Level of Immunity Against Poliovirus InfectionNCT00260312
Study of Inactivated Poliovirus Vaccine Given at an Earlier Schedule With Shorter Intervals
A study testing Inactivated Polio Vaccine given at an accelerated schedule in people with Level of Immunity Against Poliovirus Infection, run by Pan American Health Organization.
Trial summary
The purpose of this study was to evaluated the effectiveness of inactivated poliovirus vaccine at a vaccine schedule that is commonly used in developing countries. The effectiveness of inactivated poliovaccine given at this schedule is important to national policy makers as they consider vaccination policies after the… Read more about this study
- Who is it for?
- Ages 6 weeks to 2 months, men onlyHealthy volunteers can take part
- Conditions the study is for
- Level of Immunity Against Poliovirus Infection
- What is being tested?
- Inactivated Polio Vaccine given at an accelerated schedule
- Type of treatment
- Vaccines
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Aug 2001to Jan 2003
- Phase
- Interventional
- 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 weeks to 2 months
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants born 18 - 20 weeks prior to the first round of the 2002 National Immunization Days in cuba (in March 2002).
- Born healthy at one of the 4 designated maternity hospitals in Cuba
Who cannot join
- Serious congenital defect/disease at birth
- -
About this study
Official title: Randomized Placebo-Controlled Trial of Inactivated Poliovirus Vaccine in Cuba
The purpose of this study was to evaluated the effectiveness of inactivated poliovirus vaccine at a vaccine schedule that is commonly used in developing countries. The effectiveness of inactivated poliovaccine given at this schedule is important to national policy makers as they consider vaccination policies after the use of oral polio vaccine is discontinued.
Read the detailed description
After polio eradication, access to live polioviruses will be highly restricted, and oral poliovirus vaccine (OPV) use must be discontinued. OPV-using countries must decide whether to switch to inactivated poliovirus vaccine (IPV) or stop polio vaccination. Because only limited data are available on IPV immunogenicity in tropical developing countries, we conducted a randomized controlled trial of IPV in Cuba. The objectives of this study were to assess the humoral and mucosal immunogenicity conferred by IPV administered at the WHO-EPI schedule (6,10,14 wks of age) vs. placebo. A third arm was added to evaluate the immunogenicity of IPV administered at 2 and 4 months of age. Antibody titers were measured prior to the first dose as well as 1 month after the last dose in each study arm. Target sample size was 100 children in each arm. Mucosal (intestinal immunity) was measured indirectly through assessing poliovirus excretion in each group after a "natural challenge" of trivalent oral polio vaccine (OPV)recieved by study participants through their participation in the annual OPV mass campaigns approximately 1 month after their last dose of vaccine.
- Being tested
- Inactivated Polio Vaccine given at an accelerated schedule
- Keywords
- inactived, polio, vaccine, cuba, trial, randomized, eradication
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated Polio Vaccine given at an accelerated scheduleBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion by measuring level of poliovirus antibodies in serum. Also, measure of virus titer in stools to indirectly assess the level of intestinal mucosal immunity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startAug 2001
- Study completionJan 2003
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 Level of Immunity Against Poliovirus InfectionStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Pan American Health Organization
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, Institute Pedro Kouri, Ministry of Public Health (Cuba), Centers for Disease Control and Prevention
- Investigators
- Miguel Galindo, MD, Principal investigator, Ministry of Public Health, Cuba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260312
- Sponsor's protocol ID
- 3827
- Status last verified
- Jan 2004
- First submitted
- 29 Nov 2005
- Last updated
- 1 Dec 2005
- Results posted
- No
Publications
Cuba IPV Study Collaborative Group. Randomized, placebo-controlled trial of inactivated poliovirus vaccine in Cuba. N Engl J Med. 2007 Apr 12;356(15):1536-44. doi: 10.1056/NEJMoa054960.
PubMed 17429085
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-Controlled Trial of Inactivated Poliovirus Vaccine in Cuba
- ClinicalTrials.gov ID
- NCT00260312
- Acronym / sponsor ID
- 3827
- Keywords
- inactived, polio, vaccine, cuba, trial, randomized, eradication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Pan American Health OrganizationUniversity, hospital or other
- Collaborators
- World Health Organization, Institute Pedro Kouri, Ministry of Public Health (Cuba), Centers for Disease Control and Prevention
- Study start
- Aug 2001
- Study completion
- Jan 2003
- First posted
- 1 Dec 2005 (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.
The purpose of this study was to evaluated the effectiveness of inactivated poliovirus vaccine at a vaccine schedule that is commonly used in developing countries. The effectiveness of inactivated poliovaccine given at this schedule is important to national policy makers as they consider vaccination policies after the use of oral polio vaccine is discontinued.
Detailed description
After polio eradication, access to live polioviruses will be highly restricted, and oral poliovirus vaccine (OPV) use must be discontinued. OPV-using countries must decide whether to switch to inactivated poliovirus vaccine (IPV) or stop polio vaccination. Because only limited data are available on IPV immunogenicity in tropical developing countries, we conducted a randomized controlled trial of IPV in Cuba. The objectives of this study were to assess the humoral and mucosal immunogenicity conferred by IPV administered at the WHO-EPI schedule (6,10,14 wks of age) vs. placebo. A third arm was added to evaluate the immunogenicity of IPV administered at 2 and 4 months of age. Antibody titers were measured prior to the first dose as well as 1 month after the last dose in each study arm. Target sample size was 100 children in each arm. Mucosal (intestinal immunity) was measured indirectly through assessing poliovirus excretion in each group after a "natural challenge" of trivalent oral polio vaccine (OPV)recieved by study participants through their participation in the annual OPV mass campaigns approximately 1 month after their last dose of vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 weeks to 2 months
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants born 18 - 20 weeks prior to the first round of the 2002 National Immunization Days in cuba (in March 2002).
- Born healthy at one of the 4 designated maternity hospitals in Cuba
Key exclusion criteria (2 listed)
- Serious congenital defect/disease at birth
- -
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 |
|---|---|---|
| Inactivated Polio Vaccine given at an accelerated schedule | Biological | – |
Primary outcome
Seroconversion by measuring level of poliovirus antibodies in serum. Also, measure of virus titer in stools to indirectly assess the level of intestinal mucosal immunity
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 1 Dec 2005.
- Derived from this study: PubMed 17429085Cuba IPV Study Collaborative Group. Randomized, placebo-controlled trial of inactivated poliovirus vaccine in Cuba. N Engl J Med. 2007 Apr 12;356(15):1536-44. doi: 10.1056/NEJMoa054960.
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.
Miguel Galindo, MD principal investigator
Ministry of Public Health, Cuba
Questions about this trial
What is this clinical trial studying?
A study testing Inactivated Polio Vaccine given at an accelerated schedule in people with Level of Immunity Against Poliovirus Infection, run by Pan American Health Organization.
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 1 Dec 2005. 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.
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?
Seroconversion by measuring level of poliovirus antibodies in serum. Also, measure of virus titer in stools to indirectly assess the level of intestinal mucosal immunity. 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 NCT00260312, 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 1 Dec 2005.