Back to results

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

Primary Purpose

Poliomyelitis

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

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

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

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

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

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

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

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

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

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

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

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

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

About this trial

This is an interventional prevention trial for Poliomyelitis focused on measuring bOPV, IPV, sequential immunization, immunogenecity, safety

Eligibility Criteria

2 Months - 2 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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℃.

Exclusion Criteria:

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

Sites / Locations

Guangxi Provincial Center for Diseases Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Arm Label

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

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

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

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

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

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

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

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

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

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

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

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

Arm Description

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.

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.

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

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

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

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

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 )

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 )

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 )

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 )

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 )

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 )

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Safety:number of adverse events and serious adverse events

Local and systemic adverse events were active collected and recorded to calculate the number of adverse events and serious adverse events when the subject received each dose of vaccine ，especially the bOPV.

Long term Safety:number of serious adverse events

Over a period of 6 months the study observed for the safety of each sequential immunization schedule.Serious adverse events were collected and recorded 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

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 .The antibody seroconversion rate and antibody geometric mean titers for type I, type II and Type III of 1-dose cIPV/sIPV + 2-doses bOPV (Liquid/ candy) with 2-doses cIPV/sIPV + 1-dose bOPV(Liquid / candy) .

Full Information

NCT ID

NCT03614702

First Posted

March 3, 2017

Last Updated

October 7, 2023

Sponsor

Institute of Medical Biology, Chinese Academy of Medical Sciences

Collaborators

Guangxi Center for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT03614702

Brief Title

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

Official Title

Safety and Immunogenicity Evaluation of Different Sequential Immunization Schedules of Type1+2 Bivalent Oral Poliovirus Vaccine(bOPV) Co-administered With Inactived Poliovirus Vaccine(IPV) in Infants Aged 2 Months: a Randomized, Double Blind, Single Center, Parallel Trial

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

September 15, 2015 (Actual)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institute of Medical Biology, Chinese Academy of Medical Sciences

Collaborators

Guangxi Center for Disease Control and Prevention

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

According to the requirement of the Strategy of Polio Eradication & Endgame Strategic Plan 2013-2018, bivalent oral attenuated live poliomyelitis vaccine against type 1 and 3 (bOPV) and inactivated poliomyelitis vaccine made by Sabin strain (sIPV) need to be used to eradiation both the wild poliovirus and vaccine-derived poliovirus. By studying different sequential immunization schedules of bOPV(candy/liquid) with IPV(cIPV/sIPV) to evaluate the safety and immunogenicity of bivalent oral poliomyelitis vaccine co-administered with IPV in healthy Infants. A randomized, double blind, single center and parallel phase Ⅲ clinic trial was performed in Guangxi Province in China. A total of 1200 infants at 2 months old were selected, and randomly divided into 12 different groups (100 individuals were included in each group) administrated the vaccines at 0, 28, 56 days schedule. The bOPV(bivalent oral attenuated live poliomyelitis vaccine against type 1 and type 3), tOPV(trivalent OPV against type 1, type 2 and type 3), sIPV (Inactivated Poliomyelitis Vaccine Made from Sabin Strains)and conventional IPV (Inactivated Poliomyelitis Vaccine Made from Wild Polio Strains) were assign to different group of sequential immunization schedules. The detail of each group as following: 1)1-dose cIPV + 2-doses bOPV (Candy); 2)1-dose sIPV + 2-doses bOPV (Candy); 3)2-doses cIPV + 1-dose bOPV (Candy); 4)2-doses sIPV + 1-dose bOPV (Candy); 5)2-doses cIPV + 1-dose tOPV (Candy); 6)2-doses sIPV + 1-dose tOPV (Candy); 7)1-dose cIPV + 2-doses bOPV (Liquid); 8)1-dose sIPV + 2-doses bOPV (Liquid); 9)2-doses cIPV + 1-dose bOPV (Liquid); 10)2-doses sIPV + 1-dose bOPV (Liquid); 11)2-doses cIPV + 1-dose tOPV (Liquid); 12)2-doses sIPV + 1-dose tOPV (Liquid). Blood Sample was collected before vaccination and 28 days after the third dose of vaccination. Neutralization antibody against type I, Type I and Type III poliomyelitis virus were detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of different sequential schedule immunization for the vaccines also been monitored. The first 10% of subjects in each research site，fecal samples were collected to test polio virus shedding.The 7 times are before the second dose immunization and the 7、14、28 days after the second and the third dose immunization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Poliomyelitis

Keywords

bOPV, IPV, sequential immunization, immunogenecity, safety

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

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 )

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

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.

Description

Time Frame

at the 28 days after finishing the 3rd dose

Secondary Outcome Measure Information:

Title

Safety:number of adverse events and serious adverse events

Description

Time Frame

within 28 days after each dose injection

Title

Long term Safety:number of serious adverse events

Description

Over a period of 6 months the study observed for the safety of each sequential immunization schedule.Serious adverse events were collected and recorded after finishing the 3rd dose.

Time Frame

Up to 6month after finishing the 3rd dose

Title

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

Description

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 .The antibody seroconversion rate and antibody geometric mean titers for type I, type II and Type III of 1-dose cIPV/sIPV + 2-doses bOPV (Liquid/ candy) with 2-doses cIPV/sIPV + 1-dose bOPV(Liquid / candy) .

Time Frame

at the 28 days after finishing the 3rd dose

Other Pre-specified Outcome Measures:

Title

Viral shedding

Description

The first 10% of subjects in each research site，fecal samples were collected to test poliovirus shedding. Whether the fecal sample contain polio virus or other enterovirus,using L20B cell and RD cell to solation and identification of polio virus from subjects' fecal suspension sample. PCR and serotypes are used to identify of polio virus types（type I、II、III）. The WHO "polio laboratory manual" and the standard "diagnosis for poliomyelitis(WS 294-2016)" of PRC were used for method reference.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Months

Maximum Age & Unit of Time

2 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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℃. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhaojun Mo, Master

Organizational Affiliation

Guangxi Province Center for Diseases Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guangxi Provincial Center for Diseases Control and Prevention

City

Nanning

State/Province

Guangxi

ZIP/Postal Code

530028

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35044877

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs