A Clinical Trial With Influenza A/H1N1 Vaccines

NCT00956111 | Completed Phase 4 DMC

• 1 other identifier: PRO-PanFlu-4001
• Study Type: interventional
• Target: 1,614
• Locations: 1 country
• Sites: 1

Brief Summary

A single center, stratified, randomized and double-blind phase IV clinical trial is to be conducted in healthy elders (equal to or more than 61 years), adults (18-60 years), adolescents (12-17 years) and children (3-11 years) to evaluate the safety and immunogenicity of Sinovac's split-virion or whole-virion novel influenza A (H1N1) vaccines.

Conditions

Influenza

Keywords

Novel Influenza A/H1N1 Vaccine; Immunogenictiy; Safety

Outcome Measures

Primary Outcomes (1)

• Evaluate immunogenicity and safety of influenza A （H1N1）vaccines in elders, adults, adolescent and children .

  July 2009- Sept. 2009

Secondary Outcomes (1)

• Provide a basis to determine the best type and dose of vaccine and immunization procedures

  July 2009- Sept. 2009

Study Arms (7)

split-virion, adjuvanted H1N1 vaccine of 7.5 μg

EXPERIMENTAL

300 participants (100 adults, 100 adolescents and 100 children) to receive split-virion, adjuvanted H1N1 vaccine of 7.5 μg on day 0 and 21.

Biological: split-virion, adjuvanted H1N1 vaccine of 7.5 μg per dose

split-virion, adjuvanted H1N1 vaccine of 15 μg

EXPERIMENTAL

300 participants (100 adults, 100 adolescents and 100 children) to receive split-virion, adjuvanted H1N1 vaccine of 15 μg on day 0 and 21.

Biological: split-virion, adjuvanted H1N1 vaccine of 15 μg per dose

split-virion, non-adjuvanted H1N1 vaccine of 15 μg

EXPERIMENTAL

300 participants (100 adults, 100 adolescents and 100 children) to receive split-virion, non-adjuvanted H1N1 vaccine of 15 μg on day 0 and 21.

Biological: split-virion, non-adjuvanted H1N1 vaccine of 15 μg per dose

split-virion, non-adjuvanted H1N1 vaccine of 30 μg

EXPERIMENTAL

300 participants (100 adults, 100 adolescents and 100 children) to receive split-virion, non-adjuvanted H1N1 vaccine of 30 μg on day 0 and 21.

Biological: split-virion, non-adjuvanted H1N1 vaccine of 30 μg per dose

whole-virion, adjuvanted H1N1 vaccine of 5 μg

EXPERIMENTAL

100 adults to receive whole-virion, adjuvanted H1N1 vaccine of 5 μg on day 0 and 21.

Biological: whole-virion, adjuvanted H1N1 vaccine of 5 μg per dose

whole-virion, adjuvanted H1N1 vaccine of 10 μg

EXPERIMENTAL

200 participants: 100 adults to receive whole-virion, adjuvanted H1N1 vaccine of 10 μg on day 0 and 21. 100 elders to receive whole-virion, adjuvanted H1N1 vaccine of 10 μg on day 0 only.

Biological: whole-virion, adjuvanted H1N1 vaccine of 10 μg per dose

Placebo control

PLACEBO COMPARATOR

100 adults to receive placebo control (Phosphate Buffer Saline) on day 0 and 21.

Biological: placebo control

Interventions

split-virion, adjuvanted H1N1 vaccine of 7.5 μg per dose BIOLOGICAL

100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 7.5μg split-virion, adjuvanted H1N1 vaccine 21 days apart.

split-virion, adjuvanted H1N1 vaccine of 7.5 μg

split-virion, adjuvanted H1N1 vaccine of 15 μg per dose BIOLOGICAL

100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 15μg split-virion, adjuvanted H1N1 vaccine 21 days apart.

split-virion, adjuvanted H1N1 vaccine of 15 μg

split-virion, non-adjuvanted H1N1 vaccine of 15 μg per dose BIOLOGICAL

100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 15μg split-virion, non-adjuvanted H1N1 vaccine 21 days apart.

split-virion, non-adjuvanted H1N1 vaccine of 15 μg

split-virion, non-adjuvanted H1N1 vaccine of 30 μg per dose BIOLOGICAL

100 adults, 100 adolescents and 100 children were assigned to receive 2 doses of 30μg split-virion, non-adjuvanted H1N1 vaccine 21 days apart.

split-virion, non-adjuvanted H1N1 vaccine of 30 μg

whole-virion, adjuvanted H1N1 vaccine of 5 μg per dose BIOLOGICAL

100 adults were assigned to receive 2 doses of 5μg whole-virion, adjuvanted H1N1 vaccine 21 days apart.

whole-virion, adjuvanted H1N1 vaccine of 5 μg

whole-virion, adjuvanted H1N1 vaccine of 10 μg per dose BIOLOGICAL

100 adults were assigned to receive 2 doses of 10μg whole-virion, adjuvanted H1N1 vaccine 21 days apart. 100 elders were assigned to receive 1 doses of 10μg whole-virion, adjuvanted H1N1 vaccine

whole-virion, adjuvanted H1N1 vaccine of 10 μg

placebo control BIOLOGICAL

100 adults were assigned to receive 2 doses of placebo 21 days apart.

Placebo control

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female aged 3 and older
• Be able to show legal identity card for the sake of recruitment
• Volunteers or their guardians 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
• 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
• A singular seizure not requiring treatment within the last 3 years

Sponsors & Collaborators

• Sinovac Biotech Co., Ltd: lead

Study Sites (1)

Beijing Centers for Diseases Control and Prevention

Beijing, China

Location

Related Publications (2)

• Wu J, Li W, Wang HQ, Chen JT, Lv M, Zhou JC, Liang XF, Fang HH, Liu Y, Liu LY, Wang X, Zhang WL, Zhang XM, Song LF, Qiu YZ, Li CG, Wang JZ, Wang Y, Yin WD. A rapid immune response to 2009 influenza A(H1N1) vaccines in adults: a randomized, double-blind, controlled trial. J Infect Dis. 2010 Sep 1;202(5):675-80. doi: 10.1086/655226.

  PMID: 20632888 DERIVED

• Liang XF, Wang HQ, Wang JZ, Fang HH, Wu J, Zhu FC, Li RC, Xia SL, Zhao YL, Li FJ, Yan SH, Yin WD, An K, Feng DJ, Cui XL, Qi FC, Ju CJ, Zhang YH, Guo ZJ, Chen PY, Chen Z, Yan KM, Wang Y. Safety and immunogenicity of 2009 pandemic influenza A H1N1 vaccines in China: a multicentre, double-blind, randomised, placebo-controlled trial. Lancet. 2010 Jan 2;375(9708):56-66. doi: 10.1016/S0140-6736(09)62003-1. Epub 2009 Dec 15.

  PMID: 20018364 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2009
• First Posted: August 11, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: October 1, 2009
• Last Updated: July 29, 2021

Record last verified: 2009-10

Locations

CN (1)