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Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shanghai Institute Of Biological Products
ClinicalTrials.gov Identifier:
NCT01494740
First received: December 15, 2011
Last updated: December 16, 2011
Last verified: October 2009
History of Changes
  Purpose

The aim of this study is to investigate the immunogenicity and safety of the inactivated split-virion vaccine in infants.


Condition Intervention Phase
Influenza
 Biological: split-virion, non-adjuvanted vaccine of 7.5 μg
Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg
Biological: split-virion, non-adjuvanted vaccine of seasonal influenza
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Shanghai Institute Of Biological Products:

Primary Outcome Measures:
  • Hemagglutination inhibition antibody titer [ Time Frame: Days 35 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of solicited local and systemic adverse events after vaccination [ Time Frame: Day0-42 ] [ Designated as safety issue: Yes ]

Enrollment: 312
Study Start Date: December 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: split-virion, non-adjuvanted vaccine of 7.5 μg
split-virion, non-adjuvanted H1N1 vaccine of 7.5 μg.
 Biological: split-virion, non-adjuvanted vaccine of 7.5 μg
120 infants were assigned to receive 2 dose of 7.5μg split-virion, non-adjuvanted H1N1 vaccine.
Experimental: split-virion, non-adjuvanted vaccine of 15 μg
split-virion, non-adjuvanted H1N1 vaccine of 15 μg.
 Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg
120 infants were assigned to receive 2 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.
Placebo Comparator: split-virion, non-adjuvanted vaccine of seasonal influenza
split-virion, non-adjuvanted H1N1 vaccine of seasonal influenza.
 Biological: split-virion, non-adjuvanted vaccine of seasonal influenza
120 infants were assigned to receive 2 dose of split-virion, non-adjuvanted seasonal influenza vaccine.

  Eligibility

Ages Eligible for Study:   6 Months to 36 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy infants aged between 6 and 35 months
  2. full-term birth with birth weight above 2,500 grams
  3. Subject and parent/legal representative should be present at all scheduled visits and to obey all trial procedures

Exclusion Criteria:

  1. Volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
  2. Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg
  3. History of progressive or severe neurologic disorder
  4. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
  5. Known or suspected impairment/alteration of immune function, for example receiving immunosuppressive therapy or receiving blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
  6. Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
  7. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
  8. History of thyroidectomy or thyroid disease that required medication within the past 12 months
  9. Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
  10. Guillain-Barre Syndrome
  11. Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
  12. Any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment
  13. Axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination
  14. Any conditions may influence the evaluation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494740

Locations
China
Hunan Provincial Center of Disease Prevention and Control Changsha, Hunan, China
Changsha, China
Sponsors and Collaborators
Shanghai Institute Of Biological Products
  More Information

No publications provided

Responsible Party: Shanghai Institute Of Biological Products
ClinicalTrials.gov Identifier: NCT01494740     History of Changes
Other Study ID Numbers: SIBP-2009-1
Study First Received: December 15, 2011
Last Updated: December 16, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Institute Of Biological Products:
H1N1
Vaccine
Immunogenicity
Safety
infants

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 May 19, 2013