H5 Adult - Chiron Study of Bird Flu Vaccine
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00280033 |
Recruitment Status :
Completed
First Posted : January 20, 2006
Last Update Posted : September 13, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Influenza | Biological: Aluminum hydroxide Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron) Biological: MF-59 Drug: Placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 394 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | A Randomized, Placebo-Controlled, Phase I/II, Dose-Ranging Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine Given Alone or Combined With Adjuvants in Healthy Adults |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | November 2006 |
Actual Study Completion Date : | November 2006 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: 9
Saline administered on days 0 and 28.
|
Drug: Placebo
Saline placebo. |
Experimental: 8
45 mcg alone administered on days 0 and 28.
|
Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron)
Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit-dose vials containing 60 mcg/mL A/H5N1 HA as determined by single radial immunodiffusion. It may be formulated with MF59 or aluminum hydroxide. Dosages: 7.5 mcg, 15 mcg, 30 mcg, or 45 mcg. |
Experimental: 7
30 mcg plus aluminum hydroxide administered on days 0 and 28.
|
Biological: Aluminum hydroxide
Provided in vials that contain 0.8 mL volume per vial. Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron) Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit-dose vials containing 60 mcg/mL A/H5N1 HA as determined by single radial immunodiffusion. It may be formulated with MF59 or aluminum hydroxide. Dosages: 7.5 mcg, 15 mcg, 30 mcg, or 45 mcg. |
Experimental: 6
30 mcg alone administered on days 0 and 28.
|
Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron)
Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit-dose vials containing 60 mcg/mL A/H5N1 HA as determined by single radial immunodiffusion. It may be formulated with MF59 or aluminum hydroxide. Dosages: 7.5 mcg, 15 mcg, 30 mcg, or 45 mcg. |
Experimental: 5
15 mcg plus aluminum hydroxide administered on days 0 and 28.
|
Biological: Aluminum hydroxide
Provided in vials that contain 0.8 mL volume per vial. Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron) Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit-dose vials containing 60 mcg/mL A/H5N1 HA as determined by single radial immunodiffusion. It may be formulated with MF59 or aluminum hydroxide. Dosages: 7.5 mcg, 15 mcg, 30 mcg, or 45 mcg. |
Experimental: 4
15 mcg plus MF59 administered on days 0 and 28.
|
Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron)
Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit-dose vials containing 60 mcg/mL A/H5N1 HA as determined by single radial immunodiffusion. It may be formulated with MF59 or aluminum hydroxide. Dosages: 7.5 mcg, 15 mcg, 30 mcg, or 45 mcg. Biological: MF-59 Proprietary experimental adjuvant. Provided in vials that contain 0.7 mL volume per vial. |
Experimental: 3
15 mcg alone administered on days 0 and 28.
|
Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron)
Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit-dose vials containing 60 mcg/mL A/H5N1 HA as determined by single radial immunodiffusion. It may be formulated with MF59 or aluminum hydroxide. Dosages: 7.5 mcg, 15 mcg, 30 mcg, or 45 mcg. |
Experimental: 2
7.5 mcg plus aluminum hydroxide administered on days 0 and 28.
|
Biological: Aluminum hydroxide
Provided in vials that contain 0.8 mL volume per vial. Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron) Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit-dose vials containing 60 mcg/mL A/H5N1 HA as determined by single radial immunodiffusion. It may be formulated with MF59 or aluminum hydroxide. Dosages: 7.5 mcg, 15 mcg, 30 mcg, or 45 mcg. |
Experimental: 1
7.5 mcg plus MF59 administered on days 0 and 28.
|
Biological: Inactivated Influenza A/H5N1 Vaccine (Chiron)
Monovalent subvirion H5N1 vaccine (HA of A/Vietnam/1203/04) provided in unit-dose vials containing 60 mcg/mL A/H5N1 HA as determined by single radial immunodiffusion. It may be formulated with MF59 or aluminum hydroxide. Dosages: 7.5 mcg, 15 mcg, 30 mcg, or 45 mcg. Biological: MF-59 Proprietary experimental adjuvant. Provided in vials that contain 0.7 mL volume per vial. |
- Geometric mean titer and frequency of 4-fold or greater increases in serum hemagglutination inhibition (HAI) antibody titers in each group 28 days after receipt of the second dose of vaccine. [ Time Frame: Approximately Day 56. ]
- Adverse event or SAE information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessments). [ Time Frame: Adverse events will be collected through 28 days following the second dose of vaccine (approximately Day 56). Serious adverse events will be collected throughout the study through Day 208. ]
- Proportion of subjects in each group achieving a serum neutralizing antibody titer ratio of 1:40 against the influenza A/H5N1 virus 28 days following second dose of vaccine. [ Time Frame: Approximately Day 56. ]
- Proportion of subjects in each dose group achieving a serum hemagglutination (HAI) antibody titer of 1:40 against the influenza A/H5N1 virus 28 days after receipt of the second dose of vaccine. [ Time Frame: Approximately Day 56. ]
- Geometric mean titer (GMT) and frequency of 4-fold or greater increases in neutralizing antibody titers in each group 28 days after receipt of the second dose of vaccine. [ Time Frame: Approximately Day 56. ]
- Geometric mean titer and the frequency of 4-fold or greater increases in neutralizing antibody titers in each group 1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine. [ Time Frame: Blood samples for serum assays will be collected at Day 0 and at Days 28, 56, and 208 after the first immunization. ]
- Geometric mean titer and the frequency of 4-fold or greater increases in serum HAI antibody titers 1 month after receipt of each dose, and 7 months after receipt of the first dose of vaccine. [ Time Frame: Blood samples for serum assays will be collected at Day 0 and at Days 28, 56, and 208 after the first immunization. ]
- Development of serum antibody responses against antigenically drifted variants of H5N1influenza virus. [ Time Frame: Blood samples for serum assays will be collected at Day 0 and at Days 28, 56, and 208 after the first immunization. ]

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy male or nonpregnant female (as indicated by a negative urine pregnancy test immediately prior to vaccine administration) between the ages of 18 and 64 years, inclusive.
- Women of childbearing potential (not surgically sterile or post menopausal for greater than or equal to one year) must agree to practice adequate contraception (i.e., barrier method, abstinence, and licensed hormonal methods) for the entire study period.
- Is in good health, as determined by vital signs (heart rate, blood pressure, oral temperature), medical history and a targeted physical examination based on medical history.
- Subjects should have normal safety laboratory values (Hgb, WBC, Plt, ALT, and creatinine) prior to the first immunization.
- Able to understand and comply with planned study procedures.
- Provides written informed consent prior to initiation of any study procedures.
Exclusion Criteria:
- Has a known allergy to eggs or other components of the vaccine or latex.
- Has a positive urine pregnancy test prior to vaccination (if female of childbearing potential) or women who are breastfeeding.
- Is undergoing immunosuppression as a result of an underlying illness or treatment.
- Has an active neoplastic disease or a history of any hematologic malignancy.
- Is using oral or parenteral steroids, high-dose inhaled steroids (greater than 800 micrograms/day of beclomethasone dipropionate or equivalent) or other immunosuppressive or cytotoxic drugs (nasal and topical steroids are allowed).
- Has a history of receiving immunoglobulin or other blood products within the 3 months prior to vaccination in this study.
- Has received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to vaccination in this study.
- Has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (this includes, but is not limited to: known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
- Has a history of severe reactions following immunization with contemporary influenza virus vaccines.
- Has an acute illness, including an oral temperature greater than 100.4 degrees F, within 1 week of vaccination.
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study, or expects to receive an experimental agent during the 7-month study period.
- Has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- Participated in H5 vaccine study in the past.
- Known current HIV, hepatitis B (HBsAg) or hepatitis C infection.
- History of alcohol or drug abuse in the last 5 years.
- Planned travel outside the US between vaccination and the second study visit.
- History of Guillain-Barre.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280033
United States, California | |
Stanford University | |
Stanford, California, United States, 94305-5208 | |
United States, Missouri | |
Saint Louis University | |
St. Louis, Missouri, United States, 63110 | |
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229-3039 | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 |
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00280033 |
Other Study ID Numbers: |
04-062 |
First Posted: | January 20, 2006 Key Record Dates |
Last Update Posted: | September 13, 2013 |
Last Verified: | January 2009 |
H5N1, Influenza, vaccine, parent protocol |
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Aluminum Hydroxide |
Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Antacids Molecular Mechanisms of Pharmacological Action Gastrointestinal Agents |