Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Children

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01776554
First received: January 20, 2013
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in children.


Condition Intervention Phase
Pandemic H5N1 Influenza
Biological: Adjuvanted H5N1 pandemic influenza vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Phase II, Randomized, Observer-Blind, Multi-Center, Study to Evaluate Safety, Tolerability and Immunogenicity of an Adjuvanted Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine at Two Different Formulations in Healthy Pediatric Subjects.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To select a vaccine dose based on the achievement of CBER criteria for further development [ Time Frame: Day 43 (3 weeks after second vaccination) ] [ Designated as safety issue: No ]
    Seroprotection and Seroconversion rate measured 3 weeks after second dose of vaccine administration

  • Percentage of subjects with solicited local and systemic adverse events [ Time Frame: 7 days post vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with unsolicited adverse events [ Time Frame: 3 weeks post vaccination ] [ Designated as safety issue: Yes ]
  • Percentage of subjects with serious adverse events, medically attended adverse events, adverse events leading to withdrawal and adverse events of special interest [ Time Frame: Day 1 through Day 732 ] [ Designated as safety issue: Yes ]

Enrollment: 661
Study Start Date: January 2013
Study Completion Date: June 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: aH5N1c-High dose Biological: Adjuvanted H5N1 pandemic influenza vaccine
Comparison of two doses of aH5N1c vaccine
Experimental: aH5N1c-Low dose Biological: Adjuvanted H5N1 pandemic influenza vaccine
Comparison of two doses of aH5N1c vaccine

  Eligibility

Ages Eligible for Study:   6 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy pediatric subjects 6 months to 17 years of age,
  2. Children's parent(s) or legal guardian(s) willing to provide written informed consent,
  3. Individuals in good health,
  4. Individuals/parent(s)/legal guardian(s) willing to allow serum samples to be stored beyond the study period,
  5. Individuals willing to provide informed assent (where applicable).

Exclusion Criteria:

  1. Individuals not able to understand and follow study procedures,
  2. History of any significant illness,
  3. History of any chronic medical condition or progressive disease,
  4. Presence of medically significant cancer,
  5. Known or suspected impairment/alteration of immune function,
  6. Presence of any progressive or severe neurologic disorder,
  7. Presence of any bleeding disorders or conditions that prolongs bleeding time,
  8. History of allergy to vaccine components,
  9. Receipt of any other investigational product within 30 days prior to entry into the study,
  10. History of previous H5N1 vaccination,
  11. Receipt of any other type of seasonal vaccination within 2 months prior to entry into the study,
  12. Receipt of any other vaccine within 2 weeks prior to entry into the study,
  13. Body temperature ≥38°C.0 (≥100.4° F) and/or acute illness within 3 days of intended study vaccination,
  14. Pregnant or breast feeding,
  15. Females of childbearing potential refusing to use acceptable method of birth control,
  16. Body mass index (BMI) ≥ 35 kg/m2,
  17. History of drug or alcohol abuse,
  18. Any planned surgery during study period,
  19. Individuals conducting the study and their immediate family members,
  20. Individuals with behavioral or cognitive impairment or psychiatric diseases,
  21. Individuals diagnosed with any growth disorders.
  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: NCT01776554

Locations
United States, Florida
3 Meridian Clinical Research
Miami, Florida, United States, 68005
6 Meridian Clinical Research
Miami, Florida, United States, 68134
United States, Kansas
5 Heartland Research Associates
Wichita, Kansas, United States, 67207
7 Heartland Research Associates
Wichita, Kansas, United States, 67114
9 Heartland Research Associates
Wichita, Kansas, United States, 67207
United States, Missouri
1 Saint Louis University
St. Louis, Missouri, United States, 63110
United States, Texas
10 Tekton Research
Georgetown, Texas, United States, 78745
United States, Utah
4 Foothill Family Clinic
South Cottonwood Heights, Utah, United States, 84121
8 Foothill Family Clinic
South Cottonwood Heights, Utah, United States, 84121
United States, Washington
2 Rockwood Clinic P S
Spokane, Washington, United States, 99204
Thailand
75 Phramongkutklao Hospital
Bangkok, Thailand, 10400
76 Faculty of Tropical Medicine Mahidol University
Bangkok, Thailand, 10400
Sponsors and Collaborators
Novartis Vaccines
Investigators
Study Chair: Novartis vaccines and Diagnostics Novartis Vaccines
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01776554     History of Changes
Other Study ID Numbers: V89_11
Study First Received: January 20, 2013
Last Updated: June 24, 2014
Health Authority: United States: Food and Drug Administration
Thailand: Food and Drug Administration

Keywords provided by Novartis:
Influenza, Pandemic, H5N1, Children

Additional relevant MeSH terms:
Influenza in Birds
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014