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 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.Blood was collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Vaccine. Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.Participants maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). Read … ARTICLE . Listing a study does not mean it has been evaluated by the U.S. Federal Government. Participants will be randomly (by chance) assigned to 1 of 2 possible H1N1 vaccine groups. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. Following immunization, safety will be measured by assessment of adverse events through 21 days following the last vaccination (Day 42 for those receiving both doses and Day 21 for those who do not receive the second dose), serious adverse events and new-onset chronic medical conditions through 7 months post first vaccination (Day 201), and reactogenicity to the vaccine for 8 days following each vaccination (Day 0-7). 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. 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 8-10 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 titer was an increase by 4-fold or more.Blood was collected from all participants prior to vaccination and at the 21 day follow up visit for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.Blood was to be collected from the first 30 participants enrolled in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen.  (Clinical Trial),Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor),A Phase II Study in Infants (Greater Than or Equal to 6 - Less Than 36 Months), Children (Greater Than or Equal to 36 Months - 9 Years) and Adolescents (10 - 17 Years) to Assess the Safety and Immunogenicity of an Unadjuvanted Sanofi Pasteur H1N1 Influenza Vaccine Administered at Two Dose Levels,Experimental: Group 2: 30 mcg H1N1 Vaccine,Experimental: Group 1: 15 mcg H1N1 Vaccine,University of Maryland School of Medicine - Center for Vaccine Development - Baltimore,Baltimore, Maryland, United States, 21201,Children's Mercy Hospital and Clinics - Infectious Diseases,Kansas City, Missouri, United States, 64108,Saint Louis University - Center for Vaccine Development,Saint Louis, Missouri, United States, 63104-1015,Duke Translational Medicine Institute - Clinical Vaccine Unit,Durham, North Carolina, United States, 27704,Cincinnati Children's Hospital Medical Center - Infectious Diseases,Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center,Nashville, Tennessee, United States, 37232-2573,University of Texas Medical Branch - Pediatrics - Infectious Diseases and Immunology - Galveston,Galveston, Texas, United States, 77555-5302,Baylor College of Medicine - Molecular Virology and Microbiology,Houston, Texas, United States, 77030-3411,Seattle Children's Hospital - Infectious Diseases,Seattle, Washington, United States, 98105,H1N1, influenza A viruses, vaccine, infants, children,Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination [ Time Frame: Day 0-7 after first vaccination ],Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination [ Time Frame: Day 0-7 after second vaccination ],Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination [ Time Frame: Day 0-7 after first vaccination ],Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination [ Time Frame: Day 0-7 after second vaccination ],Number of Participants Reporting Solicited Quantitative Systemic Reactions After the First Vaccination [ Time Frame: Day 0-7 after first vaccination ],Number of Participants Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination [ Time Frame: Day 0-7 after second vaccination ],Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the First Vaccination [ Time Frame: Day 0-7 after first vaccination ],Number of Participants Age 6 to Less Than 36 Months Reporting Solicited Subjective Systemic Reactions After the Second Vaccination [ Time Frame: Day 0-7 after second vaccination ],Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination [ Time Frame: Day 0-7 after first vaccination ],Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination [ Time Frame: Day 0-7 after second vaccination ],Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination [ Time Frame: Day 0-7 after first vaccination ],Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination [ Time Frame: Day 0-7 after second vaccination ],Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs) [ Time Frame: Day 0 through Day 180 after last vaccination ],Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0 [ Time Frame: Day 0 ],Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine [ Time Frame: Day 8-10 ],Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine [ Time Frame: Day 21 ],Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0 [ Time Frame: Day 0 ],Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine [ Time Frame: Day 8-10 ],Number of Participants Age 36 Months to 9 Years Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine [ Time Frame: Day 21 ],Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 0 and at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to vaccination and Days 8-10 and 21 after first vaccination ],Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ],Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to and Day 21 after first vaccination ],Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following a Single Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to and Day 8-10 after first vaccination ],Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following a Single Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to and Day 21 after first vaccination ],Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Days 8-10 and 21 Following a Single Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to and Days 8-10 and 21 after first vaccination ],Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 8-10 after the second vaccination ],Number of Participants Age 6 to Less Than 36 Months With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus Day 21 Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 21 after the second vaccination ],Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 8-10 after the second vaccination ],Number of Participants Age 36 Months to 9 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 21 after the second vaccination ],Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 8-10 after the second vaccination ],Number of Participants Age 10 to 17 Years With a Serum Hemagglutination Inhibition Assay (HAI) Antibody Titer of 1:40 or Greater Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 21 after the second vaccination ],Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to first vaccination and Day 8-10 after the second vaccination ],Number of Participants Age 6 to Less Than 36 Months With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to first vaccination and Day 21 after the second vaccination ],Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to first vaccination and Day 8-10 after the second vaccination ],Number of Participants Age 36 Months to 9 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to first vaccination and Day 21 after the second vaccination ],Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 8-10 Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to first vaccination and Day 8-10 after the second vaccination ],Number of Participants Age 10 to 17 Years With 4-Fold or Greater HAI Antibody Titer Increases Against the Influenza H1N1 2009 Virus at Day 21 Following the Second Dose of H1N1 Vaccine [ Time Frame: Day 0 prior to first vaccination and Day 21 after the second vaccination ].Are males or non-pregnant females aged 6 months to 17 years, inclusive.Subjects of child-bearing potential must agree to practice adequate contraception that may include, but is not limited to, abstinence, 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.The subject must be in good health as determined by axillary (<10 years of age) or oral temperature (axillary temperature <100 degrees Fahrenheit or oral temperature <101 degrees Fahrenheit), medical history, and targeted physical examination based on medical history.Subject and/or parent(s)/legal guardian(s) must be willing and able to comply with planned study procedures and be available for all study visits.Subject and/or parent(s) legal guardian(s) must provide written informed consent prior to initiation of any study procedures, and subject may provide written assent as appropriate.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 or 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 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months.

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