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

December 29, 2009 updated by: Centers for Disease Control and Prevention, China
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

900

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Guilin, Guangxi, China, 541000
        • Recruiting
        • Lingchuan County CDC
        • Contact:
    • Hunan
      • Xiangxi Prefecture, Hunan, China, 416100
    • Jiangsu
      • Yancheng, Jiangsu, China, 224001
        • Recruiting
        • Yandu District CDC
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Anticipated)

February 1, 2010

Study Completion (Anticipated)

June 1, 2010

Study Registration Dates

First Submitted

December 24, 2009

First Submitted That Met QC Criteria

December 24, 2009

First Posted (Estimate)

December 25, 2009

Study Record Updates

Last Update Posted (Estimate)

December 30, 2009

Last Update Submitted That Met QC Criteria

December 29, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20090601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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