PoliomyelitisPhase 4fIPVNCT02847026
Fractional Inactivated Poliovirus Vaccine Booster and Rotavirus Study
A Phase 4 study testing IPV at 14 and 22 weeks of age, Rotarix, IPV at 14 and 22 weeks of age, RotaTeq and IPV at 14 and fIPV at 22 weeks, Rotarix in people with Poliomyelitis, run by Centers for Disease Control and Prevention at 1 site in Bangladesh.
Trial summary
This is an open-label phase IV, randomized controlled trial of inactivated poliovirus vaccine (IPV) and rotavirus vaccines. This trial will assess immunogenicity of a booster dose of fractional IPV (fIPV) in comparison with a full dose of IPV when given after varying IPV and fIPV schedules. Read more about this study
- Who is it for?
- Ages 6 to 6 weeksHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- IPV at 14 and 22 weeks of age, Rotarix, IPV at 14 and 22 weeks of age, RotaTeq and IPV at 14 and fIPV at 22 weeks, Rotarix
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,144 participants
- Where
- 1 siteBangladesh
- Study dates
- Sep 2016to May 2017
- Phase
- Phase 4
- 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 6 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants 6 weeks of age (range: 42-48 days).
- Parents that consent for participation in the full length of the study.
- Parents that are able to understand and comply with planned study procedures.
Who cannot join
- Parents and infants who are unable to participate in the full length of the study.
- A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
- A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral administration of IPV or collection of blood by venipuncture.
- Acute diarrhea, infection or illness at the time of enrollment (6 weeks of age) that would require infant's admission to a hospital.
- Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit (6 weeks of age).
- Evidence of a chronic medical condition identified by a study medical officer during physical exam.
Show all 12Show fewer
- Receipt of any polio vaccine (OPV or IPV) before enrollment based upon documentation or parental recall.
- Receipt of any rotavirus vaccine (RV1 or RV5) before enrollment based upon documentation or parental recall.
- Known allergy/sensitivity or reaction to polio or rotavirus vaccine, or contents of polio or rotavirus vaccine.
- Infants from multiple births. Infants from multiple births will be excluded because the infant(s) who is/are not enrolled would likely receive OPV through routine immunization and transmit vaccine poliovirus to the enrolled infant.
- Infants from premature births (<37 weeks of gestation).
- History of intussusception, intestinal malformations, or abdominal surgery.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Center for Diarrhoeal Disease Research, Bangladesh
Dhaka
About this study
Official title: Immunogenicity of a Booster Dose of Fractional Inactivated Poliovirus Vaccine (fIPV) Delivered Intradermally Concomitantly With Rotavirus Vaccines
This is an open-label phase IV, randomized controlled trial of inactivated poliovirus vaccine (IPV) and rotavirus vaccines. This trial will assess immunogenicity of a booster dose of fractional IPV (fIPV) in comparison with a full dose of IPV when given after varying IPV and fIPV schedules. Differences in immunogenicity of the varying schedules of IPV and fIPV will also be examined. Concomitantly, immunogenicity to two different rotavirus vaccines will be evaluated.
Read the detailed description
With the switch from trivalent to bivalent oral poliovirus vaccine (OPV) in 2016, the Global Polio Eradication Initiative (GPEI) is recommending inactivated poliovirus vaccine (IPV) use as one of the potential strategies to respond to outbreaks of type 2 wild type and/or circulating vaccine-derived polioviruses. However, the current global inactivated poliovirus vaccine (IPV; 0.5 mL, full-dose) supply shortage dramatically limits the number of doses available for an effective outbreak response. Therefore, GPEI has proposed use of intradermal administration of a booster of fractional IPV (fIPV; 0.1 mL, one-fifth the full-dose) as a dose-sparing strategy to increase the number of children vaccinated and stretch IPV supplies. No study has compared immunogenicity of a fIPV booster in children previously vaccinated with a single IPV. Furthermore, the IPV shortage has led to reconsideration of fIPV use in routine immunization programs. Previous studies found that in one and two dose head-to-head comparisons, fIPV induced a lower proportion of seroconversion and antibody responses than IPV. However, recent studies of seroconversion and priming suggest two fIPV given at least eight weeks apart may be more immunogenic than one IPV. Because of these findings and the global IPV shortage, the most recent WHO position paper suggests that countries consider administering two fIPV at 6 and 14 weeks of age as an alternative to one IPV after the OPV2 cessation in April 2016. However, no trial has conducted a direct comparison of the immunogenicity of IPV at 14 weeks of age with that of fIPV at 6 and 14 weeks of age.
The immunogenicity of rotavirus (RV) vaccines will also be assessed when given concomitantly with IPV/fIPV. Currently, WHO recommends either of two licensed, live attenuated oral rotavirus vaccines for all children worldwide: the pentavalent RotaTeq (RV5) and monovalent Rotarix (RV1). Many lower income countries where IPV is being introduced are also poised to introduce rotavirus vaccine in the coming years. The first dose of OPV interferes with RV vaccines and RV vaccines may be more immunogenic when delivered with IPV compared with OPV. The proposed study presents an opportunity to compare the two and three dose responses of RV1 and RV5 when delivered with IPV compared with previous studies in Bangladesh when co-administered with OPV.
In addition, recent studies have suggested that host genetic factors (i.e., Secretor status and Lewis and salivary ABO blood group phenotype) mediate susceptibility to rotavirus infection. More precisely, non-secretors (i.e., children lacking a functional fucosyl transferse-2 [FUT2] gene) have substantially reduced risk of rotavirus infection of certain genotypes. Furthermore, certain rotavirus genotypes infected mainly Lewis negative children, independent of secretor status. In addition, blood group antigen status has been proposed to be associated with infection (or lack of infection) by particular rotavirus genotypes. The proposed trial will assess whether Secretor status, Lewis and salivary ABO blood group phenotype are also associated with vaccine response.
- Conditions
- Poliomyelitis
- Being tested
- IPV at 14 and 22 weeks of age, Rotarix, IPV at 14 and 22 weeks of age, RotaTeq, IPV at 14 and fIPV at 22 weeks, Rotarix, IPV at 14 and fIPV at 22 weeks, RotaTeq, IPV at 6 and fIPV at 22 weeks, Rotarix
- Keywords
- inactivated poliovirus vaccine, fractional inactivated poliovirus vaccine, Rotavirus, Rotarix, RotaTeq, fIPV, IPV
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPV at 14 and 22 weeks of age, RotarixBiological
Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 14 weeks of age and a full dose IPV booster at 22 weeks of age. They will also receive the rotavirus vaccine, Rotarix, at 6 and 10 weeks of age.
IPV at 14 and 22 weeks of age, RotaTeqBiological
Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 14 weeks of age and a full dose IPV booster at 22 weeks of age. They will also receive the rotavirus vaccine, RotaTeq, at 6, 10, and 14 weeks of age.
IPV at 14 and fIPV at 22 weeks, RotarixBiological
Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 14 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. They will also receive the rotavirus vaccine, Rotarix, at 6 and 10 weeks of age.
IPV at 14 and fIPV at 22 weeks, RotaTeqBiological
Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 14 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. They will also receive the rotavirus vaccine, RotaTeq, at 6, 10, and 14 weeks of age.
IPV at 6 and fIPV at 22 weeks, RotarixBiological
Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 6 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. They will also receive the rotavirus vaccine, Rotarix, at 6 and 10 weeks of age.
IPV at 6 and fIPV at 22 weeks, RotaTeqBiological
Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 6 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. They will also receive the rotavirus vaccine, RotaTeq, at 6, 10, and 14 weeks of age.
fIPV at 6-14-22 weeks of age, RotarixBiological
Participants in this arm will receive a fractional doses of inactivated poliovirus vaccine (fIPV) at 6 and 14 weeks of age and a fIPV booster at 22 weeks of age. They will also receive the rotavirus vaccine, Rotarix, at 6 and 10 weeks of age.
fIPV at 6-14-22 weeks of age, RotaTeqBiological
Participants in this arm will receive a fractional doses of inactivated poliovirus vaccine (fIPV) at 6 and 14 weeks of age and a fIPV booster at 22 weeks of age. They will also receive the rotavirus vaccine, RotaTeq, at 6, 10, and 14 weeks of age.
| Study group | Role | What they receive |
|---|---|---|
| IPV at 14 and 22 weeks of age, Rotarix | Active comparator | Participants in this arm will receive a full dose of IPV at 14 weeks of age and a full dose IPV booster at 22 weeks of age. Rotarix will also be given at 6 and 10 weeks of age. Receives: Biological: IPV at 14 and 22 weeks of age, Rotarix |
| IPV at 14 and 22 weeks of age, RotaTeq | Active comparator | Participants in this arm will receive a full dose of IPV at 14 weeks of age and a full dose IPV booster at 22 weeks of age. RotaTeq will also be given at 6, 10, and 14 weeks of age. Receives: Biological: IPV at 14 and 22 weeks of age, RotaTeq |
| IPV at 14 and fIPV at 22 weeks, Rotarix | Active comparator | Participants in this arm will receive a full dose of IPV at 14 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. Rotarix will also be given at 6 and 10 weeks of age. Receives: Biological: IPV at 14 and fIPV at 22 weeks, Rotarix |
| IPV at 14 and fIPV at 22 weeks, RotaTeq | Active comparator | Participants in this arm will receive a full dose of IPV at 14 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. RotaTeq will also be given at 6, 10, and 14 weeks of age. Receives: Biological: IPV at 14 and fIPV at 22 weeks, RotaTeq |
| IPV at 6 and fIPV at 22 weeks, Rotarix | Active comparator | Participants in this arm will receive a full dose of IPV at 6 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. Rotarix will also be given at 6 and 10 weeks of age. Receives: Biological: IPV at 6 and fIPV at 22 weeks, Rotarix |
| IPV at 6 and fIPV at 22 weeks, RotaTeq | Active comparator | Participants in this arm will receive a full dose of IPV at 6 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. RotaTeq will also be given at 6, 10, and 14 weeks of age. Receives: Biological: IPV at 6 and fIPV at 22 weeks, RotaTeq |
| fIPV at 6-14-22 weeks of age, Rotarix | Active comparator | Participants in this arm will receive fractional doses of IPV (fIPV) at 6 and 14 weeks of age and a fIPV booster at 22 weeks of age. Rotarix will also be given at 6 and 10 weeks of age. Receives: Biological: fIPV at 6-14-22 weeks of age, Rotarix |
| fIPV at 6-14-22 weeks of age, RotaTeq | Active comparator | Participants in this arm will receive fractional doses of IPV (fIPV) at 6 and 14 weeks of age and a fIPV booster at 22 weeks of age. RotaTeq will also be given at 6, 10, and 14 weeks of age. Receives: Biological: fIPV at 6-14-22 weeks of age, RotaTeq |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response (yes/no) as measured by antibody titers to poliovirus types 1, 2, and 3 after vaccination with study vaccines.
Immune response will be defined as either a four-fold increase in titer or a seronegative participant (<1:8 titers) who becomes seropositive (≥1:8) between designated time points. For selected objectives, baseline maternal antibody titer will be determined at 6 weeks of age and the estimated maternal antibody level at each blood collection will be calculated assuming an exponential decline with a half-life of 28 days.
Measured: Measured at 26 weeks of age.
Immune response (yes/no) as measured by antibody titers to poliovirus types 1, 2, and 3 after vaccination with study vaccines (priming).
Priming is defined as the absence of type-specific immune response at 22 weeks with evidence of type-specific seroconversion at 23 weeks. That is, seronegative participants at 22 weeks (<1:8 titers) who become seropositive at 23 weeks (≥1:8) or a four-fold rise in type-specific antibody titers at 23 weeks compared to 22 weeks.
Measured: Measured at 23 weeks of age.
Immune response (yes/no) as measured by antibody titers to poliovirus types 1, 2, and 3 after vaccination with study vaccines.
Immune response will be defined as either a four-fold increase in titer or a seronegative participant (<1:8 titers) who becomes seropositive (≥1:8) between designated time points. Baseline maternal antibody titer will be determined at 6 weeks of age and the estimated maternal antibody level at each blood collection will be calculated assuming an exponential decline with a half-life of 28 days.
Measured: Measured at 22 weeks of age.
Secondary outcomes (6)
Median antibody titers at 26 weeks to poliovirus types 1, 2, and 3
Median antibody titers to poliovirus types 1, 2, and 3 after vaccination with study vaccines.
Measured: Measured at 26 weeks of age
Median antibody titers at 23 weeks to poliovirus types 1, 2, and 3
Median antibody titers to poliovirus types 1, 2, and 3 after vaccination with study vaccines.
Measured: Measured at 23 weeks of age
Median antibody titers at 22 weeks to poliovirus types 1, 2, and 3
Median antibody titers to poliovirus types 1, 2, and 3 after vaccination with study vaccines.
Measured: Measured at 22 weeks of age
Percentage of children achieving rotavirus IgA seroconversion
Seropositive defined as anti-Rotavirus IgA titer ≥40. Seroconversion defined as a titer ≥40 if anti-rotavirus IgA negative at 6 weeks of age (baseline) or ≥4-fold rise in titer if anti-rotavirus IgA positive at baseline, upon completion of vaccine series
Measured: Change after completion of study vaccine series in comparison with 6 weeks of age.
Rotavirus IgA geometric mean titers
Measured: Change after completion of study vaccine series in comparison with 6 weeks of age.
Rotavirus IgA seroconversion and geometric mean titers by Secretor status, Lewis and salivary ABO blood group phenotype
Seropositive defined as anti-Rotavirus IgA titer ≥40. Seroconversion defined as a titer ≥40 if anti-rotavirus IgA negative at 6 weeks of age (baseline) or ≥4-fold rise in titer if anti-rotavirus IgA positive at baseline, upon completion of vaccine series
Measured: Change after completion of study vaccine series in comparison with 6 weeks of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847026
- Sponsor's protocol ID
- ICDDRB-RRC-PR-15105
- Acronym
- fIPV
- Status last verified
- Aug 2016
- First submitted
- 25 Jul 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: De-identified individual participant data will not be shared beyond use by co-investigators.
Publications
Velasquez-Portocarrero DE, Wang X, Cortese MM, Snider CJ, Anand A, Costantini VP, Yunus M, Aziz AB, Haque W, Parashar U, Sisay Z, Soeters HM, Hyde TB, Jiang B, Zaman K. Head-to-head comparison of the immunogenicity of RotaTeq and Rotarix rotavirus vaccines and factors associated with seroresponse in infants in Bangladesh: a randomised, controlled, open-label, parallel, phase 4 trial. Lancet Infect Dis. 2022 Nov;22(11):1606-1616. doi: 10.1016/S1473-3099(22)00368-1. Epub 2022 Aug 9.
PubMed 35961362Snider CJ, Zaman K, Estivariz CF, Yunus M, Weldon WC, Wannemuehler KA, Oberste MS, Pallansch MA, Wassilak SG, Bari TIA, Anand A. Immunogenicity of full and fractional dose of inactivated poliovirus vaccine for use in routine immunisation and outbreak response: an open-label, randomised controlled trial. Lancet. 2019 Jun 29;393(10191):2624-2634. doi: 10.1016/S0140-6736(19)30503-3. Epub 2019 May 16.
PubMed 31104832
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of a Booster Dose of Fractional Inactivated Poliovirus Vaccine (fIPV) Delivered Intradermally Concomitantly With Rotavirus Vaccines
- ClinicalTrials.gov ID
- NCT02847026
- Acronym / sponsor ID
- fIPV / ICDDRB-RRC-PR-15105
- Conditions
- Poliomyelitis
- Keywords
- inactivated poliovirus vaccine, fractional inactivated poliovirus vaccine, Rotavirus, Rotarix, RotaTeq, fIPV, IPV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,144 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- Sep 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 27 Jul 2016 (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 is an open-label phase IV, randomized controlled trial of inactivated poliovirus vaccine (IPV) and rotavirus vaccines. This trial will assess immunogenicity of a booster dose of fractional IPV (fIPV) in comparison with a full dose of IPV when given after varying IPV and fIPV schedules. Differences in immunogenicity of the varying schedules of IPV and fIPV will also be examined. Concomitantly, immunogenicity to two different rotavirus vaccines will be evaluated.
Detailed description
With the switch from trivalent to bivalent oral poliovirus vaccine (OPV) in 2016, the Global Polio Eradication Initiative (GPEI) is recommending inactivated poliovirus vaccine (IPV) use as one of the potential strategies to respond to outbreaks of type 2 wild type and/or circulating vaccine-derived polioviruses. However, the current global inactivated poliovirus vaccine (IPV; 0.5 mL, full-dose) supply shortage dramatically limits the number of doses available for an effective outbreak response. Therefore, GPEI has proposed use of intradermal administration of a booster of fractional IPV (fIPV; 0.1 mL, one-fifth the full-dose) as a dose-sparing strategy to increase the number of children vaccinated and stretch IPV supplies. No study has compared immunogenicity of a fIPV booster in children previously vaccinated with a single IPV. Furthermore, the IPV shortage has led to reconsideration of fIPV use in routine immunization programs. Previous studies found that in one and two dose head-to-head comparisons, fIPV induced a lower proportion of seroconversion and antibody responses than IPV. However, recent studies of seroconversion and priming suggest two fIPV given at least eight weeks apart may be more immunogenic than one IPV. Because of these findings and the global IPV shortage, the most recent WHO position paper suggests that countries consider administering two fIPV at 6 and 14 weeks of age as an alternative to one IPV after the OPV2 cessation in April 2016. However, no trial has conducted a direct comparison of the immunogenicity of IPV at 14 weeks of age with that of fIPV at 6 and 14 weeks of age.
The immunogenicity of rotavirus (RV) vaccines will also be assessed when given concomitantly with IPV/fIPV. Currently, WHO recommends either of two licensed, live attenuated oral rotavirus vaccines for all children worldwide: the pentavalent RotaTeq (RV5) and monovalent Rotarix (RV1). Many lower income countries where IPV is being introduced are also poised to introduce rotavirus vaccine in the coming years. The first dose of OPV interferes with RV vaccines and RV vaccines may be more immunogenic when delivered with IPV compared with OPV. The proposed study presents an opportunity to compare the two and three dose responses of RV1 and RV5 when delivered with IPV compared with previous studies in Bangladesh when co-administered with OPV.
In addition, recent studies have suggested that host genetic factors (i.e., Secretor status and Lewis and salivary ABO blood group phenotype) mediate susceptibility to rotavirus infection. More precisely, non-secretors (i.e., children lacking a functional fucosyl transferse-2 [FUT2] gene) have substantially reduced risk of rotavirus infection of certain genotypes. Furthermore, certain rotavirus genotypes infected mainly Lewis negative children, independent of secretor status. In addition, blood group antigen status has been proposed to be associated with infection (or lack of infection) by particular rotavirus genotypes. The proposed trial will assess whether Secretor status, Lewis and salivary ABO blood group phenotype are also associated with vaccine response.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| IPV at 14 and 22 weeks of age, Rotarix | Active comparator | Biological: IPV at 14 and 22 weeks of age, RotarixParticipants in this arm will receive a full dose of IPV at 14 weeks of age and a full dose IPV booster at 22 weeks of age. Rotarix will also be given at 6 and 10 weeks of age. |
| IPV at 14 and 22 weeks of age, RotaTeq | Active comparator | Biological: IPV at 14 and 22 weeks of age, RotaTeqParticipants in this arm will receive a full dose of IPV at 14 weeks of age and a full dose IPV booster at 22 weeks of age. RotaTeq will also be given at 6, 10, and 14 weeks of age. |
| IPV at 14 and fIPV at 22 weeks, Rotarix | Active comparator | Biological: IPV at 14 and fIPV at 22 weeks, RotarixParticipants in this arm will receive a full dose of IPV at 14 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. Rotarix will also be given at 6 and 10 weeks of age. |
| IPV at 14 and fIPV at 22 weeks, RotaTeq | Active comparator | Biological: IPV at 14 and fIPV at 22 weeks, RotaTeqParticipants in this arm will receive a full dose of IPV at 14 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. RotaTeq will also be given at 6, 10, and 14 weeks of age. |
| IPV at 6 and fIPV at 22 weeks, Rotarix | Active comparator | Biological: IPV at 6 and fIPV at 22 weeks, RotarixParticipants in this arm will receive a full dose of IPV at 6 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. Rotarix will also be given at 6 and 10 weeks of age. |
| IPV at 6 and fIPV at 22 weeks, RotaTeq | Active comparator | Biological: IPV at 6 and fIPV at 22 weeks, RotaTeqParticipants in this arm will receive a full dose of IPV at 6 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. RotaTeq will also be given at 6, 10, and 14 weeks of age. |
| fIPV at 6-14-22 weeks of age, Rotarix | Active comparator | Biological: fIPV at 6-14-22 weeks of age, RotarixParticipants in this arm will receive fractional doses of IPV (fIPV) at 6 and 14 weeks of age and a fIPV booster at 22 weeks of age. Rotarix will also be given at 6 and 10 weeks of age. |
| fIPV at 6-14-22 weeks of age, RotaTeq | Active comparator | Biological: fIPV at 6-14-22 weeks of age, RotaTeqParticipants in this arm will receive fractional doses of IPV (fIPV) at 6 and 14 weeks of age and a fIPV booster at 22 weeks of age. RotaTeq will also be given at 6, 10, and 14 weeks of age. |
Who may qualify
- Ages
- 6 to 6 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants 6 weeks of age (range: 42-48 days).
- Parents that consent for participation in the full length of the study.
- Parents that are able to understand and comply with planned study procedures.
Key exclusion criteria (12 listed)
- Parents and infants who are unable to participate in the full length of the study.
- A diagnosis or suspicion of immunodeficiency disorder either in the infant or in an immediate family member.
- A diagnosis or suspicion of bleeding disorder that would contraindicate parenteral administration of IPV or collection of blood by venipuncture.
- Acute diarrhea, infection or illness at the time of enrollment (6 weeks of age) that would require infant's admission to a hospital.
- Acute vomiting and intolerance to liquids within 24 hours before the enrollment visit (6 weeks of age).
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 |
|---|---|---|
| IPV at 14 and 22 weeks of age, RotarixParticipants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 14 weeks of age and a full dose IPV booster at 22 weeks of age. They will also receive the rotavirus vaccine, Rotarix, at 6 and 10 weeks of age. | Biological | IPV at 14 and 22 weeks of age, Rotarix |
| IPV at 14 and 22 weeks of age, RotaTeqParticipants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 14 weeks of age and a full dose IPV booster at 22 weeks of age. They will also receive the rotavirus vaccine, RotaTeq, at 6, 10, and 14 weeks of age. | Biological | IPV at 14 and 22 weeks of age, RotaTeq |
| IPV at 14 and fIPV at 22 weeks, RotarixParticipants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 14 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. They will also receive the rotavirus vaccine, Rotarix, at 6 and 10 weeks of age. | Biological | IPV at 14 and fIPV at 22 weeks, Rotarix |
| IPV at 14 and fIPV at 22 weeks, RotaTeqParticipants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 14 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. They will also receive the rotavirus vaccine, RotaTeq, at 6, 10, and 14 weeks of age. | Biological | IPV at 14 and fIPV at 22 weeks, RotaTeq |
| IPV at 6 and fIPV at 22 weeks, RotarixParticipants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 6 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. They will also receive the rotavirus vaccine, Rotarix, at 6 and 10 weeks of age. | Biological | IPV at 6 and fIPV at 22 weeks, Rotarix |
| IPV at 6 and fIPV at 22 weeks, RotaTeqParticipants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 6 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. They will also receive the rotavirus vaccine, RotaTeq, at 6, 10, and 14 weeks of age. | Biological | IPV at 6 and fIPV at 22 weeks, RotaTeq |
| fIPV at 6-14-22 weeks of age, RotarixParticipants in this arm will receive a fractional doses of inactivated poliovirus vaccine (fIPV) at 6 and 14 weeks of age and a fIPV booster at 22 weeks of age. They will also receive the rotavirus vaccine, Rotarix, at 6 and 10 weeks of age. | Biological | fIPV at 6-14-22 weeks of age, Rotarix |
| fIPV at 6-14-22 weeks of age, RotaTeqParticipants in this arm will receive a fractional doses of inactivated poliovirus vaccine (fIPV) at 6 and 14 weeks of age and a fIPV booster at 22 weeks of age. They will also receive the rotavirus vaccine, RotaTeq, at 6, 10, and 14 weeks of age. | Biological | fIPV at 6-14-22 weeks of age, RotaTeq |
Primary outcome
Immune response (yes/no) as measured by antibody titers to poliovirus types 1, 2, and 3 after vaccination with study vaccines.
Time frame: Measured at 26 weeks of age.
Immune response will be defined as either a four-fold increase in titer or a seronegative participant (<1:8 titers) who becomes seropositive (≥1:8) between designated time points. For selected objectives, baseline maternal antibody titer will be determined at 6 weeks of age and the estimated maternal antibody level at each blood collection will be calculated assuming an exponential decline with a half-life of 28 days.
Immune response (yes/no) as measured by antibody titers to poliovirus types 1, 2, and 3 after vaccination with study vaccines (priming).
Time frame: Measured at 23 weeks of age.
Priming is defined as the absence of type-specific immune response at 22 weeks with evidence of type-specific seroconversion at 23 weeks. That is, seronegative participants at 22 weeks (<1:8 titers) who become seropositive at 23 weeks (≥1:8) or a four-fold rise in type-specific antibody titers at 23 weeks compared to 22 weeks.
Immune response (yes/no) as measured by antibody titers to poliovirus types 1, 2, and 3 after vaccination with study vaccines.
Time frame: Measured at 22 weeks of age.
Immune response will be defined as either a four-fold increase in titer or a seronegative participant (<1:8 titers) who becomes seropositive (≥1:8) between designated time points. Baseline maternal antibody titer will be determined at 6 weeks of age and the estimated maternal antibody level at each blood collection will be calculated assuming an exponential decline with a half-life of 28 days.
6 secondary outcomes
Median antibody titers at 26 weeks to poliovirus types 1, 2, and 3
Time frame: Measured at 26 weeks of age
Median antibody titers at 23 weeks to poliovirus types 1, 2, and 3
Time frame: Measured at 23 weeks of age
Median antibody titers at 22 weeks to poliovirus types 1, 2, and 3
Time frame: Measured at 22 weeks of age
Percentage of children achieving rotavirus IgA seroconversion
Time frame: Change after completion of study vaccine series in comparison with 6 weeks of age.
Rotavirus IgA geometric mean titers
Time frame: Change after completion of study vaccine series in comparison with 6 weeks of age.
Rotavirus IgA seroconversion and geometric mean titers by Secretor status, Lewis and salivary ABO blood group phenotype
Time frame: Change after completion of study vaccine series in comparison with 6 weeks of age.
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 18 Jul 2018.
- Derived from this study: PubMed 35961362Velasquez-Portocarrero DE, Wang X, Cortese MM, Snider CJ, Anand A, Costantini VP, Yunus M, Aziz AB, Haque W, Parashar U, Sisay Z, Soeters HM, Hyde TB, Jiang B, Zaman K. Head-to-head comparison of the immunogenicity of RotaTeq and Rotarix rotavirus vaccines and factors associated with seroresponse in infants in Bangladesh: a randomised, controlled, open-label, parallel, phase 4 trial. Lancet Infect Dis. 2022 Nov;22(11):1606-1616. doi: 10.1016/S1473-3099(22)00368-1. Epub 2022 Aug 9.
- Derived from this study: PubMed 31104832Snider CJ, Zaman K, Estivariz CF, Yunus M, Weldon WC, Wannemuehler KA, Oberste MS, Pallansch MA, Wassilak SG, Bari TIA, Anand A. Immunogenicity of full and fractional dose of inactivated poliovirus vaccine for use in routine immunisation and outbreak response: an open-label, randomised controlled trial. Lancet. 2019 Jun 29;393(10191):2624-2634. doi: 10.1016/S0140-6736(19)30503-3. Epub 2019 May 16.
- Individual participant dataSharing planned: No. De-identified individual participant data will not be shared beyond use by co-investigators.
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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 4 study testing IPV at 14 and 22 weeks of age, Rotarix, IPV at 14 and 22 weeks of age, RotaTeq and IPV at 14 and fIPV at 22 weeks, Rotarix in people with Poliomyelitis, run by Centers for Disease Control and Prevention at 1 site in Bangladesh.
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 3 inclusion and 12 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 18 Jul 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 Bangladesh. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Immune response (yes/no) as measured by antibody titers to poliovirus types 1, 2, and 3 after vaccination with study vaccines. (time frame: Measured at 26 weeks of age.). The study lists 3 primary outcomes in all. 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 NCT02847026, which also lists 2 linked publications.
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 18 Jul 2018.