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

Tracking Information
First Received Date ^ICMJE	December 24, 2009
Last Updated Date	December 29, 2009
Start Date ^ICMJE	December 2009
Estimated Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01040078 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Novel Influenza A/H1N1 Split- Virion Vaccine in Healthy Children Aged 6 to 35 Month
Official Title ^ICMJE	Not Provided
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Influenza Swine-origin A/H1N1 Influenza
Intervention ^ICMJE	Biological: 7.5ug H1N1 Influenza vaccine 0.25 mL intramuscular injection into the deltoid region of the arm 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 Biological: seasonal influenza vaccine 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
Study Arm (s)	Experimental: 7.5ug H1N1 vaccine 360 subjects to receive two doses 7.5ug H1N1 influenza vaccine on Day 0 and Day 21. Intervention: Biological: 7.5ug H1N1 Influenza vaccine Experimental: 15ug H1N1 vaccine 360 subjects to receive two doses 15ug H1N1 influenza vaccine on Day 0 and Day 21. Intervention: Biological: 15ug H1N1 vaccine Placebo Comparator: seasonal influenza vaccine 180 subjects to receive two doses seasonal influenza vaccine on Day 0 and Day 21. Intervention: Biological: seasonal influenza vaccine
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	900
Estimated Completion Date	June 2010
Estimated Primary Completion Date	February 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	6 Months to 35 Months
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT01040078
Other Study ID Numbers ^ICMJE	20090601
Has Data Monitoring Committee	Yes
Responsible Party	Xiaofeng Liang
Study Sponsor ^ICMJE	Centers for Disease Control and Prevention, China
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Centers for Disease Control and Prevention, China
Verification Date	December 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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