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Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age

12 april 2016 uppdaterad av: Sanofi Pasteur, a Sanofi Company

Evaluation of Serologic Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® Vaccine at 2 Months of Age

The study is to compare the 2 Groups with respect to antibody responses to inactivated influenza vaccine.

Observational Objectives:

  • To describe the percentage of participants with protective Hemagglutinin (HAI) antibody titers to each of the 3 vaccine antigens in both study groups following each vaccination.
  • To describe the HAI geometric mean titer (GMTs) to each of the 3 vaccine antigens in both study groups following each vaccination.
  • To describe the safety of the 2005-2006 pediatric formulation of Fluzone® vaccine in both study groups.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This is a descriptive study that will provide preliminary comparative information about the safety and immunogenicity of Fluzone® vaccine among children who were given Fluzone® vaccine at 2 months of age (Study GRC27 NCT00858468)and those who never received influenza vaccine.

Studietyp

Interventionell

Inskrivning (Faktisk)

242

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Arkansas
      • Little Rock, Arkansas, Förenta staterna, 72205
    • Georgia
      • Marietta, Georgia, Förenta staterna, 30062
    • North Carolina
      • Durham, North Carolina, Förenta staterna, 27704
    • Ohio
      • Dayton, Ohio, Förenta staterna, 45404
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Förenta staterna, 15241
    • Washington
      • Seattle, Washington, Förenta staterna, 98040

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

6 månader till 11 månader (Barn)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Participant is between 6 and 10 months of age on the day of inclusion (has reached 6-month but has not reached 11-month anniversary of birth).
  • Available for the duration of the study.
  • Born at full term of pregnancy (≥ 36 weeks) with a birth weight ≥ 2.5 kg
  • Parent/legal acceptable representative willing and able to provide informed consent.
  • Parent/legal acceptable representative able to attend all scheduled visits and comply with all trial procedures.
  • Parent/legal acceptable representative willing to permit venipuncture for purposes of collecting a blood sample.
  • Previously enrolled in the 2-month-old group in Study GRC27 or approved by sponsor for enrollment as control.

Exclusion Criteria:

  • Reported allergy to egg proteins, chicken proteins, or any other constituent of Fluzone vacccine.
  • Previous history of influenza vaccination (Group 2 subjects only).
  • Receipt of any vaccine in the 14 days prior to enrollment.
  • An acute illness with or without fever (rectal temperature ≥ 38.0 °C [or ≥100.4 °F]) in the 72 hours preceding enrollment in the trial.
  • Known bleeding disorder.
  • Participation in any other interventional (e.g., vaccine, drug) clinical trial (except Study GRC27) within 30 days prior to enrollment, or planned participation in another interventional clinical trial prior to termination of the subject's participation in this study.
  • Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
  • Personal or immediate family history of congenital immune deficiency.
  • Developmental delay, neurologic disorder, or seizure disorder.
  • Chronic medical, congenital or developmental disorder that could interfere with trial conduct or completion.
  • Known human immunodeficiency virus (HIV)-positive or hepatitis B surface antigen (HBsAg)-positive mother.
  • Known HIV, hepatitis B, or hepatitis C infection.
  • Receipt of blood or blood-derived products within the past 2 months.
  • Prior history of Guillain-Barré syndrome.
  • Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Fluzone® Vaccine-Primed Group
Participants received 2 doses of Fluzone® vaccine at 2 months (in Study GRC 27)
0.25 mL, Intramuscular
Andra namn:
  • Fluzone® 2005-2006 Pediatric Formulation
Aktiv komparator: Influenza Vaccine-Naive Group
Participants who have never received influenza vaccine (and not in Study GRC27)
0.25 mL, Intramuscular
Andra namn:
  • Fluzone® 2005-2006 Pediatric Formulation

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Summary of Influenza Seroprotection Post-vaccination With Fluzone® Vaccine.
Tidsram: Day 28 Post-vaccination
Seroprotection was defined as a Reciprocal Hemagglutination Inhibition Titers of ≥ 40 Post-vaccination with Fluzone® Vaccine.
Day 28 Post-vaccination

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibody Titers Post-Vaccination With Fluzone® Vaccine.
Tidsram: Day 28 Post-vaccination
Antibodies against Influenza virus in Fluzone® Vaccine determined by the Hemagglutination inhibition (HAI) assay method.
Day 28 Post-vaccination
Geometric Mean Titers (GMTs) for Pertussis, Tetanus, Diphtheria, and Haemophilus Influenzae, Antigens Post-vaccination With Fluzone® Vaccine.
Tidsram: Day 28 Post-vaccination

Antibodies against Pertussis, Tetanus, and Haemophilus influenzae antigens were determined by an indirect Enzyme linked immunosorbent assay (ELISA).

Anti-diphtheria antibody response was measured by the Vero Cells - diphtheria toxin challenge method.

The serological determinations of total anti-PRP antibody was performed using a Farr-type radioimmunoassay.

Day 28 Post-vaccination
Geometric Mean Titers (GMTs) for Polyribosylribitol Phosphate and Pneumococcal Antibodies After Concomitant Vaccination With Fluzone® Vaccine.
Tidsram: Day 28 post-vaccination
Human antibodies to Streptococcus pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) were determined by an Enzyme linked immunosorbent assay (ELISA).
Day 28 post-vaccination
Geometric Mean Titers (GMTs) for Polio Antibodies After Concomitant Vaccination With Fluzone® Vaccine.
Tidsram: Day 28 post-vaccination
Antibodies to polio viruses were measured by a serum neutralization assay.
Day 28 post-vaccination
Percentage of Participants With Solicited Injection Site and Systemic Reactions Post-vaccination With Fluzone® Vaccine.
Tidsram: Days 0 up to 7 post-vaccination
Solicited injection site reactions: Tenderness, erythema and swelling. Solicited systemic reactions: Fever (temperature), vomiting, abnormal crying, drowsiness, loss of appetite, and irritability.
Days 0 up to 7 post-vaccination

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2005

Primärt slutförande (Faktisk)

1 januari 2006

Avslutad studie (Faktisk)

1 september 2007

Studieregistreringsdatum

Först inskickad

20 april 2009

Först inskickad som uppfyllde QC-kriterierna

20 april 2009

Första postat (Uppskatta)

21 april 2009

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

14 april 2016

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 april 2016

Senast verifierad

1 april 2016

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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