Rotavirus VaccinePhase 3NCT02193061
Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between RV5 and RV1 Using Seven Combined Anti-rotavirus Prevention Programs
A Phase 3 study testing Rotarix and RotaTeq in people with Rotavirus Vaccine, run by National Institute of Pediatrics, Mexico at 1 site in Mexico.
Trial summary
Assess the immunological behavior of children from 2 months of age that receive one out of seven anti-rotavirus vaccination programs: Group 1 (routine schedule with two doses of RV1 - Rotarix plus sterile water) and Group 2 (routine schedule with three doses of RV5 - RotaTeq) versus Group 3 (one dose of monovalent… Read more about this study
- Who is it for?
- Ages 6 to 10 weeksHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Vaccine
- What is being tested?
- Rotarix and RotaTeq
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,498 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2013to Nov 2017
- 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 10 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The subject is a boy or a girl 2 months ± one week old at the time of the first dose of the vaccine.
- The subject is considered to be healthy based on the clinical history and the physical examination.
- The subject has not received any anti-rotavirus vaccine.
- The parent/tutor fully understands the study's procedures and voluntarily accepts to participate and signs a written informed consent.
- The parent/tutor can meet the study's requirements, such as attending the programmed visits and filling in the journal.
- Written informed consent signed by the parent/tutor before any procedure.
Who cannot join
- The subject has a background of serious allergic reaction to any of the vaccine's components.
- The subject has a digestive tract malformation or acute/chronic disease.
- The subject has some kind of immunodeficiency including HIV.
- The subject suffers from a haemato-oncological disease.
- The subject has been under treatment with an immunosuppressing medicine including prednisone for two or more weeks.
- The subject has received gamma-globulin or any other blood-derived product or its administration is programmed during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between Rota Vaccine 5 and Rota Vaccine 1 Using Seven Combined Anti-rotavirus Prevention Programs: ROTA 1,ROTA 2,ROTA 3,ROTA 4,ROTA 5,ROTA 6,ROTA 7 in Infants at 2, 4 and 6 Months of Age in Mexico City.
Assess the immunological behavior of children from 2 months of age that receive one out of seven anti-rotavirus vaccination programs: Group 1 (routine schedule with two doses of RV1 - Rotarix plus sterile water) and Group 2 (routine schedule with three doses of RV5 - RotaTeq) versus Group 3 (one dose of monovalent vaccine followed by two doses of pentavalent vaccine), Group 4 (one dose of pentavalent vaccine followed by two doses of monovalent vaccine), Group 5 (two doses of pentavalent vaccine followed by a dose of monovalent vaccine), Group 6 (one dose of pentavalent vaccine followed by a dose of monovalent vaccine and a dose of pentavalent vaccine), and Group 7 (a dose of monovalent vaccine followed by a dose of pentavalent vaccine and a dose of monovalent vaccine) in children from Mexico City.
Secondary objectives
Read more
- To describe number and features of acute diarrheal disease (ADD) due to rotavirus displayed in the seven prevention schedules.
- To describe the adverse events temporarily associated with the seven prevention schedules.
Hypotheses The seroconversion percentages and geometric mean titers (GMT) of anti-rotavirus antibodies from Groups 3, 4, 5, 6 and 7 are not inferior to the seroconversion percentages and the GMTs induced in subjects that received the routine vaccination schedules with two doses of the monovalent vaccine and three doses of the pentavalent vaccine (Groups 1 and 2).
Read the detailed description
In this protocol we included 1498 at 6 to 8 weeks of age with a second visit at 2 months, a third visit at 4months four visit at 5 months after the first vaccination, ( 1st, second and 3erd visits for vaccine administration) phone calls every month and not schedule visits at the center when parents required and the last protocol visit was at one year of age This follow up to one year was to access security.
- Conditions
- Rotavirus Vaccine
- Being tested
- Rotarix, RotaTeq
- Keywords
- Rotavirus, immunological behavior, Rotarix, RotaTeq, vaccine interchangeability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RotarixBiological
RotaTeqBiological
| Study group | Role | What they receive |
|---|---|---|
| ROTA 1 | Active comparator | two doses of monovalent vaccine Rotarix followed by one dose of sterile water Receives: Biological: Rotarix |
| ROTA 2 | Active comparator | three doses of pentavalent vaccine RotaTeq Receives: Biological: RotaTeq |
| ROTA 3 | Active comparator | one dose of monovalent Rotarix vaccine followed by two doses of pentavalent vaccine Rotateq Receives: Biological: Rotarix; Biological: RotaTeq |
| ROTA 4 | Active comparator | one dose of pentavalent RotaTeq vaccine followed by two doses of monovalent vaccine Rotarix Receives: Biological: Rotarix; Biological: RotaTeq |
| ROTA 5 | Active comparator | two doses of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix Receives: Biological: Rotarix; Biological: RotaTeq |
| ROTA 6 | Active comparator | one dose of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix and a dose of pentavalent vaccine RotaTeq Receives: Biological: Rotarix; Biological: RotaTeq |
| ROTA 7 | Active comparator | a dose of monovalent vaccine Rotarix followed by a dose of pentavalent vaccine and a dose of monovalent vaccine Rotarix Receives: Biological: Rotarix; Biological: RotaTeq |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Symptoms - Temperature
The subject temperature will be registered with a rectal thermometer during 5 days since the vaccination day in a diary card .
If the subject presents fever, the temperature will be recorded in a specific diary card section.
Measured: subsequent 5 days since the vaccination day
Secondary outcomes (1)
Evacuation
The number of evacuations per day and their characteristics will be registered in a diary card
Measured: subsequent 30 days since the vaccination day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startNov 2013
- Primary completionJun 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotavirus VaccineStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,498 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Pediatrics, Mexico
- Sponsor type
- Other government
- Collaborators
- Centro Nacional para la Salud de la Infancia y la Adolescencia, Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Mercedes Macias Parra, National Institute of Pediatrics, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193061
- Sponsor's protocol ID
- Rota/CeNSIA
- Status last verified
- Aug 2018
- First submitted
- 7 Jul 2014
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Macias-Parra M, Vidal-Vazquez P, Reyna-Figueroa J, Rodriguez-Weber MA, Moreno-Macias H, Hernandez-Benavides I, Fortes-Gutierrez S, Richardson VL, Vazquez-Cardenas P. Immunogenicity of RV1 and RV5 vaccines administered in standard and interchangeable mixed schedules: a randomized, double-blind, non-inferiority clinical trial in Mexican infants. Front Public Health. 2024 Feb 23;12:1356932. doi: 10.3389/fpubh.2024.1356932. eCollection 2024.
PubMed 38463163
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Single-blind Clinical Study to Assess Vaccine Interchangeability Between Rota Vaccine 5 and Rota Vaccine 1 Using Seven Combined Anti-rotavirus Prevention Programs: ROTA 1,ROTA 2,ROTA 3,ROTA 4,ROTA 5,ROTA 6,ROTA 7 in Infants at 2, 4 and 6 Months of Age in Mexico City.
- ClinicalTrials.gov ID
- NCT02193061
- Acronym / sponsor ID
- Rota/CeNSIA
- Conditions
- Rotavirus Vaccine
- Keywords
- Rotavirus, immunological behavior, Rotarix, RotaTeq, vaccine interchangeability
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,498 participants (actual)
- Lead sponsor
- National Institute of Pediatrics, MexicoOther government
- Collaborators
- Centro Nacional para la Salud de la Infancia y la Adolescencia, Merck Sharp & Dohme LLC
- Study start
- Nov 2013 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 17 Jul 2014 (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.
Assess the immunological behavior of children from 2 months of age that receive one out of seven anti-rotavirus vaccination programs: Group 1 (routine schedule with two doses of RV1 - Rotarix plus sterile water) and Group 2 (routine schedule with three doses of RV5 - RotaTeq) versus Group 3 (one dose of monovalent vaccine followed by two doses of pentavalent vaccine), Group 4 (one dose of pentavalent vaccine followed by two doses of monovalent vaccine), Group 5 (two doses of pentavalent vaccine followed by a dose of monovalent vaccine), Group 6 (one dose of pentavalent vaccine followed by a dose of monovalent vaccine and a dose of pentavalent vaccine), and Group 7 (a dose of monovalent vaccine followed by a dose of pentavalent vaccine and a dose of monovalent vaccine) in children from Mexico City.
Secondary objectives
- To describe number and features of acute diarrheal disease (ADD) due to rotavirus displayed in the seven prevention schedules.
- To describe the adverse events temporarily associated with the seven prevention schedules.
Hypotheses The seroconversion percentages and geometric mean titers (GMT) of anti-rotavirus antibodies from Groups 3, 4, 5, 6 and 7 are not inferior to the seroconversion percentages and the GMTs induced in subjects that received the routine vaccination schedules with two doses of the monovalent vaccine and three doses of the pentavalent vaccine (Groups 1 and 2).
Detailed description
In this protocol we included 1498 at 6 to 8 weeks of age with a second visit at 2 months, a third visit at 4months four visit at 5 months after the first vaccination, ( 1st, second and 3erd visits for vaccine administration) phone calls every month and not schedule visits at the center when parents required and the last protocol visit was at one year of age This follow up to one year was to access security.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| ROTA 1 | Active comparator | Biological: Rotarixtwo doses of monovalent vaccine Rotarix followed by one dose of sterile water |
| ROTA 2 | Active comparator | Biological: RotaTeqthree doses of pentavalent vaccine RotaTeq |
| ROTA 3 | Active comparator | Biological: Rotarix, Biological: RotaTeqone dose of monovalent Rotarix vaccine followed by two doses of pentavalent vaccine Rotateq |
| ROTA 4 | Active comparator | Biological: Rotarix, Biological: RotaTeqone dose of pentavalent RotaTeq vaccine followed by two doses of monovalent vaccine Rotarix |
| ROTA 5 | Active comparator | Biological: Rotarix, Biological: RotaTeqtwo doses of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix |
| ROTA 6 | Active comparator | Biological: Rotarix, Biological: RotaTeqone dose of pentavalent vaccine RotaTeq followed by a dose of monovalent vaccine Rotarix and a dose of pentavalent vaccine RotaTeq |
| ROTA 7 | Active comparator | Biological: Rotarix, Biological: RotaTeqa dose of monovalent vaccine Rotarix followed by a dose of pentavalent vaccine and a dose of monovalent vaccine Rotarix |
Who may qualify
- Ages
- 6 to 10 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The subject is a boy or a girl 2 months ± one week old at the time of the first dose of the vaccine.
- The subject is considered to be healthy based on the clinical history and the physical examination.
- The subject has not received any anti-rotavirus vaccine.
- The parent/tutor fully understands the study's procedures and voluntarily accepts to participate and signs a written informed consent.
- The parent/tutor can meet the study's requirements, such as attending the programmed visits and filling in the journal.
Key exclusion criteria (6 listed)
- The subject has a background of serious allergic reaction to any of the vaccine's components.
- The subject has a digestive tract malformation or acute/chronic disease.
- The subject has some kind of immunodeficiency including HIV.
- The subject suffers from a haemato-oncological disease.
- The subject has been under treatment with an immunosuppressing medicine including prednisone for two or more weeks.
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 |
|---|---|---|
| Rotarix | Biological | ROTA 1, ROTA 3, ROTA 4, ROTA 5, ROTA 6, ROTA 7 |
| RotaTeq | Biological | ROTA 2, ROTA 3, ROTA 4, ROTA 5, ROTA 6, ROTA 7 |
Primary outcome
General Symptoms - Temperature
Time frame: subsequent 5 days since the vaccination day
The subject temperature will be registered with a rectal thermometer during 5 days since the vaccination day in a diary card . If the subject presents fever, the temperature will be recorded in a specific diary card section.
1 secondary outcome
Evacuation
Time frame: subsequent 30 days since the vaccination day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Derived from this study: PubMed 38463163Macias-Parra M, Vidal-Vazquez P, Reyna-Figueroa J, Rodriguez-Weber MA, Moreno-Macias H, Hernandez-Benavides I, Fortes-Gutierrez S, Richardson VL, Vazquez-Cardenas P. Immunogenicity of RV1 and RV5 vaccines administered in standard and interchangeable mixed schedules: a randomized, double-blind, non-inferiority clinical trial in Mexican infants. Front Public Health. 2024 Feb 23;12:1356932. doi: 10.3389/fpubh.2024.1356932. eCollection 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rotarix and RotaTeq in people with Rotavirus Vaccine, run by National Institute of Pediatrics, Mexico at 1 site in Mexico.
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 6 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 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
General Symptoms - Temperature (time frame: subsequent 5 days since the vaccination day). 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 NCT02193061, 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 8 Aug 2018; AzTrials last refreshed its copy on 31 Oct 2026.