PoliomyelitisPhase 3NCT01870206
Randomized Clinical Trial to Evaluate Immunogenicity and Safety in Mexicans Newborns
A Phase 3 study testing Trivalent OPV Birmex and Trivalent OPV Sanofi Pasteur in people with Poliomyelitis, run by Laboratorios de Biologicos y Reactivos de México, S.A. de C.V. at 1 site in Mexico.
Trial summary
Polio is a highly infectious disease caused by a virus. It invades the nervous system, and can cause total paralysis in a matter of hours. The virus enters the body through the mouth and multiplies in the intestine. Initial symptoms are fever, fatigue, headache, vomiting, stiffness in the neck and pain in the limbs. Read more about this study
- Who is it for?
- Ages 1 day to 2 weeks
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- Trivalent OPV Birmex and Trivalent OPV Sanofi Pasteur
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2013to Jan 2014
- 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 1 day to 2 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns babies
- Weight ≥ 2.5 kg
- Have not received any doses of Polio Vaccine
- Whose parents or guardians reside in the work area
- Whose parent or guardian accept to sign written informed consent (by the other, father or guardian).
Who cannot join
- Born of a high-risk pregnancy.
- Weight ≤ 2.5 kg
- Presence of fever, diarrhea, known immunosuppression, respiratory infections.
- Treatment with immunosuppressants.
- Having neurological diseases.
- Require or received surgery in oropharynx.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital General de Chalco Dr. Fernando Quiroz Gutierrez
Valle de Chalco, State of Mexico, 56613
Monserrat Ávila-Flores, Pediatrics
About this study
Official title: Phase III Immunogenicity, Safety, Poliovirus Excretion and Acceptance of Vaccination OPV (Vero Cells) in Newborns Mexicans
Polio is a highly infectious disease caused by a virus. It invades the nervous system, and can cause total paralysis in a matter of hours. The virus enters the body through the mouth and multiplies in the intestine. Initial symptoms are fever, fatigue, headache, vomiting, stiffness in the neck and pain in the limbs. One in 200 infections leads to irreversible paralysis (usually in the legs). Among those paralysed, 5% to 10% die when their breathing muscles become immobilized. There is no cure for polio, it can only be prevented. Polio vaccine, given multiple times, can protect a child for life.
Compare in newborns the immunogenicity and safety of the vaccine OPV produced by Birmex compared with the vaccine OPV produced by Sanofi Pasteur, both produced in Vero cells.
Read the detailed description
This is a randomized clinical trial, which includes 320 newborns of both sexes and residents of the state of México, 160 newborns receive the vaccine OPV Birmex and 160 newborns receive the vaccine OPV Sanofi Pasteur
- Conditions
- Poliomyelitis
- Being tested
- Trivalent OPV Birmex, Trivalent OPV Sanofi Pasteur
- Keywords
- Immunogenicity, Safety, Efficacy, Poliomyelitis, Newborn
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent OPV BirmexBiological
Also called tOPV
Newborns who receive OPV vaccine produced in Vero cells by Birmex one dose of vaccine immediately after random allocation (at birth). A second dose is given four weeks after the first application.
Trivalent OPV Sanofi PasteurBiological
Also called tOPV
Newborns who receive OPV vaccine produced in Vero cells by Sanofi Pasteur one dose of vaccine immediately after random allocation (at birth). A second dose is given four weeks after the first application.
| Study group | Role | What they receive |
|---|---|---|
| Trivalent OPV Birmex | Experimental | Newborns receive OPV vaccine produced in Vero cells by Birmex one dose of vaccine. A second dose four weeks after the first application. Receives: Biological: Trivalent OPV Birmex |
| Trivalent OPV Sanofi Pasteur | Active comparator | Newborns who receive OPV vaccine produced in Vero cells by Sanofi Pasteur one dose of vaccine. A second dose four weeks after the first application. Receives: Biological: Trivalent OPV Sanofi Pasteur |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change seroconversion after one dose of trivalent vaccine OPV
Measured: after the first dose is taken blood samples (baseline, 30 and 60 days)
Secondary outcomes (1)
Evaluate the adverse events in newborns babies
Measured: inmediately after treatment and during 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PoliomyelitisStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mauricio Rodríguez Álvarez, PhD, Principal investigator, Laboratorios de Biológicos y Reactivos de México S.A de C.V
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01870206
- Sponsor's protocol ID
- Birmex-ECA-01-2013
- Status last verified
- Sep 2013
- First submitted
- 15 May 2013
- Last updated
- 30 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Immunogenicity, Safety, Poliovirus Excretion and Acceptance of Vaccination OPV (Vero Cells) in Newborns Mexicans
- ClinicalTrials.gov ID
- NCT01870206
- Acronym / sponsor ID
- Birmex-ECA-01-2013
- Conditions
- Poliomyelitis
- Keywords
- Immunogenicity, Safety, Efficacy, Poliomyelitis, Newborn
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.University, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 5 Jun 2013 (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.
Polio is a highly infectious disease caused by a virus. It invades the nervous system, and can cause total paralysis in a matter of hours. The virus enters the body through the mouth and multiplies in the intestine. Initial symptoms are fever, fatigue, headache, vomiting, stiffness in the neck and pain in the limbs. One in 200 infections leads to irreversible paralysis (usually in the legs). Among those paralysed, 5% to 10% die when their breathing muscles become immobilized. There is no cure for polio, it can only be prevented. Polio vaccine, given multiple times, can protect a child for life.
Compare in newborns the immunogenicity and safety of the vaccine OPV produced by Birmex compared with the vaccine OPV produced by Sanofi Pasteur, both produced in Vero cells.
Detailed description
This is a randomized clinical trial, which includes 320 newborns of both sexes and residents of the state of México, 160 newborns receive the vaccine OPV Birmex and 160 newborns receive the vaccine OPV Sanofi Pasteur
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trivalent OPV Birmex | Experimental | Biological: Trivalent OPV BirmexNewborns receive OPV vaccine produced in Vero cells by Birmex one dose of vaccine. A second dose four weeks after the first application. |
| Trivalent OPV Sanofi Pasteur | Active comparator | Biological: Trivalent OPV Sanofi PasteurNewborns who receive OPV vaccine produced in Vero cells by Sanofi Pasteur one dose of vaccine. A second dose four weeks after the first application. |
Who may qualify
- Ages
- 1 day to 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Newborns babies
- Weight ≥ 2.5 kg
- Have not received any doses of Polio Vaccine
- Whose parents or guardians reside in the work area
- Whose parent or guardian accept to sign written informed consent (by the other, father or guardian).
Key exclusion criteria (6 listed)
- Born of a high-risk pregnancy.
- Weight ≤ 2.5 kg
- Presence of fever, diarrhea, known immunosuppression, respiratory infections.
- Treatment with immunosuppressants.
- Having neurological diseases.
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 |
|---|---|---|
| Trivalent OPV BirmexAlso: tOPVNewborns who receive OPV vaccine produced in Vero cells by Birmex one dose of vaccine immediately after random allocation (at birth). A second dose is given four weeks after the first application. | Biological | Trivalent OPV Birmex |
| Trivalent OPV Sanofi PasteurAlso: tOPVNewborns who receive OPV vaccine produced in Vero cells by Sanofi Pasteur one dose of vaccine immediately after random allocation (at birth). A second dose is given four weeks after the first application. | Biological | Trivalent OPV Sanofi Pasteur |
Primary outcome
Change seroconversion after one dose of trivalent vaccine OPV
Time frame: after the first dose is taken blood samples (baseline, 30 and 60 days)
1 secondary outcome
Evaluate the adverse events in newborns babies
Time frame: inmediately after treatment and during 60 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2013.
- Laboratorios de Biológicos y Reactivos de México S.A de C.VLink provided by the sponsor.
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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.
Mauricio Rodríguez Álvarez, PhD principal investigator
Laboratorios de Biológicos y Reactivos de México S.A de C.V
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 Trivalent OPV Birmex and Trivalent OPV Sanofi Pasteur in people with Poliomyelitis, run by Laboratorios de Biologicos y Reactivos de México, S.A. de C.V. 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 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: status not confirmed, as of the sponsor's last update on 30 Sep 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alvaro García-Pérez, MD (5554222840 ext. 139, agarciap@birmex.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change seroconversion after one dose of trivalent vaccine OPV (time frame: after the first dose is taken blood samples (baseline, 30 and 60 days)). 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 30 Sep 2013.