Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Two Different Influenza Vaccines in Healthy Children Aged 6 to <60 Months

A Phase II, Observer-Blind, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Investigational Vaccine and Active Influenza Vaccine in Healthy Children Aged 6 to <60 Months

This a multicenter phase II trial will evaluate safety and immunogenicity of two 0.25 mL or 0.5 mL doses of investigational influenza vaccine and active control influenza vaccine in healthy children aged 6 to <60 months.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Influenza Trivalent Inactivated vaccines Novartis; Biological: Influenza Trivalent Inactivated vaccines

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Phase 2

Contacts and Locations

Study Locations

• Guatemala
  • Guatemala City, Guatemala
    • Centro Clínico La Quinta
  • Guatemala City, Guatemala
    • Clínicas Dr. Rafael Montiel
  • Guatemala City, Guatemala
    • Dr. Carlos Fernando Grazioso Aragón
  • Guatemala City, Guatemala
    • Fundación Pediátrica Guatemalteca
  • Guatemala City, Guatemala
    • Hospital Infantil de Infectologia y rehabilitacion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children of 6 to <60 months of age, whose parents/legal guardians have given written informed consent prior to study entry.
• In good health as determined by: medical history, physical examination, clinical judgment of the investigator.
• Able to comply with all study procedure

Exclusion Criteria:

• Any serious disease, such as: cancer,autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic and renal disease, acute or progressive neurological or neuromuscular disease;
• History of any anaphylaxis or serious reaction following administration of vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, or any other vaccine component, chemically related substance, or component of the potential packaging materials;
• Known or suspected impairment/alteration of immune function, including: immunosuppressive therapy, cancer chemotherapy, receipt of immunostimulants within 60 days prior to Visit 1, receipt of parenteral immunoglobulin known HIV infection or HIV-related disease;
• Bleeding diathesis;
• Surgery planned during the study period;
• Receipt of another investigational agent within 90 days
• Laboratory-confirmed influenza disease within 6 months prior to Visit 1;
• Ever received two doses of an influenza vaccine before the study
• Receipt of an influenza vaccine within 6 months prior to Visit 1;
• Experienced a temperature 38.0°C within 3 days prior to Visit 1

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Biological: Influenza Trivalent Inactivated vaccines Novartis; Children 6 to <36 months of age will receive two 0.25 mL doses, and children 36 to <60 months of age will receive two 0.5 mL doses of investigational influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.
Active Comparator: 2	Biological: Influenza Trivalent Inactivated vaccines; Children 6 to <36 months of age will receive two 0.25 mL doses, and children 36 to <60 months of age will receive two 0.5 mL doses of active control influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the safety and tolerability of one and two doses of investigational vaccines or active control influenza vaccine in unprimed healthy children aged 6 months to <36 months.	211 days

Secondary Outcome Measures

Outcome Measure	Time Frame
To evaluate the immunogenicity of two doses of investigational influenza vaccine or active control influenza vaccines, as measured by HI assay in children aged 36 to <60 months.	211 days

Collaborators and Investigators

• Sponsor: Novartis
• Collaborators: Novartis Vaccines

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): October 1, 2008

Study Registration Dates

• First Submitted: March 25, 2008
• First Submitted That Met QC Criteria: March 27, 2008
• First Posted (Estimate): April 1, 2008

Study Record Updates

• Last Update Posted (Actual): April 7, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: vaccine; Influenza; children
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: V70P6