Randomized Controlled Trial for Immunogenicity and Safety Evaluation of Bivalent Types 1 and 3 Oral Poliovirus Vaccine (TTbOPV)

May 25, 2016 updated by: Zhaojun Mo, Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

Immunogenicity and Safety Evaluation of Bivalent Types 1 and 3 Oral Poliovirus Vaccine by Comparing Different Poliomyelitis Vaccination Schedules in Chinese Infant: a Randomized Controlled Non-Inferiority Clinical Trial

Type 2 component of oral poliovirus vaccine is slated for global withdrawal through a switch from trivalent oral poliovirus vaccine (tOPV) to bivalent oral poliovirus vaccine (bOPV) for preventing paralytic polio caused by circulating vaccine-derived poliovirus type 2. We aimed to assess immunogenicity and safety profile of six vaccination schedules with different sequential doses of inactivated poliovirus vaccine (IPV), tOPV, or bOPV.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A randomized controlled trial was conducted in China in 2015. After informed consent was obtained from a parent or legally acceptable representative, healthy newborn babies were randomly allocated to one of six groups: cIPV-bOPV-bOPV, cIPV-tOPV-tOPV, cIPV-cIPV-bOPV, cIPV-cIPV-tOPV, cIPV-cIPV-cIPV, and tOPV-tOPV-tOPV. The key eligibility criteria were: full-term birth (37-42 weeks of gestation), birthweight ≥2·5 kg, no obvious medical disorders and no polio vaccination. Infants received following three doses sequentially with 4- 6 weeks interval after collecting blood sample: cIPV-bOPV-bOPV, cIPV-tOPV-tOPV, cIPV-cIPV-bOPV, cIPV-cIPV-tOPV, cIPV-cIPV-cIPV, and tOPV-tOPV-tOPV; and will be proactively followed up for observing adverse events after the first dose and 30 days after all doses. Antibodies of type 1, 2, and 3 poliovirus were tested 30 days after the third dose. The primary study objective was to investigate immunogenicity and safety profile of different vaccine schedules, evaluated by seroconversion, seroprotection and antibody titre against poliovirus types 1, 2, and 3 in the per-protocol population.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Eligible participants were healthy full-term (37-42 weeks) infants aged 60-90 days who weighed more than 2·5 kg at birth with no obvious medical disorders, no polio vaccination, no immunoglobulin vaccinated, no other attenuated vaccine immured in the past 14 days and no other inactivated vaccine immured.

Exclusion Criteria:

  • Participants were excluded if meet one or more of following criteria: were or were at risk of immunodeficiency, severe allergic reaction, acute fever and infectious diseases, severe chronic diseases, family history of allergies, convulsions, seizures, encephalopathy and psychiatric diseases, oral steroids at least 14 consecutive days in the past month, axillary temperature equal or greater than 38·0°C in the past three days, diarrhea (defection frequency equal or greater than three times per day) in the past seven days, and participated in other drug clinical trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: cIPV-bOPV-bOPV poliovirus vaccine
Participants would be vaccine with trivalent conventional inactivated poliovirus vaccine, and two bivalent types 1 and 3 oral poliovirus vaccine sequentially.
Biological: poliovirus vaccine
Different vaccination schedules with bOPV, tOPV and cIPV would be provided for 6 arms respectively.
Other Names:
  • bivalent types 1 and 3 oral poliovirus vaccine
  • trivalent conventional inactivated poliovirus vaccine
  • trivalent types 1, 2 and 3 oral poliovirus vaccine
Experimental: cIPV-tOPV-tOPV poliovirus vaccine
Participants would be vaccine with trivalent conventional inactivated poliovirus vaccine, and two trivalent types 1, 2 and 3 oral poliovirus vaccine sequentially.
Biological: poliovirus vaccine
Different vaccination schedules with bOPV, tOPV and cIPV would be provided for 6 arms respectively.
Other Names:
  • bivalent types 1 and 3 oral poliovirus vaccine
  • trivalent conventional inactivated poliovirus vaccine
  • trivalent types 1, 2 and 3 oral poliovirus vaccine
Experimental: cIPV-cIPV-bOPV poliovirus vaccine
Participants would be vaccine with two shots of trivalent conventional inactivated poliovirus vaccine, and one bivalent types 1 and 3 oral poliovirus vaccine sequentially.
Biological: poliovirus vaccine
Different vaccination schedules with bOPV, tOPV and cIPV would be provided for 6 arms respectively.
Other Names:
  • bivalent types 1 and 3 oral poliovirus vaccine
  • trivalent conventional inactivated poliovirus vaccine
  • trivalent types 1, 2 and 3 oral poliovirus vaccine
Experimental: cIPV-cIPV-tOPV poliovirus vaccine
Participants would be vaccine with two shots of trivalent conventional inactivated poliovirus vaccine, and one trivalent types 1, 2 and 3 oral poliovirus vaccine sequentially.
Biological: poliovirus vaccine
Different vaccination schedules with bOPV, tOPV and cIPV would be provided for 6 arms respectively.
Other Names:
  • bivalent types 1 and 3 oral poliovirus vaccine
  • trivalent conventional inactivated poliovirus vaccine
  • trivalent types 1, 2 and 3 oral poliovirus vaccine
Experimental: cIPV-cIPV-cIPV poliovirus vaccine
Participants would be vaccine with three shots of trivalent conventional inactivated poliovirus vaccine.
Biological: poliovirus vaccine
Different vaccination schedules with bOPV, tOPV and cIPV would be provided for 6 arms respectively.
Other Names:
  • bivalent types 1 and 3 oral poliovirus vaccine
  • trivalent conventional inactivated poliovirus vaccine
  • trivalent types 1, 2 and 3 oral poliovirus vaccine
Experimental: tOPV-tOPV-tOPV poliovirus vaccine
Participants would be vaccine with three times of trivalent types 1, 2 and 3 oral poliovirus vaccine .
Biological: poliovirus vaccine
Different vaccination schedules with bOPV, tOPV and cIPV would be provided for 6 arms respectively.
Other Names:
  • bivalent types 1 and 3 oral poliovirus vaccine
  • trivalent conventional inactivated poliovirus vaccine
  • trivalent types 1, 2 and 3 oral poliovirus vaccine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of infants with seroconversion
Time Frame: 30 days after vaccination
Primary immunogenicity outcome was the proportion of infants with seroconversion, which was defined as the 30 days post-vaccination titer equal or greater than eight for susceptible infants and the post-vaccination titer is four times higher than pre-vaccination titer for unsusceptible infants. Here, susceptible infants are the ones whose pre-vaccination titer less than eight. Otherwise, the subjects are categories as unsusceptible ones.
30 days after vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall seroprotection rate
Time Frame: 30 days after vaccination
Overall seroprotection rate was defined as the proportion of subjects with reciprocal titre of at least eight.
30 days after vaccination
Geometric mean of antibody titres (GMT)
Time Frame: 30 days after vaccination
30 days after vaccination
Increase of geometric mean of antibody titres (GMI)
Time Frame: 30 days after vaccination
30 days after vaccination
Proportion of infants with serious adverse events
Time Frame: Six months after vaccination
Six months after vaccination
Solicited adverse events
Time Frame: 30 days after vaccination
Solicited adverse events involving both systemic reactions (including fever, irritability/fussiness, somnolence, vomit, diarrhea, and allergic reaction) and local reactions (including tenderness, redness, swelling, and callous around the injection sites).
30 days after vaccination

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of infants with seroconversion in susceptible population
Time Frame: 30 days after vaccination
Proportion of infants with seroconversion, which was defined as the 30 days post-vaccination titer equal or greater than eight for susceptible infants. Here, susceptible infants are the ones whose pre-vaccination titer less than eight.
30 days after vaccination
Proportion of infants with seroconversion in unsusceptible population
Time Frame: 30 days after vaccination
Proportion of infants with seroconversion, which was defined as the 30 days post-vaccination titer is four times higher than pre-vaccination titer for unsusceptible infants.
30 days after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Air Force Military Medical University, China
Beijing Tiantan Biological Products Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhaojun Mo, Center of Diseases Control and Prevention (CDC) of Hezhou County and Zhongshan County in Guangxi Zhuang Autonomous Region in China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 30, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Tiantan-201417903

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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