Health TrialsbyHealthPanel

Study of Co-administered (Types 1 & 2) Novel Oral Poliomyelitis Vaccines Evaluation

ConditionPoliomyelitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6-7
SponsorPATH

About this trial

The purpose of this study is to evaluate the safety and tolerability of co-administration of nOPV1 + nOPV2 in infants, relative to those receiving monovalent nOPV vaccines alone and whether two and/or three doses of co-administered nOPV1 and nOPV2 are non-inferior to corresponding doses of nOPV1 alone and nOPV2 alone.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy male or female infant 16 weeks (+ 7 days) of age, at the time of first study vaccination. 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 by the investigator.

Parent(s) willing and able to provide written informed consent prior to performance of any study-specific procedure.

Resides in study area and parent 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).

Prior to study vaccination has received EPI vaccines as per the study EPI schedule and has received a single dose of IPV at 6 weeks (+7 days) of age.

Disqualifiers

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 (as per local guidelines) with respect to poliovirus vaccines at the time of study vaccine administration.

Member of the participant's household (living in the same house or apartment unit) who has received OPV based on the vaccination records in the previous 3 months before study vaccine administration. Participants from household where a member received investigational nOPV3 vaccine will also be excluded from the study.

Low birth weight (LBW), defined as a birth weight of less than 2500 g (up to and including 2499 g) at the time of birth.

Premature birth (less than 37 weeks gestation).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Novel Oral Polio Vaccine Type 1 (nOPV1)

    Biological/Vaccine

    nOPV1 containing \>10\^7.0 CCID50 per dose

  • Novel Oral Polio Vaccine Type 2 (nOPV2)

    Biological/Vaccine

    nOPV2 containing ≥10\^5.0 CCID50 per dose

  • Placebo (Sterile Water)

    Biological/Vaccine

    Sterile, nonpyrogenic preparation of water which contains no bacteriostat, antimicrobial agent, or added buffer

Treatment groups

675 Participants
are divided into 3 treatment groups
Group A: Group 1: Novel Oral Polio Vaccine Type 1 (nOPV1) and placeboExperimental treatment 2 interventions
Group B: Group 2: Novel Oral Polio Vaccine Type 2 (nOPV2) and placeboExperimental treatment 2 interventions
Group C: Group 3: nOPV1 and nOPV2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Frequency of serious adverse events (SAEs)

Serious adverse event is any adverse event that results in any of the following outcomes: 1) Death, 2) 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, or 5) Important medical event that may not result in one of the above outcomes but may jeopardize the health of the study participant or (and) require medical or surgical intervention to prevent one of the outcomes listed in the above

Time frame
From time of Dose 1 to end of study at Day 113
2

Frequency of solicited adverse events (AEs)

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. The following solicited AEs will be monitored for this trial: Fever (axillary temperature ≥ 37.5°C), Vomiting, Diarrhea, Irritability or Abnormal Crying, Decreased feeding or appetite, and Fatigue or decreased activity

Time frame
From time of vaccination until 7 days after Dose 1 (Day 8), Dose 2 (Day 36), and Dose 3 (Day 57)
3

Frequency of unsolicited AEs

Unsolicited AEs are any AEs reported spontaneously by the participant's parent, observed by the study personnel during study visits or identified during review of medical records or source documents. In the absence of a diagnosis, abnormal physical examination findings or abnormal clinical safety laboratory test results that are assessed by the investigator to be clinically significant will be reported as an AE.

Time frame
From time of vaccination to 28 days after Dose 1 (Day 29), Dose 2 (Day 57), and Dose 3 (Day 85)
4

Percentage of participants demonstrating cumulative seroconversion of types 1 and 2 anti-polio serum neutralizing antibody (NAb)

Cumulative Seroconversion is defined as type specific minimum 4-fold rise from baseline in those seropositive (NAb titer ≥1:8) at baseline, or post-vaccination seropositivity (titer ≥1:8) among those seronegative at baseline

Time frame
28 days after Dose 2 (Day 57)

Secondary outcomes

1

Percentage of participants demonstrating cumulative seroconversion of type 1 and 2 anti-polio serum NAb

Cumulative Seroconversion is defined as type specific minimum 4-fold rise from baseline in those seropositive (NAb titer ≥1:8) at baseline, or post-vaccination seropositivity (titer ≥1:8) among those seronegative at baseline.

Time frame
28 days after Dose 1
2

Median titer for type 1 and 2 anti-polio serum NAb

Time frame
28 days after Dose 1, Dose 2, and Dose 3
3

Geometric mean titer (GMT) for Types 1 and 2 anti-polio serum NAb

Time frame
28 days after Dose 1, Dose 2, and Dose 3
4

Post-vaccination GMT ratios of types 1 and 2 anti-polio serum NAb

Time frame
Baseline compared to 28 days after Dose 1, Dose 2, and Dose 3

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PATH

Lead sponsor

Bill and Melinda Gates Foundation

Collaborator

PT Bio Farma

Collaborator

Centers for Disease Control and Prevention

Collaborator

Technical Resources International, Inc.

Collaborator

Centro de Vacunación e Investigación (Cevaxin)

Collaborator

Source ClinicalTrials.gov
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