Advertisement

Topics

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

2014-07-23 21:35:10 | BioPortfolio

Summary

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.

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.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Conditions

Influenza

Intervention

Vaxigrip® trivalent inactivated influenza vaccine, Intradermal spacer on Biojector® 2000 jet injector

Location

Hospital Infantíl Dr. Robert Reid Cabral
Santo Domingo
Distrito Nacional
Dominican Republic
2

Status

Completed

Source

Centers for Disease Control and Prevention

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:35:10-0400

Clinical Trials [2639 Associated Clinical Trials listed on BioPortfolio]

Study of Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route Versus Vaxigrip® in Adults

This is a follow-up of a previous dose-ranging study aimed at investigating 2 doses of the trivalent inactivated split virion influenza vaccine when administered by intradermal route with ...

Safety, Tolerability, and Immunogenicity of Different Combinations of Trivalent Influenza Vaccine Varying Influenza Antigen Dose, Adjuvant Dose, and Route of Administration in Healthy Elderly Individuals Ages 65 Years and Older

The study will evaluate the safety, tolerability and immunogenicity of different doses and types of Influenza Vaccine in healthy elderly subjects.

Direct and Indirect Protection by Influenza Vaccine Given to Children in India

The study described here will immunize children with trivalent influenza vaccine (TIV) and determine whether this reduces influenza illness among the immunized children and their older fam...

A Study to Evaluate the Immunogenicity and Safety of bioCSL Quadrivalent Influenza Vaccine (QIV) in Adults Aged 18 Years and Above.

This is a study to assess the immune (antibody) response and safety of a bioCSL split virion, inactivated quadrivalent influenza vaccine, in comparison with a US licensed 2014/2015 trivale...

Study of Inactivated, Split-Virion Influenza Vaccine and Standard Fluzone® Vaccine in Adult and Elderly Subjects

The present formulations are being developed for further study in the elderly population in order to generate additional supporting data. Primary Objective: To demonstrate non-infe...

PubMed Articles [2506 Associated PubMed Articles listed on BioPortfolio]

Immunogenicity and Safety of the New Inactivated Quadrivalent Influenza Vaccine Vaxigrip Tetra: Preliminary Results in Children ≥6 Months and Older Adults.

Since the mid-1980s, two lineages of influenza B viruses have been distinguished. These can co-circulate, limiting the protection provided by inactivated trivalent influenza vaccines (TIVs). This has ...

Immunogenicity and Reactogenicity of High- Versus Standard-Dose Trivalent Inactivated Influenza Vaccine in Healthcare Workers: a Pilot Randomized Controlled Trial.

To compare immunogenicity, reactogenicity and acceptability of high- and standard-dose trivalent inactivated influenza vaccine (HDTIV, SDTIV) in 18-64 year olds.

Moderate influenza vaccine effectiveness against influenza A(H1N1)pdm09 virus and low effectiveness against A(H3N2) virus among older adults during 2013-2014 influenza season in Beijing, China.

Since 2007, trivalent inactivated influenza vaccine has been provided free-of-charge to older adults aged ≥60 years in Beijing, China, but the data regarding influenza vaccine effectiveness (VE) am...

Mouse strain and sex as determinants of immune response to trivalent influenza vaccine.

The study examined the influence of sex and mouse strain on germinal center (GC) reaction and antibody responses to seasonal split trivalent influenza vaccine (TIV).

A Systematic Review of Safety and Immunogenicity of Influenza Vaccination Strategies in Solid Organ Transplant Recipients.

Immunogenicity from seasonal inactivated influenza vaccine (IIV) remains suboptimal in solid organ transplant recipients (SOTR). We conducted a systematic review that compared the safety and immunogen...

Medical and Biotech [MESH] Definitions

Vaccines used to prevent infection by viruses in the family ORTHOMYXOVIRIDAE. It includes both killed or attenuated vaccines. The composition of the vaccines is changed each year in response to antigenic shifts and changes in prevalence of influenza virus strains. The vaccine is usually bivalent or trivalent, containing one or two INFLUENZAVIRUS A strains and one INFLUENZAVIRUS B strain.

Vaccines used to prevent POLIOMYELITIS. They include inactivated (POLIOVIRUS VACCINE, INACTIVATED) and oral vaccines (POLIOVIRUS VACCINE, ORAL).

A suspension of formalin-inactivated poliovirus grown in monkey kidney cell tissue culture and used to prevent POLIOMYELITIS.

A persistent progressive non-elevated red scaly or crusted plaque which is due to an intradermal carcinoma and is potentially malignant. Atypical squamous cells proliferate through the whole thickness of the epidermis. The lesions may occur anywhere on the skin surface or on mucosal surfaces. The cause most frequently found is trivalent arsenic compounds. Freezing, cauterization or diathermy coagulation is often effective. (From Rook et al., Textbook of Dermatology, 4th ed, pp2428-9)

A combined vaccine used to prevent infection with diphtheria and tetanus toxoid. This is used in place of DTP vaccine (DIPHTHERIA-TETANUS-PERTUSSIS VACCINE) when PERTUSSIS VACCINE is contraindicated.

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

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Clincial Trials
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...

Public Health
Alternative Medicine Cleft Palate Complementary & Alternative Medicine Congenital Diseases Dentistry Ear Nose & Throat Food Safety Geriatrics Healthcare Hearing Medical Devices MRSA Muscular Dyst...

Pediatrics
Pediatrics is the general medicine of childhood. Because of the developmental processes (psychological and physical) of childhood, the involvement of parents, and the social management of conditions at home and at school, pediatrics is a specialty. With ...


Searches Linking to this Trial