InfluenzaPhase 2NCT00944073

Peds Sanofi H1N1 Influenza Vaccine Administered at Two Dose Levels

A Phase 2 study testing Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 6 months to 17 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 583 participants
Where: 9 sitesUnited States
Study dates: Aug 2009to Apr 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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. (Nasal and topical steroids are allowed.)
Have a diagnosis of schizophrenia, bipolar disease, or other major psychiatric diagnosis including major depression.

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Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others.
Are receiving any 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) or any drugs for treatment of depression.
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 this study (prior to the Day 201 follow-up call - 180 days after the second 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 second vaccination. This is inclusive of routine childhood immunizations provided outside the scope of this study, and seasonal influenza vaccines. The initiation of this protocol does not take precedence over routine immunizations.
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 axillary temperature greater than 100 degrees Fahrenheit or an oral temperature greater than or equal to 101 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.
Plan to travel outside of North America in the time between the first vaccination and 42 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.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, 21201
Cincinnati Children's Hospital Medical Center - Infectious Diseases
Cincinnati, Ohio, 45231
Duke Translational Medicine Institute - Clinical Vaccine Unit
Durham, North Carolina, 27704
University of Texas Medical Branch - Pediatrics - Infectious Diseases and Immunology - Galveston
Galveston, Texas, 77555-5302
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, 77030-3411
Children's Mercy Hospital and Clinics - Infectious Diseases
Kansas City, Missouri, 64108
Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
Nashville, Tennessee, 37232-2573
Seattle Children's Hospital - Infectious Diseases
Seattle, Washington, 98105
Saint Louis University - Center for Vaccine Development
St Louis, Missouri, 63104-1015

Other trials in United States

About this study

Official title: 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

The purpose of this study is to assess the safety and the body's immune response (body's defense against disease) to an experimental H1N1 influenza vaccine. Up to 650 healthy volunteers from three age groups (greater than or equal to 6 months to less than 36 months, greater than or equal to 36 months to 9 years, and 10 - 17 years) with no history of influenza H1N1 2009 influenza infection or influenza H1N1 2009 vaccination will participate. Participants will be randomly (by chance) assigned to 1 of 2 possible H1N1 vaccine groups. Group 1 will receive 15 mcg of vaccine; Group 2 will receive 30 mcg of vaccine. Participants will receive vaccine injections on Days 0 and 21 in the arm or thigh muscle. Study procedures include: medical history, physical exam, maintaining a memory aid, and blood sample collection. Participants will be involved in study related procedures for approximately 7 months.

Read the 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. Based on clinical data from other novel influenza A viruses, a higher dose, or multiple doses of an unadjuvanted, inactivated influenza H1N1 vaccine may be necessary to confer protection to a maximal number of vaccine recipients. This protocol explores the antibody response following vaccination at 2 different dosage levels (15 mcg and 30 mcg) in up to 650 children aged 6 months to 17 years, inclusive. This study assesses the immune response following a single dose of vaccine, to assess whether individuals have any pre-existing 'prime' immunity, such that the initial H1N1 vaccination serves as a boost, thus conferring a more rapid time to protection and the need for fewer doses. Antibody responses will be assessed after a second dose. This is a randomized, double-blinded, Phase II study in healthy infants, toddlers, children, and adolescents and is designed to investigate the safety, reactogenicity, and immunogenicity of an inactivated influenza H1N1 virus vaccine. The primary objectives are safety, to assess the safety of the unadjuvanted, inactivated influenza H1N1 vaccine when administered at the 15 mcg or 30 mcg dose; and immunogenicity, to assess the antibody response following a single dose of unadjuvanted, inactivated influenza H1N1 vaccine, stratified by age of recipient, when administered at the 15 mcg or 30 mcg dose. The secondary immunogenicity objective is to assess the antibody response following two doses of unadjuvanted, inactivated influenza H1N1 vaccine, stratified by age of recipient, when administered at the 15 mcg or 30 mcg dose. There will be 3 age strata, each containing 200 subjects: greater than or equal to 6 months to less than 36 months, greater than or equal to 36 months to 9 years, and 10 - 17 years . Subjects will be randomized into 2 groups, with 300 subjects per group (100 per strata), to receive intramuscular inactivated influenza H1N1 vaccine at 15 mcg (Group 1) or 30 mcg (Group 2). The vaccine will be administered on Days 0 and 21. Following immunization, safety will be measured by assessment of adverse events (AEs) for 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 (SAEs) and new-onset chronic medical conditions through 7 months post first vaccination (Day 201); and reactogenicity to the vaccines for 8 days following each vaccination (Day 0-7). Immunogenicity testing will include HAI and neutralizing antibody testing on serum obtained on the day of each vaccination (prior to vaccination) and 21 days following the second vaccination (Day 42). For subjects aged 10-17 years, serum for antibody assays will also be obtained at Day 8-10 following each vaccination. However, for the greater than or equal to 6 months - less than 36 months and the greater than o

Conditions: Influenza
Being tested: Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A
Keywords: H1N1, influenza A viruses, vaccine, infants, children
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179ABiological
Two doses of inactivated influenza H1N1 vaccine delivered intramuscularly as 15 or 30 micrograms per dose. Both doses of the vaccine will be administered as a single 0.5 mL injection in the deltoid muscle of the preferred arm or into the anterolateral thigh muscle.

Study groups in NCT00944073
Study group	Role	What they receive
Group 2: 30 mcg H1N1 Vaccine	Experimental	300 subjects to receive 30 mcg of Inactivated H1N1 Vaccine on Day 0 and Day 21. Receives: Biological: Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A
Group 1: 15 mcg H1N1 Vaccine	Experimental	300 subjects to receive 15 mcg of Inactivated H1N1 Vaccine on Day 0 and Day 21. Receives: Biological: Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination
Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Measured: Day 0-7 after first vaccination
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination
Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Measured: Day 0-7 after second vaccination
Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination
Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). 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.
Measured: Day 0-7 after first vaccination
Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination
Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). 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.
Measured: Day 0-7 after second vaccination
Number of Participants Reporting Solicited Quantitative Systemic Reactions After the First Vaccination
Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.
Measured: Day 0-7 after first vaccination
Number of Participants Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination
Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.
Measured: 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
Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Measured: 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
Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Measured: Day 0-7 after second vaccination
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination
Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Measured: Day 0-7 after first vaccination
Number of Participants Age 36 Months to 9 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination
Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Measured: Day 0-7 after second vaccination
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the First Vaccination
Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea, decreased general activity, and malaise for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Measured: Day 0-7 after first vaccination
Number of Participants Age 10 to 17 Years Reporting Solicited Subjective Systemic Reactions After the Second Vaccination
Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea, decreased general activity, and malaise for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Measured: Day 0-7 after second vaccination
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; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.
Measured: 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
Blood was collected from all participants prior to vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Measured: 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
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. 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.
Measured: 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
Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Measured: 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
Blood was collected from all participants prior to vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Measured: 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
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. 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.
Measured: 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
Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Measured: 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
Blood was collected from all participants prior to vaccination and at Days 8-10 and 21 for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Measured: 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
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. 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.
Measured: 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
Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, 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 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.
Measured: 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
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. 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.
Measured: 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
Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, 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 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.
Measured: 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
Blood was to be collected from all participants enrolled in this age stratum 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 8-10 or Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 or Day 21 titer was an increase by 4-fold or more.
Measured: Day 0 prior to and Days 8-10 and 21 after first vaccination

Secondary outcomes (12)

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
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. 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.
Measured: 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
Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Measured: 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
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. 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.
Measured: 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
Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Measured: 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
Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Measured: 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
Blood was to be collected from all participants enrolled in this age stratum for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
Measured: 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
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. 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.
Measured: 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
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. 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.
Measured: 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
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. 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.
Measured: 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
Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum 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 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.
Measured: 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
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. 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.
Measured: 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
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. 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.
Measured: Day 0 prior to first vaccination and Day 21 after the second vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2009Apr 2010

First posted22 Jul 2009 (estimated)
Study startAug 2009
Primary completionApr 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 583 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00944073
Sponsor's protocol ID: 09-0054
Status last verified: Mar 2010
First submitted: 21 Jul 2009
Last updated: 18 Feb 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Kotloff KL, Halasa NB, Harrison CJ, Englund JA, Walter EB, King JC, Creech CB, Healy SA, Dolor RJ, Stephens I, Edwards KM, Noah DL, Hill H, Wolff M. Clinical and immune responses to inactivated influenza A(H1N1)pdm09 vaccine in children. Pediatr Infect Dis J. 2014 Aug;33(8):865-71. doi: 10.1097/INF.0000000000000329.
PubMed 25222307

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

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Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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See locations

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All Influenza trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00944073
Acronym / sponsor ID: 09-0054
Conditions: Influenza
Keywords: H1N1, influenza A viruses, vaccine, infants, children
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 583 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: Aug 2009
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 22 Jul 2009 (estimated)
Results: Posted 13 Apr 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group 2: 30 mcg H1N1 Vaccine	Experimental	Biological: Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A300 subjects to receive 30 mcg of Inactivated H1N1 Vaccine on Day 0 and Day 21.
Group 1: 15 mcg H1N1 Vaccine	Experimental	Biological: Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179A300 subjects to receive 15 mcg of Inactivated H1N1 Vaccine on Day 0 and Day 21.

Who may qualify

Ages: 6 months to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (21 listed)

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. (Nasal and topical steroids are allowed.)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Influenza Virus Vaccine, Monovalent A/H1N1 A/California/7/2009 NYMC X-179ATwo doses of inactivated influenza H1N1 vaccine delivered intramuscularly as 15 or 30 micrograms per dose. Both doses of the vaccine will be administered as a single 0.5 mL injection in the deltoid muscle of the preferred arm or into the anterolateral thigh muscle.	Biological	Group 1: 15 mcg H1N1 Vaccine, Group 2: 30 mcg H1N1 Vaccine

Primary outcome

Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination
Time frame: Day 0-7 after first vaccination
Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination
Time frame: Day 0-7 after second vaccination
Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of pain, tenderness and swelling for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination
Time frame: Day 0-7 after first vaccination
Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). 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 Vaccination
Time frame: Day 0-7 after second vaccination
Participants or their parents/guardians maintained a memory aid to record daily the occurrence of local reactions of swelling and redness for 8 days after vaccination (Day 0-7). 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 Systemic Reactions After the First Vaccination
Time frame: Day 0-7 after first vaccination
Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.
Number of Participants Reporting Solicited Quantitative Systemic Reactions After the Second Vaccination
Time frame: Day 0-7 after second vaccination
Participants or their parents/guardians maintained a memory aid to record daily oral/axillary temperatures and the number of vomiting episodes, if experienced, for 8 days after vaccination (Day 0-7). Participants are counted as experiencing fever if they reported oral temperatures of 38.3 degrees Celsius or higher, or axillary temperatures of 37.8 degrees Celsius or higher, on any of the 8 days. Participants are counted as experiencing vomiting if they reported one or more episodes of vomiting on any of the 8 days.
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
Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
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
Participants' parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of irritability, decreased appetite and lethargy for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
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
Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
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
Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea and decreased general activity for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
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
Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea, decreased general activity, and malaise for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
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
Participants or their parents/guardians maintained a memory aid to record daily the occurrence of systemic symptoms of feverishness, myalgia, headache, nausea, decreased general activity, and malaise for 8 days after vaccination (Day 0-7) based on their interference with daily activities. Participants are counted if they were reported as experiencing the symptom at any severity on any of the 8 days.
Number of Participants Reporting Vaccine-associated Serious Adverse Events (SAEs)
Time frame: Day 0 through Day 180 after 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; or may have jeopardized the participant or required intervention to prevent one of these outcomes. Association to vaccination was determined by a study clinician licensed to make medical diagnoses.
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
Blood was collected from all participants prior to vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
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
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. 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 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
Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
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
Blood was collected from all participants prior to vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
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
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. 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 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
Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
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
Blood was collected from all participants prior to vaccination and at Days 8-10 and 21 for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen. Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported. A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
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
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. 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.
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
Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, 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 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.
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
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. 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.
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
Blood was to be collected from participants enrolled after the first 30 in each dose group in this age stratum, 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 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.
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
Blood was to be collected from all participants enrolled in this age stratum 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 8-10 or Day 21 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 or Day 21 titer was an increase by 4-fold or more.

12 secondary outcomes

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

Results and safety

Results posted to the registry on 13 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
15 mcg H1N1 Vaccine	292	287
30 mcg H1N1 Vaccine	291	287

Primary outcome: Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination

Time frame: Day 0-7 after first vaccination. Number. Unit: Participants

Measure	15 mcg H1N1 Vaccine n = 292	30 mcg H1N1 Vaccine n = 291
Pain	60	69
Tenderness	102	98
Swelling	38	30

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

Primary outcome: Number of Participants Reporting Solicited Subjective Local Reactions After the Second Vaccination

Time frame: Day 0-7 after second vaccination. Number. Unit: Participants

Measure	15 mcg H1N1 Vaccine n = 286	30 mcg H1N1 Vaccine n = 285
Pain	65	75
Tenderness	90	98
Swelling	28	31

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

Primary outcome: Number of Participants Reporting Solicited Quantitative Local Reactions After the First Vaccination

Time frame: Day 0-7 after first vaccination. Number. Unit: Participants

Measure	15 mcg H1N1 Vaccine n = 292	30 mcg H1N1 Vaccine n = 291
Swelling	34	30
Redness	54	60

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

Primary outcome: Number of Participants Reporting Solicited Quantitative Local Reactions After the Second Vaccination

Time frame: Day 0-7 after second vaccination. Number. Unit: Participants

Measure	15 mcg H1N1 Vaccine n = 286	30 mcg H1N1 Vaccine n = 285
Swelling	27	30
Redness	60	62

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

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited events were collected for 8 days after each vaccination, unsolicited events through 21 days after last vaccination, and serious adverse events and new onset chronic medical conditions through 180 days after last vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
15 mcg H1N1 Vaccine	3 of 292 (1%)	253 of 292 (86.6%)	Not reported
30 mcg H1N1 Vaccine	4 of 291 (1.4%)	255 of 291 (87.6%)	Not reported

Limitations and caveats (from the sponsor): To limit blood draws, the younger 2 age strata were assigned varying blood draw schedules and there were deviations from the schedules, reducing the size of subsets on the same schedule, such uniformity being optimal for longitudinal comparisons.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25222307Kotloff KL, Halasa NB, Harrison CJ, Englund JA, Walter EB, King JC, Creech CB, Healy SA, Dolor RJ, Stephens I, Edwards KM, Noah DL, Hill H, Wolff M. Clinical and immune responses to inactivated influenza A(H1N1)pdm09 vaccine in children. Pediatr Infect Dis J. 2014 Aug;33(8):865-71. doi: 10.1097/INF.0000000000000329.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Reporting Solicited Subjective Local Reactions After the First Vaccination (time frame: Day 0-7 after first vaccination). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00944073, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2015.