Trail To Evaluate the Immune Effects of Primary and Booster Immunizations With Poliovirus Vaccine

NCT03821441 | Unknown Phase 3 DMC

• 1 other identifier: 201518502-C（bOPV-PRO-C）
• Study Type: interventional
• Target: 1,165
• Locations: 1 country
• Sites: 1

Brief Summary

Trail To Evaluate the Immunity Duration of healthy children who already took part in " The safety and immunogenicity by different sequential schedules of bOPV and bOPV in dragee candy with sIPV, a randomized, double blind, single center and parallel phase Ⅲ clinic trial was performed in Infants of two-month old in Guangxi Province, China" and continue to search for the effects of booster immunization.

Conditions

Poliomyelitis

Keywords

bOPV; IPV; Sequential immunization; Immunity Duration; Booster Immunization

Outcome Measures

Primary Outcomes (3)

• Positive rate of anti-poliovirus antibodies.

  To evaluate the effectiveness of bivalent oral attenuated live poliomyelitis vaccine against type 1 and type 3 (Human Diploid Cell) (candy/liquid) co-administered with co-administered IPV by neutralization assay. Defined ≥ 8 (1/dil) for anti-poliovirus as positive.These data is used to calculate positive rate of anti-poliovirus antibodies.When anti-poliovirus antibodies level ≥ 8 (1/dil),there is protective effect on subjects.

  at aged 24 months

• Positive rate of anti-poliovirus antibodies.

  To evaluate the effectiveness of bivalent oral attenuated live poliomyelitis vaccine against type 1 and type 3 (Human Diploid Cell) (candy/liquid) co-administered with co-administered IPV by neutralization assay. Defined ≥ 8 (1/dil) for anti-poliovirus as positive.These data is used to calculate positive rate of anti-poliovirus antibodies.When anti-poliovirus antibodies level ≥ 8 (1/dil),there is protective effect on subjects.

  at aged 36 months

• Positive rate of anti-poliovirus antibodies.

  To evaluate the effectiveness of bivalent oral attenuated live poliomyelitis vaccine against type 1 and type 3 (Human Diploid Cell) (candy/liquid) co-administered with co-administered IPV by neutralization assay. Defined ≥ 8 (1/dil) for anti-poliovirus as positive.These data is used to calculate positive rate of anti-poliovirus antibodies.When anti-poliovirus antibodies level ≥ 8 (1/dil),there is protective effect on subjects.

  at aged 48 months

Secondary Outcomes (4)

• The GMT and of positive rate anti-poliovirus antibodies in different age.

  at aged 24、36、48 months

• The adverse reaction and event of polio vaccine occur in subjects

  following 28 days after the boosting dose of bOPV

• The GMT 、seroconversion rate of poliovirus antibodies after booster immunization.

  at aged 48 months and 28 days after the boosting dose of bOPV

• Cellular immunity situation in booster immunization

  at aged 48 months and 28 days after the boosting dose of bOPV

Study Arms (3)

bOPV(Candy)

EXPERIMENTAL

bOPV (Candy): bivalent oral attenuated live poliomyelitis vaccine against type 1 and type 3 in Dragee Candy (Human Diploid Cell) Produced by Institute of Medical Biology, Chinese Academy of Medical Sciences. 1g/pill,10 pills/pach,one pill each time; each pill containing polio virus≥5.92 lgCCID50 including type1 polio virus≥5.8 lgCCID50，type 3 polio virus ≥5.3lgCCID50.

Biological: bOPV(Candy)

bOPV(Liquid)

EXPERIMENTAL

bOPV (Liquid): bivalent oral attenuated live poliomyelitis vaccine against type 1 and type 3 (Human Diploid Cell) Produced by Institute of Medical Biology, Chinese Academy of Medical Sciences. 0.5ml or 1.0ml each bottle;total content of polio virus≥7.12lgCCID50/ml，type1 polio virus≥7.0 lgCCID50/ml，type 3 polio virus ≥6.5lgCCID50/ml.(2 drops each person;be be equivalent to 0.1ml each person )

Biological: bOPV(Liquid)

bOPV（liquid）

EXPERIMENTAL

bOPV(Liquid):Poliomyelitis (Live) Vaccine Type I Type III (Human Diploid Cell), Oral Produced by Beijing Tiantan Biological Products Co., Ltd. 1.0ml each bottle,2 drops each person(be be equivalent to 0.1ml each person).(total content of polio virus≥6.12lgCCID50，type1 polio virus≥6.0 lgCCID50，type 3 polio virus ≥5.5lgCCID50 in each 0.1 ml)

Biological: bOPV(Liquid)

Interventions

bOPV(Candy) BIOLOGICAL

A single dose of 1 pill orally of bOPV to subjects aged 48 months who recieved bOPV (candy) produced by institute of Medical Biology, Chinese Academy of Medical Sciences in primary immunization. If bOPV(candy/liquid) is not available ,in order to protect the rights and interests of subjects ,the investigator can adjust other poliovirus vaccine such as IPV replace bOPV.

bOPV(Candy)

bOPV(Liquid) BIOLOGICAL

A single dose of 2 drops (0.1 ml) orally of bOPV to subjects aged 48 months who recieved bOPV (liquid) produced by institute of Medical Biology, Chinese Academy of Medical Sciences in primary immunization. If bOPV(candy/liquid) is not available,in order to protect the rights and interests of subjects ,the investigator can adjust other poliovirus vaccine such as IPV replace bOPV.

bOPV(Liquid)

Eligibility Criteria

• Age: 24 Months - 48 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who have already taken part in phase 3 clinical trail in Guangxi and were vaccinated 3-dose primary immunization with polio vaccines .Moreover，the results of the selected paired serum are required.
• months old(calendar month).
• Guardians understand the contents and requirements of this trail , meanwhile, voluntarily joined this study with informed consents.
• Able to attend all scheduled visits and to comply with all trial procedures(including vaccinate and blood collection)

You may not qualify if:

• Any booster immunization with polio vaccine after finishing 3-dose primary immunizations research.
• Polio virus infection was demonstrated in laboratory experiment.
• Participation in another clinical trial at the same times.
• Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives or increase the risk of subjects,such as acute or chronic diseases 、some abnormal detected by lab,and so on.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• Guangxi Center for Disease Control and Prevention: collaborator

Study Sites (1)

Guangxi Provincial Center for Diseases Control and Prevention

Nanning, Guangxi, China

RECRUITING

MeSH Terms

Conditions

Poliomyelitis

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Study Officials

• Zhaojun Mo, Master

  Guangxi Province Center for Diseases Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingsi Yang, Master

CONTACT

+8687168334986; yjs@imbcams.com.cn

Jing Li, Master

CONTACT

13888865251; sola@imbcams.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 29, 2019
• Study Start: January 4, 2018
• Primary Completion: May 1, 2020
• Study Completion: August 1, 2020
• Last Updated: January 29, 2019

Record last verified: 2018-05

Locations

CN (1)