Duchenne Muscular DystrophyPhase 4NCT01422200
Flu Vaccine Study in Neuromuscular Patients 2011
A Phase 4 study testing 2011-2012 seasonal flu vaccine Subcutaneous and 2011-2012 seasonal flu vaccine Intramuscular in people with Duchenne Muscular Dystrophy and Spinal Muscular Atrophy, run by Children's Hospital Medical Center, Cincinnati.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 35 years
- Conditions the study is for
- Duchenne Muscular Dystrophy, Spinal Muscular Atrophy, Congenital Muscular Dystrophy
- What is being tested?
- 2011-2012 seasonal flu vaccine Subcutaneous and 2011-2012 seasonal flu vaccine Intramuscular
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to May 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Comparison of the Immunogenicity of Intramuscular Versus Subcutaneous Administration of Trivalent Inactivated Influenza Vaccine in Individuals With Neuromuscular Diseases
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.
Read the detailed description
Individuals with neuromuscular diseases are more prone to influenza-related morbidity. Vaccination is the most effective measure to reduce the influenza disease burden. In the United States, the recommended route of administration for the inactivated influenza vaccine is intramuscular. In other countries, the subcutaneous, deep subcutaneous, and intramuscular routes are all considered acceptable for influenza vaccine administration. The United States CDC states that subcutaneous influenza vaccine doses, provided they are age-appropriate, may be counted as valid.
Those with neuromuscular diseases have muscle fibrosis that may potentially make intramuscular vaccines more effective. Those with Duchenne muscular dystrophy receive systemic corticosteroids to reduce inflammation. Corticosteroids may suppress antibody responses to vaccines. The goal of this research study is to evaluate the immunogenicity and safety of intramuscular and subcutaneous administration of inactivated influenza vaccine in individuals with neuromuscular diseases. This is a single site, open-label, randomized study. At the first visit, a blood sample was collected prior to vaccination. Each subject received either an intramuscular or subcutaneous vaccine administered in the anterolateral aspect of the thigh. Within 30 minutes of vaccination, subjects rated pain at the injection site using a numeric pain scale (0-10). Subjects and their caregivers were also asked to record local and systemic adverse events on diary sheets from day 0 to day 4 after vaccination. Subjects were instructed to notify the study staff by telephone should they develop any serious adverse reactions following vaccination. At a second study visit approximately 28 days later, a repeat blood sample was obtained. The blood samples obtained pre-vaccination and also at day 28 were tested for hemagglutination inhibition (HI) titers to the three influenza vaccine strains. rovider's office. The geometric mean titer ratios for each of the three vaccine strains were calculated as the ratios of postvaccination to prevaccination titers at geometric mean scale.
- Being tested
- 2011-2012 seasonal flu vaccine Subcutaneous, 2011-2012 seasonal flu vaccine Intramuscular
- Keywords
- DMD, SMA, CMD, flu vaccine
- Medical subject headings
- Muscular Dystrophy, Duchenne, Muscular Atrophy, Spinal, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2011-2012 seasonal flu vaccine SubcutaneousBiological
Also called fluzone
2011-2012 seasonal flu vaccine IntramuscularBiological
Also called fluzone
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous | Experimental | 0.5 mL of Fluzone (2011-2012 Northern Hemisphere formulation) influenza vaccine administered via subcutaneous route once Receives: 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 Receives: Biological: 2011-2012 seasonal flu vaccine Intramuscular |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: immediately before vaccination and 21-28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Duchenne Muscular DystrophyStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brenda Wong, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422200
- Sponsor's protocol ID
- 2010-2319
- Status last verified
- Sep 2020
- First submitted
- 22 Aug 2011
- Last updated
- 19 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Immunogenicity of Intramuscular Versus Subcutaneous Administration of Trivalent Inactivated Influenza Vaccine in Individuals With Neuromuscular Diseases
- ClinicalTrials.gov ID
- NCT01422200
- Acronym / sponsor ID
- 2010-2319
- Keywords
- DMD, SMA, CMD, flu vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 23 Aug 2011 (estimated)
- Results
- Posted 19 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Individuals with neuromuscular diseases are more prone to influenza-related morbidity. Vaccination is the most effective measure to reduce the influenza disease burden. In the United States, the recommended route of administration for the inactivated influenza vaccine is intramuscular. In other countries, the subcutaneous, deep subcutaneous, and intramuscular routes are all considered acceptable for influenza vaccine administration. The United States CDC states that subcutaneous influenza vaccine doses, provided they are age-appropriate, may be counted as valid.
Those with neuromuscular diseases have muscle fibrosis that may potentially make intramuscular vaccines more effective. Those with Duchenne muscular dystrophy receive systemic corticosteroids to reduce inflammation. Corticosteroids may suppress antibody responses to vaccines. The goal of this research study is to evaluate the immunogenicity and safety of intramuscular and subcutaneous administration of inactivated influenza vaccine in individuals with neuromuscular diseases. This is a single site, open-label, randomized study. At the first visit, a blood sample was collected prior to vaccination. Each subject received either an intramuscular or subcutaneous vaccine administered in the anterolateral aspect of the thigh. Within 30 minutes of vaccination, subjects rated pain at the injection site using a numeric pain scale (0-10). Subjects and their caregivers were also asked to record local and systemic adverse events on diary sheets from day 0 to day 4 after vaccination. Subjects were instructed to notify the study staff by telephone should they develop any serious adverse reactions following vaccination. At a second study visit approximately 28 days later, a repeat blood sample was obtained. The blood samples obtained pre-vaccination and also at day 28 were tested for hemagglutination inhibition (HI) titers to the three influenza vaccine strains. rovider's office. The geometric mean titer ratios for each of the three vaccine strains were calculated as the ratios of postvaccination to prevaccination titers at geometric mean scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous | Experimental | Biological: 2011-2012 seasonal flu vaccine Subcutaneous0.5 mL of Fluzone (2011-2012 Northern Hemisphere formulation) influenza vaccine administered via subcutaneous route once |
| Intramuscular | Active comparator | Biological: 2011-2012 seasonal flu vaccine Intramuscular0.5 mL of Fluzone (2011-2012 Northern Hemisphere formulation) influenza vaccine administered via intramuscular route once |
Who may qualify
- Ages
- 3 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2011-2012 seasonal flu vaccine SubcutaneousAlso: fluzone | Biological | Subcutaneous |
| 2011-2012 seasonal flu vaccine IntramuscularAlso: fluzone | Biological | Intramuscular |
Primary outcome
Geometric Mean Titer Ratio for Each Vaccine Strain
Time frame: immediately before vaccination and 21-28 days after vaccination
Serum HI antibody titers for each vaccine strain immediately prior to study vaccine receipt and 21-28 days after study vaccine receipt
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brenda Wong, MD principal investigator
Children's Hospital Medical Center, Cincinnati
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 2011-2012 seasonal flu vaccine Subcutaneous and 2011-2012 seasonal flu vaccine Intramuscular in people with Duchenne Muscular Dystrophy and Spinal Muscular Atrophy, run by Children's Hospital Medical Center, Cincinnati.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Titer Ratio for Each Vaccine Strain (time frame: immediately before vaccination and 21-28 days after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.