Influenza Virus InfectionPhase 4NCT00981513
Direct and Indirect Benefits of Influenza Vaccination in Schools and Households
A Phase 4 study testing Trivalent live attenuated seasonal influenza vaccine, Monovalent live attenuated pandemic influenza vaccine and Saline in people with Influenza Virus Infection and Influenza-like Illness, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The purpose of this study is to determine the degree of indirect benefits to family members and classmates resulting from administration of influenza vaccine to children. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Influenza Virus Infection, Influenza-like Illness, Acute Respiratory Infection
- What is being tested?
- Trivalent live attenuated seasonal influenza vaccine, Monovalent live attenuated pandemic influenza vaccine and Saline
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6,300 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2009to Nov 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Hong Kong residents aged between 7 and 11 and their family members.
Who cannot join
- Children with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin, or arginine or with life-threatening reactions to previous influenza vaccinations.
- Children receiving aspirin therapy or aspirin-containing therapy.
- Children with asthma or active wheezing.
- Children or family members with underlying immunocompromised condition or receiving immunosuppressive agents.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the degree of indirect benefits to family members and classmates resulting from administration of influenza vaccine to children.
- Being tested
- Trivalent live attenuated seasonal influenza vaccine, Monovalent live attenuated pandemic influenza vaccine, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent live attenuated seasonal influenza vaccineBiological
Also called FluMist, MedImmune Vaccines, Inc.
One dose
Monovalent live attenuated pandemic influenza vaccineBiological
Also called FluMist Novel H1N1, MedImmune Vaccines, Inc.
One dose
SalineBiological
Also called Saline nasal spray
One dose
| Study group | Role | What they receive |
|---|---|---|
| Influenza vaccination | Active comparator | Live attenuated influenza vaccine (seasonal and pandemic strains) by nasal spray Receives: Biological: Trivalent live attenuated seasonal influenza vaccine; Biological: Monovalent live attenuated pandemic influenza vaccine |
| Saline placebo | Placebo comparator | Saline nasal spray Receives: Biological: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical influenza by self-reported symptoms, specifically defined as at least two of fever ≥37.8ºC, cough, headache, sore throat, aches or pains in muscles or joints
Measured: One year
Influenza virus infection confirmed by RT-PCR
Measured: One year
Secondary outcomes (2)
Influenza virus infection during the follow-up period assessed by four-fold or greater rise in paired serology.
Measured: One year
Adverse events following vaccination
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza Virus InfectionStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 6,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Benjamin J Cowling, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981513
- Sponsor's protocol ID
- BJC004.6
- Status last verified
- Aug 2011
- First submitted
- 20 Sep 2009
- Last updated
- 19 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct and Indirect Benefits of Influenza Vaccination in Schools and Households
- ClinicalTrials.gov ID
- NCT00981513
- Acronym / sponsor ID
- BJC004.6
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,300 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Not posted in the source record
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 this study is to determine the degree of indirect benefits to family members and classmates resulting from administration of influenza vaccine to children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccination | Active comparator | Biological: Trivalent live attenuated seasonal influenza vaccine, Biological: Monovalent live attenuated pandemic influenza vaccineLive attenuated influenza vaccine (seasonal and pandemic strains) by nasal spray |
| Saline placebo | Placebo comparator | Biological: SalineSaline nasal spray |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Hong Kong residents aged between 7 and 11 and their family members.
Key exclusion criteria (4 listed)
- Children with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin, or arginine or with life-threatening reactions to previous influenza vaccinations.
- Children receiving aspirin therapy or aspirin-containing therapy.
- Children with asthma or active wheezing.
- Children or family members with underlying immunocompromised condition or receiving immunosuppressive agents.
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 |
|---|---|---|
| Trivalent live attenuated seasonal influenza vaccineAlso: FluMist, MedImmune Vaccines, Inc.One dose | Biological | Influenza vaccination |
| Monovalent live attenuated pandemic influenza vaccineAlso: FluMist Novel H1N1, MedImmune Vaccines, Inc.One dose | Biological | Influenza vaccination |
| SalineAlso: Saline nasal sprayOne dose | Biological | Saline placebo |
Primary outcome
Clinical influenza by self-reported symptoms, specifically defined as at least two of fever ≥37.8ºC, cough, headache, sore throat, aches or pains in muscles or joints
Time frame: One year
Influenza virus infection confirmed by RT-PCR
Time frame: One year
2 secondary outcomes
Influenza virus infection during the follow-up period assessed by four-fold or greater rise in paired serology.
Time frame: One year
Adverse events following vaccination
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2011.
Related trials for Influenza Virus Infection
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
Benjamin J Cowling, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trivalent live attenuated seasonal influenza vaccine, Monovalent live attenuated pandemic influenza vaccine and Saline in people with Influenza Virus Infection and Influenza-like Illness, run by The University of Hong Kong at 1 site in Hong Kong.
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 1 inclusion and 4 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 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical influenza by self-reported symptoms, specifically defined as at least two of fever ≥37.8ºC, cough, headache, sore throat, aches or pains in muscles or joints (time frame: One year). The study lists 2 primary outcomes in all. 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 Aug 2011.