Novel Influenza A/H1N1 Split- Virion Vaccine in Healthy Population Aged 3 Years and Older

NCT00975572 | Completed Phase 2 DMC

• 1 other identifier: JSVCT001
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 1

Brief Summary

The primary safety objective of this study is to assess the safety of split- virion inactivated H1N1 vaccine with and without adjuvant when administered at the 7.5,15 or 30 mcg dose. The primary immunogenicity objective is to assess the antibody response following each dose of split- virion inactivated A(H1N1) vaccine with and without adjuvant. Participants will include up to 2200 healthy persons age 3 and older who have no history of novel influenza H1N1 2009 infection or novel influenza H1N1 2009 vaccination. This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant females, aged 3 years and older. Subjects will be stratified by elders (equal to or more than 61 years), adults (18-60 years), adolescents (12-17 years) and children (3-11 years), elders and adolescents will be randomized into 5 dose groups (adjuvanted H1N1 vaccine of 7.5,15 or 30 mcg per dose or non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose), children will be randomized into 4 dose groups (adjuvanted H1N1 vaccine of 7.5 or 15 mcg per dose or non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose), adults will be randomized into 6 dose groups (adjuvanted H1N1 vaccine of 7.5,15 or 30 mcg per dose or non-adjuvanted H1N1 vaccine of 15 or 30 mcg per dose or placebo), 110 subjects per dose and age stratum will be to receive intramuscular influenza H1N1 vaccine. The H1N1 vaccine will be administered at Day 0 and Day 21. Following immunization, safety will be measured by assessment of adverse events through 21 days following the last vaccination (Day 42 for those receiving both doses), serious adverse events and new-onset chronic medical conditions through 6 months post the final vaccination (Day 180 after second vaccination), and reactogenicity to the vaccine for 8 days (Day 0-7) following each vaccination. Immunogenicity testing will be hemagglutination inhibiting (HAI) on serum obtained on the day 21 of each vaccination (prior to vaccination), on Day 21 after first vaccination, and 21 days following the second vaccination (Day 42).

Conditions

Virus Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Influenza; Orthomyxoviridae Infections

Keywords

Flu; adjuvanted H1N1 vaccine; non-adjuvanted H1N1 vaccine; Immunogenictiy; Safety

Outcome Measures

Primary Outcomes (1)

• Hemagglutination inhibition antibody titer

  D0,D21,D35

Secondary Outcomes (1)

• local and systemic adverse reaction after vaccination

  D0-42

Study Arms (6)

split-virion, adjuvanted H1N1 vaccine of 7.5 μg

EXPERIMENTAL

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

split-virion, adjuvanted H1N1 vaccine of 15 μg

EXPERIMENTAL

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

split-virion, adjuvanted H1N1 vaccine of 30 μg

EXPERIMENTAL

Biological: Experimental: split-virion, adjuvanted H1N1 vaccine of 30 μg

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

EXPERIMENTAL

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

Placebo control

PLACEBO COMPARATOR

Biological: Placebo Comparator: Placebo control

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

EXPERIMENTAL

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

Interventions

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

440 participants (110 elders, 110 adults, 110 adolescents and 110 children) to receive split-virion, non-adjuvanted H1N1 vaccine of 30 μg on day 0 and 21.

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

Experimental: split-virion, adjuvanted H1N1 vaccine of 7.5 μg BIOLOGICAL

440 participants (110 elders,110 adults, 110 adolescents and 110 children) to receive split-virion, adjuvanted H1N1 vaccine of 7.5 μg on day 0 and 21.

split-virion, adjuvanted H1N1 vaccine of 7.5 μg

Experimental: split-virion, adjuvanted H1N1 vaccine of 15 μg BIOLOGICAL

440 participants (110 elders, 110 adults, 110 adolescents and 110 children) to receive split-virion, adjuvanted H1N1 vaccine of 15 μg on day 0 and 21.

split-virion, adjuvanted H1N1 vaccine of 15 μg

Experimental: split-virion, adjuvanted H1N1 vaccine of 30 μg BIOLOGICAL

330 participants (110 elders, 110 adults, and 110 adolescents) to receive split-virion, adjuvanted H1N1 vaccine of 30 μg on day 0 and 21.

split-virion, adjuvanted H1N1 vaccine of 30 μg

Experimental: split-virion, non-adjuvanted H1N1 vaccine of 15 μg BIOLOGICAL

440 participants (110 elders, 110 adults, 110 adolescents and 110 children) to receive split-virion, non-adjuvanted H1N1 vaccine of 15 μg on day 0 and 21.

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

Placebo Comparator: Placebo control BIOLOGICAL

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

Placebo control

Eligibility Criteria

• Age: 3 Years - 90 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

• Jiangsu Province Centers for Disease Control and Prevention: lead
• Hualan Biological Bacterin Co. Ltd.: collaborator

Study Sites (1)

Taizhou Municipal Center for Disease Control and Prevention

Taizhou, Jiangsu, 225300, China

Location

Related Publications (2)

• 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

• Zhu FC, Wang H, Fang HH, Yang JG, Lin XJ, Liang XF, Zhang XF, Pan HX, Meng FY, Hu YM, Liu WD, Li CG, Li W, Zhang X, Hu JM, Peng WB, Yang BP, Xi P, Wang HQ, Zheng JS. A novel influenza A (H1N1) vaccine in various age groups. N Engl J Med. 2009 Dec 17;361(25):2414-23. doi: 10.1056/NEJMoa0908535. Epub 2009 Oct 21.

  PMID: 19846844 DERIVED

MeSH Terms

Conditions

Virus Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Influenza, Human; Orthomyxoviridae Infections

Condition Hierarchy (Ancestors)

Infections; RNA Virus Infections

Study Officials

• Feng-Cai Zhu, Master

  Jiangsu CDPC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: September 11, 2009
• Study Start: July 1, 2009
• Primary Completion: September 1, 2009
• Study Completion: February 1, 2010
• Last Updated: September 12, 2012

Record last verified: 2009-09

Locations

CN (1)