Condition category
Infections and Infestations
Date applied
04/10/2006
Date assigned
16/04/2007
Last edited
25/01/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Martin Friede

ORCID ID

Contact details

World Health Organization (WHO)
20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00386542

Protocol/serial number

RPC170; CDC-ISO-4785

Study information

Scientific title

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 measures

Safety

Secondary outcome measures

Immunogenicity

Overall trial start date

01/10/2006

Overall trial end date

01/08/2007

Reason abandoned

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

http://www.cdc.gov/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes