PoliomyelitisNCT00137696
Comparison of Immune Response Using 2 Vaccination Schedules Using Inactivated Polio Vaccine
A study testing Vaccination with inactivated polio vaccine and Collection of serum in people with Poliomyelitis, run by Centers for Disease Control and Prevention at 1 site in Puerto Rico.
Trial summary
As poliovirus eradication progresses rapidly, strategies to discontinue oral poliovirus vaccination need to be established. One strategy would be to use inactivated poliovirus vaccine (IPV) transitionally, and this has already occurred in the United States. Read more about this study
- Who is it for?
- Ages 1 hour to 48 hoursHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- Vaccination with inactivated polio vaccine and Collection of serum
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 473 participants
- Where
- 1 sitePuerto Rico
- Study dates
- Jul 2003to Jul 2004
- 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 1 hour to 48 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants under 48 hours of age born at San Lucas Hospital during study enrollment period
- Infants with gestational age of > 37 weeks as assessed by neonatologist
- Mother/guardian gives informed consent
- Infant is expected to reside in Puerto Rico for the following 8 months
Who cannot join
- Mother/guardian does not speak English or Spanish
- Mother/guardian has religious/philosophical objection to immunizations
- Infant has serious chronic or acute health problems that require hospitalization immediately (within 1 day) after birth (assessed by infant not being placed in San Lucas Hospital well-baby clinic)
- Mother expects to travel with infant during study period to a country known to have circulating poliovirus or that uses oral poliovirus vaccine (OPV)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity of Inactivated Polio Vaccine in Puerto Rico; A Comparative Cohort Study of Two Vaccination Schedules
As poliovirus eradication progresses rapidly, strategies to discontinue oral poliovirus vaccination need to be established. One strategy would be to use inactivated poliovirus vaccine (IPV) transitionally, and this has already occurred in the United States. It is not clear, however, if 3 doses of IPV provide sufficient immunogenicity when administered according to World Health Organization (WHO)/Expanded Programme on Immunization (EPI) schedule in a tropical, developing area where no wild-poliovirus circulates.
Puerto Rico will be the study site for this randomized clinical trial. Healthy infants will be identified at birth in a hospital-system, enrolled within 4 weeks of birth, and randomized into one of two arms: United States of America (U.S.A.) schedule (8, 16, 24 weeks/2, 4, 6 months) or WHO schedule (6, 10, 14 weeks). Both groups will receive IPV at visits 1, 2 and 3. Infants will receive all age-appropriate EPI childhood vaccinations along with IPV, to decrease confusion and inconvenience to the parent. Serum will be collected twice, at visit 1 and visit 4 (30-45 days after IPV-3), to measure antibody titers. Sera will be measured for neutralizing antibodies at the Centers for Disease Control (CDC). Based on the lowest seroconversion rate estimate of 85%, and to have a probability of .80 that the estimate from this study is in error by no more than 10%, the investigators will need to enroll 220 infants in each arm. To compensate for attrition and retain statistical power, the investigators plan to enroll up to 250 infants in each arm. This study is expected to require at least 20 months to complete. Results will provide valuable and timely information applicable to global polio eradication efforts. Any participant found not to be protected after 3 doses of IPV will be given a booster at 9-12 months. Results will provide valuable and timely information applicable to global polio eradication efforts.
Read the detailed description
The proposed study will be a prospective, randomized clinical trial of the immunogenicity of IPV among two groups of infants using different immunization schedules (WHO/EPI and US).
Study will begin with an enrollment period up to 10 months. All infants born at San Lucas Hospital will be eligible unless otherwise excluded. The study will continue until 10 months after the last infant is enrolled. There will be four or five study visits, depending on the cohort.
Study Population:
Infants will be identified at birth at San Lucas Hospital; all babies born during the enrollment period at the selected hospital will be considered eligible. Mothers will be approached in the hospital by the study -nurse after infant's birth and be informed about the study. Inclusion and exclusion criteria will be assessed at this time and if the mother agrees to the study, informed consent will be obtained.
Randomization will be based on what day the baby was born. Even days will be assigned to the WHO schedule and odd days to the US schedule. The mother will be told which cohort the infant is in and given an immunization card with dates that the infant is to return to receive vaccinations. The card will also include study contact phone numbers.
The study will be implemented through the Ponce School of Medicine at San Lucas Hospital in Ponce Puerto Rico. This teaching hospital has a 24 bed well-baby nursery where approximately 150 babies are born per month.
Interventions:
To avoid confusion, inconvenience and error, and to limit differences among participants, diphteria-tetanus-acellular pertussis (DTaP), Haemophilus influenzae type B (Hib), pneumococcal conjugate vaccine (PCV), and hepatitis B (HepB) (if appropriate) will be administered along with inactivated poliovirus vaccine (IPV) on first 3 visits in both cohorts. Both schedules meet the parameters of Advisory Committee of Immunization Practices (ACIP) (minimum interval at least 4 weeks between doses and minimum age of 6 weeks of age) 2.
Cohort A-WHO/EPI Schedule
Initial Study Visit: Visit 1 will be scheduled for 6 weeks (> 42 days and < 46 days) after birth. Blood will be drawn (sera 1) immediately prior to administration with first dose of IPV and other recommended vaccines. Mother will be reminded of infant's next appointment in 4 weeks.
Study Visit 2: Visit 2 will be scheduled for 4 weeks after last vaccination (> 28 days and < 32 days). The 2nd dose of IPV and other recommended vaccines will be administered at this time. Mother will be reminded of infant's next appointment in 4 weeks.
Study Visit 3: Visit 3 will be scheduled for 4 weeks after last vaccination (> 28 days and < 32 days). The 3rd dose of IPV and other recommended vaccines will be administered at this time. Mother will be reminded of infant's next appointment in 4 weeks.
Study Visit 4: Visit 4 will be scheduled for 4 weeks after last vaccination. A blood sample will be drawn from participant. Study visit should take place no earlier than 28 days since previous vaccination nor later than the 45th day
Study Visit 5: According to ACIP recommendations the 3rd dose of Hepatitis B has to be administered after 6 months of age. For this reason, Visit 5 will be scheduled when the child is 24 weeks of age in order to receive the 3rd dose of Hepatitis B vaccine.
Cohort B-US Schedule
Initial Study Visit: Visit 1 will be scheduled for 8 weeks after birth (> 52 days and < 60 days). Blood will be drawn (sera 1) immediately prior to administration of the first dose of IPV and other recommended vaccines. Mother will be reminded of infant's next appointment in 8 weeks.
Study Visit 2: Visit 2 will be scheduled for 8 weeks after last vaccination (> 52 days and < 60 days). The 2nd dose of IPV and other recommended vaccines will be administered. Mother will be reminded of infant's next appointment in 8 weeks.
Study Visit 3: Visit 3 will be scheduled for 8 weeks after last vaccination (> 52 days and < 60 days). The 3rd dose of IPV and other recommended vaccines will be administered at this time. Mother will be reminded of infant's next appointment in 4 weeks.
Study Visit 4: Visit 4 will be scheduled for 4 weeks after last vaccination. A blood sample will be drawn from participant. Study visit should take place no earlier than 28 days since previous vaccination nor later than the 45th day.
Specimens Collection/Handling:
Blood will be drawn to obtain serum neutralizing antibody titers prior to the first dose of IPV and subsequent to the 3rd dose of IPV. If >= 2% of children in either arm do not respond to any of the 3 types of poliovirus, two additional blood specimens will be offered to test immunity before and after the 4th dose of IPV among non responders.
A minimum of 500 µl will be collected at each bleed preferably via vein using a 23-25 gauge butterfly into a vacutainer tube (heel stick is acceptable if infant is noted to have poor venous access). Specimens will be labeled with a unique identifier and be kept cold (2-8° C), not frozen, until specimen is spun down and sera separated which should be done at end of each day (specimens should not sit out for > 12 hours).
Sera will be aliquoted and batch-stored at -20° C. A batched frozen shipment on dry ice will be made to CDC after Phase 1 (all participant study visits are complete).
Lab Evaluation and Methods:
Sera will be tested for levels of neutralizing antibody titers against poliovirus types 1, 2 and 3 at CDC by means of a modified microneutralization assay 13. Approximately 80 to 100 median tissue culture infective dose (TCID50) of each vaccine virus serotype and serial dilutions of serum (starting at 1:8 and ending at 1:1024) are incubated at 37° C for 2.5 hours before 7.5x103 Hep-2(C) cells are added to the wells. After incubation for 5 days at 37° C, each plate is stained with 0.05% crystal violet in 25% ethyl alcohol, with the optical density in each well measured by a spectrophotometer. Each specimen will be run in triplicate, with the final titer estimated by the method of Spearman-Karber. Seropositivity will be defined as a neutralization titer of greater than 1:8. It is estimated that serology results will be available 60 days after receipt of specimens at CDC.
Analysis:
This study is designed to examine and compare seroconversion in response to IPV given according to the WHO/EPI and US schedules. Our primary interest is to determine whether the seroconversion rate among children receiving the WHO/EPI schedule is no lower than 10% less than the rate among those using the US schedule. To determine the required number of study participants, we will assume that the seroconversion rate using the US schedule will be 85% and we want power of .80 to find a significant difference between the rates if the rate among the WHO/EPI schedule group is 75% or lower. Using a one-tailed test (and realizing that one-sided significance levels are uncommon in epidemiologic studies and give us a confidence level of only 90% and not the standard 95%) based on the normal approximation of the binomial distribution, a sample size of ~220 subjects per arm will satisfy these criteria. To compensate for expected attrition of ~14 % , a goal of 250 infants will be set for each arm.
Study Drug:
IPV is an FDA licensed drug. No investigational drugs are being used for the purpose of this study. No routine vaccinations are being withheld for the purpose of this study. Those participants randomized to the WHO/EPI schedule will receive their vaccines on a different time schedule than they would usually follow in Puerto Rico. However, both schedules meet the parameters of the Advisory Committee of Immunization Practices (ACIP) 2. Because participants will be followed closely for up to 6 months of life, it is likely that they will receive their vaccinations in a more timely manner than they might if not a part of the study. Parents will be given a unique immunization card showing the schedule their infant will follow; all vaccines administered will be recorded. The card will indicate that they are enrolled in a study and list study staff names and contact telephone numbers.
Informed Consent Procedures:
Prior to infant vaccination, parents will be given standard vaccine information statements (VIS) and informed consents in Spanish or English, as they would if they were to immunize their child with their pediatrician or health clinic. Information and risks of all administered vaccines will not be discussed in the study informed consent, as the form would be overwhelmingly long.
Confidentiality:
Confidentiality will be assured by keeping all identifying material in a locked cabinet in a locked office. All personal identifiers will be removed before data and specimens are shipped to CDC. Records will be held confidential to the fullest extent allowed by state and federal laws.
Information collected for this study will include only a minimum degree of sensitive personal information in the form of demographic data. Its disclosure should pose negligible risk to participant and or/parent. Parents will be provided with the usual written information discussing pros and cons on each vaccine to be administered.
- Conditions
- Poliomyelitis
- Being tested
- Vaccination with inactivated polio vaccine, Collection of serum
- Keywords
- polio, vaccine, immunogenicity
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccination with inactivated polio vaccineBiological
Collection of serumProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Cohort A-WHO/EPI Schedule | Experimental | Received IPV at ages 6, 10, and 14 weeks (this schedule is also approved for use in the United States if an accelerated schedule is needed. Receives: Biological: Vaccination with inactivated polio vaccine; Procedure: Collection of serum |
| Cohort A-US Schedule | Active comparator | Received IPV at ages 8, 16, and 24 weeks. Receives: Biological: Vaccination with inactivated polio vaccine; Procedure: Collection of serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum collection and antibody titers
Serum will be collected twice, at visit 1 and visit 4 (30-45 days after IPV-3), to measure antibody titers.
Measured: 30-45 days after vaccination
Secondary outcomes (1)
Adverse Events
Reports on adverse events will be obtained after each vaccination.
Measured: 7 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startJul 2003
- Primary completionJul 2004
- Study completionJul 2004
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 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 473 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- San Lucas Hospital, Ponce, Puerto Rico
- Responsible party
- Sponsor
- Investigators
- Gustavo H Dayan, MD, Principal investigator, Centers for Disease Control and PreventionMargaret Thorley, MPH, Study chair, Centers for Disease Control and PreventionSteve McLaughlin, DV, Study chair, Centers for Disease Control and PreventionMark Pallansch, Study chair, Centers for Disease Control and PreventionYasuhiro Yamamura, PhD, Study director, Ponce School of MedicineNayra Rodriguez, Study chair, Ponce School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00137696
- Sponsor's protocol ID
- CDC-NIP-3436
- Other IDs
- 020918-YY
- Status last verified
- May 2024
- First submitted
- 27 Aug 2005
- Last updated
- 31 May 2024
- Results posted
- No
Publications
Dayan GH, Thorley M, Yamamura Y, Rodriguez N, McLaughlin S, Torres LM, Seda A, Carbia M, Alexander LN, Caceres V, Pallansch MA. Serologic response to inactivated poliovirus vaccine: a randomized clinical trial comparing 2 vaccination schedules in Puerto Rico. J Infect Dis. 2007 Jan 1;195(1):12-20. doi: 10.1086/508427. Epub 2006 Nov 28.
PubMed 17152004
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of Inactivated Polio Vaccine in Puerto Rico; A Comparative Cohort Study of Two Vaccination Schedules
- ClinicalTrials.gov ID
- NCT00137696
- Acronym / sponsor ID
- CDC-NIP-3436
- Conditions
- Poliomyelitis
- Keywords
- polio, vaccine, immunogenicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 473 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- San Lucas Hospital, Ponce, Puerto Rico
- Study start
- Jul 2003 (actual)
- Primary completion
- Jul 2004 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 30 Aug 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.
As poliovirus eradication progresses rapidly, strategies to discontinue oral poliovirus vaccination need to be established. One strategy would be to use inactivated poliovirus vaccine (IPV) transitionally, and this has already occurred in the United States. It is not clear, however, if 3 doses of IPV provide sufficient immunogenicity when administered according to World Health Organization (WHO)/Expanded Programme on Immunization (EPI) schedule in a tropical, developing area where no wild-poliovirus circulates.
Puerto Rico will be the study site for this randomized clinical trial. Healthy infants will be identified at birth in a hospital-system, enrolled within 4 weeks of birth, and randomized into one of two arms: United States of America (U.S.A.) schedule (8, 16, 24 weeks/2, 4, 6 months) or WHO schedule (6, 10, 14 weeks). Both groups will receive IPV at visits 1, 2 and 3. Infants will receive all age-appropriate EPI childhood vaccinations along with IPV, to decrease confusion and inconvenience to the parent. Serum will be collected twice, at visit 1 and visit 4 (30-45 days after IPV-3), to measure antibody titers. Sera will be measured for neutralizing antibodies at the Centers for Disease Control (CDC). Based on the lowest seroconversion rate estimate of 85%, and to have a probability of .80 that the estimate from this study is in error by no more than 10%, the investigators will need to enroll 220 infants in each arm. To compensate for attrition and retain statistical power, the investigators plan to enroll up to 250 infants in each arm. This study is expected to require at least 20 months to complete. Results will provide valuable and timely information applicable to global polio eradication efforts. Any participant found not to be protected after 3 doses of IPV will be given a booster at 9-12 months. Results will provide valuable and timely information applicable to global polio eradication efforts.
Detailed description
The proposed study will be a prospective, randomized clinical trial of the immunogenicity of IPV among two groups of infants using different immunization schedules (WHO/EPI and US).
Study will begin with an enrollment period up to 10 months. All infants born at San Lucas Hospital will be eligible unless otherwise excluded. The study will continue until 10 months after the last infant is enrolled. There will be four or five study visits, depending on the cohort.
Study Population:
Infants will be identified at birth at San Lucas Hospital; all babies born during the enrollment period at the selected hospital will be considered eligible. Mothers will be approached in the hospital by the study -nurse after infant's birth and be informed about the study. Inclusion and exclusion criteria will be assessed at this time and if the mother agrees to the study, informed consent will be obtained.
Randomization will be based on what day the baby was born. Even days will be assigned to the WHO schedule and odd days to the US schedule. The mother will be told which cohort the infant is in and given an immunization card with dates that the infant is to return to receive vaccinations. The card will also include study contact phone numbers.
The study will be implemented through the Ponce School of Medicine at San Lucas Hospital in Ponce Puerto Rico. This teaching hospital has a 24 bed well-baby nursery where approximately 150 babies are born per month.
Interventions:
To avoid confusion, inconvenience and error, and to limit differences among participants, diphteria-tetanus-acellular pertussis (DTaP), Haemophilus influenzae type B (Hib), pneumococcal conjugate vaccine (PCV), and hepatitis B (HepB) (if appropriate) will be administered along with inactivated poliovirus vaccine (IPV) on first 3 visits in both cohorts. Both schedules meet the parameters of Advisory Committee of Immunization Practices (ACIP) (minimum interval at least 4 weeks between doses and minimum age of 6 weeks of age) 2.
Cohort A-WHO/EPI Schedule
Initial Study Visit: Visit 1 will be scheduled for 6 weeks (> 42 days and < 46 days) after birth. Blood will be drawn (sera 1) immediately prior to administration with first dose of IPV and other recommended vaccines. Mother will be reminded of infant's next appointment in 4 weeks.
Study Visit 2: Visit 2 will be scheduled for 4 weeks after last vaccination (> 28 days and < 32 days). The 2nd dose of IPV and other recommended vaccines will be administered at this time. Mother will be reminded of infant's next appointment in 4 weeks.
Study Visit 3: Visit 3 will be scheduled for 4 weeks after last vaccination (> 28 days and < 32 days). The 3rd dose of IPV and other recommended vaccines will be administered at this time. Mother will be reminded of infant's next appointment in 4 weeks.
Study Visit 4: Visit 4 will be scheduled for 4 weeks after last vaccination. A blood sample will be drawn from participant. Study visit should take place no earlier than 28 days since previous vaccination nor later than the 45th day
Study Visit 5: According to ACIP recommendations the 3rd dose of Hepatitis B has to be administered after 6 months of age. For this reason, Visit 5 will be scheduled when the child is 24 weeks of age in order to receive the 3rd dose of Hepatitis B vaccine.
Cohort B-US Schedule
Initial Study Visit: Visit 1 will be scheduled for 8 weeks after birth (> 52 days and < 60 days). Blood will be drawn (sera 1) immediately prior to administration of the first dose of IPV and other recommended vaccines. Mother will be reminded of infant's next appointment in 8 weeks.
Study Visit 2: Visit 2 will be scheduled for 8 weeks after last vaccination (> 52 days and < 60 days). The 2nd dose of IPV and other recommended vaccines will be administered. Mother will be reminded of infant's next appointment in 8 weeks.
Study Visit 3: Visit 3 will be scheduled for 8 weeks after last vaccination (> 52 days and < 60 days). The 3rd dose of IPV and other recommended vaccines will be administered at this time. Mother will be reminded of infant's next appointment in 4 weeks.
Study Visit 4: Visit 4 will be scheduled for 4 weeks after last vaccination. A blood sample will be drawn from participant. Study visit should take place no earlier than 28 days since previous vaccination nor later than the 45th day.
Specimens Collection/Handling:
Blood will be drawn to obtain serum neutralizing antibody titers prior to the first dose of IPV and subsequent to the 3rd dose of IPV. If >= 2% of children in either arm do not respond to any of the 3 types of poliovirus, two additional blood specimens will be offered to test immunity before and after the 4th dose of IPV among non responders.
A minimum of 500 µl will be collected at each bleed preferably via vein using a 23-25 gauge butterfly into a vacutainer tube (heel stick is acceptable if infant is noted to have poor venous access). Specimens will be labeled with a unique identifier and be kept cold (2-8° C), not frozen, until specimen is spun down and sera separated which should be done at end of each day (specimens should not sit out for > 12 hours).
Sera will be aliquoted and batch-stored at -20° C. A batched frozen shipment on dry ice will be made to CDC after Phase 1 (all participant study visits are complete).
Lab Evaluation and Methods:
Sera will be tested for levels of neutralizing antibody titers against poliovirus types 1, 2 and 3 at CDC by means of a modified microneutralization assay 13. Approximately 80 to 100 median tissue culture infective dose (TCID50) of each vaccine virus serotype and serial dilutions of serum (starting at 1:8 and ending at 1:1024) are incubated at 37° C for 2.5 hours before 7.5x103 Hep-2(C) cells are added to the wells. After incubation for 5 days at 37° C, each plate is stained with 0.05% crystal violet in 25% ethyl alcohol, with the optical density in each well measured by a spectrophotometer. Each specimen will be run in triplicate, with the final titer estimated by the method of Spearman-Karber. Seropositivity will be defined as a neutralization titer of greater than 1:8. It is estimated that serology results will be available 60 days after receipt of specimens at CDC.
Analysis:
This study is designed to examine and compare seroconversion in response to IPV given according to the WHO/EPI and US schedules. Our primary interest is to determine whether the seroconversion rate among children receiving the WHO/EPI schedule is no lower than 10% less than the rate among those using the US schedule. To determine the required number of study participants, we will assume that the seroconversion rate using the US schedule will be 85% and we want power of .80 to find a significant difference between the rates if the rate among the WHO/EPI schedule group is 75% or lower. Using a one-tailed test (and realizing that one-sided significance levels are uncommon in epidemiologic studies and give us a confidence level of only 90% and not the standard 95%) based on the normal approximation of the binomial distribution, a sample size of ~220 subjects per arm will satisfy these criteria. To compensate for expected attrition of ~14 % , a goal of 250 infants will be set for each arm.
Study Drug:
IPV is an FDA licensed drug. No investigational drugs are being used for the purpose of this study. No routine vaccinations are being withheld for the purpose of this study. Those participants randomized to the WHO/EPI schedule will receive their vaccines on a different time schedule than they would usually follow in Puerto Rico. However, both schedules meet the parameters of the Advisory Committee of Immunization Practices (ACIP) 2. Because participants will be followed closely for up to 6 months of life, it is likely that they will receive their vaccinations in a more timely manner than they might if not a part of the study. Parents will be given a unique immunization card showing the schedule their infant will follow; all vaccines administered will be recorded. The card will indicate that they are enrolled in a study and list study staff names and contact telephone numbers.
Informed Consent Procedures:
Prior to infant vaccination, parents will be given standard vaccine information statements (VIS) and informed consents in Spanish or English, as they would if they were to immunize their child with their pediatrician or health clinic. Information and risks of all administered vaccines will not be discussed in the study informed consent, as the form would be overwhelmingly long.
Confidentiality:
Confidentiality will be assured by keeping all identifying material in a locked cabinet in a locked office. All personal identifiers will be removed before data and specimens are shipped to CDC. Records will be held confidential to the fullest extent allowed by state and federal laws.
Information collected for this study will include only a minimum degree of sensitive personal information in the form of demographic data. Its disclosure should pose negligible risk to participant and or/parent. Parents will be provided with the usual written information discussing pros and cons on each vaccine to be administered.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A-WHO/EPI Schedule | Experimental | Biological: Vaccination with inactivated polio vaccine, Procedure: Collection of serumReceived IPV at ages 6, 10, and 14 weeks (this schedule is also approved for use in the United States if an accelerated schedule is needed. |
| Cohort A-US Schedule | Active comparator | Biological: Vaccination with inactivated polio vaccine, Procedure: Collection of serumReceived IPV at ages 8, 16, and 24 weeks. |
Who may qualify
- Ages
- 1 hour to 48 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants under 48 hours of age born at San Lucas Hospital during study enrollment period
- Infants with gestational age of > 37 weeks as assessed by neonatologist
- Mother/guardian gives informed consent
- Infant is expected to reside in Puerto Rico for the following 8 months
Key exclusion criteria (4 listed)
- Mother/guardian does not speak English or Spanish
- Mother/guardian has religious/philosophical objection to immunizations
- Infant has serious chronic or acute health problems that require hospitalization immediately (within 1 day) after birth (assessed by infant not being placed in San Lucas Hospital well-baby clinic)
- Mother expects to travel with infant during study period to a country known to have circulating poliovirus or that uses oral poliovirus vaccine (OPV)
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 |
|---|---|---|
| Vaccination with inactivated polio vaccine | Biological | Cohort A-US Schedule, Cohort A-WHO/EPI Schedule |
| Collection of serum | Procedure or surgery | Cohort A-US Schedule, Cohort A-WHO/EPI Schedule |
Primary outcome
Serum collection and antibody titers
Time frame: 30-45 days after vaccination
Serum will be collected twice, at visit 1 and visit 4 (30-45 days after IPV-3), to measure antibody titers.
1 secondary outcome
Adverse Events
Time frame: 7 days after vaccination
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 31 May 2024.
- Results publication: PubMed 17152004Dayan GH, Thorley M, Yamamura Y, Rodriguez N, McLaughlin S, Torres LM, Seda A, Carbia M, Alexander LN, Caceres V, Pallansch MA. Serologic response to inactivated poliovirus vaccine: a randomized clinical trial comparing 2 vaccination schedules in Puerto Rico. J Infect Dis. 2007 Jan 1;195(1):12-20. doi: 10.1086/508427. Epub 2006 Nov 28.
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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.
Gustavo H Dayan, MD principal investigator
Centers for Disease Control and Prevention
Margaret Thorley, MPH study chair
Centers for Disease Control and Prevention
Steve McLaughlin, DV study chair
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaccination with inactivated polio vaccine and Collection of serum in people with Poliomyelitis, run by Centers for Disease Control and Prevention at 1 site in Puerto Rico.
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 4 inclusion and 4 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 31 May 2024. 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 Puerto Rico. 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.
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?
Serum collection and antibody titers (time frame: 30-45 days after vaccination). 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 NCT00137696, 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 31 May 2024.