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Vaccinating schoolchildren against influenza would prevent the disease among non-vaccinated household members.
Children and adolescents play an important role in sustaining the transmission of influenza. Moreover, with the occurrence of influenza in children, there are important socioeconomic consequences to families affected by the disease, related to absenteeism, expenditure on health services and medication use. This study presents an evaluation of direct and indirect effectiveness of influenza vaccination in school age children and their unvaccinated household contacts. It was conducted in 2009, in Sao Paulo - Brazil, through a randomized double-blind community trial, with six months of follow up. For the evaluation of vaccine effectiveness, the influenza vaccine was used for the experimental group, and meningitis conjugate and varicella vaccines for the control group. After vaccination, the volunteers and their families were followed for six months, in order to identify cases of acute respiratory infection (ARI) and to collect biological samples for testing with RT-PCR for diagnosis of influenza.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza vaccine | Experimental | Schoolchildren from 6 to 8 years received two intra-muscular doses of 0.5 ml of inactivated influenza vaccine, of the Southern Hemisphere, 2009. Schoolchildren above 8 years received one intra-muscular dose of 0.5 ml of inactivated influenza vaccine, of the Southern Hemisphere, 2009. |
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| Control vaccine | Sham Comparator | Schoolchildren received one intra-muscular dose of 0.5 ml of Meningococcal C conjugate vaccine. Schoolchildren under nine years of age received also one intra-muscular dose of 0.5 ml of varicella vaccine one month after the Meningococcal C vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine | Biological | Influenza vaccine: schoolchidren in the experimental group received IM administered:
|
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory confirmed influenza | RT-PCR confirmed influenza in respiratory secretions samples | June 01, 2009 to November 30, 2009 |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Repiratory Infection (ARI) | Presence of at least of two symptoms of ARI: fever, cough, sore throat, headache, appetite loss, running nose | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participantes with any adverse event as a measure of safety and tolerability | Any solicited or unsolicited adverse event | 30 days after vaccination |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Expedito J Luna, MD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Butantan Institute | São Paulo | 05503900 | Brazil |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| C410218 | serogroup C meningococcal conjugate vaccine |
| D019433 | Chickenpox Vaccine |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Control vaccine | Biological | Schoolchildren from 6 to 8 years of age: - One dose (0.5ml), IM administered, of Meningococcal C conjugate vaccine, and one dose (0.5ml), one month later, of varicella vaccine, IM administered. |
|
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D022283 |
| Herpesvirus Vaccines |