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

NCT ID: NCT00158665

Last Updated: 2017-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2004-12-31

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.

Conditions

Influenza

Keywords

Influenza; Vaccination; Immunization; Flu; Immunogenicity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Subjects receiving vaccine

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

Group Type: EXPERIMENTAL

2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine

Intervention Type: BIOLOGICAL

2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine

Interventions

2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine

2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine

Intervention Type: BIOLOGICAL

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.

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa A Jackson, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Kaiser Permanente

Locations

Group Health Research Institute

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 16991077 (View on PubMed)

Other Identifiers

VSD contract #200-2002-00732

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CDC Protocol 4258

Identifier Type: -

Identifier Source: org_study_id