Randomised, Double-blinded, Placebo-controlled Clinical Trial of Pandemic Influenza Inactive Vaccine on Healthy Subjects
| ISRCTN | ISRCTN53344556 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53344556 |
| ClinicalTrials.gov (NCT) | NCT00356798 |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | PRO-PanFlu-1001 |
| Sponsor | Sinovac Biotech Co. Ltd (China) |
| Funder | The study was funded by a grant (2005BA723B02) from Ministry of Science and Technology of the People's Republic of China. |
- Submission date
- 25/07/2006
- Registration date
- 17/08/2006
- Last edited
- 03/05/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jiangtao Lin
Scientific
Scientific
Department of Respiratory Internal
China-Japan Friendship Hospital
Hepinli Yinhua East Road
Chaoyang District
Beijing
100029
China
| Phone | +86 106 422 1122 2313 |
|---|---|
| jiangtao_L@263.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A stratified, randomised, placebo-controlled and double-blind phase I clinical trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Randomised, Double-blinded, Placebo-controlled Clinical Trial of Pandemic Influenza Inactive Vaccine on Healthy Subjects |
| Study acronym | RDPCTPIIVHS |
| Study objectives | An inactivated monovalent A/H5N1 (influenza A virus) whole-virion, aluminum hydroxide adjuvated influenza vaccine will be safe and immunogenic in humans. |
| Ethics approval(s) | Ethics approval gained from the ethical review committee of China Japan Friendship Hospital dated on 12 December 2005 (reference: 2005NO[37]Total[99]). |
| Health condition(s) or problem(s) studied | Pandemic influenza |
| Intervention | The trial is divided into four dosage groups and processed from low dosage vaccine to high dosage vaccine: 1. Group A: 30 subjects will be randomly injected with vaccines among which 24 subjects will be injected with the trial vaccine (1.25 µg) antigen and the other six subjects will be randomised into a placebo group. All subjects will be observed for 30 minutes for immediate reactions. Local reactions and systemic reactions were then observed at six, 24, 48 and 72 hours. The second dose will be injected 28 days after the first dose. The dosage, injection and observation method are the same as the first one. Subjects will be followed up for 210 days. Serum will be collected before the injection and then at 14, 28, 42, 56, 210 days after injection. The serums will be tested by the Haemagglutination-Inhibition (HI) assay. 2. Group B: 72 hours after the injection of Group A, when the safety of the vaccine is confirmed, 30 subjects will be randomly injected with vaccines, among them, 24 subjects will receive the trial vaccine (2.5 µg) and the other six subjects will be receive the control. The methods of safety observation and blood collection are as same as Group A. 3. Group C: 72 hours after the injection of Group B, when the safety of vaccine is confirmed, 30 subjects will be randomly injected with the vaccine. In the same way, 24 subjects will receive the trial vaccine (5.0 µg) and the other six subjects will receive the control. The methods of safety observation and blood collection are as same as Group A. 4. Group D: 72 hours after injection for the Group C, when the safety of vaccine is confirmed, 30 subjects will be randomly injected with vaccines. Among them, 24 subjects will receive the trial vaccine (10.0 µg) and the other six subjects will receive the control. The methods of safety observation and blood collection are as same as Group A. Trial vaccine is designed 0.5 ml per dose. The administration regimen is designed as a two dose schedule, which are given at day zero and day 28. |
| Intervention type | Drug |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Influenza A virus vaccine |
| Primary outcome measure(s) |
To evaluate the safety of pandemic inactivated influenza vaccine by different doses. |
| Key secondary outcome measure(s) |
To evaluate the immunogenicity of pandemic inactivated influenza vaccine by different doses. |
| Completion date | 05/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | All |
| Target sample size at registration | 120 |
| Total final enrolment | 120 |
| Key inclusion criteria | 1. Males and females, aged from 18 to 60 years old 2. Able to provide proof of identity to the satisfaction of the study clinician completing the enrolment process 3. Able and willing to complete the informed consent process |
| Key exclusion criteria | 1. Women who are breast-feeding or planning to become pregnant during the following 210 days of study participation 2. Subjects who engage in the occupations of culturist, slaughter, sale and forwarder of any avian organisms 3. Subject has a medical history of any of the following: a. allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein etc. b. serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain c. autoimmune disease or immunodeficiency d. asthma that is unstable or required emergency care, urgent care, hospitalisation or intubation during the past two years or that requires the use of oral or intravenous corticosteroids e. diabetes mellitus (type I or II), with the exception of gestational diabetes f. history of thyroidectomy or thyroid disease that required medication within the past 12 months g. serious angioedema episodes within the previous three years or requiring medication in the previous two years h. bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with Intramuscular (IM) injections or blood draws i. malignancy that is active or treated malignancy for which there is not reasonable assurance of sustained cure or malignancy that is likely to recur during the period of study j. seizure disorder other than febrile seizures under the age of two, seizures secondary to alcohol withdrawal more than three years ago, or a singular seizure not requiring treatment within the last three years k. asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen l. Guillain-Barre Syndrome (GBS) 4. The abnormal result of laboratory tests as below: a. biochemistry assaying: Alanine Aminotransferase (ALT)/Serum Glutamate Pyruvate Transaminase, Total Bilirubine (TBIL), Direct Bilirubine (DBIL), Blood Urea Nitrogen (BUN) and Creatinine (Cr) b. Routine blood assaying, routine urine assaying c. Hepatitis B surface Antigen (HBsAg) positive d. pregnancy test positive 5. Subject has received any of the following substances: a. immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis) b. blood products within three months prior to initial study vaccine administration c. other study drug within 30 days prior to initial study vaccine administration d. live attenuated vaccines within 30 days prior to initial study vaccine administration e. medically indicated subunit or killed vaccines, e.g. pneuomococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration f. current anti-tuberculosis prophylaxis or therapy 6. Fever before vaccination, axillary temperature 37.0°C 7. Psychiatric condition that precludes compliance with the protocol, past or present psychoses, past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years, disorder requiring lithium, or suicidal ideation occurring within five years prior to enrolment 8. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent |
| Date of first enrolment | 20/12/2005 |
| Date of final enrolment | 05/06/2006 |
Locations
Countries of recruitment
- China
Study participating centre
Department of Respiratory Internal
Beijing
100029
China
100029
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 16/09/2006 | 03/05/2019 | Yes | No |
Editorial Notes
03/05/2019: The following changes were made:
1. Publication reference added.
2. The total final enrolment was added.
3. The ClinicalTrials.gov number was added.
