Infections, RotavirusPhase 3NCT00139347
Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants
A Phase 3 study testing 2-dose oral live attenuated G1P[8] human rotavirus vaccine in people with Infections, Rotavirus, run by GlaxoSmithKline at 17 sites in 6 countries.
Trial summary
The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age. Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Infections, Rotavirus
- What is being tested?
- 2-dose oral live attenuated G1P[8] human rotavirus vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- How many people
- 6,360 participants
- Where
- 17 sitesin 6 countries
- Study dates
- Dec 2003to Mar 2007
- Phase
- Phase 3
- 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 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.
Who cannot join
- Allergic reaction to vaccine components;
- clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol;
- immunocompromised.
Trial locations and contacts
17 sites in 6 countries.
17 sites in 6 countries
Argentina8 sites
GSK Investigational Site
Colonia Caroya, Córdoba Province, X5223CDT
GSK Investigational Site
Córdoba, Córdoba Province, 5016
GSK Investigational Site
Córdoba, 5000
GSK Investigational Site
La Plata, 1900
GSK Investigational Site
Mendoza, Mendoza Province, 5500
GSK Investigational Site
Río Cuarto, Córdoba Province, 5800
GSK Investigational Site
Tunuyan, Mendoza Province, 5560
GSK Investigational Site
Villanueva, Mendoza Province, 5521
Colombia3 sites
GSK Investigational Site
Bogotá, 805
GSK Investigational Site
Cali
GSK Investigational Site
Cali Colombia
Dominican Republic2 sites
GSK Investigational Site
Santo Domingo
GSK Investigational Site
Santo Domingo, Distrito Nacional, Sant Dom- Distrito Nacional
Panama2 sites
GSK Investigational Site
David, Chiriquí Province, Panamá 937, David
GSK Investigational Site
Panama City
Brazil1 site
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: A Multi-country & Multi-center Study to Assess the Efficacy, Immunogenicity & Safety of Two Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants
The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age.
Read the detailed description
The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-12 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine EPI vaccinations are given at the discretion of the investigator and according to local National Plans of Immunisation schedule in each participating country.
- Conditions
- Infections, Rotavirus
- Being tested
- 2-dose oral live attenuated G1P[8] human rotavirus vaccine
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-dose oral live attenuated G1P[8] human rotavirus vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until 1 year old.
Secondary outcomes (1)
Vaccine efficacy against severe rotavirus gastroenteritis by serotypes until 1 year of age; Safety; Immunogenicity of HRV and co-administered EPI vaccines
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2005 (estimated)
- Study startDec 2003
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Double blind
- Enrolment
- 6,360 participants
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
- NCT00139347
- Sponsor's protocol ID
- 444563/024
- Status last verified
- Oct 2016
- First submitted
- 30 Aug 2005
- Last updated
- 28 Oct 2016
- Results posted
- No
- 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.
Publications
Gonzalez Ayala et al. Co-administration with rotavirus vaccine rix4414 (rotarix™) does not interfere with the immunogenicity of oral polio vaccine (OPV). Poster presented at WSPID Bangkok, Thailand, 15-18 Nov 2007.
Lopez P et al. Immunogenicity of an Oral Polio Vaccine is Unaffected when Co-Administered with a Human Rotavirus Vaccine RIX4414 (Rotarix™) in Latin America. Poster presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008.
Tregnaghi MW, Abate HJ, Valencia A, Lopez P, Da Silveira TR, Rivera L, Rivera Medina DM, Saez-Llorens X, Gonzalez Ayala SE, De Leon T, Van Doorn LJ, Pilar Rubio MD, Suryakiran PV, Casellas JM, Ortega-Barria E, Smolenov IV, Han HH; Rota-024 Study Group. Human rotavirus vaccine is highly efficacious when coadministered with routine expanded program of immunization vaccines including oral poliovirus vaccine in Latin America. Pediatr Infect Dis J. 2011 Jun;30(6):e103-8. doi: 10.1097/INF.0b013e3182138278.
PubMed 21378594Tregnaghi M et al. Oral Human Rotavirus Vaccine RIX4414(Rotarix™) Co-administered with Routine EPI Vaccinations Including Oral Polio Vaccine(OPV) Is Highly Efficacious in Latin-America. Poster presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008.
Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, Abate H, Breuer T, Clemens SC, Cheuvart B, Espinoza F, Gillard P, Innis BL, Cervantes Y, Linhares AC, Lopez P, Macias-Parra M, Ortega-Barria E, Richardson V, Rivera-Medina DM, Rivera L, Salinas B, Pavia-Ruz N, Salmeron J, Ruttimann R, Tinoco JC, Rubio P, Nunez E, Guerrero ML, Yarzabal JP, Damaso S, Tornieporth N, Saez-Llorens X, Vergara RF, Vesikari T, Bouckenooghe A, Clemens R, De Vos B, O'Ryan M; Human Rotavirus Vaccine Study Group. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006 Jan 5;354(1):11-22. doi: 10.1056/NEJMoa052434.
PubMed 16394298
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-country & Multi-center Study to Assess the Efficacy, Immunogenicity & Safety of Two Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants
- ClinicalTrials.gov ID
- NCT00139347
- Acronym / sponsor ID
- 444563/024
- Conditions
- Infections, Rotavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6,360 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 31 Aug 2005 (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.
The main objectives of this study is to determine vaccine efficacy against severe rotavirus (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year of age.
Detailed description
The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy infants who are 6-12 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month schedule. Routine EPI vaccinations are given at the discretion of the investigator and according to local National Plans of Immunisation schedule in each participating country.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy infants 6 -12 weeks old at Dose 1 with written informed consent.
Key exclusion criteria (3 listed)
- Allergic reaction to vaccine components;
- clinically significant history of chronic GI disease (uncorrected GI congenital malformation) or other serious medical condition per investigator, received vaccines or treatment prohibited by the protocol;
- immunocompromised.
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 |
|---|---|---|
| 2-dose oral live attenuated G1P[8] human rotavirus vaccine | Biological | – |
Primary outcome
Occurrence of severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until 1 year old.
1 secondary outcome
Vaccine efficacy against severe rotavirus gastroenteritis by serotypes until 1 year of age; Safety; Immunogenicity of HRV and co-administered EPI vaccines
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 28 Oct 2016.
- BackgroundGonzalez Ayala et al. Co-administration with rotavirus vaccine rix4414 (rotarix™) does not interfere with the immunogenicity of oral polio vaccine (OPV). Poster presented at WSPID Bangkok, Thailand, 15-18 Nov 2007.
- BackgroundLopez P et al. Immunogenicity of an Oral Polio Vaccine is Unaffected when Co-Administered with a Human Rotavirus Vaccine RIX4414 (Rotarix™) in Latin America. Poster presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008.
- Background: PubMed 21378594Tregnaghi MW, Abate HJ, Valencia A, Lopez P, Da Silveira TR, Rivera L, Rivera Medina DM, Saez-Llorens X, Gonzalez Ayala SE, De Leon T, Van Doorn LJ, Pilar Rubio MD, Suryakiran PV, Casellas JM, Ortega-Barria E, Smolenov IV, Han HH; Rota-024 Study Group. Human rotavirus vaccine is highly efficacious when coadministered with routine expanded program of immunization vaccines including oral poliovirus vaccine in Latin America. Pediatr Infect Dis J. 2011 Jun;30(6):e103-8. doi: 10.1097/INF.0b013e3182138278.
- BackgroundTregnaghi M et al. Oral Human Rotavirus Vaccine RIX4414(Rotarix™) Co-administered with Routine EPI Vaccinations Including Oral Polio Vaccine(OPV) Is Highly Efficacious in Latin-America. Poster presented at the 13th International Congress on Infectious Diseases (ICID), Kuala Lumpur, Malaysia, 19-22 June 2008.
- Derived from this study: PubMed 16394298Ruiz-Palacios GM, Perez-Schael I, Velazquez FR, Abate H, Breuer T, Clemens SC, Cheuvart B, Espinoza F, Gillard P, Innis BL, Cervantes Y, Linhares AC, Lopez P, Macias-Parra M, Ortega-Barria E, Richardson V, Rivera-Medina DM, Rivera L, Salinas B, Pavia-Ruz N, Salmeron J, Ruttimann R, Tinoco JC, Rubio P, Nunez E, Guerrero ML, Yarzabal JP, Damaso S, Tornieporth N, Saez-Llorens X, Vergara RF, Vesikari T, Bouckenooghe A, Clemens R, De Vos B, O'Ryan M; Human Rotavirus Vaccine Study Group. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med. 2006 Jan 5;354(1):11-22. doi: 10.1056/NEJMoa052434.
- 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
17 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 2-dose oral live attenuated G1P[8] human rotavirus vaccine in people with Infections, Rotavirus, run by GlaxoSmithKline at 17 sites in 6 countries.
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 1 inclusion and 3 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 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Argentina, Colombia, Dominican Republic, Panama, Brazil and 1 more country. 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.
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?
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 severe RV GE caused by the wild RV strains during the period starting from 2 weeks after Dose 2 until 1 year old.. 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 NCT00139347, which also lists 5 linked publications.
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 Oct 2016.