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
| ISRCTN | ISRCTN64287576 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64287576 |
| ClinicalTrials.gov number | NCT00386542 |
| Secondary identifying numbers | RPC170; CDC-ISO-4785 |
- Submission date
- 04/10/2006
- Registration date
- 16/04/2007
- Last edited
- 09/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Martin Friede
Scientific
Scientific
World Health Organization (WHO)
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
Study information
| Study design | Clinical research, randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Influenza vaccine |
| Primary outcome measure | Safety |
| Secondary outcome measures | Immunogenicity |
| Overall study start date | 01/10/2006 |
| Completion date | 01/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 24 Months |
| Sex | Not Specified |
| Target number of participants | 450 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2006 |
| Date of final enrolment | 01/08/2007 |
Locations
Countries of recruitment
- Dominican Republic
- Switzerland
Study participating centre
World Health Organization (WHO)
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
Sponsor information
Centers for Disease Control and Prevention
Government
Government
1600 Clifton Road (D-26)
Atlanta
GA 30333
United States of America
| Phone | +1 404 639 8779 |
|---|---|
| bgw2@cdc.gov | |
| Website | http://www.cdc.gov/ |
"ROR" |
https://ror.org/042twtr12 |
Funders
Funder type
Government
Centers for Disease Control and Prevention
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- United States Centers for Disease Control and Prevention, Centros para el Control y la Prevención de Enfermedades, Centers for Disease Control, U.S. Centers for Disease Control and Prevention, CDC, U.S. CDC
- Location
- United States of America
PATH
Government organisation / Other non-profit organizations
Government organisation / Other non-profit organizations
- Alternative name(s)
- Program for Appropriate Technology in Health
- Location
- United States of America
World Health Organization (WHO) (Switzerland) (ref: RPC170)
Private sector organisation / International organizations
Private sector organisation / International organizations
- Alternative name(s)
- منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
- Location
- Switzerland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | Interim results of phase I | No | No |
Editorial Notes
09/01/2020: Internal review.
09/08/2019: Internal review.
31/01/2019: Interim results added to publication and dissemination plan
