Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00386542
Protocol/serial number
RPC170; CDC-ISO-4785
Study information
Scientific title
Clinical trial of safety (reactogenicity) and immunogenicity of needle-free jet injection of reduced-dose, intradermal, Influenza vaccine (INF) administered to more than or equal to six month- to less than 24 month-old infants and toddlers in the Dominican Republic
Acronym
Study hypothesis
Intradermal administration of a fraction (40%) of a dose of influenza vaccine with a needle-free injector induces a non-inferior immune response compared to intramuscular injection of a full dose, in infants and toddlers.
Ethics approval
Approval received from:
1. Dominican Republic: Local ethics committee (Consejo Nacional de Bioética en salud (CONABIOS Universidad Catolica Santo Domingo) on 27th June 2006
2. USA: Centres for Disease Control and prevention (CDC) Institutional Review Board on 23rd June 2006
3. Switzerland: World Health Organization Research Ethics Review Committee (WHO ERC) on 28th August 2006
Study design
Clinical research, randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Influenza
Intervention
All volunteers are bled at day of first injection and receive:
Group 1: intramuscular injection with needle 0.25 mL influenza vaccine
Group 2: intramuscular injection with needle 0.1 mL influenza vaccine
Group 3: intradermal injection jet injector 0.1 mL influenza vaccine
All volunteers are bled 28 days after first injection and receive:
Group 1: intramuscular injection with needle 0.25 mL influenza vaccine
Group 2: intramuscular injection with needle 0.1 mL influenza vaccine
Group 3: intradermal injection jet injector 0.1 mL influenza vaccine
All volunteers bled 56 days afer first injection and receive:
Groups 2 and 3 (those who received only 0.1 mL doses) receive intramuscular injection of 0.25 mL influenza vaccine.
The Principal Investigator for this trial is:
Bruce Weniger
Centres for Disease Control and prevention (CDC)
1600 Clifton Road (D-26)
Atlanta, GA 30333
United States of America
Telephone: +1 404 639 8779
Email: bgw2@cdc.gov
Intervention type
Drug
Phase
Not Specified
Drug names
Influenza vaccine
Primary outcome measure
Safety
Secondary outcome measures
Immunogenicity
Overall trial start date
01/10/2006
Overall trial end date
01/08/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age from six or older to less than 24 months
2. Born after a full-term pregnancy of gestational age of more than or equal to 37 weeks, and a birth weight of more than or equal to 2.5 kg
3. History of prior or first attendance as a patient, or as a sibling of a patient, seeking routine immunisation or other clinical care at the Hospital Infantil Robert Reid Cabral (HIRRC)
4. Up-to-date for routine doses of vaccines officially recommended for the participants age in the Dominican Republic
5. In good health
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
450
Participant exclusion criteria
1. Have fever (by parental report or by rectal temperature greater than or equal to 38.5°C or axillary greater than or equal to 38.0°C) currently or within the past three days, or who are currently suffering from an acute or chronic infectious disease
2. Have had an acute or chronic infection requiring systemic antimicrobial therapy (antibiotic or antiviral) or other prescribed treatment within the past 21 days
3. Are malnourished, defined by weight less than two standard deviations below the median weight for their age
4. Are allergic to eggs, or have a history of any anaphylactic shock, asthma, urticaria, or other allergic reaction after previous vaccinations, or have allergy or hypersensitivity to any component of the study vaccine
5. Have ever received previously any influenza vaccine
6. Have received within the prior 28 days, or for whom there is the indication to receive in the next 56 days, any non-study vaccination or investigational agent outside of the study
7. Have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
8. Have currently any serious confirmed or suspected disease, such as metabolic, cardiac, or autoimmune disease, or diabetes
9. Have a history of epilepsy or a seizure disorder, or neurodevelopmental disorders such as autism
10. Have any condition which, in the opinion of the investigator, may interfere in the evaluation of the objectives of the study
Recruitment start date
01/10/2006
Recruitment end date
01/08/2007
Locations
Countries of recruitment
Dominican Republic
Trial participating centre
World Health Organization (WHO)
Geneva-27
CH-1211
Switzerland
Sponsor information
Organisation
Centres for Disease Control and prevention (CDC) (USA)
Sponsor details
1600 Clifton Road (D-26)
Atlanta
GA 30333
United States of America
+1 404 639 8779
bgw2@cdc.gov
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Centres for Disease Control and prevention (CDC) (USA) (ref: CDC-ISO-4785)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Program for Appropriate Technology in Health (PATH) (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
World Health Organization (WHO) (Switzerland) (ref: RPC170)
Alternative name(s)
WHO
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
Switzerland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 Interim results of phase I, presented at the 11th Annual Conference on Vaccine Research, May 2008. Abstract P-25 available on nominal page 80 (81 of 106) in the abstract book: http://www.nfid.org/pdf/conferences/vaccine08abstracts.pdf