Rotavirus InfectionsPhase 3NCT00092443
Dose Confirmation Efficacy Study (V260-007)
A Phase 3 study testing RotaTeq™, rotavirus vaccine, live, oral, pentavalent in people with Rotavirus Infections, run by Merck Sharp & Dohme LLC.
Trial summary
This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis. Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Infections
- What is being tested?
- RotaTeq™, rotavirus vaccine, live, oral, pentavalent
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,312 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Jun 2004
- 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 6 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants
Who cannot join
- History of abdominal disorders from a birth defect, intussusception, or abdominal surgery
- Known or suspected problems with immune system
- Fever at time of immunization
- Prior administration of a rotavirus vaccine
- History of known prior rotavirus disease
- Chronic diarrhea, or failure to thrive
About this study
Official title: Study of the Efficacy, Safety, and Immunogenicity of V260 at Expiry
This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.
Read the detailed description
The duration of treatment is 10 months.
- Conditions
- Rotavirus Infections
- Being tested
- RotaTeq™, rotavirus vaccine, live, oral, pentavalent, Comparator: Placebo matching RotaTeq™
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RotaTeq™, rotavirus vaccine, live, oral, pentavalentBiological
Also called V260
Three doses of RotaTeq™ administered 28 to 70 days apart.
Comparator: Placebo matching RotaTeq™Biological
Placebo matching RotaTeq™ administered 28 to 70 days apart.
| Study group | Role | What they receive |
|---|---|---|
| RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | Experimental | Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent)
administered 28 to 70 days apart. Receives: Biological: RotaTeq™, rotavirus vaccine, live, oral, pentavalent |
| Placebo matching RotaTeq™ | Placebo comparator | Placebo matching RotaTeq™ administered 28 to 70 days apart. Receives: Biological: Comparator: Placebo matching RotaTeq™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose.
G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition
Measured: At least 14 days following the 3rd vaccination
Secondary outcomes (1)
Number of Subjects With ≥3 Fold Rise in Antibody Titer
Induction of postdose 3 rotavirus Serum neutralizing antibody (SNA) response (Number of subjects with ≥3 fold rise in antibody titer)
Measured: 14 days following the 3rd vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2004 (estimated)
- Study startSep 2002
- Primary completionJun 2004
- Study completionJun 2004
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotavirus InfectionsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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
- Who is masked
- Participant, Investigator
- Enrolment
- 1,312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00092443
- Sponsor's protocol ID
- V260-007
- Other IDs
- 2004_077
- Status last verified
- Sep 2015
- First submitted
- 22 Sep 2004
- Last updated
- 14 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Block SL, Vesikari T, Goveia MG, Rivers SB, Adeyi BA, Dallas MJ, Bauder J, Boslego JW, Heaton PM; Pentavalent Rotavirus Vaccine Dose Confirmation Efficacy Study Group. Efficacy, immunogenicity, and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine at the end of shelf life. Pediatrics. 2007 Jan;119(1):11-8. doi: 10.1542/peds.2006-2058.
PubMed 17200266
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy, Safety, and Immunogenicity of V260 at Expiry
- ClinicalTrials.gov ID
- NCT00092443
- Acronym / sponsor ID
- V260-007
- Conditions
- Rotavirus Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,312 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Jun 2004 (actual)
- Study completion
- Jun 2004 (actual)
- First posted
- 27 Sep 2004 (estimated)
- Results
- Posted 10 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.
Detailed description
The duration of treatment is 10 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) | Experimental | Biological: RotaTeq™, rotavirus vaccine, live, oral, pentavalentThree doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart. |
| Placebo matching RotaTeq™ | Placebo comparator | Biological: Comparator: Placebo matching RotaTeq™Placebo matching RotaTeq™ administered 28 to 70 days apart. |
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy infants
Key exclusion criteria (6 listed)
- History of abdominal disorders from a birth defect, intussusception, or abdominal surgery
- Known or suspected problems with immune system
- Fever at time of immunization
- Prior administration of a rotavirus vaccine
- History of known prior rotavirus disease
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 |
|---|---|---|
| RotaTeq™, rotavirus vaccine, live, oral, pentavalentAlso: V260Three doses of RotaTeq™ administered 28 to 70 days apart. | Biological | RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose) |
| Comparator: Placebo matching RotaTeq™Placebo matching RotaTeq™ administered 28 to 70 days apart. | Biological | Placebo matching RotaTeq™ |
Primary outcome
Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose.
Time frame: At least 14 days following the 3rd vaccination
G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition
1 secondary outcome
Number of Subjects With ≥3 Fold Rise in Antibody Titer
Time frame: 14 days following the 3rd vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17200266Block SL, Vesikari T, Goveia MG, Rivers SB, Adeyi BA, Dallas MJ, Bauder J, Boslego JW, Heaton PM; Pentavalent Rotavirus Vaccine Dose Confirmation Efficacy Study Group. Efficacy, immunogenicity, and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine at the end of shelf life. Pediatrics. 2007 Jan;119(1):11-8. doi: 10.1542/peds.2006-2058.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RotaTeq™, rotavirus vaccine, live, oral, pentavalent in people with Rotavirus Infections, run by Merck Sharp & Dohme LLC.
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 6 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 14 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
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 10 Jul 2009). 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?
Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose. (time frame: At least 14 days following the 3rd 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 NCT00092443, 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 14 Sep 2015; AzTrials last refreshed its copy on 30 Oct 2026.