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Sponsors and Collaborators: |
Centers for Disease Control and Prevention Fundación Dominicana de Infectología, Santo Domingo, Dominican Republic Hospital Infantíl Dr. Robert Reid Cabral, Santo Domingo, Dominican Republic World Health Organization Pan American Health Organization Program for Appropriate Technology in Health, Seattle, WA, USA Bioject Medical Technologies, Inc. Sanofi Pasteur SA [vaccine donor] |
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Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00386542 |
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 0.1 mL of a trivalent inactivated influenza vaccine (INF) administered by the intradermal (ID) route with an investigational ID spacer on a United States (U.S.)-licensed needle-free jet injector (JI), compared to two standard intramuscular (IM) 0.25 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.
Condition | Intervention | Phase |
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Influenza |
Biological: Vaxigrip® trivalent inactivated influenza vaccine Device: Intradermal spacer on Biojector® 2000 jet injector |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 450 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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ID-JI-0.1: Experimental
Group "ID-JI-0.1" (n = 16) - reduced 0.1 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)
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Biological: Vaxigrip® trivalent inactivated influenza vaccine
See full description elsewhere in this record.
Device: Intradermal spacer on Biojector® 2000 jet injector
See elsewhere in this record for full description.
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IM-NS-0.1: Active Comparator
Group "IM-NS-0.1" (n = 16) - reduced 0.1 mL INF doses administered intramuscularly (IM) needle-syringe (NS) (via 22-25 gauge needle, minimum 25 mm/1-inch length)
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Biological: Vaxigrip® trivalent inactivated influenza vaccine
See full description elsewhere in this record.
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IM-NS-0.25 control: Active Comparator
Group "IM-NS-0.25" (controls) (n = 16) - full 0.25 mL INF doses administered intramuscularly (IM) by needle-syringe (NS) (22-25 gauge needle, minimum 25 mm/1-inch length)
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Biological: Vaxigrip® trivalent inactivated influenza vaccine
See full description elsewhere in this record.
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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 1:1:1 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):
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, 0.25 mL dose (#3) of influenza vaccine by NS IM, unless he or she is in the full-dose IM control group IM-NS-0.25, 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 Etica/Investigaciones.
Ages Eligible for Study: | 6 Months to 24 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Infants WHOSE PARENT(S)/LEGAL GUARDIAN(S):
INFANTS who:
Contact: Jesús M Feris Iglesias, MD | +1 (809) 532-5872 | infectologia@codetel.net.do |
Contact: Virgen Gómez, MD | +1 (809) 449-2913 | virgen.gomez@codetel.net.do |
Dominican Republic, Distrito Nacional | |
Hospital Infantíl Dr. Robert Reid Cabral | Recruiting |
Santo Domingo, Distrito Nacional, Dominican Republic | |
Sub-Investigator: Jacqueline Sánchez, MD | |
Sub-Investigator: Glenny Gúzman, MD |
Principal Investigator: | Bruce G Weniger, MD, MPH | Immunization Safety Office, Centers for Disease Control and Prevention |
Study Director: | Virgen Gómez, MD | Hospital Infantíl Dr. Robert Reid Cabral |
Study Director: | Jesús M Feris Iglesias, MD | Hospital Infantíl Dr. Robert Reid Cabral |
Study Director: | Josefina Fernández, MD | Hospital Infantíl Dr. Robert Reid Cabral |
Study Director: | Pedro Moro, MD, MPH | Immunization Safety Office, Centers for Disease Control and Prevention |
Study Chair: | Martin Friede, PhD | Initiative for Vaccine Research, World Health Organization |
Responsible Party: | Centers for Disease Control and Prevention (CDC) ( Bruce G. Weniger, MD, MPH, Chief, Vaccine Technology, Immunization Safety Office ) |
Study ID Numbers: | CDC-ISO-4785 |
Study First Received: | October 10, 2006 |
Last Updated: | July 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00386542 |
Health Authority: | United States: Federal Government; Dominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS) |
vaccination influenza vaccine jet injection intradermal injection infancy children Dominican Republic pandemic preparedness dose-sparing |
reduced dosage immunogenicity reactogenicity safety needle-free immune response hemagglutination inhibition Infant |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
RNA Virus Infections |