search
Back to results

A Comparison of One Versus Two Doses of Influenza Vaccine in Children 5-8 Years of Age

Primary Purpose

Influenza

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Vaccination, Immunization, Flu, Immunogenicity

Eligibility Criteria

5 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Immunocompetent children who are at least 5 and no more than 8 years of age on the date of the first vaccination. Parents able to give informed consent and child available for all study visits. Family able to understand and comply with planned study procedures. Family must have telephone accessibility. Exclusion Criteria: Previous receipt of influenza vaccine of any kind (shot or nasal spray). Active cancer or blood system abnormalities such as leukemia. Immunocompromising illnesses or current receipt of immunosuppressive agents Allergy to eggs or egg protein, or to gentamicin (an antibiotic that is present in trace amounts in the vaccine). Any acute or chronic condition that (in the opinion of the investigator) would render vaccination unsafe or would interfere with the evaluation of responses. Temporary Exclusion Criteria: Acute disease, defined as the presence of moderate or severe illness with or without fever, at the time of enrollment. Influenza vaccine may be administered to children with minor illnesses, such as diarrhea, mild upper respiratory infection and low-grade febrile illness with an oral temperature <100.4 F.

Sites / Locations

  • Group Health Research Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subjects receiving vaccine

Arm Description

2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine 4 weeks apart.

Outcomes

Primary Outcome Measures

Comparison of antibody response after 1 dose of influenza vaccine with that after 2 doses of influenza vaccine.

Secondary Outcome Measures

To describe and compare the safety profile after 1 and 2 doses of vaccine.

Full Information

First Posted
September 8, 2005
Last Updated
October 11, 2017
Sponsor
Kaiser Permanente
Collaborators
Centers for Disease Control and Prevention
search

1. Study Identification

Unique Protocol Identification Number
NCT00158665
Brief Title
A Comparison of One Versus Two Doses of Influenza Vaccine in Children 5-8 Years of Age
Official Title
A Comparison of One Versus Two Doses of Influenza Vaccine in Children Aged 5-8 Years of Age Receiving Influenza Vaccine for the First Time
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study was to find out if children 5 through 8 years of age who are getting influenza vaccine for the first time should get one or two doses.
Detailed Description
Currently, two doses of influenza vaccine are recommended for children younger than 9 years receiving influenza vaccine for the first time. While the scientific support for 2 doses of vaccine in infants and toddlers is sound, the need for 2 doses of vaccine for adequate immunogenicity in older children is less certain. If the immunogenicity of a one-dose vaccine regimen is comparable to a two-dose regimen, then one dose would be preferable for reasons of safety, practicality and economics, and would reduce a major barrier to vaccination in this injection-adverse age group. This study compared the immunogenicity and reactogenicity of one versus two doses of influenza vaccine in children aged 5 to 8 years old receiving influenza vaccine for the first time. All children enrolled in the study received two doses of vaccine, and the immune response after one dose of vaccine was compared to the immune response after two doses of vaccine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Vaccination, Immunization, Flu, Immunogenicity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subjects receiving vaccine
Arm Type
Experimental
Arm Description
2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine 4 weeks apart.
Intervention Type
Biological
Intervention Name(s)
2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine
Intervention Description
2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine
Primary Outcome Measure Information:
Title
Comparison of antibody response after 1 dose of influenza vaccine with that after 2 doses of influenza vaccine.
Time Frame
Blood samples were obtained at 3 time points, before dose 1 of vaccine, 4 weeks after receipt of dose 1 and before dose 2, and 4 weeks after dose 2 of vaccine.
Secondary Outcome Measure Information:
Title
To describe and compare the safety profile after 1 and 2 doses of vaccine.
Time Frame
Study diaries were kept from the day of vaccination daily for the 4 days after vaccination.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Immunocompetent children who are at least 5 and no more than 8 years of age on the date of the first vaccination. Parents able to give informed consent and child available for all study visits. Family able to understand and comply with planned study procedures. Family must have telephone accessibility. Exclusion Criteria: Previous receipt of influenza vaccine of any kind (shot or nasal spray). Active cancer or blood system abnormalities such as leukemia. Immunocompromising illnesses or current receipt of immunosuppressive agents Allergy to eggs or egg protein, or to gentamicin (an antibiotic that is present in trace amounts in the vaccine). Any acute or chronic condition that (in the opinion of the investigator) would render vaccination unsafe or would interfere with the evaluation of responses. Temporary Exclusion Criteria: Acute disease, defined as the presence of moderate or severe illness with or without fever, at the time of enrollment. Influenza vaccine may be administered to children with minor illnesses, such as diarrhea, mild upper respiratory infection and low-grade febrile illness with an oral temperature <100.4 F.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa A Jackson, MD, MPH
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Group Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16991077
Citation
Neuzil KM, Jackson LA, Nelson J, Klimov A, Cox N, Bridges CB, Dunn J, DeStefano F, Shay D. Immunogenicity and reactogenicity of 1 versus 2 doses of trivalent inactivated influenza vaccine in vaccine-naive 5-8-year-old children. J Infect Dis. 2006 Oct 15;194(8):1032-9. doi: 10.1086/507309. Epub 2006 Sep 11.
Results Reference
result

Learn more about this trial

A Comparison of One Versus Two Doses of Influenza Vaccine in Children 5-8 Years of Age

We'll reach out to this number within 24 hrs