- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00943488
CSL H1N1 Influenza Vaccine Administered at Two Dose Levels in Adult and Elderly Populations
25. Oktober 2012 aktualisiert von: National Institute of Allergy and Infectious Diseases (NIAID)
A Phase II Study in Healthy Adult and Elderly Populations to Assess the Safety and Immunogenicity of an Unadjuvanted CSL H1N1 Influenza Vaccine Administered at Two Dose Levels
The purpose of this study is to assess the safety and immune response (body's defense against disease) to an experimental H1N1 influenza vaccine in healthy adult and elderly populations.
The study will enroll up to 450 healthy adults ages 18 and older with no history of H1N1 infection or vaccination.
Two hundred individuals will be 18-64 years old, and the other 200 will be greater than or equal to 65 years of age.
Participants will be randomly assigned to 1 of 2 possible vaccine groups: group 1 will receive 15 micrograms (mcg) of H1N1 vaccine; group 2 will receive 30 mcg of H1N1 vaccine.
Both groups will receive vaccine injections on days 0 and 21 in the arm 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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 (WHO) 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.
In addition, 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.
The primary safety objective of this study is to assess the safety of the unadjuvanted, inactivated H1N1 vaccine when administered at the 15 or 30 microgram (mcg) dose.
The primary immunogenicity objective is to assess the antibody response following a single dose of unadjuvanted, inactivated H1N1 vaccine, stratified by age of recipient, when administered at the 15 or 30 mcg dose.
The secondary immunogenicity objective is to assess the antibody response following 2 doses of unadjuvanted, inactivated H1N1 vaccine, stratified by age of recipient, when administered at the 15 or 30 mcg dose.
Participants will include up to 450 healthy adults age 18 and older who have no history of novel influenza H1N1 2009 infection or novel influenza H1N1 2009 vaccination.
This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant females designed to investigate the safety, reactogenicity, and immunogenicity of an inactivated influenza H1N1 virus vaccine at 2 dose levels.
Subjects will be randomized into 2 dose groups, stratified by age (200 subjects per dose group with 100 subjects per age stratum, 18-64 or greater than or equal to 65 years of age) to receive intramuscular inactivated influenza H1N1 vaccine at 15 mcg (Group 1) or 30 mcg (Group 2).
The H1N1 vaccine will be administered at Day 0 and Day 21.
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).
Immunogenicity testing will include HAI and neutralizing antibody testing on serum obtained on the day of each vaccination (prior to vaccination), on Day 8-10 after each vaccination, and 21 days following the second vaccination (Day 42).
Studientyp
Interventionell
Einschreibung (Tatsächlich)
408
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
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Iowa
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Iowa City, Iowa, Vereinigte Staaten, 52242
- University of Iowa
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Ohio
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Cincinnati, Ohio, Vereinigte Staaten, 45231
- Cincinnati Children's Hospital Medical Center - Infectious Diseases
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Washington
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Seattle, Washington, Vereinigte Staaten, 98104
- University of Washington
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Seattle, Washington, Vereinigte Staaten, 98101
- Group Health Cooperative
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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 as defined in inclusion criteria), 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 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 seasonal influenza vaccines.
- 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 a 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 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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Gruppe 2: H1N1-Impfstoff 30 µg
200 Probanden (100 Probanden im Alter von 18 bis 64 Jahren und 100 Probanden über oder gleich 65 Jahren) erhalten an den Tagen 0 und 21 30 µg H1N1-Impfstoff.
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Zwei Dosen des inaktivierten Influenza-H1N1-Impfstoffs werden intramuskulär verabreicht, jeweils 15 oder 30 µg.
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Experimental: Gruppe 1: H1N1-Impfstoff 15 µg
200 Probanden (100 Probanden im Alter von 18 bis 64 Jahren und 100 Probanden über oder gleich 65 Jahren) erhalten an den Tagen 0 und 21 15 µg H1N1-Impfstoff.
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Zwei Dosen des inaktivierten Influenza-H1N1-Impfstoffs werden intramuskulär verabreicht, jeweils 15 oder 30 µg.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Anzahl der Teilnehmer, die impfbedingte schwerwiegende unerwünschte Ereignisse (SAEs) melden
Zeitfenster: Tag 0 bis Tag 180 nach der letzten Impfung
|
Zu den schwerwiegenden unerwünschten Ereignissen gehörten alle ungünstigen medizinischen Ereignisse, die zum Tod führten; war lebensbedrohlich; war eine anhaltende/erhebliche Behinderung/Unfähigkeit; erforderlicher stationärer Krankenhausaufenthalt oder dessen Verlängerung; zu einer angeborenen Anomalie/einem Geburtsfehler geführt hat; oder den Teilnehmer gefährdet haben oder ein Eingreifen erforderlich gemacht haben, um eines dieser Ergebnisse zu verhindern.
Der Zusammenhang mit der Impfung wurde von einem Studienarzt festgestellt, der für die Erstellung medizinischer Diagnosen zugelassen ist.
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Tag 0 bis Tag 180 nach der letzten Impfung
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Anzahl der Teilnehmer, die nach der ersten Impfung gemessene Schwellungen und Rötungen an der Injektionsstelle meldeten
Zeitfenster: Tag 0–7 nach der ersten Impfung
|
Die Teilnehmer führten acht Tage nach der Impfung (Tag 0–7) eine Gedächtnishilfe, um täglich das Auftreten lokaler Schwellungs- und Rötungsreaktionen aufzuzeichnen.
Wenn die Reaktion vorhanden war, wurde der maximale Durchmesser in Millimetern (mm) gemessen.
Teilnehmer werden gezählt, wenn sie angaben, an einem der 8 Tage eine Reaktion bei einem Messwert größer als 0 mm festgestellt zu haben.
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Tag 0–7 nach der ersten Impfung
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Anzahl der Teilnehmer, die nach der zweiten Impfung gemessene Schwellungen und Rötungen an der Injektionsstelle meldeten
Zeitfenster: Tag 0–7 nach der zweiten Impfung
|
Die Teilnehmer führten acht Tage nach der Impfung (Tag 0–7) eine Gedächtnishilfe, um täglich das Auftreten lokaler Schwellungs- und Rötungsreaktionen aufzuzeichnen.
Wenn die Reaktion vorhanden war, wurde der maximale Durchmesser in Millimetern (mm) gemessen.
Teilnehmer werden gezählt, wenn sie angaben, an einem der 8 Tage eine Reaktion bei einem Messwert größer als 0 mm festgestellt zu haben.
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Tag 0–7 nach der zweiten Impfung
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Anzahl der Teilnehmer, die nach der ersten Impfung Fieber meldeten
Zeitfenster: Tag 0–7 nach der ersten Impfung
|
Den Teilnehmern wurde ein Thermometer und eine Erinnerungshilfe zur Verfügung gestellt, mit der sie acht Tage lang nach der Impfung (Tag 0–7) die tägliche orale Temperatur aufzeichnen konnten.
Das Protokoll definierte Fieber als orale Temperatur von 38,0 Grad Celsius oder höher.
Als Teilnehmer mit Fieber gelten Teilnehmer, die an einem der 8 Tage Mundtemperaturen von 38,0 Grad Celsius oder mehr meldeten.
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Tag 0–7 nach der ersten Impfung
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Anzahl der Teilnehmer, die nach der zweiten Impfung Fieber meldeten
Zeitfenster: Tag 0–7 nach der zweiten Impfung
|
Den Teilnehmern wurde ein Thermometer und eine Erinnerungshilfe zur Verfügung gestellt, mit der sie acht Tage lang nach der Impfung (Tag 0–7) die tägliche orale Temperatur aufzeichnen konnten.
Das Protokoll definierte Fieber als orale Temperatur von 38,0 Grad Celsius oder höher.
Als Teilnehmer mit Fieber gelten Teilnehmer, die an einem der 8 Tage Mundtemperaturen von 38,0 Grad Celsius oder mehr meldeten.
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Tag 0–7 nach der zweiten Impfung
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Anzahl der Teilnehmer im Alter von 18 bis 64 Jahren mit einem Serum-Hämagglutinationshemmung (HAI)-Antikörpertiter von 1:40 oder mehr gegen das Influenza-H1N1-2009-Virus 21 Tage nach 1 Dosis H1N1-Impfstoff
Zeitfenster: Tag 21 nach der ersten Impfung
|
Bei der 21-tägigen Nachuntersuchung wurde allen Teilnehmern Blut entnommen, um sie im HAI-Test mit dem Influenza-H1N1-2009-Virus als Testantigen zu testen.
Jede Probe wurde mindestens zweimal gemäß Standardarbeitsanweisungen getestet und das Ergebnis jeder Wiederholung wurde gemeldet.
Ein Teilnehmer wird gezählt, wenn das geometrische Mittel der Wiederholungswerte 1:40 oder mehr betrug.
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Tag 21 nach der ersten Impfung
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Anzahl der Teilnehmer in der Altersgruppe 65 Jahre und älter mit einem Serum-Hämagglutinationshemmung (HAI)-Antikörpertiter von 1:40 oder mehr gegen das Influenza-H1N1-2009-Virus 21 Tage nach 1 Dosis H1N1-Impfstoff
Zeitfenster: Tag 21 nach der ersten Impfung
|
Bei der 21-tägigen Nachuntersuchung wurde allen Teilnehmern Blut entnommen, um sie im HAI-Test mit dem Influenza-H1N1-2009-Virus als Testantigen zu testen.
Jede Probe wurde mindestens zweimal gemäß Standardarbeitsanweisungen getestet und das Ergebnis jeder Wiederholung wurde gemeldet.
Ein Teilnehmer wird gezählt, wenn das geometrische Mittel der Wiederholungswerte 1:40 oder mehr betrug.
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Tag 21 nach der ersten Impfung
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Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the First Vaccination
Zeitfenster: Day 0-7 after first vaccination
|
Participants 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, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity.
Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
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Day 0-7 after first vaccination
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Number of Participants Reporting Solicited Local Reactions Based on the Functional Grading Scale After the Second Vaccination
Zeitfenster: Day 0-7 after second vaccination
|
Participants 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, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity.
Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
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Day 0-7 after second vaccination
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Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the First Vaccination
Zeitfenster: Day 0-7 after 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 after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity.
Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
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Day 0-7 after first vaccination
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Number of Participants Reporting Solicited Systemic Symptoms Based on the Functional Grading Scale After the Second Vaccination
Zeitfenster: Day 0-7 after 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 after vaccination (Day 0-7) based on their interference with daily activities, with a severity grade of mild meaning no interference, moderate as some interference and severe as significant interference/prevented daily activity.
Participants are counted if they reported experiencing the symptom at any severity on any of the 8 days.
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Day 0-7 after second vaccination
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Number of Participants in the 18-64 Year Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine
Zeitfenster: Day 0 prior to and Day 8-10 after first vaccination
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Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit 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.
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Day 0 prior to and Day 8-10 after first vaccination
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Number of Participants in the 65 Years and Older Age Stratum With a Serum Hemagglutination Inhibition (HAI) Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus Prior to and 8-10 Days Following 1 Dose of H1N1 Vaccine
Zeitfenster: Day 0 prior to and Day 8-10 after first vaccination
|
Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit 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.
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Day 0 prior to and Day 8-10 after first vaccination
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Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine
Zeitfenster: Day 0 prior to and Day 8-10 after first vaccination
|
Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit 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.
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Day 0 prior to and Day 8-10 after first vaccination
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Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 1 Dose of Vaccine
Zeitfenster: Day 0 prior to and Day 8-10 after first vaccination
|
Blood was collected from all participants prior to vaccination and at the 8-10 day follow up visit 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.
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Day 0 prior to and Day 8-10 after first vaccination
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Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine
Zeitfenster: Day 0 prior to and Day 21 after first vaccination
|
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 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.
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Day 0 prior to and Day 21 after first vaccination
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Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 1 Dose of Vaccine
Zeitfenster: Day 0 prior to and Day 21 after first vaccination
|
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 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.
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Day 0 prior to and Day 21 after first vaccination
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.
Zeitfenster: Day 0 prior to first vaccination and Day 8-10 after the second vaccination
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Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination 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 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 post vaccination 2 titer was an increase by 4-fold or more.
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Day 0 prior to first vaccination and Day 8-10 after the second vaccination
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Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.
Zeitfenster: Day 0 prior to first vaccination and Day 8-10 after the second vaccination
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Blood was collected from all participants prior to the initial vaccination and 8-10 days after the second vaccination 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 post vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 8-10 post vaccination 2 titer was an increase by 4-fold or more.
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Day 0 prior to first vaccination and Day 8-10 after the second vaccination
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Number of Participants in the 18-64 Year Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.
Zeitfenster: Day 0 prior to first vaccination and Day 21 after the second vaccination
|
Blood was collected from all participants prior to the initial vaccination and 21 days after the second vaccination 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 vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.
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Day 0 prior to first vaccination and Day 21 after the second vaccination
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Number of Participants in the 65 Years and Older Age Stratum With 4-fold or Greater HAI Antibody Titer Increases Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.
Zeitfenster: Day 0 prior to first vaccination and Day 21 after the second vaccination
|
Blood was collected from all participants prior to the initial vaccination and 21 days after the second vaccination 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 vaccination 2 titer was 1:40 or greater, or the Day 0 titer was greater than or equal to 1:10 and the Day 21 post vaccination 2 titer was an increase by 4-fold or more.
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Day 0 prior to first vaccination and Day 21 after the second vaccination
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Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.
Zeitfenster: Day 8-10 after the second vaccination
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Blood was collected from all participants at Day 8-10 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen.
Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported.
A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
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Day 8-10 after the second vaccination
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Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 8-10 Days Following 2 Doses of H1N1 Vaccine.
Zeitfenster: Day 8-10 after the second vaccination
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Blood was collected from all participants at Day 8-10 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen.
Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported.
A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
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Day 8-10 after the second vaccination
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Number of Participants in the 18-64 Year Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.
Zeitfenster: Day 21 after the second vaccination
|
Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen.
Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported.
A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
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Day 21 after the second vaccination
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Number of Participants in the 65 Years and Older Age Stratum With a Serum HAI Antibody Titer of 1:40 or Greater Against Influenza H1N1 2009 Virus at 21 Days Following 2 Doses of H1N1 Vaccine.
Zeitfenster: Day 21 after the second vaccination
|
Blood was collected from all participants at Day 21 post second vaccination for testing in the HAI assay with Influenza H1N1 2009 virus as the assay antigen.
Each sample was tested at least twice according to standard operating procedures and the result of each replicate reported.
A participant is counted if the geometric mean of the replicate values was 1:40 or greater.
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Day 21 after the second vaccination
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. August 2009
Primärer Abschluss (Tatsächlich)
1. März 2010
Studienabschluss (Tatsächlich)
1. März 2010
Studienanmeldedaten
Zuerst eingereicht
21. Juli 2009
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
21. Juli 2009
Zuerst gepostet (Schätzen)
22. Juli 2009
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
31. Oktober 2012
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
25. Oktober 2012
Zuletzt verifiziert
1. März 2010
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 09-0043
- N01AI80008C
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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