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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

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
Guatemala
Study Type
Interventional
Intervention
Influenza Trivalent Inactivated vaccines Novartis
Influenza Trivalent Inactivated vaccines
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, vaccine, children

Eligibility Criteria

6 Months - 59 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 25, 2008
Last Updated
April 5, 2017
Sponsor
Novartis
Collaborators
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT00649883
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
Collaborators
Novartis Vaccines

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, vaccine, children

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Influenza Trivalent Inactivated vaccines Novartis
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Influenza Trivalent Inactivated vaccines
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
211 days
Secondary Outcome Measure Information:
Title
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.
Time Frame
211 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Centro Clínico La Quinta
City
Guatemala City
Country
Guatemala
Facility Name
Clínicas Dr. Rafael Montiel
City
Guatemala City
Country
Guatemala
Facility Name
Dr. Carlos Fernando Grazioso Aragón
City
Guatemala City
Country
Guatemala
Facility Name
Fundación Pediátrica Guatemalteca
City
Guatemala City
Country
Guatemala
Facility Name
Hospital Infantil de Infectologia y rehabilitacion
City
Guatemala City
Country
Guatemala

12. IPD Sharing Statement

Learn more about this trial

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

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