Clinical trial NCT01310374: Immune Response Study of Influenza Vaccine
Official title: Humoral and Cellular Immune Response Study of Influenza Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza Vaccine Allergy
Cell Mediated Reaction
Keywords: influenza vaccine
immune response
dynamic changes
Lead sponsor: Centers for Disease Control and Prevention, China
Sponsor class: OTHER_GOV
First posted: 2011-03-08
Enrollment: 207
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: An observational clinical study will be performed in subjects aged 12-60 years old to describe the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine, and to discuss the role of different antibodies against influenza virus infection, and to look for possible factors related to side effects with the vaccine.

Detailed description: A randomized clinical trial will be conducted to describe immune response of seasonal influenza virus vaccine in a single center in China. 200 subjects aged 18-60 years will be enrolled under the premise of informed consent and receive one dose of vaccine. All vaccinations will be done by specific study personnel, who do not take part in the assessment of safety or immunogenicity. Adverse events will be recorded after vaccination and blood samples were collected at 0,7,14,28 days for antibody detection and split vaccine neutralizing antibody detection, determination of cellular immune function in the same time.

The clinical program approved by the ethics committee will be performed by the researchers independently. Inspectors designated by the sponsor will take meticulous on-site audits to ensure the safety specifications during the whole process of research.

Eligibility criteria: Inclusion Criteria:

* aged 12-60 years old
* male or non-pregnant female
* volunteers
* clinically healthy as determined by: medical history inquiring and physical examination
* provide written informed consents before joining the trial

Exclusion Criteria:

* infected with Influenza A virus subtype H1N1(2009),
* vaccinated with seasonal influenza vaccine,
* allergic to any ingredient of vaccine,
* autoimmune disease or immunodeficiency,
* active malignancy,
* bleeding disorder,
* seizure disorder,
* Guillain-Barre Syndrome,
* treatment with cytotoxic or immunosuppressive drugs within the past 6 months,
* receipt of blood products within the past 3 months,
* administration of any other investigational research agents or live attenuated vaccine within 30 days,
* administration of subunit or inactivated vaccines within 14 days,
* axillary temperature over 37.0℃ at the time of vaccination.

Primary outcomes:
measure: the dynamic changes of humoral immune/cellular immunity after vaccination of influenza vaccine
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Centers for Disease Control and Prevention
name: jiang wu, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: