Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386542
Status:
COMPLETED
Last Update Posted:
2010-06-09
First Post:
2006-10-10
Brief Title:
Needle-free Jet Injection of Reduced-dose Intradermal Influenza Vaccine in 6 to 24-month-old Children
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Clinical Trial of Safety Reactogenicity and Immunogenicity of Needle-free Jet Injection of Reduced-dose Intradermal Influenza Vaccine INF Administered to 6 to 24 Month-old Infants and Toddlers in the Dominican Republic
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a sequential phase I and II controlled double-blinded study to determine whether immune responses suggesting protection against influenza can safely be induced in young children by two reduced doses one month apart of 01 mL of a trivalent inactivated influenza vaccine INF administered by the intradermal ID route with an investigational ID spacer on a United States US-licensed needle-free jet injector JI compared to two standard intramuscular IM 025 mL doses by needle-syringe N-S in this age group The locale is a developing country where financial restraints for the use of full-dose influenza vaccine would limit protection from an influenza pandemic threat where N-Ss pose dangers and drawbacks in clinical use and where Mantoux-type N-S ID injections are difficult to administer during mass campaigns
Detailed Description:
Randomized observer-blinded clinical pilot phase I trial of safety followed by a clinical phase II trial of safety and non-inferiority of immune response to the standard route and dose for the merged subjects from both phases
Phase I - Influenza-vaccine naïve children n 48 aged 6 to 24 months will be randomized in a 111 ratio to the following three study arms each to receive two doses on days 0 and 28 of trivalent inactivated influenza INF vaccine Vaxigrip Sanofi Pasteur Lyon France into the left thigh 12 months or left deltoid 12 months
Group ID-JI-01 n 16 - reduced 01 mL INF doses administered intradermally ID by needle-free jet injector JI Biojector 2000 subcutaneous syringe no 2 green color code with 2 cm investigational spacer Bioject Medical Technologies Inc Portland OR USA
Group IM-NS-01 n 16 - reduced 01 mL INF doses administered intramuscularly IM needle-syringe NS via 22-25 gauge needle minimum 25 mm1-inch length
Group IM-NS-025 controls n 16 - full 025 mL INF doses administered intramuscularly IM by needle-syringe NS 22-25 gauge needle minimum 25 mm1-inch length
Phase II - Upon assessment of the safety profile from phase I by the unblinded Data Safety Monitoring Board DSMB with its approval an additional 402 children will be recruited and randomized 134 per group as in phase I above Total subjects in phase I and II 450 150 in each of three study arms
Adverse Event Diaries Parents will be trained to complete a diary form to observe measure and record solicited local reactions for the injection site and systemic signs and symptoms for the child for days 0 through 7 after vaccination plus unsolicited symptoms illness and medications for days 0 through 28
Followup Return clinic visits will be scheduled on days 2 7 and 28 after INF dose 1 at which times the diary card data will be recorded by staff and the card collected on day 28 Upon receiving dose 2 of vaccine patients will be scheduled again to return to the study center 2 7 and 28 days afterwards The same procedures as for dose 1 regarding diary cards telephone followup and home visits will apply after dose 2
Upon returning to clinic on day 28 after dose 2 day 56 after dose 1 the child will receive an unblinded insurance full-volume 025 mL dose 3 of influenza vaccine by NS IM unless he or she is in the full-dose IM control group IM-NS-025 in which case a mock injection will be administered instead of a 3rd full dose beyond the usual 2-dose series All participants will return 6 months after this third injection for a fourth bonus dose of influenza vaccine to ensure protection for the following season
Serum Collection Blood specimens to measure serologic responses will be collected three times just prior to vaccination on day 0 INF dose 1 on day 28 INF dose 2 and on day 56 INF insurance dose 3
Ethical oversight additional to CDC IRB G by 1 World Health Organization Research Ethics Review Committee 2 Consejo Nacional de Bioética en Salud and 3 Fundación Dominicana de Infectología Comité de EticaInvestigaciones
Phase I - Influenza-vaccine naïve children n 48 aged 6 to 24 months will be randomized in a 111 ratio to the following three study arms each to receive two doses on days 0 and 28 of trivalent inactivated influenza INF vaccine Vaxigrip Sanofi Pasteur Lyon France into the left thigh 12 months or left deltoid 12 months
Group ID-JI-01 n 16 - reduced 01 mL INF doses administered intradermally ID by needle-free jet injector JI Biojector 2000 subcutaneous syringe no 2 green color code with 2 cm investigational spacer Bioject Medical Technologies Inc Portland OR USA
Group IM-NS-01 n 16 - reduced 01 mL INF doses administered intramuscularly IM needle-syringe NS via 22-25 gauge needle minimum 25 mm1-inch length
Group IM-NS-025 controls n 16 - full 025 mL INF doses administered intramuscularly IM by needle-syringe NS 22-25 gauge needle minimum 25 mm1-inch length
Phase II - Upon assessment of the safety profile from phase I by the unblinded Data Safety Monitoring Board DSMB with its approval an additional 402 children will be recruited and randomized 134 per group as in phase I above Total subjects in phase I and II 450 150 in each of three study arms
Adverse Event Diaries Parents will be trained to complete a diary form to observe measure and record solicited local reactions for the injection site and systemic signs and symptoms for the child for days 0 through 7 after vaccination plus unsolicited symptoms illness and medications for days 0 through 28
Followup Return clinic visits will be scheduled on days 2 7 and 28 after INF dose 1 at which times the diary card data will be recorded by staff and the card collected on day 28 Upon receiving dose 2 of vaccine patients will be scheduled again to return to the study center 2 7 and 28 days afterwards The same procedures as for dose 1 regarding diary cards telephone followup and home visits will apply after dose 2
Upon returning to clinic on day 28 after dose 2 day 56 after dose 1 the child will receive an unblinded insurance full-volume 025 mL dose 3 of influenza vaccine by NS IM unless he or she is in the full-dose IM control group IM-NS-025 in which case a mock injection will be administered instead of a 3rd full dose beyond the usual 2-dose series All participants will return 6 months after this third injection for a fourth bonus dose of influenza vaccine to ensure protection for the following season
Serum Collection Blood specimens to measure serologic responses will be collected three times just prior to vaccination on day 0 INF dose 1 on day 28 INF dose 2 and on day 56 INF insurance dose 3
Ethical oversight additional to CDC IRB G by 1 World Health Organization Research Ethics Review Committee 2 Consejo Nacional de Bioética en Salud and 3 Fundación Dominicana de Infectología Comité de EticaInvestigaciones
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None