Sinovac, H1N1 Vaccine + Trivalent Inactivated Influenza Vaccine, Adults
Cell-mediated Immunity Study of H1N1 Influenza A Vaccine With Trivalent Inactivated Influenza Vaccine in Healthy Adults
1 other identifier
interventional
150
1 country
1
Brief Summary
A single center, randomized clinical trial is to be conducted in healthy adults (18-60 years) to evaluate the safety and immunogenicity and study the cell-mediated Immunity of Sinovac's H1N1 influenza A Vaccine (PANFLU.1) with Trivalent Inactivated Influenza Vaccine (ANFLU).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2009
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 29, 2009
CompletedFirst Posted
Study publicly available on registry
November 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2010
CompletedNovember 27, 2012
November 1, 2012
2 months
October 29, 2009
November 26, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Study the cell-mediated immunity of H1N1 vaccine with seasonal influenza vaccine
6 months
Secondary Outcomes (2)
Evaluate immunogenicity of H1N1 vaccine with seasonal influenza vaccine in adults
3 months
Evaluate safety of H1N1 vaccine with seasonal influenza vaccine in adults
3 months
Study Arms (3)
Group 1: Day 0-PANFLU.1; Day 21-ANFLU
EXPERIMENTAL50 subjects to receive-Day 0: 15 μg PANFLU.1 vaccine; Day 21: 15 μg ANFLU vaccine.
Group 2: Day 0-ANFLU; Day 21-PANFLU.1
EXPERIMENTAL50 subjects to receive-Day 0: 15 μg ANFLU vaccine; Day 21: 15 μg PANFLU.1 vaccine.
Group 3: Day 0-PANFLU.1+ANFLU
EXPERIMENTAL50 subjects to receive-Day 0: 15 μg PANFLU.1 vaccine+ANFLU vaccine.
Interventions
H1N1 influenza A Vaccine (PANFLU.1), 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (randomized in one arm)
Trivalent Inactivated Influenza Vaccine (ANFLU), 15 micrograms per dose. Vaccines will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm (injected in the other arm)
Eligibility Criteria
You may qualify if:
- Healthy male or female aged between 18 and 60
- Be able to show legal identity card for the sake of recruitment
- Volunteers are able to understand and sign the informed consent
You may not qualify if:
- Cases, cured cases and close contact of influenza A (H1N1) virus
- History of H1N1 vaccine or seasonal influenza vaccine administration
- Women of pregnancy, lactation or about to be pregnant in 60 days
- Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
- Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
- Autoimmune disease or immunodeficiency
- 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
- Diabetes mellitus (type I or II), with the exception of gestational diabetes
- 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
- 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
- Active malignancy 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
- Seizure disorder other than:
- Febrile seizures under the age of two years old
- Seizures secondary to alcohol withdrawal more than 3 years ago, or
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Centers for Diseases Control and Prevention
Beijing, China
Related Publications (1)
Wu J, Zhong X, Li CK, Zhou JF, Lu M, Huang KY, Dong M, Liu Y, Luo FJ, Du N, Chui C, Liu LQ, Smith NM, Li B, Shi NM, Song LF, Gao Y, Wang DY, Wang X, Zhu WF, Yan Y, Li Z, Chen JT, McMichael AJ, Yin WD, Xu XN, Shu Y. Optimal vaccination strategies for 2009 pandemic H1N1 and seasonal influenza vaccines in humans. Vaccine. 2011 Jan 29;29(5):1009-16. doi: 10.1016/j.vaccine.2010.11.058. Epub 2010 Dec 2.
PMID: 21130194DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2009
First Posted
November 5, 2009
Study Start
October 1, 2009
Primary Completion
December 1, 2009
Study Completion
January 1, 2010
Last Updated
November 27, 2012
Record last verified: 2012-11