MedDataX Logo

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

NCT ID: NCT02785705

Last Updated: 2016-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Poliomyelitis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

immunization vaccine schedule poliomyelitis polio oral polio vaccine inactivated polio vaccine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

poliovirus vaccine

Intervention Type BIOLOGICAL

Different vaccination schedules with bOPV, tOPV and cIPV would be provided for 6 arms respectively.

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.

Group Type EXPERIMENTAL

poliovirus vaccine

Intervention Type BIOLOGICAL

Different vaccination schedules with bOPV, tOPV and cIPV would be provided for 6 arms respectively.

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.

Group Type EXPERIMENTAL

poliovirus vaccine

Intervention Type BIOLOGICAL

Different vaccination schedules with bOPV, tOPV and cIPV would be provided for 6 arms respectively.

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.

Group Type EXPERIMENTAL

poliovirus vaccine

Intervention Type BIOLOGICAL

Different vaccination schedules with bOPV, tOPV and cIPV would be provided for 6 arms respectively.

cIPV-cIPV-cIPV poliovirus vaccine

Participants would be vaccine with three shots of trivalent conventional inactivated poliovirus vaccine.

Group Type EXPERIMENTAL

poliovirus vaccine

Intervention Type BIOLOGICAL

Different vaccination schedules with bOPV, tOPV and cIPV would be provided for 6 arms respectively.

tOPV-tOPV-tOPV poliovirus vaccine

Participants would be vaccine with three times of trivalent types 1, 2 and 3 oral poliovirus vaccine .

Group Type EXPERIMENTAL

poliovirus vaccine

Intervention Type BIOLOGICAL

Different vaccination schedules with bOPV, tOPV and cIPV would be provided for 6 arms respectively.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

poliovirus vaccine

Different vaccination schedules with bOPV, tOPV and cIPV would be provided for 6 arms respectively.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

bivalent types 1 and 3 oral poliovirus vaccine trivalent conventional inactivated poliovirus vaccine trivalent types 1, 2 and 3 oral poliovirus vaccine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

60 Days

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Air Force Military Medical University, China

OTHER

Sponsor Role collaborator

Beijing Tiantan Biological Products Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhaojun Mo

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhaojun Mo

Role: PRINCIPAL_INVESTIGATOR

Center of Diseases Control and Prevention (CDC) of Hezhou County and Zhongshan County in Guangxi Zhuang Autonomous Region in China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Tiantan-201417903

Identifier Type: -

Identifier Source: org_study_id