VomitingPhase 3NCT00362648
Developing World Study for RotaTeq™ (V260-015)(COMPLETED)
A Phase 3 study testing RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent in people with Vomiting and Diarrhea, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries. Read more about this study
- Who is it for?
- Ages 4 to 12 weeksHealthy volunteers can take part
- 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
- 7,504 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Mar 2009
- 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 4 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 4 weeks through 12 weeks at Dose 1
- Parent able to understand study procedures and give consent
Who cannot join
- Clinical evidence of active gastrointestinal disease
- Subjects who are currently or expected to participate in other studies of investigational products during the 6 weeks after receiving the last dose of RotaTeq™/placebo
About this study
Official title: Efficacy, Safety, and Immunogenicity of RotaTeq™ Among Infants in Asia and Africa
The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.
- Being tested
- RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent, Comparator: Placebo
- Medical subject headings
- Vomiting, Diarrhea, Fever
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 RotaTeq™, V260
2.0 mL oral dose of RotaTeq™. 14 week treatment period
Comparator: PlaceboBiological
Arm 2: Placebo. 14 week treatment period
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | RotaTeq™ Receives: Biological: RotaTeq™ - 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.
Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose
Measured: At least 14 days following the third vaccination
Secondary outcomes (2)
Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)
Measured: 14 days following the 3rd vaccination
Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Induction of postdose 3 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 posted10 Aug 2006 (estimated)
- Study startMar 2007
- Primary completionMar 2009
- Study completionMar 2009
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 (4)Papers the sponsor has linked to this study.
- Other trials for VomitingStudies 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
- 7,504 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
- NCT00362648
- Sponsor's protocol ID
- V260-015
- Other IDs
- 2006_027
- Status last verified
- Mar 2017
- First submitted
- 8 Aug 2006
- Last updated
- 13 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
Publications
Gruber JF, Becker-Dreps S, Hudgens MG, Brookhart MA, Thomas JC, Jonsson Funk M. Timing and predictors of severe rotavirus gastroenteritis among unvaccinated infants in low- and middle-income countries. Epidemiol Infect. 2018 Apr;146(6):698-704. doi: 10.1017/S0950268818000626. Epub 2018 Mar 22.
PubMed 29564996Gruber JF, Hille DA, Liu GF, Kaplan SS, Nelson M, Goveia MG, Mast TC. Heterogeneity of Rotavirus Vaccine Efficacy Among Infants in Developing Countries. Pediatr Infect Dis J. 2017 Jan;36(1):72-78. doi: 10.1097/INF.0000000000001362.
PubMed 27755463Zaman K, Dang DA, Victor JC, Shin S, Yunus M, Dallas MJ, Podder G, Vu DT, Le TP, Luby SP, Le HT, Coia ML, Lewis K, Rivers SB, Sack DA, Schodel F, Steele AD, Neuzil KM, Ciarlet M. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Aug 21;376(9741):615-23. doi: 10.1016/S0140-6736(10)60755-6. Epub 2010 Aug 6.
PubMed 20692031Armah GE, Sow SO, Breiman RF, Dallas MJ, Tapia MD, Feikin DR, Binka FN, Steele AD, Laserson KF, Ansah NA, Levine MM, Lewis K, Coia ML, Attah-Poku M, Ojwando J, Rivers SB, Victor JC, Nyambane G, Hodgson A, Schodel F, Ciarlet M, Neuzil KM. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Aug 21;376(9741):606-14. doi: 10.1016/S0140-6736(10)60889-6. Epub 2010 Aug 6.
PubMed 20692030
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety, and Immunogenicity of RotaTeq™ Among Infants in Asia and Africa
- ClinicalTrials.gov ID
- NCT00362648
- Acronym / sponsor ID
- V260-015
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,504 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 10 Aug 2006 (estimated)
- Results
- Posted 13 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.
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: RotaTeq™ - Rotavirus Vaccine, Live, Oral, PentavalentRotaTeq™ |
| 2 | Placebo comparator | Biological: Comparator: PlaceboPlacebo |
Who may qualify
- Ages
- 4 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age 4 weeks through 12 weeks at Dose 1
- Parent able to understand study procedures and give consent
Key exclusion criteria (2 listed)
- Clinical evidence of active gastrointestinal disease
- Subjects who are currently or expected to participate in other studies of investigational products during the 6 weeks after receiving the last dose of RotaTeq™/placebo
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: RotaTeq™, V2602.0 mL oral dose of RotaTeq™. 14 week treatment period | Biological | 1 |
| Comparator: PlaceboArm 2: Placebo. 14 week treatment period | Biological | 2 |
Primary outcome
Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose
Time frame: At least 14 days following the third vaccination
2 secondary outcomes
Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
Time frame: 14 days following the 3rd vaccination
Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]
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 13 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29564996Gruber JF, Becker-Dreps S, Hudgens MG, Brookhart MA, Thomas JC, Jonsson Funk M. Timing and predictors of severe rotavirus gastroenteritis among unvaccinated infants in low- and middle-income countries. Epidemiol Infect. 2018 Apr;146(6):698-704. doi: 10.1017/S0950268818000626. Epub 2018 Mar 22.
- Derived from this study: PubMed 27755463Gruber JF, Hille DA, Liu GF, Kaplan SS, Nelson M, Goveia MG, Mast TC. Heterogeneity of Rotavirus Vaccine Efficacy Among Infants in Developing Countries. Pediatr Infect Dis J. 2017 Jan;36(1):72-78. doi: 10.1097/INF.0000000000001362.
- Derived from this study: PubMed 20692031Zaman K, Dang DA, Victor JC, Shin S, Yunus M, Dallas MJ, Podder G, Vu DT, Le TP, Luby SP, Le HT, Coia ML, Lewis K, Rivers SB, Sack DA, Schodel F, Steele AD, Neuzil KM, Ciarlet M. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Aug 21;376(9741):615-23. doi: 10.1016/S0140-6736(10)60755-6. Epub 2010 Aug 6.
- Derived from this study: PubMed 20692030Armah GE, Sow SO, Breiman RF, Dallas MJ, Tapia MD, Feikin DR, Binka FN, Steele AD, Laserson KF, Ansah NA, Levine MM, Lewis K, Coia ML, Attah-Poku M, Ojwando J, Rivers SB, Victor JC, Nyambane G, Hodgson A, Schodel F, Ciarlet M, Neuzil KM. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: a randomised, double-blind, placebo-controlled trial. Lancet. 2010 Aug 21;376(9741):606-14. doi: 10.1016/S0140-6736(10)60889-6. Epub 2010 Aug 6.
- Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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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 Vomiting and Diarrhea, 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 2 inclusion and 2 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 13 Apr 2017. 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 13 May 2010). 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?
Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose (time frame: At least 14 days following the third 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 NCT00362648, which also lists 4 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 13 Apr 2017.