Infections, RotavirusPhase 3NCT00420316
Long-term Efficacy and Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GSK Bio's HRV Vaccine.
A Phase 3 study testing Rotarix (primary vaccination study) in people with Infections, Rotavirus, run by GlaxoSmithKline at 15 sites in Finland.
Trial summary
To assess the long-term efficacy and safety of the subjects during the third year after priming with 2 doses of GSK Biologicals' oral live attenuated HRV vaccine (Rotarix) in the primary vaccination study (102247). The Rotarix vaccine was administered in the primary vaccination study. Read more about this study
- Who is it for?
- Ages 32 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Rotavirus
- What is being tested?
- Rotarix (primary vaccination study)
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,613 participants
- Where
- 15 sitesFinland
- Study dates
- 12 Feb 2007to 8 Aug 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 32 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A male or female who has completed the second year efficacy follow-up of the primary vaccination study in Finland.
- Written informed consent obtained from the parent or guardian of the subject.
Who cannot join
None listed.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Finland15 sites
GSK Investigational Site
Espoo, 02100
GSK Investigational Site
Helsinki, 00100
GSK Investigational Site
Helsinki, 00930
GSK Investigational Site
Jarvenpaa, 04400
GSK Investigational Site
Kotka, 48600
GSK Investigational Site
Kuopio, 70100
GSK Investigational Site
Lahti, 15140
GSK Investigational Site
Oulu, 90100
GSK Investigational Site
Pori, 28120
GSK Investigational Site
Seinäjoki, 60100
GSK Investigational Site
Tampere, 33100
GSK Investigational Site
Tampere, 33520
GSK Investigational Site
Turku, 20520
GSK Investigational Site
Vantaa, 01300
GSK Investigational Site
Vantaa, 01600
About this study
Official title: To Assess Long-term Efficacy & Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine (Rotarix) in the Primary Vaccination Study (102247).
To assess the long-term efficacy and safety of the subjects during the third year after priming with 2 doses of GSK Biologicals' oral live attenuated HRV vaccine (Rotarix) in the primary vaccination study (102247). The Rotarix vaccine was administered in the primary vaccination study. There was no vaccine/intervention in this long-term efficacy study.
- Conditions
- Infections, Rotavirus
- Being tested
- Rotarix (primary vaccination study), Placebo (primary vaccination study)
- Keywords
- Intussusception, Gastroenteritis, Finland
- Medical subject headings
- Rotavirus Infections, Intussusception, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotarix (primary vaccination study)Biological
GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine.
Placebo (primary vaccination study)Biological
Two liquid oral doses of placebo
| Study group | Role | What they receive |
|---|---|---|
| Rotarix Group | Experimental | Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study. Receives: Biological: Rotarix (primary vaccination study) |
| Placebo Group | Placebo comparator | Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study. Receives: Biological: Placebo (primary vaccination study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Any Rotavirus Gastroenteritis (RVGE)
Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.
Measured: During the study period for the long-term follow-up (i.e. 6 months)
Secondary outcomes (8)
Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE)
Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.
Measured: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With G1 Serotype
Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes. Only GE episodes in which wild-type RV strain of G1 serotype was identified in a stool specimen, were included in the efficacy analysis.
Measured: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With G1 Serotype
Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain of serotype G1 and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.
Measured: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype
Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain of non-G1 serotype was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.
Measured: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype
Number of rotavirus gastroenteritis (RVGE) episodes caused by the wild-type rotavirus strain of non-G1 serotype and reported during the efficacy period, were presented by severity, using the Vesikari scale. The assessment of intensity of GE episodes was done using the 20-point Vesikari scale, according to which episodes with scores greater than or equal to (≥) 11 were labeled as severe.
Measured: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects With Severe Gastroenteritis (GE)
Severe GE was defined as a GE episode requiring hospitalization and/or re-hydration therapy in a medical facility.
Measured: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects Reporting Serious Adverse Events (SAEs)
An SAE was any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Measured: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects Reporting Intussusception (IS)
Intussusception is defined as the telescoping of the intestine.
Measured: During the period starting from the end of the second follow-up up to the start of the study (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study start12 Feb 2007
- Primary completion8 Aug 2007
- Study completion8 Aug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infections, RotavirusStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,613 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
- NCT00420316
- Sponsor's protocol ID
- 109810
- Status last verified
- Jul 2018
- First submitted
- 10 Jan 2007
- Last updated
- 28 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess Long-term Efficacy & Safety of Subjects Approximately 3 Years After Priming With 2 Doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine (Rotarix) in the Primary Vaccination Study (102247).
- ClinicalTrials.gov ID
- NCT00420316
- Acronym / sponsor ID
- 109810
- Conditions
- Infections, Rotavirus
- Keywords
- Intussusception, Gastroenteritis, Finland
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,613 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2007 (actual)
- Primary completion
- 8 Aug 2007 (actual)
- Study completion
- 8 Aug 2007 (actual)
- First posted
- 11 Jan 2007 (estimated)
- Results
- Posted 23 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the long-term efficacy and safety of the subjects during the third year after priming with 2 doses of GSK Biologicals' oral live attenuated HRV vaccine (Rotarix) in the primary vaccination study (102247). The Rotarix vaccine was administered in the primary vaccination study. There was no vaccine/intervention in this long-term efficacy study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotarix Group | Experimental | Biological: Rotarix (primary vaccination study)Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two powdered oral doses of Rotarix™ vaccine in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study. |
| Placebo Group | Placebo comparator | Biological: Placebo (primary vaccination study)Healthy children between and including 6 to 12 weeks of age at the time of first vaccination, who received two liquid oral doses of placebo in the Rota-036 primary vaccination study (102247), were subsequently followed-up for 6 months during their third year of age, in scope of the present study. |
Who may qualify
- Ages
- 32 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- A male or female who has completed the second year efficacy follow-up of the primary vaccination study in Finland.
- Written informed consent obtained from the parent or guardian of the subject.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Rotarix (primary vaccination study)GlaxoSmithKline Biologicals' oral live attenuated human rotavirus vaccine. | Biological | Rotarix Group |
| Placebo (primary vaccination study)Two liquid oral doses of placebo | Biological | Placebo Group |
Primary outcome
Number of Subjects With Any Rotavirus Gastroenteritis (RVGE)
Time frame: During the study period for the long-term follow-up (i.e. 6 months)
Occurence of any rotavirus gastroenteritis (RVGE) caused by the circulating wild-type rotavirus strain was assessed in terms of number of subjects experiencing diarrhoea with or without vomiting. Two occurrences of diarrhoea were classified as separate episodes if there were 5 or more diarrhoea-free days between the episodes.
8 secondary outcomes
Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE)
Time frame: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With G1 Serotype
Time frame: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With G1 Serotype
Time frame: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype
Time frame: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects With Severe Rotavirus Gastroenteritis (RVGE) With Non-G1 Serotype
Time frame: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects With Severe Gastroenteritis (GE)
Time frame: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: During the study period for the long-term follow-up (i.e. 6 months)
Number of Subjects Reporting Intussusception (IS)
Time frame: During the period starting from the end of the second follow-up up to the start of the study (up to 6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rotarix (primary vaccination study) in people with Infections, Rotavirus, run by GlaxoSmithKline at 15 sites in Finland.
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 2 inclusion and 0 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 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Finland. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With Any Rotavirus Gastroenteritis (RVGE) (time frame: During the study period for the long-term follow-up (i.e. 6 months)). 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 28 Aug 2018.