InfluenzaPhase 3NCT01040078
Novel Influenza A/H1N1 Split- Virion Vaccine in Healthy Children Aged 6 to 35 Month
A Phase 3 study testing 7.5ug H1N1 Influenza vaccine, 15ug H1N1 vaccine and seasonal influenza vaccine in people with Influenza and Swine-origin A/H1N1 Influenza, run by Centers for Disease Control and Prevention, China at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Swine-origin A/H1N1 Influenza
- What is being tested?
- 7.5ug H1N1 Influenza vaccine, 15ug H1N1 vaccine and seasonal influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 3 sitesChina
- Study dates
- Dec 2009to Jun 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Lingchuan County CDC
Guilin, Guangxi, 541000
Yanping Li, Doctor, 0773 6812175, lyp898@163.com
- Recruiting
Luxi County CDC
Xiangxi Prefecture, Hunan, 416100
Fangjun Li, Doctor, 0743 4265397, fangjunliself678@sina.com
- Recruiting
Yandu District CDC
Yancheng, Jiangsu, 224001
Yuemei Hu, Doctor, 0515 8324084, 993832717@qq.com
About this study
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.
- Conditions
- Influenza, Swine-origin A/H1N1 Influenza
- Being tested
- 7.5ug H1N1 Influenza vaccine, 15ug H1N1 vaccine, seasonal influenza vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7.5ug H1N1 Influenza vaccineBiological
0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
15ug H1N1 vaccineBiological
0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
seasonal influenza vaccineBiological
0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21
| Study group | Role | What they receive |
|---|---|---|
| 7.5ug H1N1 vaccine | Experimental | 360 subjects to receive two doses 7.5ug H1N1 influenza vaccine on Day 0 and Day 21. Receives: Biological: 7.5ug H1N1 Influenza vaccine |
| 15ug H1N1 vaccine | Experimental | 360 subjects to receive two doses 15ug H1N1 influenza vaccine on Day 0 and Day 21. Receives: Biological: 15ug H1N1 vaccine |
| seasonal influenza vaccine | Placebo comparator | 180 subjects to receive two doses seasonal influenza vaccine on Day 0 and Day 21. Receives: Biological: seasonal influenza vaccine |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionFeb 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention, China
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040078
- Sponsor's protocol ID
- 20090601
- Status last verified
- Dec 2009
- First submitted
- 24 Dec 2009
- Last updated
- 30 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Influenza A/H1N1 Split- Virion Vaccine in Healthy Children Aged 6 to 35 Month
- ClinicalTrials.gov ID
- NCT01040078
- Acronym / sponsor ID
- 20090601
- Conditions
- Influenza, Swine-origin A/H1N1 Influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Centers for Disease Control and Prevention, ChinaOther government
- Study start
- Dec 2009
- Primary completion
- Feb 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 25 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 7.5ug H1N1 vaccine | Experimental | Biological: 7.5ug H1N1 Influenza vaccine360 subjects to receive two doses 7.5ug H1N1 influenza vaccine on Day 0 and Day 21. |
| 15ug H1N1 vaccine | Experimental | Biological: 15ug H1N1 vaccine360 subjects to receive two doses 15ug H1N1 influenza vaccine on Day 0 and Day 21. |
| seasonal influenza vaccine | Placebo comparator | Biological: seasonal influenza vaccine180 subjects to receive two doses seasonal influenza vaccine on Day 0 and Day 21. |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7.5ug H1N1 Influenza vaccine0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21 | Biological | 7.5ug H1N1 vaccine |
| 15ug H1N1 vaccine0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21 | Biological | 15ug H1N1 vaccine |
| seasonal influenza vaccine0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21 | Biological | seasonal influenza vaccine |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 7.5ug H1N1 Influenza vaccine, 15ug H1N1 vaccine and seasonal influenza vaccine in people with Influenza and Swine-origin A/H1N1 Influenza, run by Centers for Disease Control and Prevention, China at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2009.