Infections, RotavirusPhase 3NCT00334607
Study of 2 Doses of HRV Vaccine Given Concomitantly or Separately With Routine Vaccinations in Healthy Infants in USA
A Phase 3 study testing 2-dose oral live attenuated G1P[8] human rotavirus vaccine in people with Infections, Rotavirus, run by GlaxoSmithKline at 42 sites in United States.
Trial summary
The aim of this this study is to confirm absence of immune interference between HRV vaccine and routine infant vaccinations currently in use in the USA. Read more about this study
- Who is it for?
- Ages 6 to 16 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
- 484 participants
- Where
- 42 sitesUnited States
- Study dates
- Jun 2006to Jun 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 16 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
42 sites in 1 country.
42 sites in 1 country
United States42 sites
GSK Investigational Site
Akron, Ohio, 44304
GSK Investigational Site
Benton, Arkansas, 72015
GSK Investigational Site
Boardman, Ohio, 44512
GSK Investigational Site
Bristol, Tennessee, 37620
GSK Investigational Site
Bryan, Texas, 77802
GSK Investigational Site
Bryson City, North Carolina, 28713
GSK Investigational Site
Cabot, Arkansas, 72023
GSK Investigational Site
Charleston, South Carolina, 29407
GSK Investigational Site
Charleston, South Carolina, 29412
GSK Investigational Site
Charlottesville, Virginia, 22911
GSK Investigational Site
Clyde, North Carolina, 28721
GSK Investigational Site
Commerce Twp, Michigan, 48382
GSK Investigational Site
Dayton, Ohio, 45406
GSK Investigational Site
Deerfield, North Carolina, 28607
GSK Investigational Site
DeKalb, Illinois, 60115
GSK Investigational Site
East Providence, Rhode Island, 02914
GSK Investigational Site
Englewood, Colorado, 80112
GSK Investigational Site
Franklin, North Carolina, 28734
GSK Investigational Site
Houston, Texas, 77074
GSK Investigational Site
Jonesboro, Arkansas, 72401
GSK Investigational Site
Kingsport, Tennessee, 37660
GSK Investigational Site
Lakewood, California, 90711
GSK Investigational Site
Laurinburg, North Carolina, 28352
GSK Investigational Site
Layton, Utah, 84041
GSK Investigational Site
Lebanon, New Hampshire, 03756
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Marshfield, Wisconsin, 54449
GSK Investigational Site
North Charleston, South Carolina, 29405
GSK Investigational Site
North Little Rock, Arkansas, 72117
GSK Investigational Site
Ogden, Utah, 84405
GSK Investigational Site
Orem, Utah, 84057
GSK Investigational Site
Overland Park, Kansas, 66202
GSK Investigational Site
Paramount, California, 90723
GSK Investigational Site
Pasadena, California, 91107
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Providence, Rhode Island, 02903
GSK Investigational Site
Provo, Utah, 84604
GSK Investigational Site
South Jordan, Utah, 84095
GSK Investigational Site
West Jordan, Utah, 84088
GSK Investigational Site
Winston-Salem, North Carolina, 27103
GSK Investigational Site
Youngstown, Ohio, 44505
GSK Investigational Site
Youngstown, Ohio, 44514
About this study
Official title: Assess the Immunogenicity of 3 Doses of Pediarix®, Prevnar® & ActHIB® Given to Healthy Infants When Administered With GSK Biologicals' 2 Dose Oral Live Attenuated Human Rotavirus Vaccine Given During the Same Vaccination Visit or Separately
The aim of this this study is to confirm absence of immune interference between HRV vaccine and routine infant vaccinations currently in use in the USA.
Read the detailed description
A phase III randomized multi-center study to assess the immunogenicity of three doses of Pediarix®, Prevnar® and ActHIB® given to healthy infants at 2, 4 and 6 months of age when administered with GlaxoSmithKline (GSK) Biologicals' two-dose oral live attenuated human rotavirus (HRV) vaccine given during the same vaccination visit (at 2 and 4 months of age) or given separately (at 3 and 5 months of age).
- Conditions
- Infections, Rotavirus
- Being tested
- 2-dose oral live attenuated G1P[8] human rotavirus vaccine
- Keywords
- HRV vaccine, diarrhoea, rotavirus
- Medical subject headings
- Rotavirus Infections, Diarrhea
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.
Demonstrate that coadministration with HRV vaccine does not impair the immune response to all antigens contained in each of the routine infant vaccines.
Secondary outcomes (1)
Assess immunogenicity and safety of HRV vaccine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionFeb 2007
- Study completionJun 2007
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 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
- 484 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
- NCT00334607
- Sponsor's protocol ID
- 107531
- Status last verified
- Nov 2016
- First submitted
- 7 Jun 2006
- Last updated
- 4 Nov 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
Dennehy PH, Bertrand HR, Silas PE, Damaso S, Friedland LR, Abu-Elyazeed R. Coadministration of RIX4414 oral human rotavirus vaccine does not impact the immune response to antigens contained in routine infant vaccines in the United States. Pediatrics. 2008 Nov;122(5):e1062-6. doi: 10.1542/peds.2008-1059.
PubMed 18977955
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess the Immunogenicity of 3 Doses of Pediarix®, Prevnar® & ActHIB® Given to Healthy Infants When Administered With GSK Biologicals' 2 Dose Oral Live Attenuated Human Rotavirus Vaccine Given During the Same Vaccination Visit or Separately
- ClinicalTrials.gov ID
- NCT00334607
- Acronym / sponsor ID
- 107531
- Conditions
- Infections, Rotavirus
- Keywords
- HRV vaccine, diarrhoea, rotavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 8 Jun 2006 (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 aim of this this study is to confirm absence of immune interference between HRV vaccine and routine infant vaccinations currently in use in the USA.
Detailed description
A phase III randomized multi-center study to assess the immunogenicity of three doses of Pediarix®, Prevnar® and ActHIB® given to healthy infants at 2, 4 and 6 months of age when administered with GlaxoSmithKline (GSK) Biologicals' two-dose oral live attenuated human rotavirus (HRV) vaccine given during the same vaccination visit (at 2 and 4 months of age) or given separately (at 3 and 5 months of age).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 16 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
Demonstrate that coadministration with HRV vaccine does not impair the immune response to all antigens contained in each of the routine infant vaccines.
1 secondary outcome
Assess immunogenicity and safety of HRV vaccine.
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 Nov 2016.
- Background: PubMed 18977955Dennehy PH, Bertrand HR, Silas PE, Damaso S, Friedland LR, Abu-Elyazeed R. Coadministration of RIX4414 oral human rotavirus vaccine does not impact the immune response to antigens contained in routine infant vaccines in the United States. Pediatrics. 2008 Nov;122(5):e1062-6. doi: 10.1542/peds.2008-1059.
- 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
42 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 2-dose oral live attenuated G1P[8] human rotavirus vaccine in people with Infections, Rotavirus, run by GlaxoSmithKline at 42 sites in United States.
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 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States. 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?
Demonstrate that coadministration with HRV vaccine does not impair the immune response to all antigens contained in each of the routine infant vaccines.. 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 NCT00334607, 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 4 Nov 2016.