Rotavirus GastroenteritisPhase 1NCT00953056
A Study of V260 in Healthy Chinese Adults, Children and Infants (V260-028)(COMPLETED)
A Phase 1 study testing Rotavirus Vaccine, Live, Oral, Pentavalent in people with Rotavirus Gastroenteritis, run by Merck Sharp & Dohme LLC.
Trial summary
This study will assess the safety and tolerability of RotaTeq™ (V260) in the healthy Chinese populations. Approximately 144 participants will be enrolled and equally stratified into three age cohorts, Cohort I ages 19-47 years, Cohort II ages 2-6 years, and Cohort III ages 6-12 weeks. Read more about this study
- Who is it for?
- Ages 6 weeks to 47 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Gastroenteritis
- 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
- 144 participants
- Where
- No sites listed yet
- Study dates
- Sep 2009to Mar 2010
- Phase
- Phase 1
- 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 weeks to 47 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy adults ages 19 to 47 years for Cohort I
- Healthy children ages 2 to 6 years for Cohort II
- Healthy infants ages 6 to 12 weeks for Cohort III
- Negative pregnancy test for females in Cohort I
- Signed Informed Consent Forms (ICFs)
Who cannot join
- Participants in Cohorts I and II receiving any vaccine 14 days before or anticipated after study vaccine
- Participants in Cohort III receiving non-concomitant live vaccines 14 days before or after study vaccine
- Prior administration of any rotavirus vaccine
- Elevated temperature, with axillary temperature ≥37.1 Degrees C 24 hours before study vaccine
- Prior or active gastrointestinal illnesses, immunodeficiency
- Any condition which may interfere with evaluation of study objectives or make participation in the study unsafe for the participant
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Safety and Tolerability Study of Live Pentavalent Human-Bovine Reassortant Rotavirus Vaccine in Chinese Healthy Adults, Children and Infants
This study will assess the safety and tolerability of RotaTeq™ (V260) in the healthy Chinese populations. Approximately 144 participants will be enrolled and equally stratified into three age cohorts, Cohort I ages 19-47 years, Cohort II ages 2-6 years, and Cohort III ages 6-12 weeks. Randomization ratio is 1:1 in each cohort. The study will be conducted sequentially, participants in Cohort I then Cohort II receiving 1 dose of, and then participants in Cohort III receiving 3 doses of RotaTeq™/placebo. The primary investigator and the Ethics Review Committee will review blinded safety data and make decision based on their best clinical judgment to move study forward between cohorts. Duration for the entire study will be approximately 6-9 months.
- Conditions
- Rotavirus Gastroenteritis
- Being tested
- Rotavirus Vaccine, Live, Oral, Pentavalent, Comparator: Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotavirus Vaccine, Live, Oral, PentavalentBiological
Also called V260, RotaTeq™
Single 2.0 mL dose V260 (RotaTeq™) administered orally at enrollment.
The 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses.
Comparator: PlaceboBiological
Single 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment.
Rotavirus Vaccine, Live, Oral, PentavalentBiological
Also called V260, RotaTeq™.
Three 2.0 mL doses of RotaTeq™ administered orally at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.
The 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses.
Comparator: PlaceboBiological
Three 2.0 mL doses of matching placebo to RotaTeq™ administered orally at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age.
| Study group | Role | What they receive |
|---|---|---|
| Cohort I - RotaTeq™, Adults | Experimental | Adults randomized to receive a single dose of RotaTeq™. Receives: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent |
| Cohort I - Placebo, Adults | Placebo comparator | Adults randomized to receive a single dose of matching placebo to RotaTeq™. Receives: Biological: Comparator: Placebo |
| Cohort II - RotaTeq™, Children | Experimental | Children randomized to receive a single dose of RotaTeq™. Receives: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent |
| Cohort II - Placebo, Children | Placebo comparator | Children randomized to receive a single dose of matching placebo to RotaTeq™. Receives: Biological: Comparator: Placebo |
| Cohort III - RotaTeq™, Infants | Experimental | Infants randomized to receive 3 doses of RotaTeq™. Receives: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent |
| Cohort III - Placebo, Infants | Placebo comparator | Infants randomized to receive 3 doses of matching placebo to RotaTeq™. Receives: Biological: Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Serious Adverse Events
All serious adverse events (SAEs) were collected for 14 days following each dose to obtain the number of participants with serious adverse events.
Measured: up to 14 days post vaccination
Number of Serious Adverse Events
The total number of serious adverse experiences (events) in participants up to 14 days post vaccination.
Measured: 14 days post vaccination
Secondary outcomes (1)
Number of Infants With Fecal Vaccine Virus Shedding
Fecal shedding of vaccine rotavirus in Cohort III (infants) was evaluated by determining the number of participants whose stool was positive by both (1) the Enzyme-linked Immunosorbent Assay (EIA) to detect the rotavirus antigen, and (2) PCR VP6 Genotyping (a polymerase chain reaction assay specific for rotavirus genome 6, coding for the VP6 protein of the vaccine virus). For analysis, two stool samples were collected per participant on separate days between Day 3 and Day 7 following each vaccination dose.
Measured: Between Day 3 and Day 7 following each of 3 doses of RotaTeq™/placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionMar 2010
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.
- Other trials for Rotavirus GastroenteritisStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 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
- NCT00953056
- Sponsor's protocol ID
- V260-028
- Other IDs
- 2009_627
- Status last verified
- Oct 2015
- First submitted
- 4 Aug 2009
- Last updated
- 2 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Safety and Tolerability Study of Live Pentavalent Human-Bovine Reassortant Rotavirus Vaccine in Chinese Healthy Adults, Children and Infants
- ClinicalTrials.gov ID
- NCT00953056
- Acronym / sponsor ID
- V260-028
- Conditions
- Rotavirus Gastroenteritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Posted 15 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety and tolerability of RotaTeq™ (V260) in the healthy Chinese populations. Approximately 144 participants will be enrolled and equally stratified into three age cohorts, Cohort I ages 19-47 years, Cohort II ages 2-6 years, and Cohort III ages 6-12 weeks. Randomization ratio is 1:1 in each cohort. The study will be conducted sequentially, participants in Cohort I then Cohort II receiving 1 dose of, and then participants in Cohort III receiving 3 doses of RotaTeq™/placebo. The primary investigator and the Ethics Review Committee will review blinded safety data and make decision based on their best clinical judgment to move study forward between cohorts. Duration for the entire study will be approximately 6-9 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort I - RotaTeq™, Adults | Experimental | Biological: Rotavirus Vaccine, Live, Oral, PentavalentAdults randomized to receive a single dose of RotaTeq™. |
| Cohort I - Placebo, Adults | Placebo comparator | Biological: Comparator: PlaceboAdults randomized to receive a single dose of matching placebo to RotaTeq™. |
| Cohort II - RotaTeq™, Children | Experimental | Biological: Rotavirus Vaccine, Live, Oral, PentavalentChildren randomized to receive a single dose of RotaTeq™. |
| Cohort II - Placebo, Children | Placebo comparator | Biological: Comparator: PlaceboChildren randomized to receive a single dose of matching placebo to RotaTeq™. |
| Cohort III - RotaTeq™, Infants | Experimental | Biological: Rotavirus Vaccine, Live, Oral, PentavalentInfants randomized to receive 3 doses of RotaTeq™. |
| Cohort III - Placebo, Infants | Placebo comparator | Biological: Comparator: PlaceboInfants randomized to receive 3 doses of matching placebo to RotaTeq™. |
Who may qualify
- Ages
- 6 weeks to 47 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Healthy adults ages 19 to 47 years for Cohort I
- Healthy children ages 2 to 6 years for Cohort II
- Healthy infants ages 6 to 12 weeks for Cohort III
- Negative pregnancy test for females in Cohort I
- Signed Informed Consent Forms (ICFs)
Key exclusion criteria (6 listed)
- Participants in Cohorts I and II receiving any vaccine 14 days before or anticipated after study vaccine
- Participants in Cohort III receiving non-concomitant live vaccines 14 days before or after study vaccine
- Prior administration of any rotavirus vaccine
- Elevated temperature, with axillary temperature ≥37.1 Degrees C 24 hours before study vaccine
- Prior or active gastrointestinal illnesses, immunodeficiency
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, PentavalentAlso: V260, RotaTeq™Single 2.0 mL dose V260 (RotaTeq™) administered orally at enrollment. The 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses. | Biological | Cohort I - RotaTeq™, Adults, Cohort II - RotaTeq™, Children |
| Comparator: PlaceboSingle 2.0 mL dose of matching placebo to RotaTeq™ administered orally at enrollment. | Biological | Cohort I - Placebo, Adults, Cohort II - Placebo, Children |
| Rotavirus Vaccine, Live, Oral, PentavalentAlso: V260, RotaTeq™.Three 2.0 mL doses of RotaTeq™ administered orally at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age. The 2-mL vaccine consists of an oral solution of 5 live human-bovine reassortant rotaviruses. | Biological | Cohort III - RotaTeq™, Infants |
| Comparator: PlaceboThree 2.0 mL doses of matching placebo to RotaTeq™ administered orally at 3 separate visits scheduled 28 to 70 days apart. The third dose was administered by 32 weeks of age. | Biological | Cohort III - Placebo, Infants |
Primary outcome
Number of Participants With Serious Adverse Events
Time frame: up to 14 days post vaccination
All serious adverse events (SAEs) were collected for 14 days following each dose to obtain the number of participants with serious adverse events.
Number of Serious Adverse Events
Time frame: 14 days post vaccination
The total number of serious adverse experiences (events) in participants up to 14 days post vaccination.
1 secondary outcome
Number of Infants With Fecal Vaccine Virus Shedding
Time frame: Between Day 3 and Day 7 following each of 3 doses of RotaTeq™/placebo
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 1 study testing Rotavirus Vaccine, Live, Oral, Pentavalent in people with Rotavirus Gastroenteritis, 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 5 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 2 Nov 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 15 Apr 2011). 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?
Number of Participants With Serious Adverse Events (time frame: up to 14 days post vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2015.