Clinic Trial to Evaluate the Safety and Immunogenicity by Different Sequential Schedules of bOPV and IPV

NCT03614702 | Completed Phase 3

• 1 other identifier: bOPV-PRO-001
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

With the progress of the eradication of polio, bivalent oral attenuated live poliomyelitis vaccine against type 1 and 3 (bOPV) and inactivated poliomyelitis vaccine made by Sabin strain (sIPV) are required to use in the "Strategy of Polio Eradication \& Endgame Strategic Plan 2013-2018" worldwide. To evaluate the safety and immunogenicity by different sequential schedules of bOPV/tOPV with IPV(sIPV/cIPV), a randomized, double blind, single center and parallel phase Ⅲ clinic trial was performed in Infants of two-month-old in Guangxi Province, China.

Conditions

Poliomyelitis

Keywords

bOPV; IPV; sequential immunization; immunogenecity; safety

Outcome Measures

Primary Outcomes (1)

• Antibody titers of anti-poliovirus antibodies in serum of children who received 2 -doses cIPV/sIPV+1 dose tOPV or 2-doses cIPV/sIPV +1 dose bOPV.

  Based on neutralization test to measure the production of serum antibody. In order to identify what kind of immune programme for children is best. The study will compare the antibody seroconversion rate and antibody geometric mean titers(GMTs) for Type I, Type II and Type III Poliomyelitis after sequential immunization of 2-doses cIPV/sIPV + 1-dose tOPV (Liquid / candy) with 2-doses cIPV /sIPV+ 1-dose bOPV (Liquid/ candy).

  at the 28 days after finishing the 3rd dose

Secondary Outcomes (3)

• Safety:number of adverse events and serious adverse events

  within 28 days after each dose injection

• Long term Safety:number of serious adverse events

  Up to 6month after finishing the 3rd dose

• Antibody titers of anti-poliovirus antibodies in serum of children who received 1 dose cIPV/sIPV+2 dose bOPV(candy/liquid) or 2 doses cIPV/sIPV+1 dose bOPV

  at the 28 days after finishing the 3rd dose

Other Outcomes (1)

• Viral shedding

  before the second dose;the 7 days after the second dose;the 14 days after the second dose;the 28 days after the second dose;the 7 days after the third dose;the 14 days after the third dose;the 28 days after the third dose

Study Arms (12)

1-dose cIPV + 2-doses bOPV (Candy)

EXPERIMENTAL

cIPV: Inactivated Poliomyelitis Vaccine Made from Wild Polio Strains Produced by Sanofi Pasteur Co., Ltd. 0.5ml/dose 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: 1-dose cIPV + 2-doses bOPV (Candy)

1-dose sIPV + 2-doses bOPV (Candy)

EXPERIMENTAL

sIPV: Inactivated Poliomyelitis Vaccine Made from Sabin Strains Produced by Institute of Medical Biology, Chinese Academy of Medical Sciences 0.5ml/dose 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: 1-dose sIPV + 2-doses bOPV (Candy)

2-doses cIPV + 1-dose bOPV (Candy)

EXPERIMENTAL

cIPV: Inactivated Poliomyelitis Vaccine Made from Wild Polio Strains Produced by Sanofi Pasteur Co., Ltd. 0.5ml/dose 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: 2-doses cIPV + 1-dose bOPV (Candy)

2-doses sIPV + 1-dose bOPV (Candy)

EXPERIMENTAL

sIPV: Inactivated Poliomyelitis Vaccine Made from Sabin Strains Produced by Institute of Medical Biology, Chinese Academy of Medical Sciences. 0.5ml/dose 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: 2-doses sIPV + 1-dose bOPV (Candy)

2-doses cIPV + 1-dose tOPV (Candy)

EXPERIMENTAL

cIPV: Inactivated Poliomyelitis Vaccine（Vero） Made from Wild Polio Strains Produced by Sanofi Pasteur Co., Ltd. 0.5ml/dose tOPV (Candy): Trivalent oral attenuated live poliomyelitis vaccine against type 1, type 2 and type 3 in Dragee Candy (Human Diploid Cell) Produced by Beijing Tiantan Biological Products Co., Ltd. 1g/pill,10 pills/pach;each pill containing polio virus≥5.95 lgCCID50 including type1 polio virus≥5.8 lgCCID50，type 2 polio virus ≥4.8lgCCID50，type 3 polio virus ≥5.3lgCCID50

Biological: 2-doses cIPV + 1-dose tOPV (Candy)

2-doses sIPV + 1-dose tOPV (Candy)

EXPERIMENTAL

sIPV: Inactivated Poliomyelitis Vaccine Made from Sabin Strains Produced by Institute of Medical Biology, Chinese Academy of Medical Sciences 0.5ml/dose tOPV (Candy): Trivalent oral attenuated live poliomyelitis vaccine against type 1, type 2 and type 3 in Dragee Candy (Human Diploid Cell) Produced by Beijing Tiantan Biological Products Co., Ltd.1g/pill,10 pills/pach,one pills each time;each pill containing polio virus≥5.95 lgCCID50 including type1 polio virus≥5.8 lgCCID50，type 2 polio virus ≥4.8lgCCID50，type 3 polio virus ≥5.3lgCCID50

Biological: 2-doses sIPV + 1-dose tOPV (Candy)

1-dose cIPV + 2-doses bOPV (Liquid)

EXPERIMENTAL

cIPV: Inactivated Poliomyelitis Vaccine（Vero） Made from Wild Polio Strains Produced by Sanofi Pasteur Co., Ltd. 0.5ml/dose 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 per person;be be equivalent to 0.1ml each person )

Biological: 1-dose cIPV + 2-doses bOPV (Liquid)

1-dose sIPV + 2-doses bOPV (Liquid)

EXPERIMENTAL

sIPV: Inactivated Poliomyelitis Vaccine Made from Sabin Strains Produced by Institute of Medical Biology, Chinese Academy of Medical Sciences. 0.5ml/dose 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 per person;be be equivalent to 0.1ml each person )

Biological: 1-dose sIPV + 2-doses bOPV (Liquid)

2-doses cIPV + 1-dose bOPV (Liquid)

EXPERIMENTAL

cIPV: Inactivated Poliomyelitis Vaccine Made from Wild Polio Strains Produced by Sanofi Pasteur Co., Ltd. 0.5ml/dose 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 per person;be be equivalent to 0.1ml each person )

Biological: 2-doses cIPV + 1-dose bOPV (Liquid)

2-doses sIPV + 1-dose bOPV (Liquid)

EXPERIMENTAL

sIPV: Inactivated Poliomyelitis Vaccine Made from Sabin Strains Produced by Institute of Medical Biology, Chinese Academy of Medical Sciences. 0.5ml/dose 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 per person;be be equivalent to 0.1ml each person )

Biological: 2-doses sIPV + 1-dose bOPV (Liquid)

2-doses cIPV + 1-dose tOPV (Liquid)

EXPERIMENTAL

cIPV: Inactivated Poliomyelitis Vaccine Made from Wild Polio Strains Produced by Sanofi Pasteur Co., Ltd. 0.5ml/dose tOPV(Liquid) Trivalent oral attenuated live poliomyelitis vaccine against type 1, type 2 and type 3 in Dragee Candy (Vero) Produced by Institute of Medical Biology, Chinese Academy of Medical Sciences. 1.0ml each bottle,total content of polio virus≥7.15lgCCID50/ml，type1 polio virus≥ 7.0 lgCCID50/ml，type2 polio virus ≥ 6.0lgCCID50/ml，type 3 polio virus≥ 6.5lgCCID50/ml.(2 drops per person;be be equivalent to 0.1ml each person )

Biological: 2-doses cIPV + 1-dose tOPV (Liquid)

2-doses sIPV + 1-dose tOPV (Liquid)

EXPERIMENTAL

sIPV: Inactivated Poliomyelitis Vaccine Made from Sabin Strains Produced by Institute of Medical Biology, Chinese Academy of Medical Sciences.0.5ml/dose Trivalent oral attenuated live poliomyelitis vaccine against type 1, type 2 and type 3 in Dragee Candy (vero) Produced by Institute of Medical Biology, Chinese Academy of Medical Sciences. 1.0ml each bottle,total content of polio virus≥7.15lgCCID50/ml，type1 polio virus≥7.0 lgCCID50/ml，type 2 polio virus ≥ 6.0lgCCID50/ml，type 3 polio virus ≥ 6.5lgCCID50/ml.(2 drops per person;be be equivalent to 0.1ml each person )

Biological: 2-doses sIPV + 1-dose tOPV (Liquid)

Interventions

1-dose cIPV + 2-doses bOPV (Candy) BIOLOGICAL

Health subjects received 1-dose cIPV intramuscularly in the centre of anterolateral thigh followed by 2-doses bOPV(Candy) through mouth at 0, 28, 56 days schedule.

1-dose cIPV + 2-doses bOPV (Candy)

1-dose sIPV + 2-doses bOPV (Candy) BIOLOGICAL

Health subjects received 1-dose sIPV intramuscularly in the centre of anterolateral thigh followed by 2-doses bOPV(Candy) through mouth at 0, 28, 56 days schedule.

1-dose sIPV + 2-doses bOPV (Candy)

2-doses cIPV + 1-dose bOPV (Candy) BIOLOGICAL

Health subjects received 2-doses cIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose bOPV(Candy) through mouth at 0, 28, 56 days schedule.

2-doses cIPV + 1-dose bOPV (Candy)

2-doses sIPV + 1-dose bOPV (Candy) BIOLOGICAL

Health subjects received 2-doses sIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose bOPV(Candy) through mouth at 0, 28, 56 days schedule.

2-doses sIPV + 1-dose bOPV (Candy)

2-doses cIPV + 1-dose tOPV (Candy) BIOLOGICAL

Health subjects received 2-doses cIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose tOPV(Candy) through mouth at 0, 28, 56 days schedule.

2-doses cIPV + 1-dose tOPV (Candy)

2-doses sIPV + 1-dose tOPV (Candy) BIOLOGICAL

Health subjects received 2-doses sIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose tOPV(Candy) through mouth at 0, 28, 56 days schedule.

2-doses sIPV + 1-dose tOPV (Candy)

1-dose cIPV + 2-doses bOPV (Liquid) BIOLOGICAL

Health subjects received 1-dose cIPV intramuscularly in the centre of anterolateral thigh followed by 2-doses bOPV(Liquid) through mouth at 0, 28, 56 days schedule.

1-dose cIPV + 2-doses bOPV (Liquid)

1-dose sIPV + 2-doses bOPV (Liquid) BIOLOGICAL

Health subjects received 1-dose sIPV intramuscularly in the centre of anterolateral thigh followed by 2-doses bOPV(Liquid) through mouth at 0, 28, 56 days schedule.

1-dose sIPV + 2-doses bOPV (Liquid)

2-doses cIPV + 1-dose bOPV (Liquid) BIOLOGICAL

Health subjects received 2-doses cIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose bOPV(Liquid) through mouth at 0, 28, 56 days schedule.

2-doses cIPV + 1-dose bOPV (Liquid)

2-doses sIPV + 1-dose bOPV (Liquid) BIOLOGICAL

Health subjects received 2-doses sIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose bOPV(Liquid) through mouth at 0, 28, 56 days schedule.

2-doses sIPV + 1-dose bOPV (Liquid)

2-doses cIPV + 1-dose tOPV (Liquid) BIOLOGICAL

Health subjects received 2-doses cIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose tOPV(Liquid) through mouth at 0, 28, 56 days schedule.

2-doses cIPV + 1-dose tOPV (Liquid)

2-doses sIPV + 1-dose tOPV (Liquid) BIOLOGICAL

Health subjects received 2-doses sIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose tOPV(Liquid) through mouth at 0, 28, 56 days schedule.

2-doses sIPV + 1-dose tOPV (Liquid)

Eligibility Criteria

• Age: 2 Months - 2 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Term pregnancy (37-42 weeks), birth weight meets the standards (over 2500g), aged from 60 days to 90 days old;
• parent(s) or guardians are able to understand and sign informed consent for participation;
• Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
• subject didn't administrate with any immunoglobulin after birth (except the Hepatitis B specific immunoglobulin) and did not administrate any other live vaccines within 28 days or inactivated vaccines within 14 days;
• Axillary temperature ≤37.1℃.

You may not qualify if:

• Subjects will not be eligible for the study if any of the following criteria is met：
• Subject who has a medical histroy with Hypersensitiveness, eclampsia, epilepsy, cerebropathia and neurological illness
• Subject who is allergy to Streptomycin, neomycin and polymyxin B
• Subject with immunodeficency or are in the process of immunosuppressor therapy
• Clinical diagnosis of poliomyelitis;
• Acute febrile disease or infectious disease;
• Labor abnormal, asphyxiation rescues, congenital abnormality, developmental disability, serious chronic diseases;
• Allergic to any ingredient of vaccine or with allergy history to any vaccine;
• Taking orally injecting of steroid hormone over 14 days in the recent month;
• Febrile (temperature ≥ 38.0°C) in three days;
• Diarrhea with one week (more than 3 motions a day);
• Taking part in another clinical trail;
• Any OPV vaccination contraindication and any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives

Sponsors & Collaborators

• Institute of Medical Biology, 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, 530028, China

Location

Related Publications (1)

• Chen S, Zhao Y, Yang Z, Li Y, Shi H, Zhao T, Yang X, Li J, Li G, Wang J, Ying Z, Yang J. The impact of different IPV-OPV sequential immunization programs on hepatitis A and hepatitis B vaccine efficacy. Hum Vaccin Immunother. 2022 Dec 31;18(1):2024063. doi: 10.1080/21645515.2021.2024063. Epub 2022 Jan 19.

  PMID: 35044877 DERIVED

MeSH Terms

Conditions

Poliomyelitis

Interventions

Candy; Poliovirus Vaccine, Oral; Fluid Therapy

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

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Poliovirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Drug Therapy; Therapeutics

Study Officials

• Zhaojun Mo, Master

  Guangxi Province Center for Diseases Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: August 3, 2018
• Study Start: September 15, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)