PoliomyelitisPhase 1/2NCT06137664
Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines
A Phase 1/2 study testing Novel oral poliomyelitis vaccine type 1 (nOPV1), Novel oral poliomyelitis vaccine type 2 (nOPV2) and Novel oral poliomyelitis vaccine type 3 (nOPV3) in people with Poliomyelitis, run by PATH at 2 sites in Bangladesh.
Trial summary
The main objectives of this study are to : evaluate the safety and tolerability of trivalent novel oral poliovirus vaccines (tnOPV) in healthy adults, young children, and neonates, relative to those receiving control vaccines; evaluate the safety and tolerability of combined novel oral poliovirus vaccine type 1… Read more about this study
- Who is it for?
- Ages 0 days to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- Novel oral poliomyelitis vaccine type 1 (nOPV1), Novel oral poliomyelitis vaccine type 2 (nOPV2) and Novel oral poliomyelitis vaccine type 3 (nOPV3)
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,400 participants
- Where
- 2 sitesBangladesh
- Study dates
- 20 Nov 2024to 15 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 0 days to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy, as defined by the absence of any clinically significant medical condition or congenital anomaly as determined by medical history, physical examination, and clinical assessment of the investigator.
- Participant or parent of the participant is willing and able to provide written informed consent prior to performance of any study-specific procedure.
- Resides and plans to remain in study area and participants and parent, when applicable, understands and is able and willing to adhere to all study visits and procedures (as evidenced by a signed informed consent form [ICF] and assessment by the investigator).
- Males or females, from 18 to 45 years of age (inclusive) at the time of enrollment.
- If female and of childbearing potential*, not breastfeeding and not pregnant (based on a negative urine pregnancy test at screening and a negative urine pregnancy test during the 24 hours prior to any study vaccination [if screening occurs within 24 hours prior to vaccination, a single negative pregnancy test is acceptable]), agreeing to not become pregnant through other means (e.g., artificial insemination and IVF) and have repeated pregnancy tests prior to any study vaccination, and having practiced adequate contraception** for 30 days prior to first study vaccination and willing to continue using adequate contraception consistently for at least 90 days after the last study vaccination.
- Born and raised in Bangladesh in 1990 or later; if born before 1990 or not born and raised in Bangladesh, has documentation of a complete poliomyelitis immunization series containing OPV or IPV.
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- Male or female child from 1 to less than 5 years of age at the time of enrollment (from the first birthday up to the day prior to the fifth birthday).
- Based on documentation, previously received a 3 or 4 dose primary poliomyelitis immunization series containing bOPV ± IPV, with last dose received more than 3 months prior to initial study vaccination.
- Male or female newborn neonate (day of birth+ 3-day window), at the time of initial study vaccination.
- Prior to study vaccination has received no doses of IPV or OPV or rotavirus vaccine, based upon documentation or parental history.
- Agreement to receive polio EPI vaccines under a modified schedule.
Who cannot join
- Exclusion Criteria for all participants (unless otherwise specified):
- Presence of anyone under 10 years of age in the participant's household (living in the same house or apartment unit) who does not have complete "age appropriate" vaccination status with respect to poliovirus vaccines based on the vaccination records at the time of study vaccine administration. For household members younger than 10 years of age-appropriate vaccination is a complete series of at least three doses of OPV.
- A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin).
- Any self-reported known or suspected immunosuppressive or immunodeficiency condition (including HIV infection) in the participant or household member (living under the same roof/in the same building rather than in the same compound).
- Receipt of any immune-modifying or immunosuppressant drugs within 6 months prior to the first study vaccine dose or planned use during the study.
- Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection.
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- Moderate or severe (grade ≥ 2) acute illness including vomiting, diarrhea at the time of enrollment/first study vaccination - temporary exclusion.
- Presence of fever within the 72 hours of the day of enrollment/first study vaccination (oral temperature ≥38.0˚C for Cohort 1; axillary temperature ≥37.5˚C for Cohorts 2 and 3) or any antipyretic use within past 24 hours - temporary exclusion for Cohorts 1 and 2.
- Evidence of a clinically significant major congenital or genetic defect as judged by the investigator.
- History of chronic administration (defined as more than 14 days) of immunosuppressant medications, including corticosteroids (> 0.5mg/kg/day or 20 mg/day of prednisolone (or equivalent) within 6 months prior to first study vaccine dose. Topical and inhaler steroids are permitted (unless indicative of a significant chronic illness otherwise excluding the young child).
- Participation in another investigational product (drug or vaccine, including prior polio vaccine trials) clinical trial within 30 days prior to entry in this study or receipt of any such investigational product other than the study vaccine within 30 days prior to the first administration of study vaccine, or planned participation in another investigational product clinical trial during the study period.
- Receipt of transfusion of any blood product or immunoglobulins within 12 months prior to the first administration of study vaccine or planned during the study period.
- Participant or parent, when applicable, has any condition that in the opinion of the investigator would increase the participant's health risks in study participation or would increase the risk of not achieving the study's objectives (e.g., would compromise adherence to protocol requirements or interfere with planned safety and immunogenicity assessments).
- Receipt of polio vaccine within 12 months before the start of the study.
- Having Crohn's disease or ulcerative colitis or having had major surgery of the gastrointestinal tract involving significant loss or resection of the bowel.
- Will have household direct or close professional contact during the study with pregnant women.
- Will have household direct or close professional (e.g., neonatal nurses) contact during the study with children less than 2 years of age or with individuals who are encopretic (i.e., soiling of underwear with stool by children who are past the age of toilet training or other individuals, including adults, with fecal incontinence).
- Will have professional handling of food, catering, or food production activities during the study.
- Any participating children attending day care or pre-school during their participation in the study until one month after their last study vaccine administration.
- Presence of severe malnutrition [weight-for-length/height z-score <-3SD median (per WHO published child growth standards)]-temporary exclusion if marginal and subsequently gains weight.
- Low birth weight (LBW) in newborn participants which is defined as a birth weight of less than 2500 g (up to and including 2499 g) at the time of birth or by the time of enrollment
- Premature birth (less than 37 weeks gestation).
- From multiple birth (due to increased risk of OPV transmissions between siblings).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh2 sites, 2 recruiting
- Not yet recruiting
International Centre for Diarrhoeal Disease Research
Dhaka, 1212
K. Zaman, MBBS, MPH, PhD, FRCP, +880 2 9827001 10 ext. 3806, kzaman@icddrb.org
K. Zaman, MBBS, MPH, PhD, FRCP
- Recruiting
International Centre for Diarrhoeal Disease Research
Dhaka
K. Zaman, MBBS, MPH, PhD, FRCP, +880 2 9827001 10 ext. 3806, kzaman@icddrb.org
About this study
Official title: A Phase 1/2, Randomized, Observer-Blind, Active-Controlled, Age De-escalation, Dose Combination Ranging Study to Assess the Safety and Immunogenicity of Co-administered Novel Live Attenuated Trivalent Oral Poliomyelitis Vaccine in Healthy Adults, Young Children, and Neonates and Co-administered Novel Live Attenuated Monovalent Oral Poliomyelitis Vaccines 1 and 2 in Neonates in Bangladesh
The main objectives of this study are to :
- evaluate the safety and tolerability of trivalent novel oral poliovirus vaccines (tnOPV) in healthy adults, young children, and neonates, relative to those receiving control vaccines;
- evaluate the safety and tolerability of combined novel oral poliovirus vaccine type 1 (nOPV1) + novel oral poliovirus vaccine type 2 (nOPV2) in neonates, relative to those receiving the bivalent (types 1 and 3) oral poliovirus vaccine (bOPV) control.
- compare type-specific cumulative seroconversion rates of poliovirus neutralizing antibody (NAb) titers, among all tnOPV dose combinations, following 4 vaccinations in healthy neonates;
- evaluate the type-specific cumulative seroconversion rate of poliovirus NAb titers among healthy neonates following 4 doses of combined nOPV1+nOPV2.
Read the detailed description
This trial will use co-administered novel monovalent types 1, 2, and 3 vaccines to simulate administration of a potential trivalent vaccine and compare to the active control bOPV (bivalent Sabin types 1 and 3) and will be conducted at a single clinical center.
The study population will include healthy adults (≥18 to ≤45 years old) who have previously completed their full routine polio immunization series, healthy young children (≥1 to <5 years old) who have completed their full routine polio immunization series and healthy neonates (day of birth+3 days), who have not received any polio vaccination.
Enrollment in this study will be staggered into two stages and three age-descending cohorts.
Stage 1 will consist of an age-descension/dose escalation approach from adults to young children (Cohorts 1 and 2). Enrollment will begin with Cohort 1, in which 100 adults will be randomly allocated in a 1:1 ratio to Groups 1 and 2. Following a Protocol Safety Review Team (PSRT) review of the study Day 8 safety data (i.e. safety data reported up to 7 days post-vaccination #1, collected at Visit 2) of the adults in Cohort 1, and the absence of any safety concerns, 200 young children in Cohort 2 will be randomly allocated in a 1:1:1:1 ratio to Groups 3, 4, 5, and 6, respectively.
After the completion of enrollment of Cohort 2, the study will move into Stage 2. In addition to a PSRT review of Day 8 safety data of the young children in Cohort 2, there are two triggers of data from other studies to initiate the enrollment into Cohort 3:
- Absence of safety concerns upon the safety data reviews occurring at least 8 days after receipt of the first dose of 107.5 CCID50 nOPV1 or 107.5 CCID50 nOPV3 by the first 60 IPV-vaccinated infants enrolled in each of the Phase 2 monovalent trials CVIA 093 and CVIA 101, respectively (the first 45 nOPV:15 mOPV participants randomized per dose pair).
- Favorable immunogenicity data (homotypic anti-polio serum neutralizing antibody titers) from the Phase 2 monovalent nOPV1 study (CVIA 093) in IPV-vaccinated infants, and the Phase 2 monovalent nOPV3 study (CVIA 101) in young children.
Stage 2 will consist of dose exploration in neonates (Cohort 3). In Cohort 3, Groups 7-14, 2100 neonates will be randomly allocated in a 3:3:3:3:3:3:2:1 ratio, respectively.
- Conditions
- Poliomyelitis
- Being tested
- Novel oral poliomyelitis vaccine type 1 (nOPV1), Novel oral poliomyelitis vaccine type 2 (nOPV2), Novel oral poliomyelitis vaccine type 3 (nOPV3), Bivalent Oral Poliomyelitis Vaccine (bOPV)
- Keywords
- poliovirus vaccine, Trivalent oral poliovirus vaccine, Novel oral poliovirus vaccine
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel oral poliomyelitis vaccine type 1 (nOPV1)Biological
Live attenuated novel poliomyelitis virus type 1 at two different dosages, containing middle-dose (MD) 10^6.0, or high-dose (HD) 10^6.5 CCID₅₀/dose
Novel oral poliomyelitis vaccine type 2 (nOPV2)Biological
Live attenuated novel poliomyelitis virus type 2 administered at low-dose (LD) 10^5.3 and HD 10^5.6 CCID₅₀/dose.
Novel oral poliomyelitis vaccine type 3 (nOPV3)Biological
Live attenuated novel poliomyelitis virus type 3 at two different dosages, containing MD 10^6.0, or HD 10^6.5 CCID₅₀/dose.
Bivalent Oral Poliomyelitis Vaccine (bOPV)Biological
Live attenuated poliomyelitis viruses types 1 and 3 (Sabin strains). Each dose (2 drops = 0.1 mL) contains not less than 10^6.0 infective units of type 1 and 10^5.8 of type 3.
| Study group | Role | What they receive |
|---|---|---|
| Adults: High-dose (HD) nOPV1 + HD nOPV2 + HD nOPV3 | Experimental | Adults will receive nOPV1 (10^6.5 Cell Culture Infectious Dose 50% [CCID₅₀]) plus nOPV2 (10^5.6 CCID₅₀) plus nOPV3 (10^6.5 CCID₅₀) on Day 1 and Day 29. Receives: Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1); Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2); Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3) |
| Adults:bOPV | Active comparator | Adults will receive bivalent OPV (types 1 and 3) on Day 1 and Day 29. Each dose (2 drops = 0.1 mL) contains >10^6.0 infective units of type 1 and >10^5.8 of type 3. Receives: Biological: Bivalent Oral Poliomyelitis Vaccine (bOPV) |
| Young Children: Middle-dose (MD) nOPV1 + Low-dose (LD) nOPV2 + MD nOPV3 | Experimental | Children aged ≥ 1 to < 5 years old will receive nOPV1 (10^6.0 CCID₅₀) plus nOPV2 (10^5.3 CCID₅₀) plus nOPV3 (10^6.0 CCID₅₀) on Day 1 and Day 29. Receives: Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1); Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2); Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3) |
| Young Children: HD nOPV1 + HD nOPV2 + HD nOPV3 | Experimental | Children aged ≥ 1 to < 5 years old will receive nOPV1 (10^6.5 CCID₅₀) plus nOPV2 (10^5.6 CCID₅₀) plus nOPV3 (10^6.5 CCID₅₀) on Day 1 and Day 29. Receives: Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1); Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2); Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3) |
| Young Children: Low-dose (LD) nOPV2 | Active comparator | Children aged ≥ 1 to < 5 years old will receive nOPV2 (10^5.3 CCID₅₀) on Day 1 and Day 29. Receives: Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2) |
| Young Children: bOPV | Active comparator | Children aged ≥ 1 to < 5 years old will receive bivalent OPV (types 1 and 3) on Day 1 and Day 29. Each dose (2 drops = 0.1 mL) contains > 10^6.0 infective units of type 1 and > 10^5.8 of type 3. Receives: Biological: Bivalent Oral Poliomyelitis Vaccine (bOPV) |
| Neonates: MD nOPV1 + LD nOPV2 + MD nOPV3 | Experimental | Newborns will receive nOPV1 (10^6.0 CCID₅₀) plus nOPV2 (10^5.3 CCID₅₀) plus nOPV3 (10^6.0 CCID₅₀) at birth, week 6, week 10 and week 14 of life. Receives: Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1); Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2); Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3) |
| Neonates: HD nOPV1 + LD nOPV2 + HD nOPV3 | Experimental | Newborns will receive nOPV1 (10^6.5 CCID₅₀) plus nOPV2 (10^5.3 CCID₅₀) plus nOPV3 (10^6.5 CCID₅₀) at birth, week 6, week 10 and week 14 of life. Receives: Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1); Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2); Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3) |
| Neonates: MD nOPV1 + LD nOPV2 + HD nOPV3 | Experimental | Newborns will receive nOPV1 (10^6.0 CCID₅₀) plus nOPV2 (10^5.3 CCID₅₀) plus nOPV3 (10^6.5 CCID₅₀) at birth, week 6, week 10 and week 14 of life. Receives: Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1); Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2); Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3) |
| Neonates: HD nOPV1+ LD nOPV2+ MD nOPV3 | Experimental | Newborns will receive nOPV1 (10^6.5 CCID₅₀) plus nOPV2 (10^5.3 CCID₅₀) plus nOPV3 (10^6.0 CCID₅₀) at birth, week 6, week 10 and week 14 of life. Receives: Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1); Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2); Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3) |
| Neonates: HD nOPV1 + HD nOPV2 + HD nOPV3 | Experimental | Newborns will receive nOPV1 (10^6.5 CCID₅₀) plus nOPV2 (10^5.6 CCID₅₀) plus nOPV3 (10^6.5 CCID₅₀) at birth, week 6, week 10 and week 14 of life. Receives: Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1); Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2); Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3) |
| Neonates: bOPV | Active comparator | Newborns will receive bivalent OPV (types 1 and 3) at birth, week 6, week 10 and week 14 of life. Each dose (2 drops = 0.1 mL) contains >10^6.0 infective units of type 1 and >10^5.8 of type 3. Receives: Biological: Bivalent Oral Poliomyelitis Vaccine (bOPV) |
| Neonates: MD nOPV1 + LD nOPV2 | Experimental | Newborns will receive nOPV1 (10^6.0 CCID₅₀) plus nOPV2 (10^5.3 CCID₅₀) at birth, week 6, week 10 and week 14 of life. Receives: Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1); Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2) |
| Neonates: LD nOPV2 | Active comparator | Newborns will receive nOPV2 (10^5.3 CCID₅₀) at birth, week 6, week 10 and week 14 of life. Receives: Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Serious Adverse Events (SAEs)
A serious adverse event is any adverse event that results in any of the following outcomes:
- Death.
- Is life-threatening.
- Requires inpatient hospitalization or prolongation of existing hospitalization.
- Results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.
- Congenital abnormality or birth defect.
- Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant and require medical or surgical intervention to prevent one of the outcomes listed in the above definition of serious adverse event.
Measured: From the time of first study vaccination through the end of the study (197 days)
Number of Participants with Solicited Adverse Events (AEs) for 7 Days After Each Vaccination
Solicited AEs are pre-specified AEs that are common or known to be associated with vaccination that are actively monitored as potential indicators of vaccine reactogenicity.
Measured: 7 days (day of vaccination and 6 following days) after each vaccination
Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination.
Unsolicited AEs are any AEs reported spontaneously by the participant or parent, observed by the study personnel during study visits or identified during review of medical records or source documents.
Measured: 28 days (day of vaccination and 27 following days) after each vaccination
Neonates: Seroconversion Rate of Types 1, 2, and 3 Anti-polio Serum Neutralizing Antibodies 28 Days After Last Vaccination
For vaccine-naive neonates, seroconversion is defined as seropositive (titer ≥1:8) in those initially seronegative, or among those initially seropositive, as a minimum 4-fold higher (and seropositivity) than that which is expected due to maternal antibodies. This endpoint will be analyzed in neonates who receive nOPV types 1, 2, and 3.
Measured: Baseline and 28 days following the last vaccination (week 18)
Neonates: Seroconversion Rate of Types 1, 2, and 1 & 2 Combined Anti-polio Serum Neutralizing Antibodies 28 Days After Last Vaccination
For vaccine-naive neonates, seroconversion is defined as seropositive (titer ≥1:8) in those initially seronegative, or among those initially seropositive, as a minimum 4-fold higher (and seropositivity) than that which is expected due to maternal antibodies. This endpoint will be analyzed in neonates who receive nOPV types 1 and 2 only.
Measured: Baseline and 28 days following the last vaccination (week 18)
Secondary outcomes (11)
Neonates: Type-specific and Multitypic Seroconversion Rate of Anti-polio Serum Neutralizing Antibodies
For vaccine-naive neonates, seroconversion is defined as seropositive (titer ≥1:8) in those initially seronegative, or among those initially seropositive, as a minimum 4-fold higher (and seropositivity) than that which is expected due to maternal antibodies.
Multitypic seroconversion refers to seroconversion to multiple types simultaneously, including types 1 \& 2, types 1 \& 3, types 2 \& 3, and types 1 \& 2 \& 3.
Measured: Baseline and weeks 6, 10, 14, and 18
Adults and Young Children: Type-specific and Multitypic Seroconversion Rate of Anti-polio Serum Neutralizing Antibodies 4 Weeks After Each Vaccination
For previously vaccinated cohorts, seroconversion will be defined as either a minimum 4-fold rise in titer relative to the baseline value among those initially seropositive, or post-vaccination seropositivity among those seronegative at baseline.
This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Measured: Baseline and Weeks 4 and 8
All Cohorts: Types 1, 2 and 3 Anti-polio Serum Neutralizing Antibody Titers Following Last Dose
This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Measured: Baseline and 4 weeks following the last vaccination (week 8 in adults and young children and week 18 in neonates)
Adults and Young Children: Types 1, 2 and 3 Anti-polio Serum Neutralizing Antibody Titers Following First Dose
This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Measured: Baseline and week 4
All Cohorts: Geometric Mean Titer (GMT) of Types 1, 2 and 3 Anti-polio Serum Neutralizing Antibodies Following Last Dose
This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Measured: Baseline and 4 weeks following the last vaccination (week 8 in adults and young children and week 18 in neonates)
Adults and Young Children: Geometric Mean Titer (GMT) of Types 1, 2 and 3 Anti-polio Serum Neutralizing Antibodies Following First Dose
This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Measured: Baseline and Week 4
All Cohorts: Type-specific and Multitypic Seroprotection Rate Following Last Dose
Seroprotection is defined as types 1, 2 and 3 anti-polio serum neutralizing antibody reciprocal titer ≥ 8.
This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Measured: Baseline and 4 weeks following the last vaccination (week 8 in adults and young children and week 18 in neonates)
Adults and Young Children: Type-specific and Multitypic Seroprotection Rate Following First Dose
Seroprotection is defined as types 1, 2 and 3 anti-polio serum neutralizing antibody reciprocal titer ≥ 8.
This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Measured: Baseline and week 4
Adults and Young Children: Geometric Mean Fold Rise (GMFR) in Neutralizing Antibody Titer Relative to Previous Dose
This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Measured: Baseline and weeks 4 and 8
Neonates: Geometric Mean Fold Rise (GMFR) in Neutralizing Antibody Titer Relative to the Expected Level of Maternal Antibody and Each Pre-dose Value
This endpoint will be analyzed in groups who receive nOPV types 1, 2, and 3.
Measured: Baseline and weeks 6, 10, 14, and 18
Neonates: Percentage of Participants Shedding Types 1, 2 and/or 3 Poliovirus Post-vaccination
Stool samples will be analyzed using polymerase chain reaction (PCR) to detect poliovirus types 1, 2, and 3.
Measured: From birth through 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start20 Nov 2024
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PoliomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Bio Farma, Indonesia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137664
- Sponsor's protocol ID
- CVIA 095
- Status last verified
- May 2025
- First submitted
- 14 Nov 2023
- Last updated
- 3 Jun 2025
- 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 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Randomized, Observer-Blind, Active-Controlled, Age De-escalation, Dose Combination Ranging Study to Assess the Safety and Immunogenicity of Co-administered Novel Live Attenuated Trivalent Oral Poliomyelitis Vaccine in Healthy Adults, Young Children, and Neonates and Co-administered Novel Live Attenuated Monovalent Oral Poliomyelitis Vaccines 1 and 2 in Neonates in Bangladesh
- ClinicalTrials.gov ID
- NCT06137664
- Acronym / sponsor ID
- CVIA 095
- Conditions
- Poliomyelitis
- Keywords
- poliovirus vaccine, Trivalent oral poliovirus vaccine, Novel oral poliovirus vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,400 participants (estimated)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Bio Farma, Indonesia
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 18 Nov 2023 (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.
The main objectives of this study are to :
- evaluate the safety and tolerability of trivalent novel oral poliovirus vaccines (tnOPV) in healthy adults, young children, and neonates, relative to those receiving control vaccines;
- evaluate the safety and tolerability of combined novel oral poliovirus vaccine type 1 (nOPV1) + novel oral poliovirus vaccine type 2 (nOPV2) in neonates, relative to those receiving the bivalent (types 1 and 3) oral poliovirus vaccine (bOPV) control.
- compare type-specific cumulative seroconversion rates of poliovirus neutralizing antibody (NAb) titers, among all tnOPV dose combinations, following 4 vaccinations in healthy neonates;
- evaluate the type-specific cumulative seroconversion rate of poliovirus NAb titers among healthy neonates following 4 doses of combined nOPV1+nOPV2.
Detailed description
This trial will use co-administered novel monovalent types 1, 2, and 3 vaccines to simulate administration of a potential trivalent vaccine and compare to the active control bOPV (bivalent Sabin types 1 and 3) and will be conducted at a single clinical center.
The study population will include healthy adults (≥18 to ≤45 years old) who have previously completed their full routine polio immunization series, healthy young children (≥1 to <5 years old) who have completed their full routine polio immunization series and healthy neonates (day of birth+3 days), who have not received any polio vaccination.
Enrollment in this study will be staggered into two stages and three age-descending cohorts.
Stage 1 will consist of an age-descension/dose escalation approach from adults to young children (Cohorts 1 and 2). Enrollment will begin with Cohort 1, in which 100 adults will be randomly allocated in a 1:1 ratio to Groups 1 and 2. Following a Protocol Safety Review Team (PSRT) review of the study Day 8 safety data (i.e. safety data reported up to 7 days post-vaccination #1, collected at Visit 2) of the adults in Cohort 1, and the absence of any safety concerns, 200 young children in Cohort 2 will be randomly allocated in a 1:1:1:1 ratio to Groups 3, 4, 5, and 6, respectively.
After the completion of enrollment of Cohort 2, the study will move into Stage 2. In addition to a PSRT review of Day 8 safety data of the young children in Cohort 2, there are two triggers of data from other studies to initiate the enrollment into Cohort 3:
- Absence of safety concerns upon the safety data reviews occurring at least 8 days after receipt of the first dose of 107.5 CCID50 nOPV1 or 107.5 CCID50 nOPV3 by the first 60 IPV-vaccinated infants enrolled in each of the Phase 2 monovalent trials CVIA 093 and CVIA 101, respectively (the first 45 nOPV:15 mOPV participants randomized per dose pair).
- Favorable immunogenicity data (homotypic anti-polio serum neutralizing antibody titers) from the Phase 2 monovalent nOPV1 study (CVIA 093) in IPV-vaccinated infants, and the Phase 2 monovalent nOPV3 study (CVIA 101) in young children.
Stage 2 will consist of dose exploration in neonates (Cohort 3). In Cohort 3, Groups 7-14, 2100 neonates will be randomly allocated in a 3:3:3:3:3:3:2:1 ratio, respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Adults: High-dose (HD) nOPV1 + HD nOPV2 + HD nOPV3 | Experimental | Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1), Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2), Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3)Adults will receive nOPV1 (10^6.5 Cell Culture Infectious Dose 50% [CCID₅₀]) plus nOPV2 (10^5.6 CCID₅₀) plus nOPV3 (10^6.5 CCID₅₀) on Day 1 and Day 29. |
| Adults:bOPV | Active comparator | Biological: Bivalent Oral Poliomyelitis Vaccine (bOPV)Adults will receive bivalent OPV (types 1 and 3) on Day 1 and Day 29. Each dose (2 drops = 0.1 mL) contains >10^6.0 infective units of type 1 and >10^5.8 of type 3. |
| Young Children: Middle-dose (MD) nOPV1 + Low-dose (LD) nOPV2 + MD nOPV3 | Experimental | Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1), Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2), Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3)Children aged ≥ 1 to < 5 years old will receive nOPV1 (10^6.0 CCID₅₀) plus nOPV2 (10^5.3 CCID₅₀) plus nOPV3 (10^6.0 CCID₅₀) on Day 1 and Day 29. |
| Young Children: HD nOPV1 + HD nOPV2 + HD nOPV3 | Experimental | Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1), Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2), Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3)Children aged ≥ 1 to < 5 years old will receive nOPV1 (10^6.5 CCID₅₀) plus nOPV2 (10^5.6 CCID₅₀) plus nOPV3 (10^6.5 CCID₅₀) on Day 1 and Day 29. |
| Young Children: Low-dose (LD) nOPV2 | Active comparator | Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2)Children aged ≥ 1 to < 5 years old will receive nOPV2 (10^5.3 CCID₅₀) on Day 1 and Day 29. |
| Young Children: bOPV | Active comparator | Biological: Bivalent Oral Poliomyelitis Vaccine (bOPV)Children aged ≥ 1 to < 5 years old will receive bivalent OPV (types 1 and 3) on Day 1 and Day 29. Each dose (2 drops = 0.1 mL) contains > 10^6.0 infective units of type 1 and > 10^5.8 of type 3. |
| Neonates: MD nOPV1 + LD nOPV2 + MD nOPV3 | Experimental | Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1), Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2), Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3)Newborns will receive nOPV1 (10^6.0 CCID₅₀) plus nOPV2 (10^5.3 CCID₅₀) plus nOPV3 (10^6.0 CCID₅₀) at birth, week 6, week 10 and week 14 of life. |
| Neonates: HD nOPV1 + LD nOPV2 + HD nOPV3 | Experimental | Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1), Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2), Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3)Newborns will receive nOPV1 (10^6.5 CCID₅₀) plus nOPV2 (10^5.3 CCID₅₀) plus nOPV3 (10^6.5 CCID₅₀) at birth, week 6, week 10 and week 14 of life. |
| Neonates: MD nOPV1 + LD nOPV2 + HD nOPV3 | Experimental | Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1), Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2), Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3)Newborns will receive nOPV1 (10^6.0 CCID₅₀) plus nOPV2 (10^5.3 CCID₅₀) plus nOPV3 (10^6.5 CCID₅₀) at birth, week 6, week 10 and week 14 of life. |
| Neonates: HD nOPV1+ LD nOPV2+ MD nOPV3 | Experimental | Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1), Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2), Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3)Newborns will receive nOPV1 (10^6.5 CCID₅₀) plus nOPV2 (10^5.3 CCID₅₀) plus nOPV3 (10^6.0 CCID₅₀) at birth, week 6, week 10 and week 14 of life. |
| Neonates: HD nOPV1 + HD nOPV2 + HD nOPV3 | Experimental | Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1), Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2), Biological: Novel oral poliomyelitis vaccine type 3 (nOPV3)Newborns will receive nOPV1 (10^6.5 CCID₅₀) plus nOPV2 (10^5.6 CCID₅₀) plus nOPV3 (10^6.5 CCID₅₀) at birth, week 6, week 10 and week 14 of life. |
| Neonates: bOPV | Active comparator | Biological: Bivalent Oral Poliomyelitis Vaccine (bOPV)Newborns will receive bivalent OPV (types 1 and 3) at birth, week 6, week 10 and week 14 of life. Each dose (2 drops = 0.1 mL) contains >10^6.0 infective units of type 1 and >10^5.8 of type 3. |
| Neonates: MD nOPV1 + LD nOPV2 | Experimental | Biological: Novel oral poliomyelitis vaccine type 1 (nOPV1), Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2)Newborns will receive nOPV1 (10^6.0 CCID₅₀) plus nOPV2 (10^5.3 CCID₅₀) at birth, week 6, week 10 and week 14 of life. |
| Neonates: LD nOPV2 | Active comparator | Biological: Novel oral poliomyelitis vaccine type 2 (nOPV2)Newborns will receive nOPV2 (10^5.3 CCID₅₀) at birth, week 6, week 10 and week 14 of life. |
Who may qualify
- Ages
- 0 days to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Healthy, as defined by the absence of any clinically significant medical condition or congenital anomaly as determined by medical history, physical examination, and clinical assessment of the investigator.
- Participant or parent of the participant is willing and able to provide written informed consent prior to performance of any study-specific procedure.
- Resides and plans to remain in study area and participants and parent, when applicable, understands and is able and willing to adhere to all study visits and procedures (as evidenced by a signed informed consent form [ICF] and assessment by the investigator).
- Males or females, from 18 to 45 years of age (inclusive) at the time of enrollment.
- If female and of childbearing potential*, not breastfeeding and not pregnant (based on a negative urine pregnancy test at screening and a negative urine pregnancy test during the 24 hours prior to any study vaccination [if screening occurs within 24 hours prior to vaccination, a single negative pregnancy test is acceptable]), agreeing to not become pregnant through other means (e.g., artificial insemination and IVF) and have repeated pregnancy tests prior to any study vaccination, and having practiced adequate contraception** for 30 days prior to first study vaccination and willing to continue using adequate contraception consistently for at least 90 days after the last study vaccination.
Key exclusion criteria (23 listed)
- Presence of anyone under 10 years of age in the participant's household (living in the same house or apartment unit) who does not have complete "age appropriate" vaccination status with respect to poliovirus vaccines based on the vaccination records at the time of study vaccine administration. For household members younger than 10 years of age-appropriate vaccination is a complete series of at least three doses of OPV.
- A known allergy, hypersensitivity, or intolerance to any components of the study vaccines, including all macrolide and aminoglycoside antibiotics (e.g., erythromycin and kanamycin).
- Any self-reported known or suspected immunosuppressive or immunodeficiency condition (including HIV infection) in the participant or household member (living under the same roof/in the same building rather than in the same compound).
- Receipt of any immune-modifying or immunosuppressant drugs within 6 months prior to the first study vaccine dose or planned use during the study.
- Any known or suspected bleeding disorder in the participant that would pose a risk to venipuncture or intramuscular injection.
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 |
|---|---|---|
| Novel oral poliomyelitis vaccine type 1 (nOPV1)Live attenuated novel poliomyelitis virus type 1 at two different dosages, containing middle-dose (MD) 10^6.0, or high-dose (HD) 10^6.5 CCID₅₀/dose | Biological | Adults: High-dose (HD) nOPV1 + HD nOPV2 + HD nOPV3, Neonates: HD nOPV1 + HD nOPV2 + HD nOPV3, Neonates: HD nOPV1 + LD nOPV2 + HD nOPV3, Neonates: HD nOPV1+ LD nOPV2+ MD nOPV3, Neonates: MD nOPV1 + LD nOPV2, Neonates: MD nOPV1 + LD nOPV2 + HD nOPV3, Neonates: MD nOPV1 + LD nOPV2 + MD nOPV3, Young Children: HD nOPV1 + HD nOPV2 + HD nOPV3, Young Children: Middle-dose (MD) nOPV1 + Low-dose (LD) nOPV2 + MD nOPV3 |
| Novel oral poliomyelitis vaccine type 2 (nOPV2)Live attenuated novel poliomyelitis virus type 2 administered at low-dose (LD) 10^5.3 and HD 10^5.6 CCID₅₀/dose. | Biological | Adults: High-dose (HD) nOPV1 + HD nOPV2 + HD nOPV3, Neonates: HD nOPV1 + HD nOPV2 + HD nOPV3, Neonates: HD nOPV1 + LD nOPV2 + HD nOPV3, Neonates: HD nOPV1+ LD nOPV2+ MD nOPV3, Neonates: LD nOPV2, Neonates: MD nOPV1 + LD nOPV2, Neonates: MD nOPV1 + LD nOPV2 + HD nOPV3, Neonates: MD nOPV1 + LD nOPV2 + MD nOPV3, Young Children: HD nOPV1 + HD nOPV2 + HD nOPV3, Young Children: Low-dose (LD) nOPV2, Young Children: Middle-dose (MD) nOPV1 + Low-dose (LD) nOPV2 + MD nOPV3 |
| Novel oral poliomyelitis vaccine type 3 (nOPV3)Live attenuated novel poliomyelitis virus type 3 at two different dosages, containing MD 10^6.0, or HD 10^6.5 CCID₅₀/dose. | Biological | Adults: High-dose (HD) nOPV1 + HD nOPV2 + HD nOPV3, Neonates: HD nOPV1 + HD nOPV2 + HD nOPV3, Neonates: HD nOPV1 + LD nOPV2 + HD nOPV3, Neonates: HD nOPV1+ LD nOPV2+ MD nOPV3, Neonates: MD nOPV1 + LD nOPV2 + HD nOPV3, Neonates: MD nOPV1 + LD nOPV2 + MD nOPV3, Young Children: HD nOPV1 + HD nOPV2 + HD nOPV3, Young Children: Middle-dose (MD) nOPV1 + Low-dose (LD) nOPV2 + MD nOPV3 |
| Bivalent Oral Poliomyelitis Vaccine (bOPV)Live attenuated poliomyelitis viruses types 1 and 3 (Sabin strains). Each dose (2 drops = 0.1 mL) contains not less than 10^6.0 infective units of type 1 and 10^5.8 of type 3. | Biological | Adults:bOPV, Neonates: bOPV, Young Children: bOPV |
Primary outcome
Number of Participants with Serious Adverse Events (SAEs)
Time frame: From the time of first study vaccination through the end of the study (197 days)
A serious adverse event is any adverse event that results in any of the following outcomes: 1. Death. 2. Is life-threatening. 3. Requires inpatient hospitalization or prolongation of existing hospitalization. 4. Results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions. 5. Congenital abnormality or birth defect. 6. Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant and require medical or surgical intervention to prevent one of the outcomes listed in the above definition of serious adverse event.
Number of Participants with Solicited Adverse Events (AEs) for 7 Days After Each Vaccination
Time frame: 7 days (day of vaccination and 6 following days) after each vaccination
Solicited AEs are pre-specified AEs that are common or known to be associated with vaccination that are actively monitored as potential indicators of vaccine reactogenicity.
Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination.
Time frame: 28 days (day of vaccination and 27 following days) after each vaccination
Unsolicited AEs are any AEs reported spontaneously by the participant or parent, observed by the study personnel during study visits or identified during review of medical records or source documents.
Neonates: Seroconversion Rate of Types 1, 2, and 3 Anti-polio Serum Neutralizing Antibodies 28 Days After Last Vaccination
Time frame: Baseline and 28 days following the last vaccination (week 18)
For vaccine-naive neonates, seroconversion is defined as seropositive (titer ≥1:8) in those initially seronegative, or among those initially seropositive, as a minimum 4-fold higher (and seropositivity) than that which is expected due to maternal antibodies. This endpoint will be analyzed in neonates who receive nOPV types 1, 2, and 3.
Neonates: Seroconversion Rate of Types 1, 2, and 1 & 2 Combined Anti-polio Serum Neutralizing Antibodies 28 Days After Last Vaccination
Time frame: Baseline and 28 days following the last vaccination (week 18)
For vaccine-naive neonates, seroconversion is defined as seropositive (titer ≥1:8) in those initially seronegative, or among those initially seropositive, as a minimum 4-fold higher (and seropositivity) than that which is expected due to maternal antibodies. This endpoint will be analyzed in neonates who receive nOPV types 1 and 2 only.
11 secondary outcomes
Neonates: Type-specific and Multitypic Seroconversion Rate of Anti-polio Serum Neutralizing Antibodies
Time frame: Baseline and weeks 6, 10, 14, and 18
Adults and Young Children: Type-specific and Multitypic Seroconversion Rate of Anti-polio Serum Neutralizing Antibodies 4 Weeks After Each Vaccination
Time frame: Baseline and Weeks 4 and 8
All Cohorts: Types 1, 2 and 3 Anti-polio Serum Neutralizing Antibody Titers Following Last Dose
Time frame: Baseline and 4 weeks following the last vaccination (week 8 in adults and young children and week 18 in neonates)
Adults and Young Children: Types 1, 2 and 3 Anti-polio Serum Neutralizing Antibody Titers Following First Dose
Time frame: Baseline and week 4
All Cohorts: Geometric Mean Titer (GMT) of Types 1, 2 and 3 Anti-polio Serum Neutralizing Antibodies Following Last Dose
Time frame: Baseline and 4 weeks following the last vaccination (week 8 in adults and young children and week 18 in neonates)
Adults and Young Children: Geometric Mean Titer (GMT) of Types 1, 2 and 3 Anti-polio Serum Neutralizing Antibodies Following First Dose
Time frame: Baseline and Week 4
All Cohorts: Type-specific and Multitypic Seroprotection Rate Following Last Dose
Time frame: Baseline and 4 weeks following the last vaccination (week 8 in adults and young children and week 18 in neonates)
Adults and Young Children: Type-specific and Multitypic Seroprotection Rate Following First Dose
Time frame: Baseline and week 4
Adults and Young Children: Geometric Mean Fold Rise (GMFR) in Neutralizing Antibody Titer Relative to Previous Dose
Time frame: Baseline and weeks 4 and 8
Neonates: Geometric Mean Fold Rise (GMFR) in Neutralizing Antibody Titer Relative to the Expected Level of Maternal Antibody and Each Pre-dose Value
Time frame: Baseline and weeks 6, 10, 14, and 18
Neonates: Percentage of Participants Shedding Types 1, 2 and/or 3 Poliovirus Post-vaccination
Time frame: From birth through 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Novel oral poliomyelitis vaccine type 1 (nOPV1), Novel oral poliomyelitis vaccine type 2 (nOPV2) and Novel oral poliomyelitis vaccine type 3 (nOPV3) in people with Poliomyelitis, run by PATH at 2 sites 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 11 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Grunenberg, MD (206-285-3500, ngrunenberg@path.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Serious Adverse Events (SAEs) (time frame: From the time of first study vaccination through the end of the study (197 days)). The study lists 5 primary outcomes in all. 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 3 Jun 2025.