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

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: 2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine

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.

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98101
      • Group Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects receiving vaccine; 2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine 4 weeks apart.	Biological: 2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine; 2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of antibody response after 1 dose of influenza vaccine with that after 2 doses of influenza vaccine.	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 Measures

Outcome Measure	Time Frame
To describe and compare the safety profile after 1 and 2 doses of vaccine.	Study diaries were kept from the day of vaccination daily for the 4 days after vaccination.

Collaborators and Investigators

• Sponsor: Kaiser Permanente
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Lisa A Jackson, MD, MPH, Kaiser Permanente

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2004
• Primary Completion (Actual): December 1, 2004
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: September 8, 2005
• First Submitted That Met QC Criteria: September 11, 2005
• First Posted (Estimate): September 12, 2005

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 11, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Influenza; Immunogenicity; Vaccination; Flu; Immunization
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: CDC Protocol 4258; VSD contract #200-2002-00732 (Other Grant/Funding Number: Centers for Disease Control and Prevention)