Direct and Indirect Benefits of Influenza Vaccine Versus Placebo in Healthy Children
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Influenza Virus Infection |
Biological: Inactivated influenza vaccine Biological: Saline |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | A Randomised Controlled Trial of the Effectiveness of Vaccinating Children to Reduce Household Transmission of Influenza |
- The proportions of subjects and household contacts with serology-confirmed influenza infection during follow-up among the 2 intervention arms. [ Time Frame: nine months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2800 |
| Study Start Date: | September 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Influenza vaccine
|
Biological: Inactivated influenza vaccine
0.5ml intramuscular single dose
Other Name: VAXIGRIP®, Sanofi Pasteur
|
| Placebo Comparator: 2 |
Biological: Saline
0.5ml intramuscular, one dose
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- All vaccinees must be Hong Kong residents aged between 6 and 17.
Exclusion Criteria:
- 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.
Contacts and Locations| China | |
| The University of Hong Kong | |
| Hong Kong, China | |
| Principal Investigator: | Benjamin J Cowling, PhD | The University of Hong Kong |
More Information
No publications provided
| Responsible Party: | Dr Benjamin John Cowling, The University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT00792051 History of Changes |
| Other Study ID Numbers: | GML003.4 |
| Study First Received: | November 13, 2008 |
| Last Updated: | August 18, 2011 |
| Health Authority: | Hong Kong: Centre for Health Protection |
Keywords provided by The University of Hong Kong:
|
influenza vaccination children Influenza-like illness |
Additional relevant MeSH terms:
|
Influenza, Human Virus Diseases Orthomyxoviridae Infections |
RNA Virus Infections Respiratory Tract Infections Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 19, 2013