- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00952419
A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years
12. april 2016 oppdatert av: Sanofi Pasteur, a Sanofi Company
Immunogenicity and Safety of Multiple Formulations of an A/H1N1 Pandemic Vaccine in Healthy Subjects Aged 6 Months to 9 Years
The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children.
Primary Objectives:
- To describe the immunogenicity of the candidate vaccines after each injection.
- To describe the safety of the candidate vaccines after each injection.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
Studietype
Intervensjonell
Registrering (Faktiske)
474
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Florida
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Miami Beach, Florida, Forente stater, 33141
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Georgia
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Marietta, Georgia, Forente stater, 30062
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Woodstock, Georgia, Forente stater, 30189
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Kentucky
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Crestview Hills, Kentucky, Forente stater, 41017
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Louisville, Kentucky, Forente stater, 40291
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Maddisonville, Kentucky, Forente stater, 42431
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Louisiana
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Metairie, Louisiana, Forente stater, 70006
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Nevada
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Las Vegas, Nevada, Forente stater, 89104
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New York
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Rochester, New York, Forente stater, 14609
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Pennsylvania
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Hermitage, Pennsylvania, Forente stater, 16148
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Pittsburgh, Pennsylvania, Forente stater, 15237
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Pittsburgh, Pennsylvania, Forente stater, 15241
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Rhode Island
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Cranston, Rhode Island, Forente stater, O2920
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South Carolina
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Barnwell, South Carolina, Forente stater, 29812
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Texas
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Austin, Texas, Forente stater, 78705
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Fort Worth, Texas, Forente stater, 76135
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San Angelo, Texas, Forente stater, 76904
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Utah
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Orem, Utah, Forente stater, 84057
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South Jordan, Utah, Forente stater, 84095
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Springville, Utah, Forente stater, 84663
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
6 måneder til 9 år (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria :
All subjects:
- Provision of Informed Consent Form signed by the subject's parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 7 to 9 years
- Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
Subjects aged 3 to 9 years:
- Healthy children aged 3 to 9 years on the day of inclusion
Subjects aged 6 to 35 months:
- Healthy infants and toddlers aged 6 to 35 months on the day of inclusion
- Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
Exclusion Criteria :
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination
- Planned receipt of any vaccine prior to the Day 42 blood sample
- Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- Self reported thrombocytopenia contraindicating intramuscular (IM) vaccination
- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Chronic illness that in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
- Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March 2009
- Personal or family history of Guillain-Barré syndrome
- Active neoplastic disease or a history of any hematologic malignancy
- Known seizure/epilepsy history and/or taking anti-seizure medication
- Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study
- Febrile illness (temperature ≥ 100.4°F [≥ 38.0°C]) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: A/H1N1 Vaccine Group 1
Participants will receive A/H1N1 vaccine formulation 1
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0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months)
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
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Eksperimentell: A/H1N1 Vaccine Group 2
Participants will receive A/H1N1 vaccine formulation 2
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0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months)
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
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Placebo komparator: Placebo Group
Participants will receive a placebo vaccine
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0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
Tidsramme: Pre-vaccination (Day 0) and 21 days post-vaccination
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Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
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Pre-vaccination (Day 0) and 21 days post-vaccination
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Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
Tidsramme: Pre-vaccination (Day 0) and Day 21 post-vaccination
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Seroprotection: Antibody titer of ≥ 40 1/dil.
Antibody titers were determined by the hemagglutination inhibition (HAI) test.
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Pre-vaccination (Day 0) and Day 21 post-vaccination
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Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
Tidsramme: Pre-vaccination (Day 0) and 21 days post-vaccination
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Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
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Pre-vaccination (Day 0) and 21 days post-vaccination
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Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
Tidsramme: Pre-vaccination (Day 0) and 21 days post-vaccination
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Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
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Pre-vaccination (Day 0) and 21 days post-vaccination
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Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
Tidsramme: Pre-vaccination (Day 0) and Day 21 post-vaccination
|
Seroprotection: Antibody titer ≥ 40 1/dil.
Antibody titers were determined by the hemagglutination inhibition (HAI) test.
|
Pre-vaccination (Day 0) and Day 21 post-vaccination
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Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
Tidsramme: Pre-vaccination (Day 0) and Day 21 post-vaccination
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Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
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Pre-vaccination (Day 0) and Day 21 post-vaccination
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Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months
Tidsramme: Days 0 to 7 post-vaccination
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Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising).
Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.
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Days 0 to 7 post-vaccination
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Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months
Tidsramme: Days 0 to 7 post-vaccination
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Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising).
Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.
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Days 0 to 7 post-vaccination
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Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years
Tidsramme: Days 0 to 7 post vaccination
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Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising).
Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.
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Days 0 to 7 post vaccination
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Plennevaux E, Blatter M, Cornish MJ, Go K, Kirby D, Wali M, Reeves-Hoche MK, Denis M. Influenza A (H1N1) 2009 two-dose immunization of US children: an observer-blinded, randomized, placebo-controlled trial. Vaccine. 2011 Feb 11;29(8):1569-75. doi: 10.1016/j.vaccine.2010.12.116. Epub 2011 Jan 8.
- Plennevaux E, Sheldon E, Blatter M, Reeves-Hoche MK, Denis M. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet. 2010 Jan 2;375(9708):41-8. doi: 10.1016/S0140-6736(09)62026-2. Epub 2009 Dec 15.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2009
Primær fullføring (Faktiske)
1. mars 2010
Studiet fullført (Faktiske)
1. juni 2010
Datoer for studieregistrering
Først innsendt
3. august 2009
Først innsendt som oppfylte QC-kriteriene
4. august 2009
Først lagt ut (Anslag)
6. august 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
14. april 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. april 2016
Sist bekreftet
1. april 2016
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FUF15
- UTN: U1111-1111-4713
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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