Influenza Virus InfectionNCT00792051
Direct and Indirect Benefits of Influenza Vaccine Versus Placebo in Healthy Children
A study testing Inactivated influenza vaccine and Saline in people with Influenza Virus Infection, run by The University of Hong Kong at 1 site in China.
Trial summary
While immunisation of school-age children against influenza is not recommended in Hong Kong, past experience in Japan and elsewhere suggests that immunisation of children may protect the wider community through its indirect transmission-limiting impact as well as the direct immunologic protection afforded vaccinated… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Influenza Virus Infection
- What is being tested?
- Inactivated influenza vaccine and Saline
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,800 participants
- Where
- 1 siteChina
- Study dates
- Sep 2008to Dec 2010
- Phase
- Interventional
- 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
- All vaccinees must be Hong Kong residents aged between 6 and 17.
Who cannot join
- Vaccinees should not be allergic or hypersensitive to the active substances or components (eggs, chicken proteins, formaldehyde, neomycin, etc.) used in the vaccines or where vaccination is otherwise contraindicated. Subjects should not have an underlying immunocompromised condition or be receiving immunosuppressive agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of the Effectiveness of Vaccinating Children to Reduce Household Transmission of Influenza
While immunisation of school-age children against influenza is not recommended in Hong Kong, past experience in Japan and elsewhere suggests that immunisation of children may protect the wider community through its indirect transmission-limiting impact as well as the direct immunologic protection afforded vaccinated children themselves. We aim to assess whether vaccinating children against influenza protects vaccinees as well as their household contacts from infection.
Read the detailed description
Design and subjects: A double-blind randomised controlled trial of 800 subjects aged 6-17 drawn from the general population and their 2000 household contacts. The subjects will be randomised in a 3:2 ratio to the intervention and placebo groups, respectively. Serum samples will be collected from subjects pre- and 1 month post-vaccination, and after the influenza season. Serum samples will be collected from household contacts at baseline and at the end of the influenza season. During the follow-up period, subjects and household members will keep symptom diaries and those reporting influenza-like-illness will be offered free doctor consultations or home visits where we will arrange for collection of nose and throat swabs.
Study instruments: An antibody titre of ≥40 in the post-vaccine serum will be used to define seroprotection to those particular strains, while a four-fold or higher increase in antibody titres between baseline and end-of-season follow-up of the household contacts will define influenza infection during the season. Subjects and household contacts will be asked to keep symptom diaries, and during episodes of ILI we will collect nose and throat swabs for laboratory confirmation of influenza infection; the primary serology results will then be compared with clinical and laboratory-confirmed influenza episodes.
Interventions: 1 (intervention) inactivated influenza vaccine (Vaxigrip, Sanofi Pasteur); 2 (placebo) saline injection.
Main outcome measures: The proportions of subjects and household contacts with serology-confirmed influenza infection during follow-up among the 2 intervention arms.
Analysis: Intention to treat, adjusting for within-household correlation in influenza attack rates.
- Conditions
- Influenza Virus Infection
- Being tested
- Inactivated influenza vaccine, Saline
- Keywords
- influenza, vaccination, children, Influenza-like illness
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated influenza vaccineBiological
Also called VAXIGRIP®, Sanofi Pasteur
0.5ml intramuscular single dose
SalineBiological
0.5ml intramuscular, one dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Influenza vaccine Receives: Biological: Inactivated influenza vaccine |
| 2 | Placebo comparator | Not described Receives: Biological: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportions of subjects and household contacts with serology-confirmed influenza infection during follow-up among the 2 intervention arms.
Measured: nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 2,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Research Fund for the Control of Infectious Diseases, Research Grants Council, Hong Kong, Centre for Health Protection, Hong Kong
- Investigators
- Benjamin J Cowling, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792051
- Sponsor's protocol ID
- GML003.4
- Status last verified
- Dec 2014
- First submitted
- 13 Nov 2008
- Last updated
- 30 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cowling BJ, Ng S, Ma ES, Fang VJ, So HC, Wai W, Cheng CK, Wong JY, Chan KH, Ip DK, Chiu SS, Peiris JS, Leung GM. Protective efficacy against pandemic influenza of seasonal influenza vaccination in children in Hong Kong: a randomized controlled trial. Clin Infect Dis. 2012 Sep;55(5):695-702. doi: 10.1093/cid/cis518. Epub 2012 Jun 5.
PubMed 22670050Cowling BJ, Ng S, Ma ES, Cheng CK, Wai W, Fang VJ, Chan KH, Ip DK, Chiu SS, Peiris JS, Leung GM. Protective efficacy of seasonal influenza vaccination against seasonal and pandemic influenza virus infection during 2009 in Hong Kong. Clin Infect Dis. 2010 Dec 15;51(12):1370-9. doi: 10.1086/657311. Epub 2010 Nov 10.
PubMed 21067351Cowling BJ, Perera RA, Fang VJ, Chan KH, Wai W, So HC, Chu DK, Wong JY, Shiu EY, Ng S, Ip DK, Peiris JS, Leung GM. Incidence of influenza virus infections in children in Hong Kong in a 3-year randomized placebo-controlled vaccine study, 2009-2012. Clin Infect Dis. 2014 Aug 15;59(4):517-24. doi: 10.1093/cid/ciu356. Epub 2014 May 13.
PubMed 24825868
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of the Effectiveness of Vaccinating Children to Reduce Household Transmission of Influenza
- ClinicalTrials.gov ID
- NCT00792051
- Acronym / sponsor ID
- GML003.4
- Conditions
- Influenza Virus Infection
- Keywords
- influenza, vaccination, children, Influenza-like illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Research Fund for the Control of Infectious Diseases, Research Grants Council, Hong Kong, Centre for Health Protection, Hong Kong
- Study start
- Sep 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Nov 2008 (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.
While immunisation of school-age children against influenza is not recommended in Hong Kong, past experience in Japan and elsewhere suggests that immunisation of children may protect the wider community through its indirect transmission-limiting impact as well as the direct immunologic protection afforded vaccinated children themselves. We aim to assess whether vaccinating children against influenza protects vaccinees as well as their household contacts from infection.
Detailed description
Design and subjects: A double-blind randomised controlled trial of 800 subjects aged 6-17 drawn from the general population and their 2000 household contacts. The subjects will be randomised in a 3:2 ratio to the intervention and placebo groups, respectively. Serum samples will be collected from subjects pre- and 1 month post-vaccination, and after the influenza season. Serum samples will be collected from household contacts at baseline and at the end of the influenza season. During the follow-up period, subjects and household members will keep symptom diaries and those reporting influenza-like-illness will be offered free doctor consultations or home visits where we will arrange for collection of nose and throat swabs.
Study instruments: An antibody titre of ≥40 in the post-vaccine serum will be used to define seroprotection to those particular strains, while a four-fold or higher increase in antibody titres between baseline and end-of-season follow-up of the household contacts will define influenza infection during the season. Subjects and household contacts will be asked to keep symptom diaries, and during episodes of ILI we will collect nose and throat swabs for laboratory confirmation of influenza infection; the primary serology results will then be compared with clinical and laboratory-confirmed influenza episodes.
Interventions: 1 (intervention) inactivated influenza vaccine (Vaxigrip, Sanofi Pasteur); 2 (placebo) saline injection.
Main outcome measures: The proportions of subjects and household contacts with serology-confirmed influenza infection during follow-up among the 2 intervention arms.
Analysis: Intention to treat, adjusting for within-household correlation in influenza attack rates.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: Inactivated influenza vaccineInfluenza vaccine |
| 2 | Placebo comparator | Biological: Saline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All vaccinees must be Hong Kong residents aged between 6 and 17.
Key exclusion criteria (1 listed)
- Vaccinees should not be allergic or hypersensitive to the active substances or components (eggs, chicken proteins, formaldehyde, neomycin, etc.) used in the vaccines or where vaccination is otherwise contraindicated. Subjects should not have an underlying immunocompromised condition or be 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 |
|---|---|---|
| Inactivated influenza vaccineAlso: VAXIGRIP®, Sanofi Pasteur0.5ml intramuscular single dose | Biological | 1 |
| Saline0.5ml intramuscular, one dose | Biological | 2 |
Primary outcome
The proportions of subjects and household contacts with serology-confirmed influenza infection during follow-up among the 2 intervention arms.
Time frame: nine months
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 30 Dec 2014.
- Results publication: PubMed 22670050Cowling BJ, Ng S, Ma ES, Fang VJ, So HC, Wai W, Cheng CK, Wong JY, Chan KH, Ip DK, Chiu SS, Peiris JS, Leung GM. Protective efficacy against pandemic influenza of seasonal influenza vaccination in children in Hong Kong: a randomized controlled trial. Clin Infect Dis. 2012 Sep;55(5):695-702. doi: 10.1093/cid/cis518. Epub 2012 Jun 5.
- Results publication: PubMed 21067351Cowling BJ, Ng S, Ma ES, Cheng CK, Wai W, Fang VJ, Chan KH, Ip DK, Chiu SS, Peiris JS, Leung GM. Protective efficacy of seasonal influenza vaccination against seasonal and pandemic influenza virus infection during 2009 in Hong Kong. Clin Infect Dis. 2010 Dec 15;51(12):1370-9. doi: 10.1086/657311. Epub 2010 Nov 10.
- Derived from this study: PubMed 24825868Cowling BJ, Perera RA, Fang VJ, Chan KH, Wai W, So HC, Chu DK, Wong JY, Shiu EY, Ng S, Ip DK, Peiris JS, Leung GM. Incidence of influenza virus infections in children in Hong Kong in a 3-year randomized placebo-controlled vaccine study, 2009-2012. Clin Infect Dis. 2014 Aug 15;59(4):517-24. doi: 10.1093/cid/ciu356. Epub 2014 May 13.
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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.
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 study testing Inactivated influenza vaccine and Saline in people with Influenza Virus Infection, run by The University of Hong Kong at 1 site in China.
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 1 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 30 Dec 2014. 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 China. 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.
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?
The proportions of subjects and household contacts with serology-confirmed influenza infection during follow-up among the 2 intervention arms. (time frame: nine months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00792051, which also lists 3 linked publications.
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 30 Dec 2014.