and drifted H1N1 virus antibody response as demonstrated by HI antibody titers [ Time Frame: Days 0 and 42 ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general signs and symptoms [ Time Frame: 7-day follow-up period (day of each vaccination and 6 subsequent days) ] [ Designated as safety issue: No ]
  • Occurrence of all unsolicited AEs [ Time Frame: 21 days following each dose of vaccine or saline placebo, and through Day 42 ] [ Designated as safety issue: No ]
  • Occurrence of medically attended adverse events (MAEs),potential immune-mediated disease (pIMDs), and serious adverse events (SAEs) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
  • Vaccine virus-homologous H1N1 virus antibody response as demonstrated by the HI antibody titers [ Time Frame: Days 182 and 365 ] [ Designated as safety issue: No ]

Enrollment: 6154
Study Start Date: February 2010
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects will receive 2 doses of an alternative formulation of GSK2340274A vaccine at a 21-day interval.
Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)
Intramuscular injection, one or two doses
Experimental: Group B
Subjects will receive 1 dose of an alternative formulation of GSK2340274A vaccine on Day 0 and 1 dose of saline placebo on Day 21
Biological: GSK Biologicals' investigational vaccine GSK2340274A (alternative formulations)
Intramuscular injection, one or two doses
Biological: Placebo
Intramuscular injection, one dose
Experimental: Group C
Subjects will receive 2 doses of an alternative formulation of GSK2340273A vaccine administered at a 21-day interval.
Biological: GSK Biologicals' investigational vaccine GSK2340273A (alternative formulations)
Intramuscular injection, two doses

  Eligibility

Ages Eligible for Study:   6 Months to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female children 6 months to less than 10 years of age at the time of the first vaccination. "Less than 10 years of age" implies inclusion of children who have not reached their 10th birthday as of Day 0, the day of first vaccine dose under this protocol.
  • Written informed consent obtained from the subject's parent(s)/legally acceptable representative(s) (LAR(s)); written informed assent obtained from the subject if appropriate pre local requirements).
  • Stable health status as defined by absence of a health event satisfying the definition of a SAE, or a change in an ongoing drug therapy due to therapeutic failure or symptoms of drug toxicity, within 1 month prior to enrolment.
  • Parent(s)/LAR(s) available and accessible for active surveillance contacts.
  • Parent(s)/LAR(s) and (if age-appropriate, subjects) who, in the investigator's opinion, can and will comply with the requirements of the protocol as documented by signature on the informed consent document.
  • Female subjects of non-childbearing potential (pre-menarche) may be enrolled in the study.

Exclusion Criteria:

  • Previous vaccination with an A/California/7/2009 (H1N1)v-like virus vaccine.
  • Medical history of physician-confirmed infection with an A/California/7/2009 (H1N1)v-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. 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 live attenuated vaccine within 4 weeks before the first vaccination or of any licensed inactivated vaccine within 2 weeks before the first vaccination.
  • Planned administration of any vaccine not foreseen by the study protocol between Day 0 and Day 42. 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.
  • Planned use of a pandemic monovalent A/California/7/2009 (H1N1)v-like virus vaccine other than the study vaccines during the study period.
  • Planned administration of seasonal trivalent influenza vaccine during the 4 month period following Day 0.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days before the first dose of study vaccine, or planned use during the study period.
  • Any known or suspected allergy to any constituent of influenza vaccines (including egg proteins or mercurial preservatives); 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: NCT01051661

Locations
Australia, Queensland
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Australia, Victoria
GSK Investigational Site
Carlton, Victoria, Australia, 3053
Brazil
GSK Investigational Site
Florianópolis, Santa Catarina, Brazil, 88025 300
GSK Investigational Site
São Paulo, Brazil, 04038 001
GSK Investigational Site
São Paulo, Brazil
Colombia
GSK Investigational Site
Cali, Colombia
Costa Rica
GSK Investigational Site
San Jose, Costa Rica
Mexico
GSK Investigational Site
Cuernavaca, Morelos, Mexico
GSK Investigational Site
Monterrey, Nuevo León, Mexico, 64610
GSK Investigational Site
Durango, Mexico, 3400
GSK Investigational Site
Mexico city, Mexico, 04530
Philippines
GSK Investigational Site
Dasmariñas, Cavite, Philippines, 4114
GSK Investigational Site
Muntinlupa, Philippines, 1781
GSK Investigational Site
Sampaloc, Manila, Philippines, 1008
Singapore
GSK Investigational Site
Singapore, Singapore, 768826
Thailand
GSK Investigational Site
Bangkok, Thailand, 10400
GSK Investigational Site
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01051661     History of Changes
Other Study ID Numbers: 114000
Study First Received: January 14, 2010
Last Updated: August 29, 2013
Health Authority: Colombia: INVIMA
Australia: Human Research Ethics Committee
Chile: Instituto de Salud Pública de Chile
Singapore: Health Sciences Authority
Costa Rica: CONIS
Thailand: The Ethical Review Committee for Research in Human Subjects, Ministry of Public health
Brazil: ANVISA
India: Drugs Controller General of India
Philippines: Bureau of Food and Drugs
Mexico: COFEPRIS
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Influenza
H1N1
Pandemic

ClinicalTrials.gov processed this record on September 22, 2014