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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT00158665
First received: September 8, 2005
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Influenza
Biological: 2 0.5 ml doses of '04-05 Trivalent Influenza Vaccine

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Group Health Cooperative:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Enrollment: 280
Study Start Date: August 2004
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   5 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158665

Locations
United States, Washington
Group Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Group Health Cooperative
Investigators
Principal Investigator: Lisa A Jackson, MD, MPH Group Health Cooperative
  More Information

Publications:
Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT00158665     History of Changes
Other Study ID Numbers: CDC Protocol 4258, VSD contract #200-2002-00732
Study First Received: September 8, 2005
Last Updated: February 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Group Health Cooperative:
Influenza
Vaccination
Immunization
Flu
Immunogenicity

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 20, 2014