CClinicalTrials.gg
Status unknownNCT01040078Updated Dec 30, 2009

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

A Phase 3 interventional study of 7.5ug H1N1 Influenza vaccine and 15ug H1N1 vaccine in Influenza and Swine-origin A/H1N1 Influenza, sponsored by Centers for Disease Control and Prevention, China. Status unknown at 3 sites in China. Open to participants aged 6 Months to 35 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-12-30.

Sponsored by Centers for Disease Control and Prevention, China · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
900
Allocation
Randomized
Ages
6 Months to 35 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Influenza
  • Swine-origin A/H1N1 Influenza

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03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's planned enrollment of 900 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Centers for Disease Control and Prevention, China is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 35 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
900 participants (estimated)

Study arms

  • 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

  • Experimental
    15ug H1N1 vaccine

    360 subjects to receive two doses 15ug H1N1 influenza vaccine on Day 0 and Day 21.

    Biological: 15ug H1N1 vaccine

  • Placebo comparator
    seasonal influenza vaccine

    180 subjects to receive two doses seasonal influenza vaccine on Day 0 and Day 21.

    Biological: seasonal influenza vaccine

Interventions

  • Biological7.5ug H1N1 Influenza vaccine

    0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21

  • Biological15ug H1N1 vaccine

    0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21

  • Biologicalseasonal influenza vaccine

    0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21

06

Study locations

3 of 3 sites recruiting
  • Lingchuan County CDC
    Guilin, Guangxi 541000, China
    Recruiting
  • Luxi County CDC
    Xiangxi Prefecture, Hunan 416100, China
    Recruiting
  • Yandu District CDC
    Yancheng, Jiangsu 224001, China
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01040078
Lead sponsor
Centers for Disease Control and Prevention, China
First posted
Dec 25, 2009
Start date
Dec 2009
Primary completion
Feb 2010 (estimated)
Completion
Jun 2010 (estimated)
Last update
Dec 30, 2009

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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