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

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.

Conditions

• Influenza

Interventions

BIOLOGICAL

Vaxigrip® trivalent inactivated influenza vaccine

See full description elsewhere in this record.

DEVICE

Intradermal spacer on Biojector® 2000 jet injector

See elsewhere in this record for full description.

Sponsors & Collaborators

• Fundación Dominicana de Infectología, Santo Domingo, Dominican Republic

  collaborator UNKNOWN

• Hospital Infantil Dr. Robert Reid Cabral

  collaborator OTHER

• World Health Organization

  collaborator OTHER

• Pan American Health Organization

  collaborator OTHER

• PATH

  collaborator OTHER

• Bioject Medical Technologies, Inc.

  collaborator INDUSTRY

• MCM Vaccines B.V.

  collaborator INDUSTRY

• Pedro Moro

  lead FED

Principal Investigators

• Bruce G Weniger, MD, MPH · CDC ([email protected]) ([email protected] obsolete by 2021).com)

• Virgen Gómez, MD · Hospital Infantíl Dr. Robert Reid Cabral

• Jesús M Feris Iglesias, MD · Hospital Infantíl Dr. Robert Reid Cabral

• Josefina Fernández, MD · Hospital Infantíl Dr. Robert Reid Cabral

• Pedro Moro, MD, MPH · Immunization Safety Office, Centers for Disease Control and Prevention

• Martin Friede, PhD · Initiative for Vaccine Research, World Health Organization

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Months

Max Age

24 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2006-10-31

Primary Completion

2009-11-30

Completion

2010-05-31

Countries

• Dominican Republic

Study Locations