Randomized Controlled Trial for Immunogenicity and Safety Evaluation of Bivalent Types 1 and 3 Oral Poliovirus Vaccine
TTbOPV
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
1 other identifier
interventional
600
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2015
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 25, 2016
CompletedFirst Posted
Study publicly available on registry
May 30, 2016
CompletedMay 30, 2016
May 1, 2016
4 months
May 25, 2016
May 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of infants with seroconversion
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 Outcomes (5)
Overall seroprotection rate
30 days after vaccination
Geometric mean of antibody titres (GMT)
30 days after vaccination
Increase of geometric mean of antibody titres (GMI)
30 days after vaccination
Proportion of infants with serious adverse events
Six months after vaccination
Solicited adverse events
30 days after vaccination
Other Outcomes (2)
Proportion of infants with seroconversion in susceptible population
30 days after vaccination
Proportion of infants with seroconversion in unsusceptible population
30 days after vaccination
Study Arms (6)
cIPV-bOPV-bOPV poliovirus vaccine
EXPERIMENTALParticipants would be vaccine with trivalent conventional inactivated poliovirus vaccine, and two bivalent types 1 and 3 oral poliovirus vaccine sequentially.
cIPV-tOPV-tOPV poliovirus vaccine
EXPERIMENTALParticipants would be vaccine with trivalent conventional inactivated poliovirus vaccine, and two trivalent types 1, 2 and 3 oral poliovirus vaccine sequentially.
cIPV-cIPV-bOPV poliovirus vaccine
EXPERIMENTALParticipants would be vaccine with two shots of trivalent conventional inactivated poliovirus vaccine, and one bivalent types 1 and 3 oral poliovirus vaccine sequentially.
cIPV-cIPV-tOPV poliovirus vaccine
EXPERIMENTALParticipants would be vaccine with two shots of trivalent conventional inactivated poliovirus vaccine, and one trivalent types 1, 2 and 3 oral poliovirus vaccine sequentially.
cIPV-cIPV-cIPV poliovirus vaccine
EXPERIMENTALParticipants would be vaccine with three shots of trivalent conventional inactivated poliovirus vaccine.
tOPV-tOPV-tOPV poliovirus vaccine
EXPERIMENTALParticipants would be vaccine with three times of trivalent types 1, 2 and 3 oral poliovirus vaccine .
Interventions
Different vaccination schedules with bOPV, tOPV and cIPV would be provided for 6 arms respectively.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
May 25, 2016
First Posted
May 30, 2016
Study Start
April 1, 2015
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
May 30, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share