Rotavirus GastroenteritisPhase 3NCT01003431
A Study of the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine Administered Concomitantly With RotaTeq™ (V260) or Rotarix™ (V260-036)(WITHDRAWN)
A Phase 3 study testing Rotavirus Vaccine, Live, Oral, Pentavalent, Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP) and Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP) in people with Rotavirus Gastroenteritis and Diphtheria, run by Merck Sharp & Dohme LLC.
Trial summary
This study will evaluate the immunogenicity and safety of the pertussis component of DTwP (whole-cell pertussis containing vaccine) when administered concomitantly with RotaTeq™ or Rotatrix™. Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Gastroenteritis, Diphtheria, Tetanus
- What is being tested?
- Rotavirus Vaccine, Live, Oral, Pentavalent, Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP) and Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2009to Sep 2010
- 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 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants
Who cannot join
- History of abdominal disorders, intestinal folding, or abdominal surgery
- Impaired immune system
- Prior administration of any rotavirus vaccine or DTwP/DTaP
- Fever of >= 38.1C (100.5F) at the time of vaccination
- History of prior rotavirus infection, chronic diarrhea, or failure to thrive
- Evidence of active gastrointestinal illness
About this study
Official title: A Randomized, Open-Label Clinical Study to Assess the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine When Administered Concomitantly With RotaTeq™ or Rotarix™ in Healthy Infants in South Africa
This study will evaluate the immunogenicity and safety of the pertussis component of DTwP (whole-cell pertussis containing vaccine) when administered concomitantly with RotaTeq™ or Rotatrix™.
- Conditions
- Rotavirus Gastroenteritis, Diphtheria, Tetanus, Pertussis
- Being tested
- Rotavirus Vaccine, Live, Oral, Pentavalent, Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP), Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotavirus Vaccine, Live, Oral, PentavalentBiological
[Intervention name: RotaTeq™ administered concomitantly with Tritanrix™ HepB (DTwP)] Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB will be given at the same time with about 1 month between each administration.
Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP)Biological
Two 1.0 mL oral doses of Rotarix™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB will be given at the same time with about 1 month between each administration (the second administration will be Tritanrix™ HepB only).
Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)Biological
Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of INFANRIX™ will be given at the same time with about 1 month between each administration.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | RotaTeq™ + DTwP Receives: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent |
| 2 | Active comparator | Rotarix™ + DTwP Receives: Biological: Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP) |
| 3 | Active comparator | RotaTeq™ + DTaP Receives: Biological: Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titer (GMT) for Pertussis Toxoid
Measured: 1 month post dose 3
Secondary outcomes (1)
Geometric Mean Titer (GMT) for rotavirus serotypes G1, G2, G3, G4 and P1A
Measured: 1 month post dose 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startDec 2009
- Primary completionAug 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT01003431
- Sponsor's protocol ID
- V260-036
- Other IDs
- V260-036
- Status last verified
- Oct 2015
- First submitted
- 27 Oct 2009
- Last updated
- 9 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Clinical Study to Assess the Immunogenicity and Safety of Whole-Cell Pertussis Containing Vaccine When Administered Concomitantly With RotaTeq™ or Rotarix™ in Healthy Infants in South Africa
- ClinicalTrials.gov ID
- NCT01003431
- Acronym / sponsor ID
- V260-036
- Conditions
- Rotavirus Gastroenteritis, Diphtheria, Tetanus, Pertussis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 28 Oct 2009 (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.
This study will evaluate the immunogenicity and safety of the pertussis component of DTwP (whole-cell pertussis containing vaccine) when administered concomitantly with RotaTeq™ or Rotatrix™.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Rotavirus Vaccine, Live, Oral, PentavalentRotaTeq™ + DTwP |
| 2 | Active comparator | Biological: Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP)Rotarix™ + DTwP |
| 3 | Active comparator | Biological: Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)RotaTeq™ + DTaP |
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, intestinal folding, or abdominal surgery
- Impaired immune system
- Prior administration of any rotavirus vaccine or DTwP/DTaP
- Fever of >= 38.1C (100.5F) at the time of vaccination
- History of prior rotavirus infection, chronic diarrhea, or failure to thrive
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, Pentavalent[Intervention name: RotaTeq™ administered concomitantly with Tritanrix™ HepB (DTwP)] Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB will be given at the same time with about 1 month between each administration. | Biological | 1 |
| Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP)Two 1.0 mL oral doses of Rotarix™ and three 0.5 mL intramuscular injections of Tritanrix™ HepB will be given at the same time with about 1 month between each administration (the second administration will be Tritanrix™ HepB only). | Biological | 2 |
| Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP)Three 2.0 mL oral doses of RotaTeq™ and three 0.5 mL intramuscular injections of INFANRIX™ will be given at the same time with about 1 month between each administration. | Biological | 3 |
Primary outcome
Geometric Mean Titer (GMT) for Pertussis Toxoid
Time frame: 1 month post dose 3
1 secondary outcome
Geometric Mean Titer (GMT) for rotavirus serotypes G1, G2, G3, G4 and P1A
Time frame: 1 month post dose 3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2015.
Related trials for Rotavirus Gastroenteritis
RecruitingPhase 2
PhaseⅡClinical Trial of Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)
Rotavirus Gastroenteritis
Recruiting
Artificial Intelligence-driven Virtual Standardized Pediatric Patients Trial
Pneumococcal Pneumonia, Rotavirus Enteritis With Hypovolemic Shock
Active, not recruitingPhase 2
Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers
Rotavirus Infections, Rotavirus Gastroenteritis
Active, not recruitingPhase 4
Optimising Rotavirus Vaccine in Aboriginal Children
Viral Gastroenteritis Due to Rotavirus
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, Comparator: Rotarix™ administered concomitantly with Tritanrix™ HepB (DTwP) and Comparator: RotaTeq™ administered concomitantly with INFANRIX™ (DTaP) in people with Rotavirus Gastroenteritis and Diphtheria, 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: withdrawn, as of the sponsor's last update on 9 Oct 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Geometric Mean Titer (GMT) for Pertussis Toxoid (time frame: 1 month post dose 3). 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 9 Oct 2015.