InfluenzaPhase 1/2NCT00386542

Needle-free Jet Injection of Reduced-dose, Intradermal, Influenza Vaccine in >= 6 to < 24-month-old Children

A Phase 1/2 study testing Vaxigrip® trivalent inactivated influenza vaccine and Intradermal spacer on Biojector® 2000 jet injector in people with Influenza, run by Pedro Moro at 1 site in Dominican Republic.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 6 to 24 monthsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Vaxigrip® trivalent inactivated influenza vaccine and Intradermal spacer on Biojector® 2000 jet injector
Type of treatment: Vaccines, Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 450 participants
Where: 1 siteDominican Republic
Study dates: Oct 2006to May 2010
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 24 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Age from > = 6 to < 24 months (not having reached 2nd birthday).
Born after a full-term (≥ 37 weeks), and birth weight of >= 2.5 kg (>= 5 pounds, 8 ounces)
History of prior or first attendance as a patient, or as a sibling of a patient, seeking routine immunization or other clinical care at the Hospital Infantíl Robert Reid Cabral (HIRRC)
The parent(s) or legal guardian(s) provide(s) written informed consent and agree(s) to bring the infant back to the clinic for all visits scheduled in the study
Up-to-date for routine doses of vaccines officially recommended for the patient's age in the Dominican Republic to prevent tuberculosis, polio, diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae B
In good health, as determined by medical history and physical examination collected in accordance with the Case Report Form (CRF), and by the clinical judgment of the investigators.

Who cannot join

Infants WHOSE PARENT(S)/LEGAL GUARDIAN(S):
Are unable or unwilling to give written informed consent for their infant to participate in the study
Cannot be contacted by telephone (family's own or a neighbor's) if necessary for adverse events if scheduled followup return appointments are missed
Are unable to complete the diary for adverse events; are unable to measure and record temperatures or maximal diameter of local reactions or limb circumference; or have difficulty understanding written instructions; or other factors which indicate exclusion in the judgement of the study staff.
INFANTS who:
Have fever (by parental report or by rectal temperature ≥ 38.5° C or axillary ≥ 38.0° C) currently or within the past 3 days, or who are currently suffering from an acute or chronic infectious disease (including known HIV)

Show all 20Show fewer

Have had an acute or chronic infection requiring systemic antimicrobial therapy (antibiotic or antiviral) or other prescribed treatment within the past 21 days. This includes any underlying illness that may limit their response to vaccination, such as those receiving intravenous immunoglobulin for agammaglobulinemia, or systemic steroid therapy.
Are malnourished, defined by weight less than two standard deviations below the median weight for their age
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
Have ever previously received any influenza vaccine
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
Have a known bleeding diathesis, or any condition with a prolonged bleeding time
Currently have any serious confirmed or suspected disease, such as metabolic, cardiac, or autoimmune disease, or diabetes
Have a history of epilepsy or a seizure disorder, or neurodevelopmental disorders such as autism
Have a genetic anomaly or known cytogenic disorder (e.g., Down's syndrome)
Have leukemia, lymphoma, or any other cancer/neoplasm
Have known or suspected immune dysfunction, including HIV infection, or receives(ed) immunosuppressive therapy, including systemic corticosteroids
Have ever received blood, blood products, or parenteral preparations of immunoglobulin
Have any other serious disease (e.g., with signs of cardiac or renal failure), including progressive neurologic disease
Have any condition which, in the opinion of the investigator, may interfere in the evaluation of the objectives of the study

Trial locations and contacts

1 site in 1 country.

Dominican Republic1 site

Hospital Infantíl Dr. Robert Reid Cabral
Santo Domingo, Nacional, 2

Other trials in Dominican Republic

About this 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

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.

Read the 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 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):

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)
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)
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)

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.

Conditions: Influenza
Being tested: Vaxigrip® trivalent inactivated influenza vaccine, Intradermal spacer on Biojector® 2000 jet injector
Keywords: vaccination, influenza vaccine, jet injection, intradermal injection, infancy, children, dose-sparing, cutaneous vaccination, Dominican Republic, pandemic preparedness, jet injector, reduced dosage, immunogenicity, reactogenicity, safety, needle-free, immune response, hemagglutination inhibition, Infant
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Vaxigrip® trivalent inactivated influenza vaccineBiological
See full description elsewhere in this record.
Intradermal spacer on Biojector® 2000 jet injectorDevice
See elsewhere in this record for full description.

Study groups in NCT00386542
Study group	Role	What they receive
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) Receives: Biological: Vaxigrip® trivalent inactivated influenza vaccine; Device: Intradermal spacer on Biojector® 2000 jet injector
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) Receives: Biological: Vaxigrip® trivalent inactivated influenza vaccine
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) Receives: Biological: Vaxigrip® trivalent inactivated influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Rates of seroconversion (SC) on HI assay 1 month after dose 2. SC defined as titer >= 40 among initial-seronegatives (titer < 8 on day 0); OR, a followup titer which rises >= 4-fold.
seroconversion and safety assessed through occurrence of local and systemic reactions
Measured: One month after each of doses 1 and 2.

Secondary outcomes (4)

Rates of local and systemic reactions
assessment of these reactions by study investigators
Measured: Up to 42 days for prompted symptoms after investigational doses 1 and 2. Up to 6 months for unsolicited ones.
Seroprotection (SP) on HI assay, defined as >= 40 regardless of baseline
assays were performed at CDC
Measured: One month after each of doses 1 and 2.
Geometric mean titers (GMT) on HI
assays were performed at CDC
Measured: One month after each of doses 1 and 2.
Geometric mean increase (GMI) on HI
assays were performed at CDC
Measured: One month after each of doses 1 and 2.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2006May 2010

First posted11 Oct 2006 (estimated)
Study startOct 2006
Primary completionNov 2009
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00386542
Sponsor's protocol ID: CDC-ISO-4785
Status last verified: Jul 2024
First submitted: 10 Oct 2006
Last updated: 5 Aug 2024
Results posted: No
Data monitoring committee: Yes

Publications

Palomeque FS, Weniger BG, Jet-Injected Cutaneous Influenza Vaccination Study Group. History and Technologies for Cutaneous Influenza Vaccination; and Preliminary Results from a CDC Trial of Jet-Injected, Needle-free Influenza Vaccine in ≥6 to <24-month-old Children in the Dominican Republic. CDC Vaccine Technology Seminar Series & CDC Influenza Division Seminar Series (Centers for Disease Control and Prevention), Atlanta, GA, 24 September 2013

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00386542
Acronym / sponsor ID: CDC-ISO-4785
Conditions: Influenza
Keywords: vaccination, influenza vaccine, jet injection, intradermal injection, infancy, children, dose-sparing, cutaneous vaccination
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 450 participants (actual)
Lead sponsor: Pedro MoroUS federal agency
Collaborators: Fundación Dominicana de Infectología, Santo Domingo, Dominican Republic, Hospital Infantil Dr. Robert Reid Cabral, World Health Organization, Pan American Health Organization, PATH, Bioject Medical Technologies, Inc., MCM Vaccines B.V.
Study start: Oct 2006
Primary completion: Nov 2009 (actual)
Study completion: May 2010 (actual)
First posted: 11 Oct 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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)
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)
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)

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
ID-JI-0.1	Experimental	Biological: Vaxigrip® trivalent inactivated influenza vaccine, Device: Intradermal spacer on Biojector® 2000 jet injectorGroup "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)
IM-NS-0.1	Active comparator	Biological: Vaxigrip® trivalent inactivated influenza vaccineGroup "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)
IM-NS-0.25 control	Active comparator	Biological: Vaxigrip® trivalent inactivated influenza vaccineGroup "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)

Who may qualify

Ages: 6 to 24 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

Age from > = 6 to < 24 months (not having reached 2nd birthday).
Born after a full-term (≥ 37 weeks), and birth weight of >= 2.5 kg (>= 5 pounds, 8 ounces)
History of prior or first attendance as a patient, or as a sibling of a patient, seeking routine immunization or other clinical care at the Hospital Infantíl Robert Reid Cabral (HIRRC)
The parent(s) or legal guardian(s) provide(s) written informed consent and agree(s) to bring the infant back to the clinic for all visits scheduled in the study
Up-to-date for routine doses of vaccines officially recommended for the patient's age in the Dominican Republic to prevent tuberculosis, polio, diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae B

Key exclusion criteria (20 listed)

Are unable or unwilling to give written informed consent for their infant to participate in the study
Cannot be contacted by telephone (family's own or a neighbor's) if necessary for adverse events if scheduled followup return appointments are missed
Are unable to complete the diary for adverse events; are unable to measure and record temperatures or maximal diameter of local reactions or limb circumference; or have difficulty understanding written instructions; or other factors which indicate exclusion in the judgement of the study staff.
Have fever (by parental report or by rectal temperature ≥ 38.5° C or axillary ≥ 38.0° C) currently or within the past 3 days, or who are currently suffering from an acute or chronic infectious disease (including known HIV)
Have had an acute or chronic infection requiring systemic antimicrobial therapy (antibiotic or antiviral) or other prescribed treatment within the past 21 days. This includes any underlying illness that may limit their response to vaccination, such as those receiving intravenous immunoglobulin for agammaglobulinemia, or systemic steroid therapy.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Vaxigrip® trivalent inactivated influenza vaccineSee full description elsewhere in this record.	Biological	ID-JI-0.1, IM-NS-0.1, IM-NS-0.25 control
Intradermal spacer on Biojector® 2000 jet injectorSee elsewhere in this record for full description.	Device	ID-JI-0.1

Primary outcome

Rates of seroconversion (SC) on HI assay 1 month after dose 2. SC defined as titer >= 40 among initial-seronegatives (titer < 8 on day 0); OR, a followup titer which rises >= 4-fold.
Time frame: One month after each of doses 1 and 2.
seroconversion and safety assessed through occurrence of local and systemic reactions

4 secondary outcomes

Rates of local and systemic reactions
Time frame: Up to 42 days for prompted symptoms after investigational doses 1 and 2. Up to 6 months for unsolicited ones.
Seroprotection (SP) on HI assay, defined as >= 40 regardless of baseline
Time frame: One month after each of doses 1 and 2.
Geometric mean titers (GMT) on HI
Time frame: One month after each of doses 1 and 2.
Geometric mean increase (GMI) on HI
Time frame: One month after each of doses 1 and 2.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
Results publicationPalomeque FS, Weniger BG, Jet-Injected Cutaneous Influenza Vaccination Study Group. History and Technologies for Cutaneous Influenza Vaccination; and Preliminary Results from a CDC Trial of Jet-Injected, Needle-free Influenza Vaccine in ≥6 to <24-month-old Children in the Dominican Republic. CDC Vaccine Technology Seminar Series & CDC Influenza Division Seminar Series (Centers for Disease Control and Prevention), Atlanta, GA, 24 September 2013
Palomeque FS, Weniger BG, Jet-Injected Cutaneous Influenza Vacc. Study Group. Hist. \& Technol. Cutaneous Influenza Vaccin.; \& Prelim. Results CDC Trial Jet-Injected, Needle-free Infl. Vacc. ≥6-\<24-mos-olds in Dom. Rep. (CDC Presentation)Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bruce G Weniger, MD, MPH principal investigator

CDC (bgweniger@siamlotus.com) (bgw2@cdc.gov obsolete by 2021).com)

Virgen Gómez, MD study director

Hospital Infantíl Dr. Robert Reid Cabral

Jesús M Feris Iglesias, MD study director

Hospital Infantíl Dr. Robert Reid Cabral

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Dominican Republic. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rates of seroconversion (SC) on HI assay 1 month after dose 2. SC defined as titer >= 40 among initial-seronegatives (titer < 8 on day 0); OR, a followup titer which rises >= 4-fold. (time frame: One month after each of doses 1 and 2.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00386542, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.