Intussusception (IS)NCT00595205
Intussusception Surveillance After Rotarix Introduction in Mexico
An observational study of Intussusception (IS) and Rotavirus Vaccines, run by GlaxoSmithKline at 1 site in Mexico.
Trial summary
GSK Biologicals' rotavirus vaccine, Rotarix™ has been recommended for universal use targeting infants through the Expanded Program on Immunization (EPI) in Mexico. This protocol describes a Phase IV safety study in Mexico designed to further evaluate the safety profile of Rotarix™ with regard to intussusception (IS). Read more about this study
- Who is it for?
- Ages Up to 364 days
- Conditions the study is for
- Intussusception (IS), Rotavirus Vaccines
- What is being tested?
- Hospital log review.
- How many people
- 786 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2008to Oct 2010
- 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 364 days
- All sexes
- No healthy volunteers
- Child
Study population: All eligible children < 1 year of age (children ineligible on day of first birthday) who are/have been treated at one of the study hospitals/medical facilities with definite intussusception.
Who may be able to join
- A child's clinical episode will be defined as an IS case and deemed eligible for the study if he/she meets the following criteria:
- Subject is an IMSS affiliate
- Subject is being treated/has been treated/has been referred for treatment at one of the IMSS hospitals/medical facilities with IS during the study period.
- Male or female child is <one year of age at the time of diagnosis of the IS (child becomes ineligible on the day of their first birthday)
- Subject is diagnosed with definite IS based on the Brighton criteria
- Written informed consent is obtained from the parent/guardian/legal representative of the subject Subjects meeting the above criteria will be eligible for inclusion in this study regardless of whether or not the subject has had a radiographically or surgically confirmed case of IS prior to the current episode.
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Authorization Safety Study (PASS) of Post-Marketing Surveillance for Intussusception Following Rotarix™ Introduction Into the Instituto Mexicano Del Seguro Social (IMSS) in Mexico
GSK Biologicals' rotavirus vaccine, Rotarix™ has been recommended for universal use targeting infants through the Expanded Program on Immunization (EPI) in Mexico. This protocol describes a Phase IV safety study in Mexico designed to further evaluate the safety profile of Rotarix™ with regard to intussusception (IS). The data generated by this study will be useful for public health officers and policy makers in confirming the safety profile of Rotarix™.
Read the detailed description
Rationale for amendment 3:
The findings from the first year of the implementation of the active surveillance showed that most Lower Respiratory Tract-Related Post-Neonatal (LRTI) Mortality cases could not be included into the study, because most of the grieving parents refused to participate in the study. The European Medicines Agency Marketing Authorization Holders (EMEA MAH) also generated a substantial amount of additional clinical and post-marketing safety data throughout the world, which clearly indicated the absence of any safety signal when considering the LTRI-related fatalities. Therefore surveillance for LRTI mortality cases was removed from the study design. The number of sites was reduced from approximately 230 to about 60 to 90 in order to reflect the above mentioned change that reduced the need for so many sites. Additionally, passive surveillance for IS cases through the IMSS database was not feasible, due to restrictions of the IMSS internal policies and to the current limitations in the databases linkage and structure abilities.
Lastly, SAEs reporting procedures had to be adjusted according to the Council for International Organizations of Medical Sciences (CIOMS) Working Group V, 2001 publication such that there will be no expedited safety reporting for this study.
Design This is a post marketing ,Phase IV, observational, prospective, self-controlled case series, vaccine safety study including: a) hospital-based surveillance to monitor for the occurrence of IS through active surveillance; b) a self-controlled case series (SCCS) design/analysis to assess the temporal association with Rotarix™ of the IS ascertained through active surveillance.
The aim of the active hospital-based surveillance system is to identify all definite IS cases in children younger than one year of age (children ineligible on day of first birthday) among IMSS members. Surveillance will be conducted in approximately 60 to 90 IMSS health facilities with pediatric surgery service.
Study participation for children fitting the surveillance case definition of IS will include parental/guardian/legal representative interview, as well as a review of medical charts and vaccination records. Additional medical information will be collected through medical record review during hospitalization and after the child has been discharged.
- Conditions
- Intussusception (IS), Rotavirus Vaccines
- Being tested
- Hospital log review.
- Keywords
- vaccination, intussusception, Rotavirus, vaccine
- Medical subject headings
- Intussusception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital log review.Other
Reviewing of the hospital log to monitor for the occurrence of intussusception.
| Study group | Role | What they receive |
|---|---|---|
| Group IS | Subjects <1 year of age with definite intussusception cases who had received Rotarix™. Receives: Other: Hospital log review. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of definite IS episodes within Day 0 to Day 30 following vaccination
Measured: 0- 30 days following Rotarix vaccination
Secondary outcomes (2)
Occurrence of definite IS episodes within Day 0 to Day 15 following vaccination
Measured: Day 0 to Day 15 post Rotarix vaccination
Yearly occurrence of definite IS episodes (regardless of vaccination status)
Measured: Assessed for the interim analysis and after study conclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intussusception (IS)Studies 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
- 786 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595205
- Sponsor's protocol ID
- 104435
- Status last verified
- Feb 2011
- First submitted
- 4 Jan 2008
- Last updated
- 19 Mar 2012
- Results posted
- No
Publications
Velázquez FR et al. Postmarketing surveillance to assess risk of intussusception following introduction of the G1P[8] human rotavirus vaccine in Mexico. Abstract presented at the Excellence in Paediatrics (EXPE). London, UK, 2-4 December 2010.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Authorization Safety Study (PASS) of Post-Marketing Surveillance for Intussusception Following Rotarix™ Introduction Into the Instituto Mexicano Del Seguro Social (IMSS) in Mexico
- ClinicalTrials.gov ID
- NCT00595205
- Acronym / sponsor ID
- 104435
- Conditions
- Intussusception (IS), Rotavirus Vaccines
- Keywords
- vaccination, intussusception, Rotavirus, vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 786 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 16 Jan 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.
GSK Biologicals' rotavirus vaccine, Rotarix™ has been recommended for universal use targeting infants through the Expanded Program on Immunization (EPI) in Mexico. This protocol describes a Phase IV safety study in Mexico designed to further evaluate the safety profile of Rotarix™ with regard to intussusception (IS). The data generated by this study will be useful for public health officers and policy makers in confirming the safety profile of Rotarix™.
Detailed description
Rationale for amendment 3:
The findings from the first year of the implementation of the active surveillance showed that most Lower Respiratory Tract-Related Post-Neonatal (LRTI) Mortality cases could not be included into the study, because most of the grieving parents refused to participate in the study. The European Medicines Agency Marketing Authorization Holders (EMEA MAH) also generated a substantial amount of additional clinical and post-marketing safety data throughout the world, which clearly indicated the absence of any safety signal when considering the LTRI-related fatalities. Therefore surveillance for LRTI mortality cases was removed from the study design. The number of sites was reduced from approximately 230 to about 60 to 90 in order to reflect the above mentioned change that reduced the need for so many sites. Additionally, passive surveillance for IS cases through the IMSS database was not feasible, due to restrictions of the IMSS internal policies and to the current limitations in the databases linkage and structure abilities.
Lastly, SAEs reporting procedures had to be adjusted according to the Council for International Organizations of Medical Sciences (CIOMS) Working Group V, 2001 publication such that there will be no expedited safety reporting for this study.
Design This is a post marketing ,Phase IV, observational, prospective, self-controlled case series, vaccine safety study including: a) hospital-based surveillance to monitor for the occurrence of IS through active surveillance; b) a self-controlled case series (SCCS) design/analysis to assess the temporal association with Rotarix™ of the IS ascertained through active surveillance.
The aim of the active hospital-based surveillance system is to identify all definite IS cases in children younger than one year of age (children ineligible on day of first birthday) among IMSS members. Surveillance will be conducted in approximately 60 to 90 IMSS health facilities with pediatric surgery service.
Study participation for children fitting the surveillance case definition of IS will include parental/guardian/legal representative interview, as well as a review of medical charts and vaccination records. Additional medical information will be collected through medical record review during hospitalization and after the child has been discharged.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group IS | – | Other: Hospital log review.Subjects <1 year of age with definite intussusception cases who had received Rotarix™. |
Who may qualify
- Ages
- Up to 364 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All eligible children < 1 year of age (children ineligible on day of first birthday) who are/have been treated at one of the study hospitals/medical facilities with definite intussusception.
Key inclusion criteria (6 listed)
- A child's clinical episode will be defined as an IS case and deemed eligible for the study if he/she meets the following criteria:
- Subject is an IMSS affiliate
- Subject is being treated/has been treated/has been referred for treatment at one of the IMSS hospitals/medical facilities with IS during the study period.
- Male or female child is <one year of age at the time of diagnosis of the IS (child becomes ineligible on the day of their first birthday)
- Subject is diagnosed with definite IS based on the Brighton criteria
Key exclusion criteria (1 listed)
- Not applicable
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 |
|---|---|---|
| Hospital log review.Reviewing of the hospital log to monitor for the occurrence of intussusception. | Other | Group IS |
Primary outcome
Occurrence of definite IS episodes within Day 0 to Day 30 following vaccination
Time frame: 0- 30 days following Rotarix vaccination
2 secondary outcomes
Occurrence of definite IS episodes within Day 0 to Day 15 following vaccination
Time frame: Day 0 to Day 15 post Rotarix vaccination
Yearly occurrence of definite IS episodes (regardless of vaccination status)
Time frame: Assessed for the interim analysis and after study conclusion
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 19 Mar 2012.
- BackgroundVelázquez FR et al. Postmarketing surveillance to assess risk of intussusception following introduction of the G1P[8] human rotavirus vaccine in Mexico. Abstract presented at the Excellence in Paediatrics (EXPE). London, UK, 2-4 December 2010.
Related trials for Intussusception (IS)
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Benign Versus Malignant Causes of Intussuception in Adults
Intussusception (IS)
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 (IS) and Rotavirus Vaccines, 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 6 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 19 Mar 2012. 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 definite IS episodes within Day 0 to Day 30 following vaccination (time frame: 0- 30 days following Rotarix vaccination). 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 NCT00595205, which also lists 1 linked publication.
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 19 Mar 2012.