Comparison of Flu Vaccine Doses in Children

NCT01164553 | Completed Phase 1

• 2 other identifiers: 09-0018N01AI80006C
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to evaluate the possibility that giving an increased dose of flu vaccine to children 6 through 35 months of age will improve protection against influenza without increasing side effects. Investigators will evaluate the body's response to the vaccine. Male and female participants' ages 6-35 months, who have never received flu vaccine, and those ages 12-35 months, who have been previously vaccinated, will participate in the study for about 7 months. Vaccine naïve study participants will receive two doses of flu vaccine, either the 0.25 mL dose (Group 1) or 0.5 mL dose (Group 2). Previously vaccinated subjects will receive one dose of flu vaccine, either the 0.25 mL dose (Group 1) or 0.5 mL dose (Group 2). Study procedures include physical examination, memory aids, blood sampling and a follow-up phone call about 6 months after the last vaccine dose.

Conditions

Influenza

Keywords

influenza, pediatric, vaccine

Outcome Measures

Primary Outcomes (2)

• Incidence of local and systemic side effects in children receiving the standard dose (0.25ml) or increased dose (0.5 ml) of Trivalent Inactivated Influenza Vaccine.

  In the week after each vaccination.

• Incidence of adverse events in children receiving the standard dose (0.25ml) or increased dose (0.5 ml) of Trivalent Inactivated Influenza Vaccine (TIV).

  In the 4 weeks after each vaccination.

Secondary Outcomes (2)

• Percent of children who develop hemagglutinin inhibition (HAI) antibody titers greater than or equal to 1:40 (presumed protective titers) and the percent with 4-fold rises.

  Approximately 30 days after one or two standard (0.25 ml) or increased (0.5 ml) doses of Trivalent Inactivated Influenza Vaccine (TIV) in fully primed and naive children.

• Geometric mean titer (GMT) of the hemagglutinin inhibition (HAI) antibody responses to each of the components of the Trivalent Inactivated Influenza Vaccine (TIV).

  Approximately 30 days after one or two standard (0.25 ml) or increased (0.5 ml) doses of Trivalent Inactivated Influenza Vaccine in fully primed and naïve children.

Study Arms (2)

Group 2, 0.5 mL TIV

EXPERIMENTAL

Naive cohort participants (n=180) receive 0.25 mLTrivalent Inactivated Vaccine (TIV) in two intramuscular doses 28-42 days apart. Fully Primed cohort participants (previously vaccinated) (n=40) will receive 0.5 mL Trivalent Inactivated Influenza Vaccine (TIV) in one intramuscular dose.

Biological: Trivalent Inactivated Influenza Vaccine

Group 1, 0.25 mL TIV

ACTIVE COMPARATOR

Naive cohort participants (n=90) receive 0.25 mLTrivalent Inactivated Vaccine (TIV) in two intramuscular doses 28-42 days apart. Fully Primed cohort participants (previously vaccinated) (n=20) will receive 0.25 mL Trivalent Inactivated Influenza Vaccine (TIV) in one intramuscular dose

Biological: Trivalent Inactivated Influenza Vaccine

Interventions

Trivalent Inactivated Influenza Vaccine BIOLOGICAL

Either a standard pediatric dose (0.25 ml) or a larger dose (0.5 ml) of Trivalent Inactivated Influenza Vaccine (TIV) (Fluzone®) administered intramuscularly (IM) in the thigh with a 25 gauge 1 inch needle. Naive cohort (enrolled over two influenza seasons (2010-11 and 2011-12)) will receive vaccine in two IM doses 28-42 days apart, Fully Primed cohort (enrolled in one influenza season (2010-11)) will receive vaccine in one IM dose.

Group 1, 0.25 mL TIV; Group 2, 0.5 mL TIV

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All Subjects
• Healthy children 6-35 months of age (naïve cohort) or 12-35 months of age (fully primed cohort)
• Free of obvious health problems as established by medical history and clinical examination before entering the study
• Parent/legal guardian willing and capable of signing written informed consent
• Parent/legal guardian expected to be available for entire study
• Parent/legal guardian can be reached by telephone
• Fully Primed Cohort
• Have received two doses of 2009-2010 H1N1 and two doses of trivalent inactivated influenza vaccine (TIV) at anytime in the past as defined for the purpose of this study.

You may not qualify if:

• All Subjects:
• Have known allergy to eggs or other components of the vaccine. \*Refer to the Fluzone package insert for a list of vaccine components.
• Known or suspected latex allergy.
• Former premature infants (\<32 weeks).
• History of bronchodilator use more than 2 times per week within 28 days of vaccination.
• Significant underlying chronic illness (e.g., congenital heart disease, bronchopulmonary dysplasia).
• Immunodeficiency disease or use of immunosuppressive therapy by the participant, including perinatal exposure to or infection with human immunodeficiency virus (HIV), or known infection with hepatitis B or hepatitis C.
• Any other condition that, in the clinical judgment of the investigator, may interfere with vaccine evaluation. Children receiving antibiotics are eligible for enrollment.
• Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids (\>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed.)
• Previous, exposure to an investigational drug or investigational vaccine within 28 days prior to vaccination in this trial.
• Plans for participation in another clinical trial with an investigational drug or investigational vaccine for the duration of this study.
• History of Guillain-Barré syndrome or any other neuromuscular disease.
• History of seizures (including febrile seizures).
• Naïve Cohort:
• Any prior influenza vaccination.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (7)

Emory Children's Center - Pediatric Infectious Diseases

Atlanta, Georgia, 30322-1014, United States

Location

Emory University School of Medicine - Emory Children's Center - Pediatric Infectious Diseases

Atlanta, Georgia, 30322, United States

Location

University of Iowa - Infectious Disease Clinic

Iowa City, Iowa, 52242-1009, United States

Location

University of Maryland School of Medicine - Center for Vaccine Development - Baltimore

Baltimore, Maryland, 21201-1509, United States

Location

Saint Louis University - Center for Vaccine Development

St Louis, Missouri, 63104-1015, United States

Location

Cincinnati Children's Hospital Medical Center - Infectious Diseases

Cincinnati, Ohio, 45231, United States

Location

Vanderbilt University - Pediatric - Infectious Diseases

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 16, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 29, 2013

Record last verified: 2012-10

Locations

US (7)