Open-Label Study of H5 Vaccine in Participants of Protocol 04-077

NCT00402649 | Completed Phase 1 Results

• 1 other identifier: 06-0072
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 3

Brief Summary

This study may provide safety information on a flu vaccine given to children and may provide immunogenicity information to add to what was collected in a previous flu vaccine study. Participants will include 55 healthy children, ages 2-10, who participated in 04-077 and received a placebo injection instead of the flu vaccine or were incompletely immunized. The study has 2 purposes: to make sure there are no serious side effects in children and to see how the immune systems react to the vaccine. Study procedures include up to 4 study visits, up to 9 follow-up phone calls, 2 blood samples to be collected during visits 1 and 3, and up to 3 vaccine injections in the arm or thigh muscle. Parents will be given a memory aid card to record side effects, temperatures, and medications. Parents will have the option for the child to receive a 3rd dose of vaccine if offered, at month 6. This booster shot will require a 6-month visit and participation for an additional 6 months.

Conditions

Influenza

Keywords

influenza, A/H5N1, avian influenza, vaccine

Outcome Measures

Primary Outcomes (4)

• Occurrence of Solicited Adverse Events Among All Subjects

  Number of subjects reporting solicited Adverse Events collected on Memory Aid for Days 0-7 post each vaccination for all subjects (systematic assessment), for any and severe severities.

  Days 0-7 post each vaccination

• Occurrence of the Solicited Adverse Event of Body Aches, Solicited Only From Children Age 6-10

  Number of subjects reporting solicited Adverse Event of Body Aches, collected on Memory Aid for Days 0-7 post each vaccination for children age 6-10 only (systematic assessment), of any and severe severities.

  Days 0-7 post each vaccination

• Occurrence of Unsolicited Adverse Events

  Number of subjects with spontaneous reports of Adverse Events of any and severe severities. Events reported by more than 5.6% of subjects in any group are reported by MedDRA Preferred Term.

  Through Day 28 after second vaccination

• Occurrence of Serious Adverse Events

  Number of subjects with Serious Adverse Events during the 6 months after the first vaccination.

  6 months after the first vaccination

Secondary Outcomes (3)

• Number of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Titers of 1:40 or Greater

  Day 28 after second vaccination

• Geometric Mean Titer of Hemagglutination Inhibition Antibody Titers

  Day 28 after second vaccination

• Number of Participants With a Four-fold or Greater Increase in Hemagglutination Inhibition Antibody Titers

  Day 28 after second vaccination

Study Arms (1)

1

EXPERIMENTAL

All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.

Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)

Interventions

Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) BIOLOGICAL

Inactivated influenza A/H5N1 vaccine administered via intramuscular (IM) injection; dosage 45-mcg.

1

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The subject must be male or female, aged 2 through 10 years at enrollment, and must have participated in protocol 04-077 as a placebo recipient or a subject at the UCLA site.
• The subject must be in good health (and not on any chronic medications), as determined by medical history and a history-directed targeted physical examination.
• Parents or guardians of the subject must be able to understand and comply with planned study procedures and be available for all study visits.
• Parents or guardians of the subject must provide written consent prior to initiation of any study procedures, and subject may provide written assent as appropriate.

You may not qualify if:

• The subject must not have a known allergy to eggs or other components of the vaccine or sensitivity or allergy to latex.
• The subject must not have a history of asthma or recurrent wheezing.
• The subject must not be undergoing immunosuppression as a result of an underlying illness or treatment.
• The subject must not have an active neoplastic disease or a history of any hematologic malignancy.
• The subject must not be using oral or parenteral steroids, inhaled steroids, or other immunosuppressive or cytotoxic drugs. Note: Subjects on nasal or topical steroids will be allowed to enroll in this study.
• The subject must not have a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
• The subject must not receive any other inactivated vaccines within 2 weeks before or after any study vaccine or any other live vaccines within 4 weeks before or after any study vaccine in this study.
• The subject must not have an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (these conditions include, but are not limited to, known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
• The subject must not have a history of severe reactions following immunization with contemporary influenza virus vaccines.
• The subject must not have an acute illness, including an axillary temperature greater than or equal to 100 degrees F or an oral temperature greater than or equal to 101 degrees F within 3 days prior to vaccination.
• The subject must not have received an experimental vaccine or medication within 1 month prior to enrollment in this study, or expect to receive an experimental vaccine, medication, or blood product during the 13-month study period.
• The subject must not have any condition that would, in the opinion of the investigator, place them at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
• The subject must not have a history of Guillain-Barré syndrome.
• The subject must not be participating concurrently in another clinical trial aside from DMID 04-077 (either in active phase or in follow-up phase).

Sponsors & Collaborators

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

Study Sites (3)

UCLA Center For Vaccine Research

Torrance, California, 90502, United States

Location

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

MeSH Terms

Conditions

Influenza, Human; Influenza in Birds

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Ina Stephens, MD
• Organization: University of Maryland Center for Vaccine Development

istephen@medicine.umaryland.edu

410-706-1123

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 21, 2006
• First Posted: November 22, 2006
• Study Start: February 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: December 1, 2007
• Last Updated: June 13, 2011
• Results First Posted: November 24, 2008

Record last verified: 2008-05

Locations

US (3)