IntussusceptionNCT00436358
Implementing Hospital-based Active Surveillance Procedures for Vaccine Safety Monitoring at IMSS Hospitals in Mexico
An observational study of Intussusception and LRTI-related Post Neonatal Deaths, run by GlaxoSmithKline at 1 site in Mexico.
Trial summary
This is an epidemiology study designed to implement hospital-based active surveillance for intussusception (IS) in children <1 year of age and lower respiratory tract infection (LRTI)-related deaths among children between 29 days and 1 year of age in Mexico. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Intussusception, LRTI-related Post Neonatal Deaths
- What is being tested?
- Not applicable: none
- How many people
- 134 participants
- Where
- 1 siteMexico
- Study dates
- Apr 2007to Jan 2008
- Phase
- Observational
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: IMSS hospitals with pediatric medical care in Mexico
Who may be able to join
- An IS case deemed eligible for the study must meet the following criteria:
- Subject is an IMSS affiliate
- Subject is being treated/has been treated at one of the IMSS hospitals/medical facilities with IS during the study period.
- Male or female child is <1 year of age at the time of diagnosis of the IS
- Subject is diagnosed with definite IS
- Written informed consent for definite IS cases is obtained from the parent/guardian/legal representative of the subject.
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- Only subjects who the investigator believes will meet the requirements of the protocol should be enrolled in the study.
- A death deemed eligible for the study must meet the following criteria:
- Subject is an IMSS affiliate
- Death certificate is available
- Male or female child between 29 days and 1 year of age, at the time of death
- Post-neonatal LRTI-related death occurred during the study period
- Written informed consent is obtained from the parent/guardian/legal representative of the subject.
- For a child to be included in the random sample selected from the IMSS dataset must meet the following criteria:
- Subject is an IMSS affiliate.
- Male or female child belonging to the annual birth cohort selected for the evaluation.
- Written informed consent is obtained from the parent/guardian/legal representative of the subject.
- Subject did not die.
- Subject currently lives in Mexico.
- IS Cases Selected from IMSS Dataset must meet the following criteria:
- Subject with an IS identified in the IMSS dataset.
- Male or female child is <1 year of age at the time of diagnosis of the IS (patient becomes ineligible on the day of their first birthday).
- Subject belongs to the annual birth cohort selected for the evaluation.
- Children Selected as Controls for Matched Assessment
- subject matched to a case by gender, hospital of birth and date of birth as described above.
Who cannot join
- For a child to be included as a matched control:
- subject is dead
- subject is not currently living in Mexico
- subject experienced an IS episode recorded in the IMSS database.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of Hospital-based Active Surveillance Procedures for Vaccine Safety Monitoring at IMSS Hospitals With Pediatric Medical Care in Mexico
This is an epidemiology study designed to implement hospital-based active surveillance for intussusception (IS) in children <1 year of age and lower respiratory tract infection (LRTI)-related deaths among children between 29 days and 1 year of age in Mexico. An existing linked database of the "Instituto Mexicano del Seguro Social (IMSS)" will be used. The study described in this protocol is a pilot study, which will evaluate the methodology to be used in a later Post-Marketing Surveillance (PMS) study.
The planned epidemiology study will be conducted in IMSS hospitals and potentially use the IMSS database to re-capture potential cases of IS and fatal cases and as a source of matched case controls. The purpose of this project is to complement this data link system with an active surveillance system for IS - in order to assess the feasibility of using the IMSS data system by generating results that provide scientific validity. Such comprehensive (passive and active) surveillance systems will facilitate the post licensure safety profile evaluation of vaccines such as a vaccine against rotavirus diarrhoea.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Read the detailed description
The main aim of this pilot study is to allow for the implementation of active hospital-based surveillance for IS in children <1 year of age in IMSS hospitals with pediatric medical care, and LRTI-related post-neonatal deaths among children between 29 days and 1 year of age participating in the IMSS system. Surveillance will be conducted in each of the approximately 230 IMSS hospitals with pediatric medical care (tertiary care and secondary care hospitals), which have 40 million affiliates and an annual birth cohort of 575,000.
During the pilot phase the completeness and validity of electronic vaccination and demographic data contained in the IMSS dataset will be assessed to determine whether or not these data will be used during the actual post licensure study implementation. Study participation for database validation will include parental/guardian/legal representative interview and review of vaccination records.
Study staff at each of the approximately 230 IMSS hospitals will review medical records daily for potential cases of IS in children <1 year of age.
Medical records of potential IS cases will be reviewed to determine eligibility, in terms of IS, based on the Brighton criteria Parents/guardians/legal representative of definite IS cases will be contacted by study staff to recruit their child into the study.
After the informed consent is signed, the parental/guardian interview will be conducted.
Additional medical information will be collected through medical record review during hospitalization and after the child has been discharged.
A central Information Coordinator (IMSS staff member) will perform monthly reviews of the IMSS database to search for definite IS cases.
A cross-check will be performed with IMSS database to identify definite IS cases not yet enrolled. In that situation, parents/guardians/legal representative will be contacted by study staff to recruit their child into the study. Either in-hospital interviews or in-home interviews will be arranged to collect data.
Study staff will perform the same review as above but for LTRI-related deaths in children between 29 days and 1 year of age. They will also review morgue records for LRTI-related deaths.
A central Information Coordinator (IMSS staff member) will perform monthly reviews of the IMSS database for post-neonatal LRTI-related deaths.
Study staff will contact the parents/guardians/legal representative of the deceased child to explain the study and request enrollment.
After informed consent is obtained, an interview will be conducted with parents/guardians/legal representative.
IMSS medical records will be reviewed by study staff. All LTRI related post-neonatal deaths will be reported to the Principal Investigator (PI) and to the Safety Review Expert Committee (SReC).
The SReC, which is completely independent from GSK Biologicals, will assign causes of death (CoD) for all enrolled LTRI-related post-neonatal death cases.
All definite IS cases and LTRI related post-neonatal fatalities will be reported to the GSK local operating company within 24 hours of identification. In addition all SAEs, deemed to be related to a GSK vaccine will be reported based on discharged diagnosis only.
The completeness of key demographic data (date of birth, hospital of birth, gender, and residential address) will be assessed for a sample of children in the IMSS dataset in a single annual birth cohort.
A random sample (N=1,200) of children from a single annual birth cohort will be selected from the IMSS dataset for verification of demographic data and vaccination history (the selection process will continue until informed consent has been obtained for a total of 1,200 children). In-home interviews will be conducted with parents/guardians/legal representative of all 1200 subjects to gather demographic and vaccination history (EPI card - Cartilla Nacional de Vacunacion).
Demographic data collected in the interview will be compared to that in the IMSS dataset.
Vaccine history (two doses of DTP) collected from the EPI vaccination cards will be compared to that in the IMSS dataset. The agreement for DTP will be assessed.
All IS episodes in a single annual birth cohort of children in the IMSS dataset will be identified. Data necessary for selection of matched controls (date of birth, hospital of birth, and gender) will be extracted for these children.
Five controls for identified IS cases will be selected from the IMSS dataset based on the ability to fulfil the matching criteria. Statistics on the number of matched controls and the quality of the match will be assessed by IMSS and Rixensart statisticians.
Primary outcome measure: occurrence of IS by passive (IMSS database) and active (RDE) surveillance and of LRTI-related post-neonatal deaths by passive and active surveillance.
Secondary outcome measure: demography data of IMSS affiliate, from IMSS record and parent interview; DTP history from IMSS dataset and EPI
- Conditions
- Intussusception, LRTI-related Post Neonatal Deaths
- Being tested
- Not applicable: none
- Keywords
- Mexico, Intussusception, Epidemiology
- Medical subject headings
- Intussusception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable: noneOther
Please refer to the detailed description section
| Study group | Role | What they receive |
|---|---|---|
| Group A | IS case deemed children Receives: Other: Not applicable: none | |
| Group B | LRTI-related post-neonatal deaths deemed Children Receives: Other: Not applicable: none | |
| Group C | A random sample of children from an annual birth cohort within the electronic IMSS dataset Receives: Other: Not applicable: none | |
| Group D | All children from a single annual birth cohort with IS identified in their electronic IMSS data Receives: Other: Not applicable: none | |
| Group E | A sample of children from the electronic IMSS dataset selected to match the selected IS cases on age, gender, and hospital of birth. Receives: Other: Not applicable: none |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of IS by passive (IMSS database) and active (RDE) surveillance
Measured: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
Occurrence of LRTI-related post-neonatal deaths by passive surveillance (IMSS database) and active surveillance (RDE)
Measured: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
Key demographic data (date of birth, hospital of birth, gender, and residential address) of IMSS affiliate
Measured: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
Demographic data (date of birth, hospital of birth, gender, and residential address) from the electronic IMSS record of IMSS affiliate
Measured: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
Demographic data (date of birth, hospital of birth, gender, and residential address) collected from parent/guardian/legal representative/guardian interview
Measured: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
Vaccination history (DTP) from electronic IMSS dataset of IMSS affiliate
Measured: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
Vaccination history (DTP) from EPI cards of IMSS affiliate.
Measured: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startApr 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntussusceptionStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436358
- Sponsor's protocol ID
- 106175
- Status last verified
- Jan 2011
- First submitted
- 16 Feb 2007
- Last updated
- 31 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Hospital-based Active Surveillance Procedures for Vaccine Safety Monitoring at IMSS Hospitals With Pediatric Medical Care in Mexico
- ClinicalTrials.gov ID
- NCT00436358
- Acronym / sponsor ID
- 106175
- Conditions
- Intussusception, LRTI-related Post Neonatal Deaths
- Keywords
- Mexico, Intussusception, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 19 Feb 2007 (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.
This is an epidemiology study designed to implement hospital-based active surveillance for intussusception (IS) in children <1 year of age and lower respiratory tract infection (LRTI)-related deaths among children between 29 days and 1 year of age in Mexico. An existing linked database of the "Instituto Mexicano del Seguro Social (IMSS)" will be used. The study described in this protocol is a pilot study, which will evaluate the methodology to be used in a later Post-Marketing Surveillance (PMS) study.
The planned epidemiology study will be conducted in IMSS hospitals and potentially use the IMSS database to re-capture potential cases of IS and fatal cases and as a source of matched case controls. The purpose of this project is to complement this data link system with an active surveillance system for IS - in order to assess the feasibility of using the IMSS data system by generating results that provide scientific validity. Such comprehensive (passive and active) surveillance systems will facilitate the post licensure safety profile evaluation of vaccines such as a vaccine against rotavirus diarrhoea.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
The main aim of this pilot study is to allow for the implementation of active hospital-based surveillance for IS in children <1 year of age in IMSS hospitals with pediatric medical care, and LRTI-related post-neonatal deaths among children between 29 days and 1 year of age participating in the IMSS system. Surveillance will be conducted in each of the approximately 230 IMSS hospitals with pediatric medical care (tertiary care and secondary care hospitals), which have 40 million affiliates and an annual birth cohort of 575,000.
During the pilot phase the completeness and validity of electronic vaccination and demographic data contained in the IMSS dataset will be assessed to determine whether or not these data will be used during the actual post licensure study implementation. Study participation for database validation will include parental/guardian/legal representative interview and review of vaccination records.
Study staff at each of the approximately 230 IMSS hospitals will review medical records daily for potential cases of IS in children <1 year of age.
Medical records of potential IS cases will be reviewed to determine eligibility, in terms of IS, based on the Brighton criteria Parents/guardians/legal representative of definite IS cases will be contacted by study staff to recruit their child into the study.
After the informed consent is signed, the parental/guardian interview will be conducted.
Additional medical information will be collected through medical record review during hospitalization and after the child has been discharged.
A central Information Coordinator (IMSS staff member) will perform monthly reviews of the IMSS database to search for definite IS cases.
A cross-check will be performed with IMSS database to identify definite IS cases not yet enrolled. In that situation, parents/guardians/legal representative will be contacted by study staff to recruit their child into the study. Either in-hospital interviews or in-home interviews will be arranged to collect data.
Study staff will perform the same review as above but for LTRI-related deaths in children between 29 days and 1 year of age. They will also review morgue records for LRTI-related deaths.
A central Information Coordinator (IMSS staff member) will perform monthly reviews of the IMSS database for post-neonatal LRTI-related deaths.
Study staff will contact the parents/guardians/legal representative of the deceased child to explain the study and request enrollment.
After informed consent is obtained, an interview will be conducted with parents/guardians/legal representative.
IMSS medical records will be reviewed by study staff. All LTRI related post-neonatal deaths will be reported to the Principal Investigator (PI) and to the Safety Review Expert Committee (SReC).
The SReC, which is completely independent from GSK Biologicals, will assign causes of death (CoD) for all enrolled LTRI-related post-neonatal death cases.
All definite IS cases and LTRI related post-neonatal fatalities will be reported to the GSK local operating company within 24 hours of identification. In addition all SAEs, deemed to be related to a GSK vaccine will be reported based on discharged diagnosis only.
The completeness of key demographic data (date of birth, hospital of birth, gender, and residential address) will be assessed for a sample of children in the IMSS dataset in a single annual birth cohort.
A random sample (N=1,200) of children from a single annual birth cohort will be selected from the IMSS dataset for verification of demographic data and vaccination history (the selection process will continue until informed consent has been obtained for a total of 1,200 children). In-home interviews will be conducted with parents/guardians/legal representative of all 1200 subjects to gather demographic and vaccination history (EPI card - Cartilla Nacional de Vacunacion).
Demographic data collected in the interview will be compared to that in the IMSS dataset.
Vaccine history (two doses of DTP) collected from the EPI vaccination cards will be compared to that in the IMSS dataset. The agreement for DTP will be assessed.
All IS episodes in a single annual birth cohort of children in the IMSS dataset will be identified. Data necessary for selection of matched controls (date of birth, hospital of birth, and gender) will be extracted for these children.
Five controls for identified IS cases will be selected from the IMSS dataset based on the ability to fulfil the matching criteria. Statistics on the number of matched controls and the quality of the match will be assessed by IMSS and Rixensart statisticians.
Primary outcome measure: occurrence of IS by passive (IMSS database) and active (RDE) surveillance and of LRTI-related post-neonatal deaths by passive and active surveillance.
Secondary outcome measure: demography data of IMSS affiliate, from IMSS record and parent interview; DTP history from IMSS dataset and EPI
Study design
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Not applicable: noneIS case deemed children |
| Group B | – | Other: Not applicable: noneLRTI-related post-neonatal deaths deemed Children |
| Group C | – | Other: Not applicable: noneA random sample of children from an annual birth cohort within the electronic IMSS dataset |
| Group D | – | Other: Not applicable: noneAll children from a single annual birth cohort with IS identified in their electronic IMSS data |
| Group E | – | Other: Not applicable: noneA sample of children from the electronic IMSS dataset selected to match the selected IS cases on age, gender, and hospital of birth. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- IMSS hospitals with pediatric medical care in Mexico
Key inclusion criteria (25 listed)
- Subject is an IMSS affiliate
- Subject is being treated/has been treated at one of the IMSS hospitals/medical facilities with IS during the study period.
- Male or female child is <1 year of age at the time of diagnosis of the IS
- Subject is diagnosed with definite IS
- Written informed consent for definite IS cases is obtained from the parent/guardian/legal representative of the subject.
Key exclusion criteria (4 listed)
- subject is dead
- subject is not currently living in Mexico
- subject experienced an IS episode recorded in the IMSS database.
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 |
|---|---|---|
| Not applicable: nonePlease refer to the detailed description section | Other | Group A, Group B, Group C, Group D, Group E |
Primary outcome
Occurrence of IS by passive (IMSS database) and active (RDE) surveillance
Time frame: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
Occurrence of LRTI-related post-neonatal deaths by passive surveillance (IMSS database) and active surveillance (RDE)
Time frame: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
Key demographic data (date of birth, hospital of birth, gender, and residential address) of IMSS affiliate
Time frame: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
Demographic data (date of birth, hospital of birth, gender, and residential address) from the electronic IMSS record of IMSS affiliate
Time frame: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
Demographic data (date of birth, hospital of birth, gender, and residential address) collected from parent/guardian/legal representative/guardian interview
Time frame: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
Vaccination history (DTP) from electronic IMSS dataset of IMSS affiliate
Time frame: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
Vaccination history (DTP) from EPI cards of IMSS affiliate.
Time frame: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.
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 31 Jan 2011.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intussusception and LRTI-related Post Neonatal Deaths, run by GlaxoSmithKline at 1 site in Mexico.
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 25 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 31 Jan 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 Mexico. 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. 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?
Occurrence of IS by passive (IMSS database) and active (RDE) surveillance (time frame: Approx 3 months to initiate the active surveillance systems in approx 230 hospitals. Three additional months, after implementation, may be required to generate some baseline data as well as to start generating database validation results.). The study lists 7 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 31 Jan 2011.