CompletedNCT05033561Updated Aug 23, 2024Results posted

Study to Evaluate Safety and Immunogenicity of nOPV2 at Different Intervals in Infants

A Phase 3 interventional study of nOPV2 in Poliomyelitis, sponsored by Fidec Corporation. Completed at 2 sites in Dominican Republic. Open to participants aged 6 Weeks to 8 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-23.

Sponsored by Fidec Corporation · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 905
Allocation: Randomized
Ages: 6 Weeks to 8 Weeks
Sex: All

Study summary

Study to determine immunogenicity and safety following administration of 2 doses of novel oral poliovirus vaccine type 2 (nOPV2) given at different intervals of 1 week or 2 weeks or the standard 4-week interval in infants

Read the detailed description

This will be a multicenter, randomized, controlled, open-label, parallel-group Phase III study in healthy infants aged 6 to 8 weeks who have never been vaccinated against poliomyelitis. Approximately 900 infants will be included in the study and randomized with a 1:1:1 ratio to the following treatment groups:

Group A: approximately 300 subjects to receive 2 doses of nOPV2 administered 1 week apart, at Day 0 and Day 7;
Group B: approximately 300 subjects to receive 2 doses of nOPV2 administered 2 weeks apart, at Day 0 and Day 14;
Group C (control group): approximately 300 subjects to receive 2 doses of nOPV2 administered 4 weeks apart, at Day 0 and Day 28. A total of 4 on-site visits are planned. Approximately 7 days after each administration of study vaccine, a phone call or on-site visit will be performed to monitor subjects' safety and review with the subject's parent(s)/guardian(s) any solicited AEs reported in the electronic diary card. All subjects will have a safety follow-up phone call 6 months after the last dose of study vaccine.

Conditions studied

Poliomyelitis

Browse trials for

Poliomyelitis 274

In context

Poliomyelitis

274 studies on the registry are indexed under Poliomyelitis; 18 are open to participants now.

This study's enrollment of 905 is above the median of 476 across 249 interventional studies indexed under Poliomyelitis.

Browse Poliomyelitis studies →

Lead sponsor

Fidec Corporation is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Weeks to 8 Weeks
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Infants aged 6 to 8 weeks with birth weight > 2,500 g.
Healthy infants without obvious medical conditions like immunodeficiency diseases, severe congenital malformations, severe neurological diseases or any other disease that require high doses of or immunotherapies that preclude the subject from participating in the study as established by the medical history and physical examination.
Written obtained from 1 or 2 parent(s) or legal guardian(s) as per country regulations.

Exclusion criteria

Exclusion Criteria:

Infants who have received previous vaccination against poliomyelitis.
Infants with anyone under 5 years of age in their household (living in the same house or apartment unit) who does not have the complete "age appropriate" vaccination status with respect to poliovirus vaccines at the time of study vaccine administration according to the Dominican Republic National Immunization Program (NIP).
Infants having a member of their household (living in the same house or apartment unit) who is under 6 months of age at the moment of study vaccine administration.
Infants having a member of their household (living in the same house or apartment unit) who has received oral poliomyelitis vaccine (OPV) in the previous 3 months before study vaccine administration.
Any confirmed or suspected or known immunodeficient condition including infection in the potential participant or any member of the subject's household.
Family history of congenital or hereditary immunodeficiency.
Major congenital defects or serious uncontrolled chronic illness (neurologic, pulmonary, gastrointestinal, hepatic, renal, or endocrine).
Known allergy to any component of the study vaccine or to any antibiotics that share molecular composition with the nOPV2 vaccine.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Acute severe febrile illness on the day of vaccination deemed by the Investigator to be a for vaccination (the child can be included at a later time if within age window and all inclusion criteria are met.).
Subject who, in the opinion of the Investigator, is unlikely to comply with the protocol or is inappropriate to be included in the study for the safety or the benefit-risk ratio of the subject.
Infants from multiple births or born prematurely (\< 37 weeks of gestation)

Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 905 participants (actual)

Study arms

Experimental
2 doses, 1 week apart
Administration of 2 doses of nOPV2, 1 week apart
Biological: nOPV2
Experimental
2 doses, 2 week apart
Administration of 2 doses of nOPV2, 2 weeks apart
Biological: nOPV2
Active comparator
2 doses, 4 week apart
Administration of 2 doses of nOPV2, 4 weeks apart
Biological: nOPV2

Interventions

BiologicalnOPV2
Novel Oral Poliomyelitis Type 2 Vaccine

What researchers measure

Primary outcomes

Seroconversion Rate at 1, 2 & 4 Weeks Interval
Cumulative seroconversion rate of type 2 polio neutralizing antibodies 28 days following administration of 2 doses of nOPV2 in 1-week, 2-week and 4-weeks interval to infants 6 to 8 weeks of age
Time frame: Up to max 8 weeks

Secondary outcomes

Neutralizing Antibodies at 1, 2 & 4 Week Interval
Geometric mean titers of type 2 polio neutralizing antibodies at Day 0 and 28 days after the second dose of nOPV2 when administered 1, 2 \& 4 weeks apart.
Time frame: Up to max 8 weeks
Serious Adverse Events (SAEs) and Important Medical Events (IMEs)
Number of participants experiencing SAEs and IMEs from the date of informed consent throughout the study period in all groups by severity and by causal association.
Time frame: 6 months
Solicited Adverse Events (AEs)
Number of participants experiencing mild, moderate and severe solicited AEs (fever, vomiting, abnormal crying, drowsiness, loss of appetite, diarrhea and irritability) for 7 days after each dose of study vaccine in all groups.
Time frame: Up to max 5 weeks
Unsolicited Adverse Events (AEs)
Number of participants experiencing mild, moderate, and severe solicited AEs (fever, vomiting, abnormal crying, drowsiness, loss of appetite, diarrhea, and irritability) for 28 days after each dose of study vaccine in all groups.
Time frame: Up to max 8 weeks

Results

Posted Aug 23, 2024

Participant flow

Participant flow — Overall Study
Milestone	Group A	Group B	Group C
Started	302	300	303
Completed	297	297	298
Not completed	5	3	5

Outcome measures

PrimarySeroconversion Rate at 1, 2 & 4 Weeks Interval

Cumulative seroconversion rate of type 2 polio neutralizing antibodies 28 days following administration of 2 doses of nOPV2 in 1-week, 2-week and 4-weeks interval to infants 6 to 8 weeks of age

Time frame:: Up to max 8 weeks
Reported as:: Count of participants · Participants

Seroconversion Rate at 1, 2 & 4 Weeks Interval
Participants	Group A	Group B	Group C
Seroconversion Rate at 1, 2 & 4 Weeks Interval	253	269	277

Statistical analysis

Group A vs Group C · Miettinen-Nurminen · p = 0.05 (This is the nominal alpha level for the two-sided confidence interval comparison.)Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.
Group B vs Group C · Miettinen-Nurminen · p = 0.05 (This is the nominal alpha level for the two-sided confidence interval comparison.)Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.

SecondaryNeutralizing Antibodies at 1, 2 & 4 Week Interval

Geometric mean titers of type 2 polio neutralizing antibodies at Day 0 and 28 days after the second dose of nOPV2 when administered 1, 2 \& 4 weeks apart.

Time frame:: Up to max 8 weeks
Reported as:: Geometric mean · titers

Neutralizing Antibodies at 1, 2 & 4 Week Interval
titers	Group A	Group B	Group C
Day 0	10.7 (8.5 to 13.5)	11.5 (9 to 14.7)	10.2 (8.1 to 12.9)
28 days after 2nd dose	1232.3 (909 to 1670.5)	1726.3 (1252.1 to 2380.1)	2327.6 (1654.3 to 3275.2)

Statistical analysis

Group A vs Group C · Miettinen-Nurminen · p = 0.05 (This is the nominal alpha level for the two-sided confidence interval comparison.)Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.
Group B vs Group C · Miettinen-Nurminen · p = 0.05 (This is the nominal alpha level for the two-sided confidence interval comparison.)Pairwise comparisons with two-sided Miettinen-Nurminen confidence intervals.

SecondarySerious Adverse Events (SAEs) and Important Medical Events (IMEs)

Number of participants experiencing SAEs and IMEs from the date of informed consent throughout the study period in all groups by severity and by causal association.

Time frame:: 6 months
Reported as:: Count of participants · Participants

Serious Adverse Events (SAEs) and Important Medical Events (IMEs)
Participants	Group A	Group B	Group C
Death	0	0	1
Hospitalization	8	7	9
Birth defect	1	1	0

SecondarySolicited Adverse Events (AEs)

Number of participants experiencing mild, moderate and severe solicited AEs (fever, vomiting, abnormal crying, drowsiness, loss of appetite, diarrhea and irritability) for 7 days after each dose of study vaccine in all groups.

Time frame:: Up to max 5 weeks
Reported as:: Count of participants · Participants

Solicited Adverse Events (AEs)
Participants	Group A	Group B	Group C
Abnormal crying	84	90	83
Diarrhea	44	50	40
Drowsiness	25	38	36
Fever	134	147	139
Irritability	31	45	41
Loss of Apetite	36	49	38
Vomiting	45	75	62

SecondaryUnsolicited Adverse Events (AEs)

Number of participants experiencing mild, moderate, and severe solicited AEs (fever, vomiting, abnormal crying, drowsiness, loss of appetite, diarrhea, and irritability) for 28 days after each dose of study vaccine in all groups.

Time frame:: Up to max 8 weeks
Reported as:: Count of participants · Participants

Unsolicited Adverse Events (AEs)
Participants	Group A	Group B	Group C
Respiratory disorders	13	10	11
Infections	9	10	14
Gastrointestinal disorders	3	13	9
Musculoskeletal and connective tissue disorders	0	0	3
Skin disorders	0	2	1
Congenital disorders	0	1	1
Nervous system disorders	0	1	0
General disorders	1	8	6

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Group A	0/298 (0%)	8/298 (2.7%)	217/298 (72.8%)
Group B	0/304 (0%)	7/304 (2.3%)	247/304 (81.3%)
Group C	1/303 (0.3%)	9/303 (3%)	238/303 (78.5%)

Most frequent serious events

Showing 10 of 13

Most frequent serious events
Event	Group A	Group B	Group C
PneumoniaInfections and infestations	1/298	2/304	5/303
BronchiolitisInfections and infestations	1/298	3/304	0/303
Dengue feverInfections and infestations	2/298	0/304	0/303
Amoebic dysenteryInfections and infestations	1/298	0/304	1/303
GastroenteritisInfections and infestations	1/298	0/304	0/303
OsteomyelitisInfections and infestations	1/298	0/304	0/303
Inguinal herniaGastrointestinal disorders	1/298	0/304	0/303
Herpes virus infectionInfections and infestations	0/298	0/304	1/303
SepsisInfections and infestations	0/298	0/304	1/303
Septic shockInfections and infestations	0/298	0/304	1/303

Most frequent other events

Showing 10 of 28

Most frequent other events
Event	Group A	Group B	Group C
FeverGeneral disorders	135/298	152/304	144/303
Abnormal cryingGeneral disorders	84/298	92/304	83/303
VomitingGastrointestinal disorders	45/298	81/304	65/303
DiarrhoeaGastrointestinal disorders	46/298	56/304	44/303
Loss of apetiteGastrointestinal disorders	36/298	49/304	38/303
IrritabilityNervous system disorders	31/298	46/304	41/303
DrowsinessNervous system disorders	25/298	38/304	36/303
Nasal congestionInfections and infestations	11/298	2/304	4/303
RhinorrhoeaInfections and infestations	2/298	5/304	6/303
CoughInfections and infestations	2/298	5/304	3/303

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Group A	Group B	Group C	Total
<=18 years	302	300	303	905
Between 18 and 65 years	0	0	0	0
>=65 years	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Group A	Group B	Group C	Total
Female	134	138	146	418
Male	168	162	157	487

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Group A	Group B	Group C	Total
Hispanic	1	1	1	3
Mixed Race	301	299	301	901
Black or African American	0	0	1	1

Region of Enrollment
Region of Enrollment(participants)	Group A	Group B	Group C	Total
Dominican Republic	302	300	303	905

Study locations

2 sites

Clinica Cruz Jiminián
Santo Domingo, Dominican Republic
Hospital Universitario Maternidad Nuestra Señora de la Altagracia
Santo Domingo, Dominican Republic

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Aug 14, 2021

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05033561
Lead sponsor: Fidec Corporation
Collaborators: Bill and Melinda Gates Foundation
Responsible party: Sponsor
First posted: Sep 5, 2021
Start date: Dec 16, 2021
Primary completion: May 24, 2022
Completion: Oct 25, 2022
Results posted: Aug 23, 2024
Last update: Aug 23, 2024

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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