RotavirusPhase 3NCT00166517
V260 Registration Study (V260-013)(COMPLETED)
A Phase 3 study testing Rotavirus Vaccine, Live, Oral, Pentavalent in people with Rotavirus, run by Merck Sharp & Dohme LLC.
Trial summary
Immunogenicity and Safety of V260 in Healthy Infants in Korea Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Rotavirus
- What is being tested?
- 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
- 178 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Jul 2006
- 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
- At first study vaccination, age 6 weeks through exactly 12 weeks
Who cannot join
- History of congenital abdominal disorders, intussusception, or abdominal surgery
- History of known prior rotavirus disease
- Ongoing chronic diarrhea or failure to thrive
- Clinical evidence of active gastrointestinal illness
About this study
Official title: Immunogenicity and Safety of V260 in Healthy Infants in Korea
Immunogenicity and Safety of V260 in Healthy Infants in Korea
- Conditions
- Rotavirus
- Being tested
- Rotavirus Vaccine, Live, Oral, Pentavalent, Comparator: Placebo
- Keywords
- Gastrointestinal Rotavirus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotavirus Vaccine, Live, Oral, PentavalentBiological
3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2
Comparator: PlaceboBiological
3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | RotaTeq Receives: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent |
| 2 | Placebo comparator | Placebo Receives: Biological: Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Anti-Rotavirus IgA Response
Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in
Serum IgA 14 days Postdose 3
Measured: Baseline and 14 days Postdose 3
Secondary outcomes (1)
Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A
Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in
SNA response to G1, G2, G3, G4 and P1A 14 days Postdose 3
Measured: Baseline and 14 days Postdose 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionJul 2006
- Study completionJul 2006
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 RotavirusStudies 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
- 178 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
- NCT00166517
- Sponsor's protocol ID
- V260-013
- Other IDs
- 2005_071
- Status last verified
- Mar 2015
- First submitted
- 9 Sep 2005
- Last updated
- 1 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Kim DS, Lee TJ, Kang JH, Kim JH, Lee JH, Ma SH, Kim SY, Kim HM, Shin SM. Immunogenicity and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine in healthy infants in Korea. Pediatr Infect Dis J. 2008 Feb;27(2):177-8. doi: 10.1097/INF.0b013e31815aba79.
PubMed 18174862
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of V260 in Healthy Infants in Korea
- ClinicalTrials.gov ID
- NCT00166517
- Acronym / sponsor ID
- V260-013
- Conditions
- Rotavirus
- Keywords
- Gastrointestinal Rotavirus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Posted 23 Sep 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Immunogenicity and Safety of V260 in Healthy Infants in Korea
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Rotavirus Vaccine, Live, Oral, PentavalentRotaTeq |
| 2 | Placebo comparator | Biological: Comparator: PlaceboPlacebo |
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- At first study vaccination, age 6 weeks through exactly 12 weeks
Key exclusion criteria (4 listed)
- History of congenital abdominal disorders, intussusception, or abdominal surgery
- History of known prior rotavirus disease
- Ongoing chronic diarrhea or failure to thrive
- Clinical evidence of active gastrointestinal illness
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 |
|---|---|---|
| Rotavirus Vaccine, Live, Oral, Pentavalent3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2 | Biological | 1 |
| Comparator: Placebo3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2 | Biological | 2 |
Primary outcome
Serum Anti-Rotavirus IgA Response
Time frame: Baseline and 14 days Postdose 3
Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in Serum IgA 14 days Postdose 3
1 secondary outcome
Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A
Time frame: Baseline and 14 days Postdose 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18174862Kim DS, Lee TJ, Kang JH, Kim JH, Lee JH, Ma SH, Kim SY, Kim HM, Shin SM. Immunogenicity and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine in healthy infants in Korea. Pediatr Infect Dis J. 2008 Feb;27(2):177-8. doi: 10.1097/INF.0b013e31815aba79.
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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 Rotavirus Vaccine, Live, Oral, Pentavalent in people with Rotavirus, 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 4 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 1 Apr 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 23 Sep 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?
Serum Anti-Rotavirus IgA Response (time frame: Baseline and 14 days Postdose 3). 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 NCT00166517, 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 1 Apr 2015.