PoliomyelitisPhase 4IM and ID IPVNCT04063150
Immunogenicity of Intramuscular and Intradermal IPV
A Phase 4 study testing fIPV (0.1 mL) ID, fIPV (0.1mL) IM and fIPV (0.2mL) IM 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 clinical trial that will compare immune responses among infants who receive different dose schedules of either fractional dose or full dose inactivated poliovirus vaccine (IPV), delivered either intramuscularly or intradermally. Read more about this study
- Who is it for?
- Ages 42 to 48 daysHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- fIPV (0.1 mL) ID, fIPV (0.1mL) IM and fIPV (0.2mL) IM
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 958 participants
- Where
- 1 siteBangladesh
- Study dates
- 6 Oct 2019to 25 Mar 2020
- 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 42 to 48 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants 6 weeks of age
- 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 diarrhoea, infection or illness at the time of enrolment (6 weeks of age) that would require infant's admission to a hospital.
- Acute vomiting and intolerance to liquids within 24 hours before the enrolment visit (6 weeks of age).
- Evidence of a chronic medical condition identified by a study medical officer during physical exam.
Show all 10Show fewer
- Receipt of any polio vaccine (OPV or IPV) before enrolment based upon documentation or parental recall.
- Known allergy/sensitivity or reaction to polio vaccine, or its contents.
- 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. Even if all births from a multiple birth could be enrolled in the study, we will exclude multiple births as discontinuation of one may lead to discontinuation of multiple participants.
- Infants from premature births (<37 weeks of gestation).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity of Intramuscular and Intradermal Inactivated Poliovirus Vaccine in Routine Immunization
This is an open-label phase IV randomized clinical trial that will compare immune responses among infants who receive different dose schedules of either fractional dose or full dose inactivated poliovirus vaccine (IPV), delivered either intramuscularly or intradermally.
Note: This study was terminated early due to the COVID-19 pandemic. Due to early study closure, the study objectives could not be evaluated as planned. Both of the primary objectives and several secondary objectives could not be evaluated because none of the study participants reached the corresponding endpoint. Due to limited sample size, the analysis approach for four secondary objectives was changed from a non-inferiority assessment to a comparison of proportions between groups.
Read the detailed description
Oral poliovirus vaccine (OPV) cessation is essential to achieve eradication of polio as OPV contains live poliovirus, which can mutate and become neurovirulent. After OPV cessation, inactivated poliovirus vaccine (IPV) will be the only polio vaccine used for routine immunization. This clinical trial will provide poliovirus type-specific immunogenicity data on an IPV or fractional-dose IPV (fIPV)-only schedule for routine immunization, which will be important for post OPV cessation era. For fIPV, it will provide immunogenicity data on fIPV administered either intradermally (ID) or intramuscularly (IM) and allow a direct comparison of the two methods.
Healthy infants 6 weeks of age will be enrolled at two study clinics in Dhaka, Bangladesh, and randomized to one of seven study arms. Infants will be followed-up until 10 months of age through clinic visits. Blood specimens will be collected to test for immunological response.
- Conditions
- Poliomyelitis
- Being tested
- fIPV (0.1 mL) ID, fIPV (0.1mL) IM, fIPV (0.2mL) IM, IPV
- Keywords
- inactivated poliovirus vaccine, fractional inactivated poliovirus vaccine, intradermal, intramuscular
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fIPV (0.1 mL) IDBiological
Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intradermal (ID) injection in lieu of the full 0.5 mL dose.
fIPV (0.1mL) IMBiological
Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intramuscular (IM) injection in lieu of the full 0.5 mL dose.
fIPV (0.2mL) IMBiological
Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.2 milliliter (mL) dose (fractional) by intramuscular (IM) injection in lieu of the full 0.5 mL dose.
IPVBiological
Full dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.5 milliliter (mL) dose by intramuscular (IM) injection.
| Study group | Role | What they receive |
|---|---|---|
| IPV at 14 weeks + 9 months | Active comparator | Participants in this arm will receive full doses (0.5 mL) of IPV at 14 weeks and 9 months of age. Receives: Biological: IPV |
| IPV at 6 weeks + 9 months | Active comparator | Participants in this arm will receive full doses (0.5 mL) of IPV at 6 weeks and 9 months of age. Receives: Biological: IPV |
| fIPV ID at 6 weeks + 14 weeks + 9 months | Active comparator | Participants in this arm will receive intradermal fractional doses (0.1 mL) of IPV at 6 weeks, 14 weeks, and 9 months of age. Receives: Biological: fIPV (0.1 mL) ID |
| fIPV ID at 14 weeks + 9 months | Active comparator | Participants in this arm will receive intradermal fractional doses (0.1 mL) of IPV at 14 weeks and 9 months of age. Receives: Biological: fIPV (0.1 mL) ID |
| fIPV IM at 6 weeks + 14 weeks + 9 months | Active comparator | Participants in this arm will receive intramuscular fractional doses (0.1 mL) of IPV at 6 weeks, 14 weeks, and 9 months of age. Receives: Biological: fIPV (0.1mL) IM |
| fIPV 0.1mL IM at 14 weeks + 9 months | Active comparator | Participants in this arm will receive intramuscular fractional doses (0.1 mL) of IPV at 14 weeks and 9 months of age. Receives: Biological: fIPV (0.1mL) IM |
| fIPV 0.2mL IM at 14 weeks + 9 months | Active comparator | Participants in this arm will receive intramuscular fractional doses (0.2 mL) of IPV at 14 weeks and 9 months of age. Receives: Biological: fIPV (0.2mL) IM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine response
Dichotomous (yes/no) variable defined as participants who are either seronegative (<1:8 titers) at baseline who become seropositive (≥1:8) after vaccination (seroconversion) or participants who demonstrate a four-fold rise in titers after vaccination between two specimens, e.g. a change from 1:8 to 1:32, after adjusting for expected decay in maternal antibodies. Antibody titers at 6 weeks of age will be the starting point for the expected decline in maternal antibodies, assuming at half-life of 28 days.
Measured: Measured four weeks after administration of study vaccine(s).
Secondary outcomes (1)
Reciprocal antibody titers
Variable of the observed reciprocal antibody titer results.
Measured: Measured four weeks after administration of study vaccine(s).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start6 Oct 2019
- Primary completion25 Mar 2020
- Study completion25 Mar 2020
Why it stopped: COVID-19 pandemic
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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 958 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
- NCT04063150
- Sponsor's protocol ID
- 19058
- Acronym
- IM and ID IPV
- Status last verified
- May 2022
- First submitted
- 19 Aug 2019
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity of Intramuscular and Intradermal Inactivated Poliovirus Vaccine in Routine Immunization
- ClinicalTrials.gov ID
- NCT04063150
- Acronym / sponsor ID
- IM and ID IPV / 19058
- Conditions
- Poliomyelitis
- Keywords
- inactivated poliovirus vaccine, fractional inactivated poliovirus vaccine, intradermal, intramuscular
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic
- Enrolment
- 958 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- 6 Oct 2019 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 21 Aug 2019 (actual)
- 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 clinical trial that will compare immune responses among infants who receive different dose schedules of either fractional dose or full dose inactivated poliovirus vaccine (IPV), delivered either intramuscularly or intradermally.
Note: This study was terminated early due to the COVID-19 pandemic. Due to early study closure, the study objectives could not be evaluated as planned. Both of the primary objectives and several secondary objectives could not be evaluated because none of the study participants reached the corresponding endpoint. Due to limited sample size, the analysis approach for four secondary objectives was changed from a non-inferiority assessment to a comparison of proportions between groups.
Detailed description
Oral poliovirus vaccine (OPV) cessation is essential to achieve eradication of polio as OPV contains live poliovirus, which can mutate and become neurovirulent. After OPV cessation, inactivated poliovirus vaccine (IPV) will be the only polio vaccine used for routine immunization. This clinical trial will provide poliovirus type-specific immunogenicity data on an IPV or fractional-dose IPV (fIPV)-only schedule for routine immunization, which will be important for post OPV cessation era. For fIPV, it will provide immunogenicity data on fIPV administered either intradermally (ID) or intramuscularly (IM) and allow a direct comparison of the two methods.
Healthy infants 6 weeks of age will be enrolled at two study clinics in Dhaka, Bangladesh, and randomized to one of seven study arms. Infants will be followed-up until 10 months of age through clinic visits. Blood specimens will be collected to test for immunological response.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| IPV at 14 weeks + 9 months | Active comparator | Biological: IPVParticipants in this arm will receive full doses (0.5 mL) of IPV at 14 weeks and 9 months of age. |
| IPV at 6 weeks + 9 months | Active comparator | Biological: IPVParticipants in this arm will receive full doses (0.5 mL) of IPV at 6 weeks and 9 months of age. |
| fIPV ID at 6 weeks + 14 weeks + 9 months | Active comparator | Biological: fIPV (0.1 mL) IDParticipants in this arm will receive intradermal fractional doses (0.1 mL) of IPV at 6 weeks, 14 weeks, and 9 months of age. |
| fIPV ID at 14 weeks + 9 months | Active comparator | Biological: fIPV (0.1 mL) IDParticipants in this arm will receive intradermal fractional doses (0.1 mL) of IPV at 14 weeks and 9 months of age. |
| fIPV IM at 6 weeks + 14 weeks + 9 months | Active comparator | Biological: fIPV (0.1mL) IMParticipants in this arm will receive intramuscular fractional doses (0.1 mL) of IPV at 6 weeks, 14 weeks, and 9 months of age. |
| fIPV 0.1mL IM at 14 weeks + 9 months | Active comparator | Biological: fIPV (0.1mL) IMParticipants in this arm will receive intramuscular fractional doses (0.1 mL) of IPV at 14 weeks and 9 months of age. |
| fIPV 0.2mL IM at 14 weeks + 9 months | Active comparator | Biological: fIPV (0.2mL) IMParticipants in this arm will receive intramuscular fractional doses (0.2 mL) of IPV at 14 weeks and 9 months of age. |
Who may qualify
- Ages
- 42 to 48 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy infants 6 weeks of age
- 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 (10 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 diarrhoea, infection or illness at the time of enrolment (6 weeks of age) that would require infant's admission to a hospital.
- Acute vomiting and intolerance to liquids within 24 hours before the enrolment 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 |
|---|---|---|
| fIPV (0.1 mL) IDFractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intradermal (ID) injection in lieu of the full 0.5 mL dose. | Biological | fIPV ID at 14 weeks + 9 months, fIPV ID at 6 weeks + 14 weeks + 9 months |
| fIPV (0.1mL) IMFractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intramuscular (IM) injection in lieu of the full 0.5 mL dose. | Biological | fIPV 0.1mL IM at 14 weeks + 9 months, fIPV IM at 6 weeks + 14 weeks + 9 months |
| fIPV (0.2mL) IMFractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.2 milliliter (mL) dose (fractional) by intramuscular (IM) injection in lieu of the full 0.5 mL dose. | Biological | fIPV 0.2mL IM at 14 weeks + 9 months |
| IPVFull dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.5 milliliter (mL) dose by intramuscular (IM) injection. | Biological | IPV at 14 weeks + 9 months, IPV at 6 weeks + 9 months |
Primary outcome
Vaccine response
Time frame: Measured four weeks after administration of study vaccine(s).
Dichotomous (yes/no) variable defined as participants who are either seronegative (<1:8 titers) at baseline who become seropositive (≥1:8) after vaccination (seroconversion) or participants who demonstrate a four-fold rise in titers after vaccination between two specimens, e.g. a change from 1:8 to 1:32, after adjusting for expected decay in maternal antibodies. Antibody titers at 6 weeks of age will be the starting point for the expected decline in maternal antibodies, assuming at half-life of 28 days.
1 secondary outcome
Reciprocal antibody titers
Time frame: Measured four weeks after administration of study vaccine(s).
Results and safety
The study was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: No
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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 fIPV (0.1 mL) ID, fIPV (0.1mL) IM and fIPV (0.2mL) IM 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 10 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: stopped early, as of the sponsor's last update on 18 May 2022. 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 was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.
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?
Vaccine response (time frame: Measured four weeks after administration of study vaccine(s).). 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 18 May 2022.