H1N1 Vaccine at Two Dose Levels in HIV Positive Adults

NCT00992433 | Completed Phase 2 Results

• 2 other identifiers: 09-0073N01AI80002C
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to see how the body reacts to different strengths of the H1N1 flu shot in persons infected with human immunodeficiency virus (HIV). This study will also compare how the CD4 count (cells that help fight disease) affects the body's response to the H1N1 flu shot. In this study, 2 strengths of the H1N1 flu shot will be given twice, about 3 weeks apart. The results of this study will help researchers find out if the different strengths of the H1N1 flu shot make the body produce H1N1 antibodies that are better at fighting H1N1 flu. About 240 HIV positive subjects, ages 18-64 years, will be asked to take part in this study. Study procedures include: blood sampling, physical exams, and use of memory aids to record temperature, medications and symptoms. The length of patient participation is about 7 months.

Conditions

Influenza

Keywords

influenza, H1N1, vaccine, human immunodeficiency virus

Outcome Measures

Primary Outcomes (29)

• Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine

  Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.

  Day 0 prior to vaccination and 10 days after the first vaccination

• Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine

  Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.

  Day 0 prior to vaccination and 21 days after the first vaccination

• Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine

  Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.

  Day 0 prior to vaccination and 10 days after the second vaccination

• Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine

  Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.

  Day 0 prior to vaccination and 21 days after the second vaccination

• Number of Participants in the CD4 Less Than 200/mL Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine

  Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.

  Day 0 prior to vaccination and 180 days after the second vaccination

• Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine

  Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.

  Day 0 prior to vaccination and 10 days after the first vaccination

• Number of Participants in the CD4 CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine

  Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post first H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.

  Day 0 prior to vaccination and 21 days after the first vaccination

• Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine

  Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 10 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 10 titer was an increase by 4-fold or more.

  Day 0 prior to vaccination and 10 days after the second vaccination

• Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine

  Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 21 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 titer was an increase by 4-fold or more.

  Day 0 prior to vaccination and 21 days after the second vaccination

• Number of Participants in the CD4 200/mL or Greater Stratum With 4-Fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Influenza H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine

  Blood was collected from participants for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant met the threshold of a 4-fold rise in titer if the Day 0 titer was less than 1:10 (the assay's lowest level of detection) and the Day 180 post second H1N1 vaccination titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 180 titer was an increase by 4-fold or more.

  Day 0 prior to vaccination and 180 days after the second vaccination

• Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline and 10 Days Following the First Dose of H1N1 Vaccine

  Blood was collected from all participants at Day 0 prior to vaccination and 10 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

  Day 0 prior to vaccination and 10 days after the first vaccination

• Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine

  Blood was collected from all participants 21 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

  Day 21 after the first vaccination

• Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the Second Dose of H1N1 Vaccine

  Blood was collected from all participants 10 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

  Day 10 after the second vaccination

• Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the Second Dose of H1N1 Vaccine

  Blood was collected from all participants 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

  Day 21 after the second vaccination

• Number of Participants in the CD4 Less Than 200/mL Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine

  Blood was collected from all participants 180 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

  Day 180 after the second vaccination

• Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus at Baseline Prior to the First Dose of H1N1 Vaccine

  Blood was collected from all participants at Day 0 prior to the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

  Day 0 prior to the first vaccination

• Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 Days Following the First Dose of H1N1 Vaccine

  Blood was collected from all participants 10 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

  Day 10 after the first vaccination

• Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 21 Days Following the First Dose of H1N1 Vaccine

  Blood was collected from all participants 21 days after the first vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

  Day 21 after the first vaccination

• Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 10 and 21 Days Following the Second Dose of H1N1 Vaccine

  Blood was collected from all participants 10 and 21 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

  Day 10 and Day 21 after the second vaccination

• Number of Participants in the CD4 200/mL or Greater Stratum With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the H1N1 2009 Virus 180 Days Following the Second Dose of H1N1 Vaccine

  Blood was collected from all participants 180 days after the second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.

  Day 180 after the second vaccination

• Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination

  Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.

  Within 8 days post first vaccination (Day 0-7).

• Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination

  Participants maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, malaise, myalgia, headache, and nausea for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.

  Within 8 days post second vaccination (Day 0-7).

• Number of Participants Reporting Fever After the First Vaccination

  Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.

  Within 8 days post first vaccination (Day 0-7).

• Number of Participants Reporting Fever After the Second Vaccination

  Participants were provided a thermometer and a memory aid to record daily oral temperatures for 8 days (Day 0-7) after vaccination. Participants are counted as experiencing fever if they reported oral temperatures of 38 degrees Celsius or higher on any of the 8 days.

  Within 8 days post second vaccination (Day 0-7).

• Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination

  Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.

  Within 8 days post first vaccination (Day 0-7).

• Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination

  Participants maintained a memory aid to record daily the occurrence of local symptoms of pain, tenderness and swelling for 8 days (Day 0-7) after vaccination based on their interference with daily activities. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.

  Within 8 days post second vaccination (Day 0-7).

• Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination

  Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.

  Within 8 days post first vaccination (Day 0-7).

• Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination

  Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days (Day 0-7) after vaccination. If the reaction was present, the maximum diameter was measured in millimeters (mm). Participants are counted if they were reported as experiencing the reaction with any measurement greater than 0 mm on any of the 8 days.

  Within 8 days post second vaccination (Day 0-7).

• Number of Participants Reporting Vaccine-Associated Serious Adverse Events (SAEs)

  Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required in-patient hospitalization or prolongation thereof; resulted in a congenital anomaly/birth defect; may have jeopardized the participant or required intervention to prevent one of these outcomes; or was described as Guillain-Barré Syndrome. Association to vaccination was determined by a study clinician licensed to make medical diagnosis.

  Day 0 through Day 180 after the last vaccination

Study Arms (2)

Group 2, 30 mcg

EXPERIMENTAL

CD4\<200, n=60; CD4 greater than or equal to 200, n=60. 30 mcg H1N1 vaccine on Day 0 and Day 21.

Biological: Inactivated Influenza H1N1 vaccine

Group 1, 15 mcg

EXPERIMENTAL

CD4\<200, n=60; CD4 greater than or equal to 200, n=60. 15 micrograms (mcg) H1N1 vaccine on Day 0 and Day 21.

Biological: Inactivated Influenza H1N1 vaccine

Interventions

Inactivated Influenza H1N1 vaccine BIOLOGICAL

Two doses inactivated, licensed, Influenza A (H1N1) 2009 monovalent vaccine; 15 or 30 micrograms (mcg) per dose; slightly opalescent suspension in phosphate buffered saline. 15 mcg dose administered as a single 0.5 mL intramuscular (IM) injection. 30 mcg dose administered as two 0.5 mL IM injections.

Group 1, 15 mcg; Group 2, 30 mcg

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Human immunodeficiency virus (HIV) infection defined as documented by an enzyme-linked immunosorbent assay (ELISA) and confirmed with a Western blot at any time prior to study entry. Serum HIV-1 antigen, plasma HIV-1 ribonucleic acid (RNA), or any Food and Drug Administration (FDA) approved antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
• Males or non-pregnant females age 18-64, inclusive.
• Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for greater than or equal to 1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, Depo-Provera injections or Implanon implants for at least 30 days following the last vaccination.
• Are medically stable, as determined by the Investigator (based on review of health status, vital signs, medical history, and targeted physical examination. Vital signs must be within normal ranges prior to the first vaccination (heart rate 55-100, blood pressure systolic \<160, blood pressure diastolic \<90).
• Receipt of the 2009-2010 seasonal influenza vaccine at least two weeks prior to enrollment in this study.
• Intend to be available for follow-up visits and phone call access through 7 months following receipt of H1N1 vaccine.
• Are able to understand and comply with planned study procedures.
• Subject receiving regular medical follow-up care for HIV.
• Has a documented platelet count of \>50,000mm\^3 and an absolute neutrophil count (ANC) of \>500mm\^3 within the 3 months prior to study entry.
• Provide written informed consent prior to initiation of any study procedures.

You may not qualify if:

• Treatment for an opportunistic infection (OI) initiated within 2 weeks prior to enrollment, or have symptoms that have not stabilized.
• Have a known allergy to eggs or other components of the vaccine (including polymyxin, neomycin, and chicken protein).
• Women who are pregnant or breastfeeding.
• Have a positive urine or serum pregnancy test within 24 hours prior to vaccination.
• Use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.
• Have a neoplastic disease that will be treated with chemotherapy or radiation, or a history of any hematologic malignancy.
• Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids. For oral or parenteral: prednisone or equivalent (greater than or equal to 2.0 mg/kg per day or greater than or equal to 20 mg total dose) for more than 2 consecutive weeks (or 2 weeks total) in the past 3 months. For inhaled steroids: \>800 mcg/day of beclomethasone dipropionate or equivalent within the preceding 6 months. (Nasal and topical steroids are allowed.)
• Have an uncontrolled major psychiatric diagnosis.
• Have a history of receiving immunoglobulin or other blood products within the 3 months prior to vaccination in this study.
• Received an experimental agent (vaccine, drug, biologic, device, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study (prior to the Day 201 follow-up call).
• Have received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study or plan receipt of such vaccines within 21 days following the second vaccination.
• Have 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.
• Have a history of severe reactions following previous immunization with influenza virus vaccines.
• Have a moderate-severe acute illness, including an oral temperature greater than 100.4 degrees Fahrenheit, within 72 hours prior to vaccination. (This may result in a temporary delay of vaccination).
• Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (6)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Maryland Baltimore - Institute of Human Virology

Baltimore, Maryland, 21201, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• El Sahly HM, Davis C, Kotloff K, Meier J, Winokur PL, Wald A, Johnston C, George SL, Brady RC, Lehmann C, Stokes-Riner A, Keitel WA. Higher antigen content improves the immune response to 2009 H1N1 influenza vaccine in HIV-infected adults: a randomized clinical trial. J Infect Dis. 2012 Mar 1;205(5):703-12. doi: 10.1093/infdis/jir837. Epub 2012 Jan 24.

  PMID: 22275399 RESULT

MeSH Terms

Conditions

Influenza, Human; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Hana El Sahly, MD
• Organization: Baylor College of Medicine

hanae@bcm.edu

713-798-2058

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2009
• First Posted: October 9, 2009
• Study Start: November 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: May 16, 2012
• Results First Posted: November 17, 2011

Record last verified: 2011-02

Locations

US (6)