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Novel Influenza A/H1N1 Split- Virion Vaccine in Healthy Children Aged 6 to 35 Month

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Centers for Disease Control and Prevention, China.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Centers for Disease Control and Prevention, China
ClinicalTrials.gov Identifier:
NCT01040078
First received: December 24, 2009
Last updated: December 29, 2009
Last verified: December 2009
History of Changes
  Purpose

The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.


Condition Intervention Phase
Influenza
Swine-origin A/H1N1 Influenza
 Biological: 7.5ug H1N1 Influenza vaccine
Biological: 15ug H1N1 vaccine
Biological: seasonal influenza vaccine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention, China:

Estimated Enrollment: 900
Study Start Date: December 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 7.5ug H1N1 vaccine
360 subjects to receive two doses 7.5ug H1N1 influenza vaccine on Day 0 and Day 21.
 Biological: 7.5ug H1N1 Influenza vaccine
0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
Experimental: 15ug H1N1 vaccine
360 subjects to receive two doses 15ug H1N1 influenza vaccine on Day 0 and Day 21.
 Biological: 15ug H1N1 vaccine
0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
Placebo Comparator: seasonal influenza vaccine
180 subjects to receive two doses seasonal influenza vaccine on Day 0 and Day 21.
 Biological: seasonal influenza vaccine
0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21

  Eligibility

Ages Eligible for Study:   6 Months to 35 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female aged >= 6 months to =<35 months at the time of the first study vaccination. Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
  • Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative Subject and parent/legal representative are able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria:

  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
  • Planned receipt of any vaccine prior to the Day 42 blood sample
  • Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
  • Thrombocytopenia contraindicating intramuscular (IM) vaccination as reported by parents/legal representative
  • Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
  • Chronic illness that in the opinion of the Investigator is at a stage where it might interfere with trial conduct or completion
  • Family members of the employees or the Investigator
  • Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain
  • Confirmed infection with the novel influenza A/H1N1 strain
  • Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01040078

Locations
China, Guangxi
Lingchuan County CDC Recruiting
Guilin, Guangxi, China, 541000
Contact: Yanping Li, Doctor     0773 6812175     lyp898@163.com    
China, Hunan
Luxi County CDC Recruiting
Xiangxi Prefecture, Hunan, China, 416100
Contact: Fangjun Li, Doctor     0743 4265397     fangjunliself678@sina.com    
China, Jiangsu
Yandu District CDC Recruiting
Yancheng, Jiangsu, China, 224001
Contact: Yuemei Hu, Doctor     0515 8324084     993832717@qq.com    
Sponsors and Collaborators
Centers for Disease Control and Prevention, China
  More Information

No publications provided

Responsible Party: Xiaofeng Liang
ClinicalTrials.gov Identifier: NCT01040078     History of Changes
Other Study ID Numbers: 20090601
Study First Received: December 24, 2009
Last Updated: December 29, 2009
Health Authority: China: Ministry of Health

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 June 18, 2013