Sanofi H1N1 + TIV - Adults and Elderly

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00943878

Enrollment

805

Registered

2009-07-22

Start date

2009-08-31

Completion date

2010-04-30

Last updated

2012-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

H1N1, influenza A viruses, vaccine, elderly, TIV

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.

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

Interventions

BIOLOGICALTrivalent inactivated influenza vaccine

Licensed trivalent influenza vaccine (TIV) administered as a single 0.5 mL intramuscular injection in the deltoid muscle.

BIOLOGICALInactivated 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.

DRUGPlacebo

Normal saline (placebo control) administered as a single 0.5 mL intramuscular injection in the deltoid muscle.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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 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 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 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

Measure	Time frame	Description
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.

Countries

United States

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.

Participants by arm

Arm	Count
Group 1: H1N1+Placebo; H1N1+Placebo; TIV 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	202
Group 2: H1N1+TIV; H1N1+Placebo; Placebo 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	200
Group 3: H1N1+Placebo; H1N1+TIV; Placebo 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	203
Group 4: TIV+Placebo; H1N1+Placebo; H1N1 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	200
Total	805

Baseline characteristics

Characteristic	Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	97 Participants	101 Participants	101 Participants	98 Participants	397 Participants
Age, Categorical Between 18 and 65 years	103 Participants	102 Participants	101 Participants	102 Participants	408 Participants
Age Continuous	58.4 years STANDARD_DEVIATION 16.7	58.5 years STANDARD_DEVIATION 16.6	59.2 years STANDARD_DEVIATION 16.2	59.1 years STANDARD_DEVIATION 15.3	58.8 years STANDARD_DEVIATION 16.2
Region of Enrollment United States	200 participants	203 participants	202 participants	200 participants	805 participants
Sex: Female, Male Female	118 Participants	104 Participants	99 Participants	123 Participants	444 Participants
Sex: Female, Male Male	82 Participants	99 Participants	103 Participants	77 Participants	361 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	167 / 202	170 / 200	169 / 203	175 / 200
serious Total, serious adverse events	5 / 202	7 / 200	12 / 203	13 / 200

Outcome results

Primary

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

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

Population: 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	Measure	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	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	84 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	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	83 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	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	89 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	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	78 Participants

Primary

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

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

Arm	Measure	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	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	90 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	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	87 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	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	91 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	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	82 Participants

Primary

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

Time frame: Day 0 prior to vaccination and 21 days after the first H1N1 vaccination

Population: 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	Measure	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	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	78 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	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	72 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	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	78 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	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	68 Participants

Primary

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

Time frame: Day 21 after first H1N1 vaccination

Population: 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	Measure	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	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	81 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	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	79 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	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	88 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	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	75 Participants

Primary

Number of Participants Reporting Fever After the First Vaccination

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

Time frame: Within 8 days (Day 0-7) post first vaccination

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

Arm	Measure	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Fever After the First Vaccination	0 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Fever After the First Vaccination	1 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Fever After the First Vaccination	0 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Fever After the First Vaccination	0 Participants

Primary

Number of Participants Reporting Fever After the Second Vaccination

Time frame: Within 8 days (Day 0-7) post second vaccination

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

Arm	Measure	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Fever After the Second Vaccination	0 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Fever After the Second Vaccination	2 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Fever After the Second Vaccination	0 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Fever After the Second Vaccination	3 Participants

Primary

Number of Participants Reporting Fever After the Third Vaccination

Time frame: Within 8 days (Day 0-7) post third vaccination

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

Arm	Measure	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Fever After the Third Vaccination	0 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Fever After the Third Vaccination	0 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Fever After the Third Vaccination	1 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Fever After the Third Vaccination	0 Participants

Primary

Number of Participants Reporting Solicited Quantitative Local Reactions After the 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.

Time frame: Within 8 days (Day 0-7) post first H1N1 vaccination

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

Arm	Measure	Group	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination	Redness	32 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination	Swelling	19 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination	Swelling	16 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination	Redness	33 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination	Redness	27 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination	Swelling	19 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination	Redness	31 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination	Swelling	21 Participants

Primary

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

Time frame: Within 8 days (Day 0-7) post first placebo vaccination

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

Arm	Measure	Group	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Quantitative Local Reactions After the First Placebo Vaccination	Redness	34 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Quantitative Local Reactions After the First Placebo Vaccination	Swelling	12 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Quantitative Local Reactions After the First Placebo Vaccination	Swelling	20 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Quantitative Local Reactions After the First Placebo Vaccination	Redness	19 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Quantitative Local Reactions After the First Placebo Vaccination	Redness	21 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Quantitative Local Reactions After the First Placebo Vaccination	Swelling	12 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Quantitative Local Reactions After the First Placebo Vaccination	Redness	37 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Quantitative Local Reactions After the First Placebo Vaccination	Swelling	28 Participants

Primary

Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination

Time frame: Within 8 days (Day 0-7) post second H1N1 vaccination

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

Arm	Measure	Group	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination	Redness	29 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination	Swelling	29 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination	Swelling	18 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination	Redness	27 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination	Redness	29 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination	Swelling	19 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination	Redness	35 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination	Swelling	27 Participants

Primary

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

Time frame: Within 8 days (Day 0-7) post second placebo vaccination

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

Arm	Measure	Group	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Placebo Vaccination	Redness	30 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Placebo Vaccination	Swelling	27 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Placebo Vaccination	Swelling	17 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Placebo Vaccination	Redness	25 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Placebo Vaccination	Redness	26 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Placebo Vaccination	Swelling	14 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Placebo Vaccination	Redness	30 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Placebo Vaccination	Swelling	14 Participants

Primary

Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination

Time frame: Within 8 days (Day 0-7) post TIV vaccination

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

Arm	Measure	Group	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination	Redness	31 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination	Swelling	28 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination	Swelling	27 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination	Redness	40 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination	Redness	30 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination	Swelling	21 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination	Redness	37 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination	Swelling	28 Participants

Primary

Number of Participants Reporting Solicited Subjective Local Reactions After the 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.

Time frame: Within 8 days (Day 0-7) post first H1N1 vaccination

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

Arm	Measure	Group	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination	Pain	26 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination	Swelling	18 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination	Tenderness	45 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination	Pain	32 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination	Swelling	14 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination	Tenderness	46 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination	Tenderness	47 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination	Pain	26 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination	Swelling	16 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination	Pain	11 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination	Swelling	20 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination	Tenderness	29 Participants

Primary

Number of Participants Reporting Solicited Subjective Local Reactions After the 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.

Time frame: Within 8 days (Day 0-7) post first placebo vaccination

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

Arm	Measure	Group	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination	Pain	12 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination	Swelling	12 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination	Tenderness	21 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination	Pain	14 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination	Swelling	18 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination	Tenderness	14 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination	Tenderness	21 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination	Pain	13 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination	Swelling	12 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination	Pain	11 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination	Swelling	14 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Local Reactions After the First Placebo Vaccination	Tenderness	21 Participants

Primary

Number of Participants Reporting Solicited Subjective Local Reactions After the 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.

Time frame: Within 8 days (Day 0-7) post second H1N1 vaccination

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

Arm	Measure	Group	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination	Pain	28 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination	Swelling	28 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination	Tenderness	51 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination	Pain	22 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination	Swelling	17 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination	Tenderness	44 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination	Tenderness	58 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination	Pain	30 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination	Swelling	20 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination	Pain	19 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination	Swelling	25 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination	Tenderness	37 Participants

Primary

Number of Participants Reporting Solicited Subjective Local Reactions After the 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.

Time frame: Within 8 days (Day 0-7) post second placebo vaccination

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

Arm	Measure	Group	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination	Pain	11 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination	Swelling	25 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination	Tenderness	15 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination	Pain	9 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination	Swelling	13 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination	Tenderness	7 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination	Tenderness	9 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination	Pain	5 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination	Swelling	14 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination	Pain	8 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination	Swelling	13 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Local Reactions After the Second Placebo Vaccination	Tenderness	17 Participants

Primary

Number of Participants Reporting Solicited Subjective Local Reactions After the 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.

Time frame: Within 8 days (Day 0-7) post TIV vaccination

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

Arm	Measure	Group	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination	Pain	32 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination	Swelling	27 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination	Tenderness	71 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination	Pain	57 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination	Swelling	27 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination	Tenderness	93 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination	Tenderness	80 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination	Pain	46 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination	Swelling	22 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination	Pain	48 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination	Swelling	28 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination	Tenderness	84 Participants

Primary

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

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

Time frame: Within 8 days (Day 0-7) post first vaccination

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

Arm	Measure	Group	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination	Headache	43 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination	Malaise	30 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination	Nausea	12 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination	Myalgia	23 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination	Feverishness	12 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination	Myalgia	24 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination	Headache	44 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination	Nausea	11 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination	Malaise	41 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination	Feverishness	12 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination	Myalgia	16 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination	Feverishness	7 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination	Malaise	27 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination	Headache	35 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination	Nausea	11 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination	Headache	44 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination	Malaise	33 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination	Feverishness	13 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination	Myalgia	23 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Systemic Reactions After the First Vaccination	Nausea	12 Participants

Primary

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

Time frame: Within 8 days (Day 0-7) post second vaccination

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

Arm	Measure	Group	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination	Headache	28 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination	Malaise	29 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination	Nausea	6 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination	Myalgia	18 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination	Feverishness	14 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination	Myalgia	14 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination	Headache	26 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination	Nausea	6 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination	Malaise	29 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination	Feverishness	8 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination	Myalgia	19 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination	Feverishness	12 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination	Malaise	35 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination	Headache	29 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination	Nausea	4 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination	Headache	21 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination	Malaise	23 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination	Feverishness	10 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination	Myalgia	14 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Second Vaccination	Nausea	8 Participants

Primary

Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination

Time frame: Within 8 days (Day 0-7) post third vaccination

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

Arm	Measure	Group	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination	Headache	16 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination	Malaise	17 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination	Nausea	4 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination	Myalgia	10 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination	Feverishness	6 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination	Myalgia	12 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination	Headache	19 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination	Nausea	5 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination	Malaise	15 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination	Feverishness	8 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination	Myalgia	11 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination	Feverishness	5 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination	Malaise	18 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination	Headache	17 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination	Nausea	5 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination	Headache	15 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination	Malaise	14 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination	Feverishness	5 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination	Myalgia	6 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination	Nausea	7 Participants

Primary

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

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

Time frame: Day 0 through Day 180 after the last vaccination

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

Arm	Measure	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)	0 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)	0 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)	0 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)	0 Participants

Secondary

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

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

Population: 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	Measure	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	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	85 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	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	77 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	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	85 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	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	75 Participants

Secondary

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

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

Population: 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	Measure	Group	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	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	TIV B antigen	34 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	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	TIV H1 antigen	46 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	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	TIV H3 antigen	52 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	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	TIV H1 antigen	40 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	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	TIV B antigen	31 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	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	TIV H3 antigen	48 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	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	TIV H3 antigen	46 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	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	TIV H1 antigen	38 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	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	TIV B antigen	36 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	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	TIV H1 antigen	39 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	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	TIV B antigen	39 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	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	TIV H3 antigen	47 Participants

Secondary

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

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

Arm	Measure	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	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	89 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	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	82 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	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	87 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	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	80 Participants

Secondary

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

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

Population: 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	Measure	Group	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	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	TIV H1 antigen	79 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	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	TIV B antigen	81 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	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	TIV H3 antigen	84 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	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	TIV H1 antigen	77 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	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	TIV B antigen	75 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	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	TIV H3 antigen	80 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	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	TIV H3 antigen	77 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	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	TIV H1 antigen	78 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	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	TIV B antigen	78 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	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	TIV H1 antigen	81 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	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	TIV B antigen	81 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	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	TIV H3 antigen	84 Participants

Secondary

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

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

Population: 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	Measure	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	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	80 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	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	73 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	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	72 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	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	65 Participants

Secondary

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

Time frame: Day 63

Population: 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	Measure	Group	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	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	TIV H1 antigen	66 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	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	TIV B antigen	14 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	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	TIV H3 antigen	37 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	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	TIV H1 antigen	62 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	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	TIV B antigen	14 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	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	TIV H3 antigen	27 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	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	TIV H3 antigen	34 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	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	TIV H1 antigen	53 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	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	TIV B antigen	20 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	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	TIV H1 antigen	57 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	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	TIV B antigen	18 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	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	TIV H3 antigen	31 Participants

Secondary

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

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

Arm	Measure	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	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	83 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	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	78 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	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	81 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	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	71 Participants

Secondary

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

Time frame: Day 63

Population: 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	Measure	Group	Value (NUMBER)
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	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	TIV H1 antigen	85 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	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	TIV B antigen	71 Participants
Group 1: H1N1+Placebo; H1N1+Placebo; TIV	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	TIV H3 antigen	86 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	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	TIV H1 antigen	82 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	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	TIV B antigen	69 Participants
Group 2: H1N1+TIV; H1N1+Placebo; Placebo	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	TIV H3 antigen	80 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	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	TIV H3 antigen	83 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	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	TIV H1 antigen	81 Participants
Group 3: H1N1+Placebo; H1N1+TIV; Placebo	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	TIV B antigen	68 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	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	TIV H1 antigen	87 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	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	TIV B antigen	62 Participants
Group 4: TIV+Placebo; H1N1+Placebo; H1N1	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	TIV H3 antigen	77 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Sanofi H1N1 + TIV - Adults and Elderly

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Brief summary

Detailed description

Related papers

Interventions

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Study design

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Exclusion criteria

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Primary

Secondary

Countries

Participant flow

Recruitment details

Participants by arm

Baseline characteristics

Adverse events

Outcome results

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

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

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

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

Number of Participants Reporting Fever After the First Vaccination

Number of Participants Reporting Fever After the Second Vaccination

Number of Participants Reporting Fever After the Third Vaccination

Number of Participants Reporting Solicited Quantitative Local Reactions After the First H1N1 Vaccination

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

Number of Participants Reporting Solicited Quantitative Local Reactions After the Second H1N1 Vaccination

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

Number of Participants Reporting Solicited Quantitative Local Reactions After the TIV Vaccination

Number of Participants Reporting Solicited Subjective Local Reactions After the First H1N1 Vaccination

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

Number of Participants Reporting Solicited Subjective Local Reactions After the Second H1N1 Vaccination

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

Number of Participants Reporting Solicited Subjective Local Reactions After the TIV Vaccination

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

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

Number of Participants Reporting Solicited Subjective Systemic Reactions After the Third Vaccination

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

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

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

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

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

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

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

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

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