Sanofi H1N1 + TIV - Adults and Elderly

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00943878

Collaborator

(none)

805

Enrollment

Locations

Arms

Duration (Months)

161

Patients Per Site

20.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety and immune response (body's defense against disease) to an experimental H1N1 influenza vaccine against the 2009 H1N1 virus. This study will help determine how the H1N1 flu shot should be given with the seasonal flu shot to make it most effective. Participants will include up to 850 healthy adults, ages 18 and older. Participants will receive 2 H1N1 vaccines in addition to placebo (inactive substance) and the seasonal flu shot over 3 study visits about 21 days apart. Study procedures include: medical history, physical exam, maintaining a memory aid, and blood sample collection. Participants will be involved in the study for about 8 months.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Biological: Trivalent inactivated influenza vaccine Biological: Inactivated H1N1 Vaccine Drug: Placebo	Phase 2

Detailed Description

Recently, a novel swine-origin influenza A/H1N1 virus was identified as a significant cause of febrile respiratory illnesses in Mexico and the United States. It rapidly spread to many countries around the world, prompting the World Health Organization to declare a pandemic on June 11, 2009. Data from several cohorts in different age groups that received licensed trivalent seasonal influenza vaccines suggest that these vaccines are unlikely to provide protection against the new virus. Adults are more likely to have measurable levels of serum hemagglutination inhibition assay (HAI) or neutralizing antibody than are children. These data indicate the need to develop vaccines against the new H1N1 strain and suggest that different vaccine strategies (e.g., number of doses, need for adjuvant) may be appropriate for persons in different age groups. If the novel influenza H1N1 2009 virus continues to circulate, it is possible that it will co-circulate with the non-pandemic seasonal influenza strains. In this situation, it might be beneficial to co-administer an H1N1 vaccine concurrent with the seasonal inactivated influenza vaccine. This protocol explores if vaccination with the 2009-2010 licensed seasonal trivalent influenza vaccine (TIV) has an effect on antibody response to the novel influenza H1N1 2009 virus and examines if receiving the H1N1 vaccine either concurrent with, prior to, or following the seasonal influenza vaccine affects the antibody response to the seasonal influenza vaccine. This is a randomized, double-blinded, Phase II study in up to 850 healthy males and non-pregnant females, aged 18 and older. The study investigates the safety, reactogenicity, and immunogenicity of an inactivated influenza H1N1 virus vaccine when given concurrent with or sequentially with (before or after) TIV. The primary safety objective is to assess the safety of the unadjuvanted, inactivated H1N1 influenza vaccine when administered either concurrent with, prior to, or following licensed seasonal influenza vaccination. The primary immunogenicity objective is to assess the effect of TIV on antibody response to unadjuvanted, inactivated influenza H1N1 vaccine as assessed by hemagglutination inhibition assay (HAI), stratified by age of recipient. The secondary objective is immunogenicity, to assess the effect of H1N1 vaccine administration on antibody response to TIV as assessed by HAI, stratified by age of recipient. Subjects will be randomized into 4 groups, stratified by age (200 subjects per group with 100 subjects per age stratum, 18-64 or greater than or equal to 65 years of age). Group 1 will receive two 15 microgram (mcg) doses of H1N1 vaccine at Days 0 and 21 followed by TIV on Day 42. Group 2 will receive two 15 mcg doses of H1N1 vaccine of which the first dose is administered concurrently with TIV. Group 3 will receive two 15 mcg doses of H1N1 vaccine of which the second dose is administered concurrently with TIV. Group 4 will receive TIV administered on Day 0 followed by two 15 mcg doses of H1N1 vaccine on Days 21 and 42. In order to maintain the blind, subjects will also receive a placebo (normal saline) so that two products will be administered at both Days 0 and 21, and one product will be administered at Day 42 for all groups. Following immunization, safety will be measured by assessment of adverse events for 21 days following the last vaccination (Day 42 for those who do not receive the second dose), serious adverse events and new-onset chronic medical conditions for 8 months post the first vaccination (Day 222), and reactogenicity to the vaccines for 8 days following each vaccination (Day 0-7). Immunogenicity testing will include HAI

Study Design

Study Type:

Interventional

Actual Enrollment :

805 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effect of Administration of Licensed TIV Vaccine on the Safety and Immunogenicity of an Unadjuvanted Sanofi Pasteur H1N1 Influenza Vaccine in Healthy Adult and Elderly Populations

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 3: H1N1+placebo; H1N1+TIV; placebo 200 subjects (100 ages 18-64 years and 100 aged greater than or equal to 65 years) to receive: Day 0, 15 mcg H1N1 Vaccine + placebo; Day 21, 15 mcg H1N1 Vaccine + trivalent influenza vaccine (TIV); and Day 42, placebo.	Biological: Trivalent inactivated influenza vaccine Licensed trivalent influenza vaccine (TIV) administered as a single 0.5 mL intramuscular injection in the deltoid muscle. Biological: Inactivated H1N1 Vaccine Two doses of inactivated influenza H1N1 vaccine, 15 mcg per dose, administered as a single 0.5 milliliters (mL) intramuscular injection in the deltoid muscle. Drug: Placebo Normal saline (placebo control) administered as a single 0.5 mL intramuscular injection in the deltoid muscle.
Experimental: Group 1: H1N1+placebo; H1N1+placebo; TIV 200 subjects (100 ages 18-64 years and 100 aged greater than or equal to 65 years) to receive: Day 0, 15 mcg H1N1 Vaccine + placebo; Day 21, 15 mcg H1N1 Vaccine + placebo; and Day 42, trivalent influenza vaccine (TIV).	Biological: Trivalent inactivated influenza vaccine Licensed trivalent influenza vaccine (TIV) administered as a single 0.5 mL intramuscular injection in the deltoid muscle. Biological: Inactivated H1N1 Vaccine Two doses of inactivated influenza H1N1 vaccine, 15 mcg per dose, administered as a single 0.5 milliliters (mL) intramuscular injection in the deltoid muscle. Drug: Placebo Normal saline (placebo control) administered as a single 0.5 mL intramuscular injection in the deltoid muscle.
Experimental: Group 2: H1N1+TIV; H1N1+placebo; placebo 200 subjects (100 ages 18-64 years and 100 aged greater than or equal to 65 years) to receive: Day 0, 15 mcg H1N1 Vaccine + trivalent influenza vaccine (TIV); Day 21, 15 mcg H1N1 Vaccine + placebo; and Day 42, placebo.	Biological: Trivalent inactivated influenza vaccine Licensed trivalent influenza vaccine (TIV) administered as a single 0.5 mL intramuscular injection in the deltoid muscle. Biological: Inactivated H1N1 Vaccine Two doses of inactivated influenza H1N1 vaccine, 15 mcg per dose, administered as a single 0.5 milliliters (mL) intramuscular injection in the deltoid muscle. Drug: Placebo Normal saline (placebo control) administered as a single 0.5 mL intramuscular injection in the deltoid muscle.
Experimental: Group 4: TIV+placebo; H1N1+placebo; H1N1 200 subjects (100 ages 18-64 years and 100 aged greater than or equal to 65 years) to receive: Day 0, trivalent influenza vaccine (TIV) + placebo; Day 21, 15 mcg H1N1 Vaccine + placebo; and Day 42, 15 mcg H1N1 vaccine.	Biological: Trivalent inactivated influenza vaccine Licensed trivalent influenza vaccine (TIV) administered as a single 0.5 mL intramuscular injection in the deltoid muscle. Biological: Inactivated H1N1 Vaccine Two doses of inactivated influenza H1N1 vaccine, 15 mcg per dose, administered as a single 0.5 milliliters (mL) intramuscular injection in the deltoid muscle. Drug: Placebo Normal saline (placebo control) administered as a single 0.5 mL intramuscular injection in the deltoid muscle.

Outcome Measures

Primary Outcome Measures

Number of Participants Age 18 to 64 Years 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 [Day 21 after first H1N1 vaccination]
Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. 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.
Number of Participants Age 65 Years and Older 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 [Day 21 after first H1N1 vaccination]
Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. 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.
Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs) [Day 0 through Day 180 after the last vaccination]
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 diagnoses.
Number of Participants Age 18 to 64 Years 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 [Day 0 prior to vaccination and 21 days after the first H1N1 vaccination]
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 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.
Number of Participants Age 65 Years and Older 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 [Day 0 prior to vaccination and 21 days after the first H1N1 vaccination]
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 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.
Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination [Within 8 days (Day 0-7) post 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.
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination [Within 8 days (Day 0-7) post 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.
Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination [Within 8 days (Day 0-7) post third 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.
Number of Participants Reporting Fever After the First Vaccination [Within 8 days (Day 0-7) post 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.
Number of Participants Reporting Fever After the Second Vaccination [Within 8 days (Day 0-7) post 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.
Number of Participants Reporting Fever After the Third Vaccination [Within 8 days (Day 0-7) post third 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.
Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination [Within 8 days (Day 0-7) post first H1N1 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. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.
Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination [Within 8 days (Day 0-7) post second H1N1 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. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.
Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination [Within 8 days (Day 0-7) post TIV 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. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.
Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination [Within 8 days (Day 0-7) post first placebo 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. The first placebo vaccination was given on Study Day 0 for Groups 1, 3 and 4, and on Study Day 21 for Group 2.
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination [Within 8 days (Day 0-7) post second placebo 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. The second placebo vaccination was given on Study Day 21 for Groups 1 and 4, on Study Day 42 for Groups 2 and 3.
Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination [Within 8 days (Day 0-7) post first H1N1 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.
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination [Within 8 days (Day 0-7) post second H1N1 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.
Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination [Within 8 days (Day 0-7) post TIV 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.
Number of Participants Reporting Solicited Quantitative Local Reactions After the First Placebo Vaccination [Within 8 days (Day 0-7) post first placebo 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.
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Placebo Vaccination [Within 8 days (Day 0-7) post second placebo 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.

Secondary Outcome Measures

Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination [Day 63]
Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. 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 63 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 63 titer was an increase by 4-fold or more.
Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination [Day 63]
Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. 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 63 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 63 titer was an increase by 4-fold or more.
Number of Participants Age 18 to 64 Years 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 [Day 0 prior to vaccination and 21 days after the second H1N1 vaccination]
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 21 post second H1N1 vaccination is Study Day 63 for Group 4, and is Study Day 42 for all other groups.
Number of Participants Age 65 Years and Older 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 [Day 0 prior to vaccination and 21 days after the second H1N1 vaccination]
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 21 post second H1N1 vaccination is Study Day 63 for Group 4, and is Study Day 42 for all other groups.
Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination [Day 63]
Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater.
Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination [Day 63]
Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater.
Number of Participants Age 18 to 64 Years 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 [Day 21 after second H1N1 vaccination]
Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 63, all others it is Study Day 42. 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.
Number of Participants Age 65 Years and Older 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 [Day 21 after second H1N1 vaccination]
Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 63, all others it is Study Day 42. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Are males or non-pregnant females age 18 and older, 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, and licensed hormonal methods during the study for at least 30 days following the last vaccination.
Are in good health, as determined by vital signs, medical history to ensure any existing medical diagnoses or conditions are stable and not considered clinically significant, and targeted physical examination based on medical history. A stable chronic medical condition is defined as no change in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months. Any change that is due to change of health care provider, insurance company etc, or that is done for financial reasons, as long as in the same class of medication will not be considered a violation of this inclusion criterion. Any change in prescription medication due to improvement of a disease outcome will not be considered a violation of this inclusion criterion.
Are able to understand and comply with planned study procedures.
Provide written informed consent prior to initiation of any study procedures.

Exclusion Criteria:

Have a known allergy to eggs or other components of the vaccine (including gelatin, formaldehyde, octoxinol, thimerosal and chicken protein).
Have a positive urine or serum pregnancy test within 24 hours prior to vaccination (if female of childbearing potential), or women who are breastfeeding.
Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within the preceding 36 months.
Have an active neoplastic disease or a history of any hematologic malignancy.
Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids (>800 micrograms (mcg)/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed.)
Have a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis.
Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years.
Are receiving psychiatric drugs (aripiprazole, clozapine, ziprasidone, haloperidol, molindone, loxapine, thioridazine, thiothixene, pimozide, fluphenazine, risperidone, mesoridazine, quetiapine, trifluoperazine, chlorprothixene, chlorpromazine, perphenazine, trifluopromazine, olanzapine, carbamazepine, divalproex sodium, lithium carbonate or lithium citrate). Subjects who are receiving a single antidepressant drug and are stable for at least 3 months prior to enrollment, without de-compensating symptoms will be allowed to be enrolled in the study.
Have a history of receiving immunoglobulin or other blood product within the 3 months prior to vaccination in this study.
Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during the study period (prior to Day 180 after the third vaccination).
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 last vaccination.
Has received a licensed 2009-2010 seasonal influenza vaccine.
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 an acute illness, including an oral temperature greater than 100.4 degrees Fahrenheit, within 3 days prior to vaccination.
Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.
Participated in a novel influenza H1N1 2009 vaccine study in the past two years or have a history of novel influenza H1N1 2009 infection prior to enrollment.
Have known active human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C infection.
Have a history of alcohol or drug abuse in the last 5 years.
Plan to travel outside of North America in the time between the first vaccination and 63 days following the first vaccination.
Have a history of Guillain-Barré Syndrome.
Have any condition that the investigator believes may interfere with successful completion of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory Vaccine Center - The Hope Clinic	Decatur	Georgia	United States	30030
2	Saint Louis University Hospital - Internal Medicine - Infectious Diseases, Allergy & Immunology	St. Louis	Missouri	United States	63110
3	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229-3039
4	Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center	Nashville	Tennessee	United States	37232-2573
5	Baylor College of Medicine	Houston	Texas	United States	77030

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00943878

Other Study ID Numbers:

09-0039
N01AI80003C

First Posted:

Jul 22, 2009

Last Update Posted:

Aug 1, 2012

Last Verified:

Apr 1, 2010

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)

H1N1, influenza A viruses, vaccine, elderly, TIV

Additional relevant MeSH terms:

Influenza, Human

Vaccines

Study Results

Participant Flow

Recruitment Details	Participants were healthy adult males and females recruited from existing volunteer populations and from the communities at large around the clinical sites. Participants were enrolled between 7AUG2009 and 28AUG2009.
Pre-assignment Detail

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Period Title: Overall Study
STARTED	202	200	203	200
COMPLETED	200	198	197	198
NOT COMPLETED	2	2	6	2

Baseline Characteristics

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Total
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Total of all reporting groups
Overall Participants	202	200	203	200	805
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	101 50%	103 51.5%	102 50.2%	102 51%	408 50.7%
>=65 years	101 50%	97 48.5%	101 49.8%	98 49%	397 49.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59.2 (16.2)	58.4 (16.7)	58.5 (16.6)	59.1 (15.3)	58.8 (16.2)
Sex: Female, Male (Count of Participants)
Female	99 49%	118 59%	104 51.2%	123 61.5%	444 55.2%
Male	103 51%	82 41%	99 48.8%	77 38.5%	361 44.8%
Region of Enrollment (participants) [Number]
United States	202 100%	200 100%	203 100%	200 100%	805 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Age 18 to 64 Years 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
Description	Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. 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.
Time Frame	Day 21 after first H1N1 vaccination

Outcome Measure Data

Analysis Population Description
Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Seven participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	98	101	99	94
Number [Participants]	90 44.6%	87 43.5%	91 44.8%	82 41%

2. Primary Outcome

Title	Number of Participants Age 65 Years and Older 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
Description	Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 42, all others it is Study Day 21. 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.
Time Frame	Day 21 after first H1N1 vaccination

Outcome Measure Data

Analysis Population Description
Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. One participant was excluded due to receipt of a non-study vaccine. Analyses are as treated. This outcome restricts to age stratum.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	101	97	101	95
Number [Participants]	81 40.1%	79 39.5%	88 43.3%	75 37.5%

3. Primary Outcome

Title	Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)
Description	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 diagnoses.
Time Frame	Day 0 through Day 180 after the last vaccination

Outcome Measure Data

Analysis Population Description
All participants receiving the first vaccination are included in the safety cohort. Analyses are as treated.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	202	200	203	200
Number [Participants]	0 0%	0 0%	0 0%	0 0%

4. Primary Outcome

Title	Number of Participants Age 18 to 64 Years 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
Description	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 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.
Time Frame	Day 0 prior to vaccination and 21 days after the first H1N1 vaccination

Outcome Measure Data

Analysis Population Description
Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint, both within 4 days of the window, are included. Seven participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	98	101	99	94
Number [Participants]	84 41.6%	83 41.5%	89 43.8%	78 39%

5. Secondary Outcome

Title	Number of Participants Age 18 to 64 Years With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination
Description	Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. 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 63 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 63 titer was an increase by 4-fold or more.
Time Frame	Day 63

Outcome Measure Data

Analysis Population Description
Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	91	89	88	90
TIV H1 antigen	46 22.8%	40 20%	38 18.7%	39 19.5%
TIV H3 antigen	52 25.7%	48 24%	46 22.7%	47 23.5%
TIV B antigen	34 16.8%	31 15.5%	36 17.7%	39 19.5%

6. Secondary Outcome

Title	Number of Participants Age 65 Years and Older With 4-fold or Greater Hemagglutination Inhibition Assay (HAI) Antibody Titer Increases Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination
Description	Blood was collected from participants for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. 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 63 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 63 titer was an increase by 4-fold or more.
Time Frame	Day 63

Outcome Measure Data

Analysis Population Description
Participants who received all vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	92	87	90	91
TIV H1 antigen	66 32.7%	62 31%	53 26.1%	57 28.5%
TIV H3 antigen	37 18.3%	27 13.5%	34 16.7%	31 15.5%
TIV B antigen	14 6.9%	14 7%	20 9.9%	18 9%

7. Secondary Outcome

Title	Number of Participants Age 18 to 64 Years 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
Description	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 21 post second H1N1 vaccination is Study Day 63 for Group 4, and is Study Day 42 for all other groups.
Time Frame	Day 0 prior to vaccination and 21 days after the second H1N1 vaccination

Outcome Measure Data

Analysis Population Description
Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	94	92	90	90
Number [Participants]	85 42.1%	77 38.5%	85 41.9%	75 37.5%

8. Secondary Outcome

Title	Number of Participants Age 65 Years and Older 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
Description	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 21 post second H1N1 vaccination is Study Day 63 for Group 4, and is Study Day 42 for all other groups.
Time Frame	Day 0 prior to vaccination and 21 days after the second H1N1 vaccination

Outcome Measure Data

Analysis Population Description
Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	96	92	93	91
Number [Participants]	80 39.6%	73 36.5%	72 35.5%	65 32.5%

9. Primary Outcome

Title	Number of Participants Age 65 Years and Older 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
Description	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 21 post first H1N1 vaccination is Study Day 42 for Group 4, and is Study Day 21 for all other groups.
Time Frame	Day 0 prior to vaccination and 21 days after the first H1N1 vaccination

Outcome Measure Data

Analysis Population Description
Participants who received the H1N1 vaccination and from whom blood was collected at the timepoint are included. One participant was excluded due to receipt of a non-study vaccine. Analyses are as treated. This outcome restricts to age stratum.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	101	97	101	95
Number [Participants]	78 38.6%	72 36%	78 38.4%	68 34%

10. Primary Outcome

Title	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination
Description	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.
Time Frame	Within 8 days (Day 0-7) post first vaccination

Outcome Measure Data

Analysis Population Description
Participants who received the first vaccination are included. Analyses are as treated.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	202	200	203	200
Feverishness	12 5.9%	12 6%	7 3.4%	13 6.5%
Malaise	30 14.9%	41 20.5%	27 13.3%	33 16.5%
Myalgia	23 11.4%	24 12%	16 7.9%	23 11.5%
Headache	43 21.3%	44 22%	35 17.2%	44 22%
Nausea	12 5.9%	11 5.5%	11 5.4%	12 6%

11. Secondary Outcome

Title	Number of Participants Age 18 to 64 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination
Description	Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater.
Time Frame	Day 63

Outcome Measure Data

Analysis Population Description
Participants who received all scheduled vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	91	89	88	90
TIV H1 antigen	79 39.1%	77 38.5%	78 38.4%	81 40.5%
TIV H3 antigen	84 41.6%	80 40%	77 37.9%	84 42%
TIV B antigen	81 40.1%	75 37.5%	78 38.4%	81 40.5%

12. Secondary Outcome

Title	Number of Participants Age 65 Years and Older With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Virus Strains in the 2009-2010 Trivalent Influenza Vaccine (TIV) 21 Days Following the Last Vaccination
Description	Blood was collected from participants 21 days after the last vaccination for testing in the HAI assay against each strain in the 2009-2010 trivalent influenza vaccine. Each sample was tested according to standard operating procedures. A participant is counted if the value at the Day 63 timepoint was 1:40 or greater.
Time Frame	Day 63

Outcome Measure Data

Analysis Population Description
Participants who received all scheduled vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	92	87	90	91
TIV H1 antigen	85 42.1%	82 41%	81 39.9%	87 43.5%
TIV H3 antigen	86 42.6%	80 40%	83 40.9%	77 38.5%
TIV B antigen	71 35.1%	69 34.5%	68 33.5%	62 31%

13. Secondary Outcome

Title	Number of Participants Age 18 to 64 Years 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
Description	Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 63, all others it is Study Day 42. 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.
Time Frame	Day 21 after second H1N1 vaccination

Outcome Measure Data

Analysis Population Description
Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Eight participants were excluded due to eligibility deviations, vaccine administration error or other protocol deviations. Analyses are as treated. This outcome restricts to age stratum.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	94	92	90	90
Number [Participants]	89 44.1%	82 41%	87 42.9%	80 40%

14. Secondary Outcome

Title	Number of Participants Age 65 Years and Older 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
Description	Blood was collected from all participants 21 days after vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. For Group 4, this timepoint is Study Day 63, all others it is Study Day 42. 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.
Time Frame	Day 21 after second H1N1 vaccination

Outcome Measure Data

Analysis Population Description
Participants who received both H1N1 vaccinations and from whom blood was collected at the timepoint, all within 4 days of the window, are included. Three participants were excluded due to receipt of non-study vaccines. Analyses are as treated. This outcome restricts to age stratum.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	96	92	93	91
Number [Participants]	83 41.1%	78 39%	81 39.9%	71 35.5%

15. Primary Outcome

Title	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination
Description	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.
Time Frame	Within 8 days (Day 0-7) post second vaccination

Outcome Measure Data

Analysis Population Description
Participants who received the second vaccination are included. Analyses are as treated.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	193	190	189	192
Feverishness	14 6.9%	8 4%	12 5.9%	10 5%
Malaise	29 14.4%	29 14.5%	35 17.2%	23 11.5%
Myalgia	18 8.9%	14 7%	19 9.4%	14 7%
Headache	28 13.9%	26 13%	29 14.3%	21 10.5%
Nausea	6 3%	6 3%	4 2%	8 4%

16. Primary Outcome

Title	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination
Description	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.
Time Frame	Within 8 days (Day 0-7) post third vaccination

Outcome Measure Data

Analysis Population Description
Participants who received the third vaccination are included. Analyses are as treated.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	190	185	183	188
Feverishness	6 3%	8 4%	5 2.5%	5 2.5%
Malaise	17 8.4%	15 7.5%	18 8.9%	14 7%
Myalgia	10 5%	12 6%	11 5.4%	6 3%
Headache	16 7.9%	19 9.5%	17 8.4%	15 7.5%
Nausea	4 2%	5 2.5%	5 2.5%	7 3.5%

17. Primary Outcome

Title	Number of Participants Reporting Fever After the First Vaccination
Description	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.
Time Frame	Within 8 days (Day 0-7) post first vaccination

Outcome Measure Data

Analysis Population Description
Participants who received the first vaccination and reported oral temperatures during the time period are included. Analyses are as treated.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	202	200	202	200
Number [Participants]	0 0%	1 0.5%	0 0%	0 0%

18. Primary Outcome

Title	Number of Participants Reporting Fever After the Second Vaccination
Description	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.
Time Frame	Within 8 days (Day 0-7) post second vaccination

Outcome Measure Data

Analysis Population Description
Participants who received the second vaccination and reported oral temperatures during the time period are included. Analyses are as treated.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	193	190	188	192
Number [Participants]	0 0%	2 1%	0 0%	3 1.5%

19. Primary Outcome

Title	Number of Participants Reporting Fever After the Third Vaccination
Description	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.
Time Frame	Within 8 days (Day 0-7) post third vaccination

Outcome Measure Data

Analysis Population Description
Participants who received the third vaccination and reported oral temperatures during the time period are included. Analyses are as treated.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	190	184	183	188
Number [Participants]	0 0%	0 0%	1 0.5%	0 0%

20. Primary Outcome

Title	Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination
Description	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. First H1N1 vaccination was given on Study Day 0 for Groups 1, 2 and 3, and on Study Day 21 for Group 4.
Time Frame	Within 8 days (Day 0-7) post first H1N1 vaccination

Outcome Measure Data

Analysis Population Description
Participants who received the first H1N1 vaccination are included. Analyses are as treated.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	202	200	203	192
Pain	26 12.9%	32 16%	26 12.8%	11 5.5%
Tenderness	45 22.3%	46 23%	47 23.2%	29 14.5%
Swelling	18 8.9%	14 7%	16 7.9%	20 10%

21. Primary Outcome

Title	Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination
Description	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. Second H1N1 vaccination was given on Study Day 21 for Groups 1, 2 and 3, and on Study Day 42 for Group 4.
Time Frame	Within 8 days (Day 0-7) post second H1N1 vaccination

Outcome Measure Data

Analysis Population Description
Participants who received the second H1N1 vaccination are included. Analyses are as treated.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	194	190	189	188
Pain	28 13.9%	22 11%	30 14.8%	19 9.5%
Tenderness	51 25.2%	44 22%	58 28.6%	37 18.5%
Swelling	28 13.9%	17 8.5%	20 9.9%	25 12.5%

22. Primary Outcome

Title	Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination
Description	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. The TIV vaccination was given on Study Day 42 for Group 1, Study Day 0 for Groups 2 and 4, and on Study Day 21 for Group 3.
Time Frame	Within 8 days (Day 0-7) post TIV vaccination

Outcome Measure Data

Analysis Population Description
Participants who received the TIV vaccination are included. Analyses are as treated.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	190	200	189	200
Pain	32 15.8%	57 28.5%	46 22.7%	48 24%
Tenderness	71 35.1%	93 46.5%	80 39.4%	84 42%
Swelling	27 13.4%	27 13.5%	22 10.8%	28 14%

23. Primary Outcome

Title	Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination
Description	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. The first placebo vaccination was given on Study Day 0 for Groups 1, 3 and 4, and on Study Day 21 for Group 2.
Time Frame	Within 8 days (Day 0-7) post first placebo vaccination

Outcome Measure Data

Analysis Population Description
Participants who received the first placebo vaccination are included. Analyses are as treated.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	202	190	203	200
Pain	12 5.9%	14 7%	13 6.4%	11 5.5%
Tenderness	21 10.4%	14 7%	21 10.3%	21 10.5%
Swelling	12 5.9%	18 9%	12 5.9%	14 7%

24. Primary Outcome

Title	Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination
Description	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. The second placebo vaccination was given on Study Day 21 for Groups 1 and 4, on Study Day 42 for Groups 2 and 3.
Time Frame	Within 8 days (Day 0-7) post second placebo vaccination

Outcome Measure Data

Analysis Population Description
Participants who received the second placebo vaccination are included. Analyses are as treated.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	194	185	183	192
Pain	11 5.4%	9 4.5%	5 2.5%	8 4%
Tenderness	15 7.4%	7 3.5%	9 4.4%	17 8.5%
Swelling	25 12.4%	13 6.5%	14 6.9%	13 6.5%

25. Primary Outcome

Title	Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination
Description	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.
Time Frame	Within 8 days (Day 0-7) post first H1N1 vaccination

Outcome Measure Data

Analysis Population Description
Participants who received the first H1N1 vaccination are included. Analyses are as treated.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	202	200	203	192
Redness	32 15.8%	33 16.5%	27 13.3%	31 15.5%
Swelling	19 9.4%	16 8%	19 9.4%	21 10.5%

26. Primary Outcome

Title	Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination
Description	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.
Time Frame	Within 8 days (Day 0-7) post second H1N1 vaccination

Outcome Measure Data

Analysis Population Description
Participants who received the second H1N1 vaccination are included. Analyses are as treated.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	194	190	189	188
Redness	29 14.4%	27 13.5%	29 14.3%	35 17.5%
Swelling	29 14.4%	18 9%	19 9.4%	27 13.5%

27. Primary Outcome

Title	Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination
Description	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.
Time Frame	Within 8 days (Day 0-7) post TIV vaccination

Outcome Measure Data

Analysis Population Description
Participants who received the TIV vaccination are included. Analyses are as treated.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	190	200	189	200
Redness	31 15.3%	40 20%	30 14.8%	37 18.5%
Swelling	28 13.9%	27 13.5%	21 10.3%	28 14%

28. Primary Outcome

Title	Number of Participants Reporting Solicited Quantitative Local Reactions After the First Placebo Vaccination
Description	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.
Time Frame	Within 8 days (Day 0-7) post first placebo vaccination

Outcome Measure Data

Analysis Population Description
Participants who received the first placebo vaccination are included. Analyses are as treated.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	202	190	203	200
Redness	34 16.8%	19 9.5%	21 10.3%	37 18.5%
Swelling	12 5.9%	20 10%	12 5.9%	28 14%

29. Primary Outcome

Title	Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Placebo Vaccination
Description	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.
Time Frame	Within 8 days (Day 0-7) post second placebo vaccination

Outcome Measure Data

Analysis Population Description
Participants who received the second placebo vaccination are included. Analyses are as treated.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42	Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
Measure Participants	194	185	183	192
Redness	30 14.9%	25 12.5%	26 12.8%	30 15%
Swelling	27 13.4%	17 8.5%	14 6.9%	14 7%

Adverse Events

	Group 1: H1N1+Placebo; H1N1+Placebo; TIV		Group 2: H1N1+TIV; H1N1+Placebo; Placebo		Group 3: H1N1+Placebo; H1N1+TIV; Placebo		Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Time Frame	Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.
Adverse Event Reporting Description	For events solicited on a Memory Aid in the 8 days after vaccination, a participant was considered to have one event if it was reported as experienced at any time in the 8 day period.

Arm/Group Title	Group 1: H1N1+Placebo; H1N1+Placebo; TIV		Group 2: H1N1+TIV; H1N1+Placebo; Placebo		Group 3: H1N1+Placebo; H1N1+TIV; Placebo		Group 4: TIV+Placebo; H1N1+Placebo; H1N1
Arm/Group Description	Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42		Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42		Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42		Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Group 1: H1N1+Placebo; H1N1+Placebo; TIV		Group 2: H1N1+TIV; H1N1+Placebo; Placebo		Group 3: H1N1+Placebo; H1N1+TIV; Placebo		Group 4: TIV+Placebo; H1N1+Placebo; H1N1
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/202 (2.5%)		7/200 (3.5%)		12/203 (5.9%)		13/200 (6.5%)
Blood and lymphatic system disorders
Anaemia	1/202 (0.5%)	1	0/200 (0%)	0	0/203 (0%)	0	0/200 (0%)	0
Cardiac disorders
Myocardial infarction	1/202 (0.5%)	1	0/200 (0%)	0	0/203 (0%)	0	0/200 (0%)	0
Coronary artery disease	1/202 (0.5%)	1	0/200 (0%)	0	0/203 (0%)	0	0/200 (0%)	0
Angina unstable	0/202 (0%)	0	0/200 (0%)	0	1/203 (0.5%)	1	0/200 (0%)	0
Atrial fibrillation	0/202 (0%)	0	0/200 (0%)	0	1/203 (0.5%)	1	0/200 (0%)	0
Coronary artery stenosis	0/202 (0%)	0	0/200 (0%)	0	1/203 (0.5%)	1	0/200 (0%)	0
Endocrine disorders
Hyperparathyroidism	0/202 (0%)	0	0/200 (0%)	0	0/203 (0%)	0	1/200 (0.5%)	1
Gastrointestinal disorders
Abdominal pain	0/202 (0%)	0	1/200 (0.5%)	1	0/203 (0%)	0	0/200 (0%)	0
Intestinal ischaemia	0/202 (0%)	0	0/200 (0%)	0	1/203 (0.5%)	1	0/200 (0%)	0
Oesophageal disorder	0/202 (0%)	0	0/200 (0%)	0	1/203 (0.5%)	1	0/200 (0%)	0
General disorders
Asthenia	0/202 (0%)	0	0/200 (0%)	0	0/203 (0%)	0	1/200 (0.5%)	1
Hepatobiliary disorders
Cholecystitis	0/202 (0%)	0	0/200 (0%)	0	0/203 (0%)	0	1/200 (0.5%)	1
Infections and infestations
Appendicitis	1/202 (0.5%)	1	0/200 (0%)	0	0/203 (0%)	0	0/200 (0%)	0
Wound infection	0/202 (0%)	0	1/200 (0.5%)	1	0/203 (0%)	0	0/200 (0%)	0
Pneumonia	0/202 (0%)	0	1/200 (0.5%)	1	0/203 (0%)	0	1/200 (0.5%)	1
Sepsis	0/202 (0%)	0	0/200 (0%)	0	1/203 (0.5%)	1	0/200 (0%)	0
Injury, poisoning and procedural complications
Lower limb fracture	1/202 (0.5%)	1	0/200 (0%)	0	0/203 (0%)	0	0/200 (0%)	0
Road traffic accident	0/202 (0%)	0	0/200 (0%)	0	1/203 (0.5%)	1	0/200 (0%)	0
Metabolism and nutrition disorders
Hypervitaminosis A	0/202 (0%)	0	0/200 (0%)	0	0/203 (0%)	0	1/200 (0.5%)	1
Musculoskeletal and connective tissue disorders
Pain in extremity	0/202 (0%)	0	0/200 (0%)	0	0/203 (0%)	0	1/200 (0.5%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gammopathy	1/202 (0.5%)	1	0/200 (0%)	0	0/203 (0%)	0	0/200 (0%)	0
Malignant melanoma	0/202 (0%)	0	1/200 (0.5%)	1	0/203 (0%)	0	0/200 (0%)	0
Brain neoplasm	0/202 (0%)	0	0/200 (0%)	0	1/203 (0.5%)	1	0/200 (0%)	0
Tonsil cancer	0/202 (0%)	0	0/200 (0%)	0	1/203 (0.5%)	1	0/200 (0%)	0
Renal cancer	0/202 (0%)	0	0/200 (0%)	0	1/203 (0.5%)	1	0/200 (0%)	0
Prostate cancer	0/202 (0%)	0	0/200 (0%)	0	0/203 (0%)	0	1/200 (0.5%)	1
Metastasis	0/202 (0%)	0	0/200 (0%)	0	0/203 (0%)	0	1/200 (0.5%)	1
Tongue neoplasm malignant stage unspecified	0/202 (0%)	0	1/200 (0.5%)	1	0/203 (0%)	0	0/200 (0%)	0
Nervous system disorders
Carotid artery stenosis	1/202 (0.5%)	1	0/200 (0%)	0	0/203 (0%)	0	0/200 (0%)	0
Cervicobrachial syndrome	0/202 (0%)	0	1/200 (0.5%)	1	0/203 (0%)	0	0/200 (0%)	0
Carotid sinus syndrome	0/202 (0%)	0	0/200 (0%)	0	1/203 (0.5%)	1	0/200 (0%)	0
Syncope	0/202 (0%)	0	0/200 (0%)	0	0/203 (0%)	0	1/200 (0.5%)	1
Cervical myelopathy	0/202 (0%)	0	0/200 (0%)	0	0/203 (0%)	0	1/200 (0.5%)	1
Radiculopathy	0/202 (0%)	0	0/200 (0%)	0	0/203 (0%)	0	1/200 (0.5%)	1
Subarachnoid haemorrhage	0/202 (0%)	0	0/200 (0%)	0	0/203 (0%)	0	1/200 (0.5%)	1
Hypoaesthesia	0/202 (0%)	0	0/200 (0%)	0	0/203 (0%)	0	1/200 (0.5%)	1
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous	0/202 (0%)	0	0/200 (0%)	0	1/203 (0.5%)	1	0/200 (0%)	0
Renal and urinary disorders
Renal failure	0/202 (0%)	0	0/200 (0%)	0	0/203 (0%)	0	1/200 (0.5%)	1
Reproductive system and breast disorders
Menorrhagia	0/202 (0%)	0	0/200 (0%)	0	1/203 (0.5%)	1	0/200 (0%)	0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	0/202 (0%)	0	0/200 (0%)	0	1/203 (0.5%)	1	0/200 (0%)	0
Chronic obstructive pulmonary disease	0/202 (0%)	0	0/200 (0%)	0	0/203 (0%)	0	1/200 (0.5%)	1
Surgical and medical procedures
Knee arthroplasty	0/202 (0%)	0	0/200 (0%)	0	0/203 (0%)	0	1/200 (0.5%)	1
Vascular disorders
Peripheral vascular disorder	0/202 (0%)	0	1/200 (0.5%)	1	0/203 (0%)	0	0/200 (0%)	0
Other (Not Including Serious) Adverse Events
	Group 1: H1N1+Placebo; H1N1+Placebo; TIV		Group 2: H1N1+TIV; H1N1+Placebo; Placebo		Group 3: H1N1+Placebo; H1N1+TIV; Placebo		Group 4: TIV+Placebo; H1N1+Placebo; H1N1
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	167/202 (82.7%)		170/200 (85%)		169/203 (83.3%)		175/200 (87.5%)
Gastrointestinal disorders
Nausea	18/202 (8.9%)	22	21/200 (10.5%)	22	16/203 (7.9%)	20	22/200 (11%)	27
General disorders
Injection site haematoma	18/202 (8.9%)	18	30/200 (15%)	35	20/203 (9.9%)	26	18/200 (9%)	20
Feeling hot	26/202 (12.9%)	32	24/200 (12%)	28	20/203 (9.9%)	24	24/200 (12%)	28
Malaise	59/202 (29.2%)	76	61/200 (30.5%)	85	57/203 (28.1%)	80	55/200 (27.5%)	70
Injection site pain	66/202 (32.7%)	97	87/200 (43.5%)	109	72/203 (35.5%)	91	67/200 (33.5%)	89
Tenderness	98/202 (48.5%)	184	115/200 (57.5%)	159	111/203 (54.7%)	162	109/200 (54.5%)	166
Injection site erythema	73/202 (36.1%)	115	67/200 (33.5%)	107	71/203 (35%)	97	75/200 (37.5%)	118
Injection site swelling (functional grading)	57/202 (28.2%)	88	56/200 (28%)	73	50/203 (24.6%)	67	59/200 (29.5%)	84
Injection site swelling (measured)	61/202 (30.2%)	93	59/200 (29.5%)	81	52/203 (25.6%)	69	61/200 (30.5%)	89
Infections and infestations
Upper respiratory tract infection	16/202 (7.9%)	16	18/200 (9%)	18	23/203 (11.3%)	23	18/200 (9%)	19
Musculoskeletal and connective tissue disorders
Myalgia	42/202 (20.8%)	51	40/200 (20%)	50	39/203 (19.2%)	46	37/200 (18.5%)	43
Nervous system disorders
Headache	64/202 (31.7%)	87	62/200 (31%)	89	60/203 (29.6%)	81	60/200 (30%)	80
Respiratory, thoracic and mediastinal disorders
Nasal congestion	3/202 (1.5%)	3	4/200 (2%)	4	12/203 (5.9%)	12	6/200 (3%)	6
Rhinorrhoea	6/202 (3%)	7	6/200 (3%)	6	4/203 (2%)	4	10/200 (5%)	10

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

Name/Title	Sharon E. Frey, M.D.
Organization	Division of Infectious Diseases and Immunology, Saint Louis University Medical School
Phone	314-977-5500
Email	freyse@slu.edu

Responsible Party:

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00943878

Other Study ID Numbers:

09-0039
N01AI80003C

First Posted:

Jul 22, 2009

Last Update Posted:

Aug 1, 2012

Last Verified:

Apr 1, 2010

Sanofi H1N1 + TIV - Adults and Elderly

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