InfluenzaPhase 4Xo_GripeNCT01693380
Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza
A Phase 4 study testing Influenza vaccine in people with Influenza and Acute Respiratory Infection, run by Butantan Institute at 1 site in Brazil.
Trial summary
Vaccinating schoolchildren against influenza would prevent the disease among non-vaccinated household members. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, Acute Respiratory Infection
- What is being tested?
- Influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,742 participants
- Where
- 1 siteBrazil
- Study dates
- May 2009to Nov 2009
- 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 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- older than six years of age;
- live in the study area;
- parent consent to participate, by signing the Informed Consent Form;
- no history of anaphilaxis or hipersensitivity to eggs or eggs proteins;
- no history no history anaphilaxis or hipersensitivity to any substances;
- no acute disease at the moment of vaccination
Show all 9Show fewer
- no use of immunesupressant drugs;
- not have received any other vaccine in the previous six months;
- no participation in other clinical trial in the previous six months.
Who cannot join
- Any condition above mentioned.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza the in São Paulo, 2009
Vaccinating schoolchildren against influenza would prevent the disease among non-vaccinated household members.
Read the detailed description
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.
- Conditions
- Influenza, Acute Respiratory Infection
- Being tested
- Influenza vaccine, Control vaccine
- Keywords
- Influenza, Vaccination, Vaccines, Schoolchildren, Effectiveness, Intervention studies, Adolescents, Laboratory Confirmed Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccineBiological
Influenza vaccine: schoolchidren in the experimental group received IM administered:
- From 6 to 9 years of age - 2 doses (0.5ml each) of the tri-valent innactivated influenza vaccine - Southern Hemisphere formulation, 2009 - one month apart.
- 9 years of age and older: one dose (0.5ml) of the tri-valent innactivated influenza vaccine - Southern Hemisphere formulation, 2009 - one month apart.
Control vaccineBiological
Also called Meningococcal C conjugate vaccine, Varicella vaccine
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Influenza vaccine |
| 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. Receives: Biological: Control vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory confirmed influenza
RT-PCR confirmed influenza in respiratory secretions samples
Measured: June 01, 2009 to November 30, 2009
Secondary outcomes (1)
Acute Repiratory Infection (ARI)
Presence of at least of two symptoms of ARI: fever, cough, sore throat, headache, appetite loss, running nose
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startMay 2009
- Primary completionJun 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,742 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butantan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Expedito J Luna, MD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693380
- Sponsor's protocol ID
- BUTANTAN
- Acronym
- Xo_Gripe
- Status last verified
- Apr 2023
- First submitted
- 10 Sep 2012
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Assessment of Vaccinating Schoolchildren Against Influenza the in São Paulo, 2009
- ClinicalTrials.gov ID
- NCT01693380
- Acronym / sponsor ID
- Xo_Gripe / BUTANTAN
- Conditions
- Influenza, Acute Respiratory Infection
- Keywords
- Influenza, Vaccination, Vaccines, Schoolchildren, Effectiveness, Intervention studies, Adolescents, Laboratory Confirmed Influenza
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,742 participants (actual)
- Lead sponsor
- Butantan InstituteOther government
- Study start
- May 2009 (actual)
- Primary completion
- Jun 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 26 Sep 2012 (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.
Vaccinating schoolchildren against influenza would prevent the disease among non-vaccinated household members.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccine | Experimental | Biological: Influenza vaccineSchoolchildren 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. |
| Control vaccine | Sham comparator | Biological: Control vaccineSchoolchildren 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- older than six years of age;
- live in the study area;
- parent consent to participate, by signing the Informed Consent Form;
- no history of anaphilaxis or hipersensitivity to eggs or eggs proteins;
- no history no history anaphilaxis or hipersensitivity to any substances;
Key exclusion criteria (1 listed)
- Any condition above mentioned.
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 |
|---|---|---|
| Influenza vaccineInfluenza vaccine: schoolchidren in the experimental group received IM administered: * From 6 to 9 years of age - 2 doses (0.5ml each) of the tri-valent innactivated influenza vaccine - Southern Hemisphere formulation, 2009 - one month apart. * 9 years of age and older: one dose (0.5ml) of the tri-valent innactivated influenza vaccine - Southern Hemisphere formulation, 2009 - one month apart. | Biological | Influenza vaccine |
| Control vaccineAlso: Meningococcal C conjugate vaccine, Varicella vaccineSchoolchildren 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. | Biological | Control vaccine |
Primary outcome
Laboratory confirmed influenza
Time frame: June 01, 2009 to November 30, 2009
RT-PCR confirmed influenza in respiratory secretions samples
1 secondary outcome
Acute Repiratory Infection (ARI)
Time frame: 6 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 4 Apr 2023.
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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.
Expedito J Luna, MD principal investigator
University of Sao Paulo
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 Influenza vaccine in people with Influenza and Acute Respiratory Infection, run by Butantan Institute at 1 site in Brazil.
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 9 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 4 Apr 2023. 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 Brazil. 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?
Laboratory confirmed influenza (time frame: June 01, 2009 to November 30, 2009). 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 4 Apr 2023.