InfluenzaPhase 2NCT01494740
Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants
A Phase 2 study testing split-virion, non-adjuvanted vaccine of 7.5 μg, split-virion, non-adjuvanted H1N1 vaccine of 15 μg and split-virion, non-adjuvanted vaccine of seasonal influenza in people with Influenza, run by Shanghai Institute Of Biological Products at 1 site in China.
Trial summary
The aim of this study is to investigate the immunogenicity and safety of the inactivated split-virion vaccine in infants. Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- split-virion, non-adjuvanted vaccine of 7.5 μg, split-virion, non-adjuvanted H1N1 vaccine of 15 μg and split-virion, non-adjuvanted vaccine of seasonal influenza
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 312 participants
- Where
- 1 siteChina
- Study dates
- Dec 2009to Jan 2010
- Phase
- Phase 2
- 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 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants aged between 6 and 35 months
- full-term birth with birth weight above 2,500 grams
- Subject and parent/legal representative should be present at all scheduled visits and to obey all trial procedures
Who cannot join
- Volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
- Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg
- History of progressive or severe neurologic disorder
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Known or suspected impairment/alteration of immune function, for example receiving immunosuppressive therapy or receiving blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
- Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
Show all 14Show fewer
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
- History of thyroidectomy or thyroid disease that required medication within the past 12 months
- Serious angioedema episodes within the previous 3 years or requiring medication in the previous two years
- Guillain-Barre Syndrome
- Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B, or Hepatitis C
- Any other vaccines or immunoglobulin preparation within 1 weeks prior to enrollment
- Axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination
- Any conditions may influence the evaluation
Trial locations and contacts
1 site in 1 country.
China1 site
Hunan Provincial Center of Disease Prevention and Control Changsha, Hunan, China
Changsha
About this study
The aim of this study is to investigate the immunogenicity and safety of the inactivated split-virion vaccine in infants.
- Conditions
- Influenza
- Being tested
- split-virion, non-adjuvanted vaccine of 7.5 μg, split-virion, non-adjuvanted H1N1 vaccine of 15 μg, split-virion, non-adjuvanted vaccine of seasonal influenza
- Keywords
- H1N1, Vaccine, Immunogenicity, Safety, infants
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
split-virion, non-adjuvanted vaccine of 7.5 μgBiological
120 infants were assigned to receive 2 dose of 7.5μg split-virion, non-adjuvanted H1N1 vaccine.
split-virion, non-adjuvanted H1N1 vaccine of 15 μgBiological
120 infants were assigned to receive 2 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.
split-virion, non-adjuvanted vaccine of seasonal influenzaBiological
120 infants were assigned to receive 2 dose of split-virion, non-adjuvanted seasonal influenza vaccine.
| Study group | Role | What they receive |
|---|---|---|
| split-virion, non-adjuvanted vaccine of 7.5 μg | Experimental | split-virion, non-adjuvanted H1N1 vaccine of 7.5 μg. Receives: Biological: split-virion, non-adjuvanted vaccine of 7.5 μg |
| split-virion, non-adjuvanted vaccine of 15 μg | Experimental | split-virion, non-adjuvanted H1N1 vaccine of 15 μg. Receives: Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg |
| split-virion, non-adjuvanted vaccine of seasonal influenza | Placebo comparator | split-virion, non-adjuvanted H1N1 vaccine of seasonal influenza. Receives: Biological: split-virion, non-adjuvanted vaccine of seasonal influenza |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemagglutination inhibition antibody titer
Measured: Days 35
Secondary outcomes (1)
Occurrence of solicited local and systemic adverse events after vaccination
Measured: Day0-42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2011 (estimated)
- Study startDec 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Shanghai Institute Of Biological ProductsThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Institute Of Biological Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01494740
- Sponsor's protocol ID
- SIBP-2009-1
- Status last verified
- Oct 2009
- First submitted
- 15 Dec 2011
- Last updated
- 19 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang S, Dong J, Chai W, Li F, Wang S, Sun B, Chen Z. Immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine in infants: randomized, observer-masked, single-center clinical study. Springerplus. 2014 Jul 31;3:397. doi: 10.1186/2193-1801-3-397. eCollection 2014.
PubMed 25110632
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of an Inactivated Split-virion 2009 Pandemic Influenza A H1N1 Vaccine in Infants
- ClinicalTrials.gov ID
- NCT01494740
- Acronym / sponsor ID
- SIBP-2009-1
- Conditions
- Influenza
- Keywords
- H1N1, Vaccine, Immunogenicity, Safety, infants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Shanghai Institute Of Biological ProductsIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 19 Dec 2011 (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 aim of this study is to investigate the immunogenicity and safety of the inactivated split-virion vaccine in infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| split-virion, non-adjuvanted vaccine of 7.5 μg | Experimental | Biological: split-virion, non-adjuvanted vaccine of 7.5 μgsplit-virion, non-adjuvanted H1N1 vaccine of 7.5 μg. |
| split-virion, non-adjuvanted vaccine of 15 μg | Experimental | Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μgsplit-virion, non-adjuvanted H1N1 vaccine of 15 μg. |
| split-virion, non-adjuvanted vaccine of seasonal influenza | Placebo comparator | Biological: split-virion, non-adjuvanted vaccine of seasonal influenzasplit-virion, non-adjuvanted H1N1 vaccine of seasonal influenza. |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy infants aged between 6 and 35 months
- full-term birth with birth weight above 2,500 grams
- Subject and parent/legal representative should be present at all scheduled visits and to obey all trial procedures
Key exclusion criteria (14 listed)
- Volunteers in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
- Volunteers allergic to ingredient of vaccine composition (can be checked from vaccination history), especially to egg
- History of progressive or severe neurologic disorder
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Known or suspected impairment/alteration of immune function, for example receiving immunosuppressive therapy or receiving blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation
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 |
|---|---|---|
| split-virion, non-adjuvanted vaccine of 7.5 μg120 infants were assigned to receive 2 dose of 7.5μg split-virion, non-adjuvanted H1N1 vaccine. | Biological | split-virion, non-adjuvanted vaccine of 7.5 μg |
| split-virion, non-adjuvanted H1N1 vaccine of 15 μg120 infants were assigned to receive 2 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine. | Biological | split-virion, non-adjuvanted vaccine of 15 μg |
| split-virion, non-adjuvanted vaccine of seasonal influenza120 infants were assigned to receive 2 dose of split-virion, non-adjuvanted seasonal influenza vaccine. | Biological | split-virion, non-adjuvanted vaccine of seasonal influenza |
Primary outcome
Hemagglutination inhibition antibody titer
Time frame: Days 35
1 secondary outcome
Occurrence of solicited local and systemic adverse events after vaccination
Time frame: Day0-42
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2011.
- Derived from this study: PubMed 25110632Wang S, Dong J, Chai W, Li F, Wang S, Sun B, Chen Z. Immunogenicity of a monovalent 2009 influenza A (H1N1) vaccine in infants: randomized, observer-masked, single-center clinical study. Springerplus. 2014 Jul 31;3:397. doi: 10.1186/2193-1801-3-397. eCollection 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing split-virion, non-adjuvanted vaccine of 7.5 μg, split-virion, non-adjuvanted H1N1 vaccine of 15 μg and split-virion, non-adjuvanted vaccine of seasonal influenza in people with Influenza, run by Shanghai Institute Of Biological Products at 1 site 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 3 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: finished, as of the sponsor's last update on 19 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemagglutination inhibition antibody titer (time frame: Days 35). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01494740, which also lists 1 linked publication.
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 19 Dec 2011.