Flu Vaccine Study in Neuromuscular Patients 2011

NCT01422200 | Completed Phase 4 Results

• 1 other identifier: 2010-2319
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of the study is to compare the immune response of two different injection methods (Intramuscular V.S. Subcutaneous) of the 2011-2012 seasonal Influenza (Flu) vaccine among patients with neuromuscular conditions who have significant muscle degeneration. This research study hypothesizes that the subcutaneous route of vaccine administration, as compared to the intramuscular route, may confer at least comparable, or possibly better, immunogenicity. At least 30 individuals followed by the CCHMC Neuromuscular Comprehensive Care Center will be recruited to participate in this study lasting approximately one to two months with two clinic visits and one follow-up telephone call. Immunogenicity will be assessed by comparing hemagglutination inhibition (HI) antibody titers obtained pre- and post-vaccination.

Conditions

Duchenne Muscular Dystrophy; Spinal Muscular Atrophy; Congenital Muscular Dystrophy

Keywords

DMD; SMA; CMD; flu vaccine

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Titer Ratio for Each Vaccine Strain

  Serum HI antibody titers for each vaccine strain immediately prior to study vaccine receipt and 21-28 days after study vaccine receipt

  immediately before vaccination and 21-28 days after vaccination

Other Outcomes (1)

• Safety: Summary of Local and Systemic Reactogenicity Symptoms

  4 days following receipt of study vaccine

Study Arms (2)

Subcutaneous

EXPERIMENTAL

0.5 mL of Fluzone (2011-2012 Northern Hemisphere formulation) influenza vaccine administered via subcutaneous route once

Biological: 2011-2012 seasonal flu vaccine Subcutaneous

Intramuscular

ACTIVE COMPARATOR

0.5 mL of Fluzone (2011-2012 Northern Hemisphere formulation) influenza vaccine administered via intramuscular route once

Biological: 2011-2012 seasonal flu vaccine Intramuscular

Interventions

2011-2012 seasonal flu vaccine Subcutaneous BIOLOGICAL

Also known as: fluzone

Subcutaneous

2011-2012 seasonal flu vaccine Intramuscular BIOLOGICAL

Also known as: fluzone

Intramuscular

Eligibility Criteria

• Age: 3 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Non-ambulatory;
• Quadriceps muscle strength of MRC (Medical Research Council Scale) grade 3 or below
• Any subject who is between 3 to 8 years of age must have received at least two doses of influenza vaccine last season or at least one dose tow or more years ago.

You may not qualify if:

• Subject must not have a history of severe reactions following previous immunization with influenza vaccine.
• Subject must not have previously received a 2011-2012 influenza vaccine.
• Subject must not have a history of Guillain-Barre syndrome.
• Subject must not have received a live viral vaccine (i.e., MMR, varicella) within 28 days prior to receipt of the study vaccine.
• Subject must not have any condition that the investigator believes would render vaccination unsafe or interfere with successful completion of the study.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Muscular Atrophy, Spinal; Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Spinal Cord Diseases; Central Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

Small sample size as a pilot study

Results Point of Contact

• Title: Dr. Brenda Wong
• Organization: Cincinnati Children's Hospital Medical Center

brenda.wong@cchmc.org

5136364222

Study Officials

• Brenda Wong, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participant, care provider, and investigator are not masked. The outcomes assessor (personnel determining the HI titers) is masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2011
• First Posted: August 23, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: May 1, 2012
• Last Updated: October 19, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-09