InfluenzaPhase 3NCT01554826
Clinical Trial of the Inactivated Influenza Vaccine (0.25ml Formulation for Pediatric Use)
A Phase 3 study testing Influenza Split Vaccine and Inactivated Influenza Vaccine in people with Influenza, run by Hualan Biological Engineering, Inc. at 1 site in China.
Trial summary
The clinical trial was designed to evaluate the immunogenicity and safety against pediatric Inactivated influenza vaccine (Split Virion) (0.25ml formulation) of Hualan administered on infants age 6 months to 36 months. 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?
- Influenza Split Vaccine and Inactivated Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 810 participants
- Where
- 1 siteChina
- Study dates
- Mar 2009to Feb 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 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants aging 6-36 months, their guardians understand and sign the informed consent
- Healthy infant by inquiring illness history, physical examination and clinical judgment and who complies with vaccination of this product
- Be able to comply with the requirement of clinical trial protocol
- Have no history of vaccination within the past 6 months and vaccination with other product within the latest 1 week
- Axillary temperature ≤37.0℃.
Who cannot join
- Exclusion criteria for primary vaccination:
- History of other vaccine or immunoglobulin inoculation within 2 weeks
- History of eclampsia, epilepsy, encephalopathy and mental disease or family disease
- History of vaccination allergy or allergy to drug and food (egg)
- Known or suspected immunological function defects, including immunosuppressant therapy (radiotherapy, chemotherapy, corticosteroid hormone, antimetabolites, cytotoxic drug), genetic defects (favism), HIV infection or other reasons
- Congenital malformation, maldevelopment or serious chronic disease (such as Down syndrome, diabetes, sickle cell anemia or neurologic disease)
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- Acute and chronic contagion, active infection (history of fever within the past 3 days (axillary temperature ≥38.0℃) or acute disease needing application of antibiotics or anti-virus treatment in the whole body)
- Organic diseases such as liver, kidney, serious cardiovascular disease
- Malignancy (tumor), serious asthma
- Thrombopenia or other coagulopathy that may cause contraindication of intramuscular injection
- Any condition resulting in the absence or removal the spleen
- Hypertension (not including the higher blood pressure below 150mmHg and lower blood pressure below 100mmHg controlled by drug)
- Participating in another clinical trial or any condition that, in the judgment of investigator, may affect trial assessment.
- Exclusion criteria for a boost vaccination:
- Any condition in the "Exclusion criteria" of the first injection after inclusion
- Adverse reactions level 3 or above within 72 hours after first vaccination;
- Serious adverse reactions having casual relationship with the first inoculation of test vaccine
- Subjects are not willing to be inoculated any more and quit
- Axillary temperature ≥37℃ before immunization
- Reasons that can not conduct inoculation, in the judgment of investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Disease Prevention and Control
Huaian, Jiangsu, 223000
About this study
Official title: A Double - Blind, Randomized, - Controlled Clinical Trial With Inactivated Influenza Vaccine (Split Virion)(0.25ml Formulation for Pediatric Use)
The clinical trial was designed to evaluate the immunogenicity and safety against pediatric Inactivated influenza vaccine (Split Virion) (0.25ml formulation) of Hualan administered on infants age 6 months to 36 months.
Read the detailed description
The clinical trial was designed randomized and double-blind. Participants included up to 810 persons (540 persons in test group and 270 persons in control group).
Healthy 6-36 months infants were selected, whose guardians were volunteers and had signed the informed consent. Subjects were selected according to the inclusion and exclusion criteria. Every subject accepted 30min's observation in the hospital after vaccination and received periodic follow-up till the fourth week after the boost vaccination.
Blood of subjects was collected at the third week after the boost vaccination for the analysis of the immunogenicity. During the test, the adverse reactions and detailed information were reported to the SFDA under the status of blinding every month. Unblinding was conducted after the completion of the follow-up of subjects.
- Conditions
- Influenza
- Being tested
- Influenza Split Vaccine, Inactivated Influenza Vaccine
- Keywords
- Pediatric 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.
Influenza Split VaccineBiological
Also called Hualan Biologicals
0.25ml, two doses (540 subjects were randomly assigned to receive the first dose, among them, 515 subjects received a boost dose); two doses were assigned to be vaccinated 4 weeks apart
Inactivated Influenza VaccineBiological
Also called Vaxigrip, Shenzhen Aventis Pasteur Biological
0.25ml, two doses (270 subjects were randomly assigned to receive the first dose; among them, 263 subjects received a boost dose); two doses was administrated at 4 weeks apart
| Study group | Role | What they receive |
|---|---|---|
| Influenza Split Vaccine | Experimental | 7.5μg HA/strain/0.25ml/syringe Receives: Biological: Influenza Split Vaccine |
| Inactivated Influenza Vaccine | Active comparator | 7.5μg HA/strain/0.25ml/syringe Receives: Biological: Inactivated Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse reactions as a measure of safety study
Local reactions, systemic reactions, severity degree and AEFI correlation
Measured: 28 days after the vaccination
Secondary outcomes (1)
Observation of the immunogenicity
HI antibody seroconversion ratios, protection ratios, GMTs and GMT increase folds
Measured: 28 days after the immunization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startMar 2009
- Primary completionMay 2009
- Study completionFeb 2010
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 810 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hualan Biological Engineering, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Feng-cai Zhu, M.D., Study director, Jiangsu Provincial Center for Disease Prevention and Control
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01554826
- Sponsor's protocol ID
- Hualanbio-influenza III-002
- Status last verified
- Apr 2012
- First submitted
- 12 Mar 2012
- Last updated
- 6 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double - Blind, Randomized, - Controlled Clinical Trial With Inactivated Influenza Vaccine (Split Virion)(0.25ml Formulation for Pediatric Use)
- ClinicalTrials.gov ID
- NCT01554826
- Acronym / sponsor ID
- Hualanbio-influenza III-002
- Conditions
- Influenza
- Keywords
- Pediatric influenza vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 810 participants (actual)
- Lead sponsor
- Hualan Biological Engineering, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- May 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 15 Mar 2012 (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 clinical trial was designed to evaluate the immunogenicity and safety against pediatric Inactivated influenza vaccine (Split Virion) (0.25ml formulation) of Hualan administered on infants age 6 months to 36 months.
Detailed description
The clinical trial was designed randomized and double-blind. Participants included up to 810 persons (540 persons in test group and 270 persons in control group).
Healthy 6-36 months infants were selected, whose guardians were volunteers and had signed the informed consent. Subjects were selected according to the inclusion and exclusion criteria. Every subject accepted 30min's observation in the hospital after vaccination and received periodic follow-up till the fourth week after the boost vaccination.
Blood of subjects was collected at the third week after the boost vaccination for the analysis of the immunogenicity. During the test, the adverse reactions and detailed information were reported to the SFDA under the status of blinding every month. Unblinding was conducted after the completion of the follow-up of subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza Split Vaccine | Experimental | Biological: Influenza Split Vaccine7.5μg HA/strain/0.25ml/syringe |
| Inactivated Influenza Vaccine | Active comparator | Biological: Inactivated Influenza Vaccine7.5μg HA/strain/0.25ml/syringe |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants aging 6-36 months, their guardians understand and sign the informed consent
- Healthy infant by inquiring illness history, physical examination and clinical judgment and who complies with vaccination of this product
- Be able to comply with the requirement of clinical trial protocol
- Have no history of vaccination within the past 6 months and vaccination with other product within the latest 1 week
- Axillary temperature ≤37.0℃.
Key exclusion criteria (20 listed)
- Exclusion criteria for primary vaccination:
- Exclusion criteria for a boost vaccination:
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 |
|---|---|---|
| Influenza Split VaccineAlso: Hualan Biologicals0.25ml, two doses (540 subjects were randomly assigned to receive the first dose, among them, 515 subjects received a boost dose); two doses were assigned to be vaccinated 4 weeks apart | Biological | Influenza Split Vaccine |
| Inactivated Influenza VaccineAlso: Vaxigrip, Shenzhen Aventis Pasteur Biological0.25ml, two doses (270 subjects were randomly assigned to receive the first dose; among them, 263 subjects received a boost dose); two doses was administrated at 4 weeks apart | Biological | Inactivated Influenza Vaccine |
Primary outcome
Number of subjects with adverse reactions as a measure of safety study
Time frame: 28 days after the vaccination
Local reactions, systemic reactions, severity degree and AEFI correlation
1 secondary outcome
Observation of the immunogenicity
Time frame: 28 days after the immunization
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 6 Sep 2012.
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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.
Feng-cai Zhu, M.D. study director
Jiangsu Provincial Center for Disease Prevention and Control
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Influenza Split Vaccine and Inactivated Influenza Vaccine in people with Influenza, run by Hualan Biological Engineering, Inc. 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 5 inclusion and 20 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 6 Sep 2012. 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. 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?
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?
Number of subjects with adverse reactions as a measure of safety study (time frame: 28 days after the vaccination). It is what the study was designed to measure, not a finding.
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 6 Sep 2012.