- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00885105
Evaluation of Responses to Fluzone® in Infants ≥ 6 Months of Age Who Did or Did Not Receive Fluzone® at 2 Months of Age
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
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
Arkansas
-
Little Rock, Arkansas, Förenta staterna, 72205
-
-
Georgia
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Marietta, Georgia, Förenta staterna, 30062
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-
North Carolina
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Durham, North Carolina, Förenta staterna, 27704
-
-
Ohio
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Dayton, Ohio, Förenta staterna, 45404
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15241
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-
Washington
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Seattle, Washington, Förenta staterna, 98040
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
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
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:
|
Aktiv komparator: Influenza Vaccine-Naive Group
Participants who have never received influenza vaccine (and not in Study GRC27)
|
0.25 mL, Intramuscular
Andra namn:
|
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
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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
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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.
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Days 0 up to 7 post-vaccination
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- GRC32
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