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

NCT00158665 | Completed

• 2 other identifiers: CDC Protocol 4258VSD contract #200-2002-00732
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

Influenza; Vaccination; Immunization; Flu; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (1)

Subjects receiving vaccine

EXPERIMENTAL

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

Interventions

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

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

Subjects receiving vaccine

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kaiser Permanente: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

Group Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (1)

• 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.

  PMID: 16991077 RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Lisa A Jackson, MD, MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: August 1, 2004
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: October 13, 2017

Record last verified: 2017-10

Locations

US (1)