PoliomyelitisIPVNCT02643446

Serological Survey on Monitoring the Positive Rate After Vaccination of Inactivated Polio Vaccine

An observational study of Poliomyelitis, run by Centers for Disease Control and Prevention, China at 5 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The Purpose of this study is to assess the seroconversion using inactivated poliovirus vaccine (IPV) and oral poliovirus vaccine (OPV) sequential schedule in pilot areas where IPV was phased introduced into national immunization program (NIP) in China. Read more about this study

Who is it for?: Ages 2 to 6 monthsHealthy volunteers can take part
Conditions the study is for: Poliomyelitis
What is being tested?: IPV and OPV
Type of treatment: Vaccines
How many people: 809 participants
Where: 5 sitesChina
Study dates: Aug 2015to Jul 2017
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 6 months
All sexes
Healthy volunteers accepted
Child

Study population: The participants will be seclected from the vaccination clinics. The study will be in five provinces, which conduct the pilot project of IPV phased introduction into national immunization program. In each province, 1-2 counties will be selected, and then selected several vaccination clinics.

Who may be able to join

Healthy children who are regular residents in the pilot counties where the immune response is evaluated in pilot provinces.
Receiving the polio vaccination at 2, 3 and 4 months old with an interval of 28-35 days between doses according to national immunization schedule. The first dose of vaccine was administered at 2 full months old and less than 3 full months old.
No rotavirus vaccine was administered during the period of primary polio vaccinations, and no vaccines of category 2 (private market) were administered simultaneously with polio vaccine. If vaccines of category 2 other than rotavirus vaccine were administered, they should be administered with a space of at least 2 weeks with polio vaccination.

Who cannot join

The first dose of polio vaccine was administered at more than 3 months old regardless of the reasons.
Children didn't get proper type and doses of vaccine as the protocal required.
Children with known immunodeficiency conditions.
Immunosuppressive agents or blood products were used after birth.
Vaccine contraindications.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

China5 sites

Jilin Center for Disease Control and Prevention
Changchun, Jilin
Guangdong Center for Disease Control and Prevention
Guangzhou, Guangdong
Tianjin Center for Disease Control and Prevention
Tianjin, Tianjin Municipality
Hubei Center for Disease Control and Prevention
Wuhan, Hubei
Ningxia Center for Disease Control and Prevention
Yinchuan, Ningxia

Other trials in China

About this study

Official title: Serological Survey on Monitoring the Population Immunity and Positive Rate After Vaccination of Inactivated Poliovirus Vaccine

Read the detailed description

Objective:

To evaluate the seroprotection rates after the 3 doses of primary polio vaccination among age eligible children in pilot areas where the IPV was introduced into NIP;
To evaluate the seroprotection rates after different dose(s) of polio vaccine(s) using sequential schedule.

Sample size:752

Jilin shall select 120 subjects to collect blood samples for evaluation of immune response,of whom 90 will be given OPV as second vaccine and 30 will be given IPV as second vaccine
Hubei shall select 132 subjects to collect blood samples for evaluation of immune response,of whom 102 will be given OPV as second vaccine and 30 will be given IPV as second vaccine
Ningxia shall select 260 subjects to collect blood samples for evaluation of immune response. The subject will be divided into 5 groups.
In Guangdong province,120 children will be selected as subjects , of whom 80 children will be given OPV as first vaccine and 40 children will be given IPV as first vaccine.
Tianjin shall select 120 subjects to collect blood samples for evaluation of immune response, of whom 80 will be given OPV as second vaccine and 30 will be given IPV as second vaccine

Organization Chart of the Study:

Chinese Centers for Disease Control and Prevention (China CDC) lead the overall study, and be responsible for the study design, supervise the five selected provinces, conduct field monitor, data analysis and result distribution and explanation.
The five pilot Provincial CDCs conduct the supervision and monitoring of 1-2 counties CDCs in each of pilot province.
The County CDCs organize several vaccination clinics to recruit the subjects who meet the Inclusion criteria.

Quality Assurance Plan:

China CDC and provincial CDC will monitor and supervise the field work, ensure the quality of the study.
County CDCs organize vaccination clinics to service the subjects receiving timely polio vaccines in accordance with the immunization schedule, and that the blood samples are collected in accordance with the required timeline in difference groups.
Clinic doctors will communicate and explain the purpose and procedure of the survey to parents, and the signed informed consent from by parents will be obtained before the children participate the study.
The target drop-out rate of subjects without the second blood samples in each province should be less than 10%.
The samples will be tested for polio antibody in a qualified laboratory, which should be a World Health Organization certified polio network laboratory in China.

Conditions: Poliomyelitis
Being tested: IPV, OPV
Keywords: Poliovirus Vaccine, Inactivated, Poliovirus Vaccine, Oral, Immunity, Seroconversion
Medical subject headings: Poliomyelitis, HIV Seropositivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IPVBiological
IPV will be vaccinated at 2 months of age act as the first dose of poliovirus vaccine in the study group1 to group 4,group8 to group 11. IPV will be given at 3 month of age act as second vaccine in group 8,9,12
OPVBiological
OPV will be vaccinated at 3 and 4 months of age, act as the second and third dose of poliovirus vaccine in the study group 1 to group 4,group 10 to group 11.
OPV will be vaccinated at 2, 3 and 4 months of age act as the full three primary immunization doses of polio virus vaccine in the study group 5 to group 7.

Study groups in NCT02643446
Study group	Role	What they receive
G1: IPV+OPV, 1 m followup		Using 1 dose IPV and 2 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of IPV, another sample at 3 months of age, that is one month after the first dose of IPV and just before the first dose of OPV. Receives: Biological: IPV; Biological: OPV
G2: IPV+OPV, 1 m+7d followup		Using 1 dose IPV and 2 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of IPV, another sample at 3 months and 7 days of age, that is 7 days after the first dose of OPV. Receives: Biological: IPV; Biological: OPV
G3: IPV+OPV, 2 m followup		Using 1 dose IPV and 2 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of IPV, another sample at 4 months of age, that is one month after the first dose of OPV and just before the second dose of OPV. Receives: Biological: IPV; Biological: OPV
G4: IPV+OPV, 3 m followup		Using 1 dose IPV and 2 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of IPV, another sample at 5 months of age, that is one month after the second dose of OPV. Receives: Biological: IPV; Biological: OPV
G5: OPV, 3 m followup		Using 3 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of OPV, another sample at 5 months of age, that is one month after the third dose of OPV. Receives: Biological: OPV
G6: OPV, 1 m followup		Using 3 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of OPV, another sample at 3 months of age, that is one month after the first dose of OPV and just before the second dose of OPV. Receives: Biological: OPV
G7: OPV, 1 m+7d followup		Using 3 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of OPV, another sample at 3 months and 7 days of age, that is 7 days after the second dose of OPV. Receives: Biological: OPV
G8: IPV+IPV, 1 m+7d followup		Using 2 dose IPV and 1 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of IPV, another sample at 3 months and 7 days of age, that is 7 days after the second dose of IPV. Receives: Biological: IPV
G9: IPV+IPV, 2 m followup		Using 2 doses of IPV and 1 doses of OPV at 2, 3,4 months of age; Collecting two blood samples: one sample just before the first dose of IPV, another sample at 4 months of age, that is one month after the second dose of IPV and just before the first dose of OPV. Receives: Biological: IPV
G10: IPV+OPV, 1 m and 3 m followup		Using 1 dose IPV and 2 doses of OPV at 2, 3 and 4 months of age; Collecting three blood samples: one sample just before the first dose of IPV, another sample at 3 months of age, that is one month after the first dose of IPV and just before the first dose of OPV;the third sample at 5 months of age, that is one month after the second dose of OPV. Receives: Biological: IPV; Biological: OPV
G11: IPV+OPV, 1 m+7d and 2 m followup		Using 1 dose IPV and 2 doses of OPV at 2, 3 and 4 months of age; Collecting three blood samples: one sample just before the first dose of IPV, another sample at 3 months and 7 days of age, that is 7 days after the first dose of OPV,the third sample at 4 months of age, that is one month after the first dose of OPV. Receives: Biological: IPV; Biological: OPV
G12: IPV+IPV,1 m+7d and 2 m followup		Using 2 dose IPV and 1 doses of OPV at 2, 3 and 4 months of age; Collecting three blood samples: one sample just before the first dose of IPV, another sample at 3 months and 7 days of age, that is 7 days after the second dose of IPV,the third sample at 4 months of age, that is one month after the second dose of IPV. Receives: Biological: IPV

What is being measured

The primary outcome is the main question the study is designed to answer.

Seroconversion rate
Calculate the percentage of subjects with seroconversion after each dose of IPV or OPV vaccination
Measured: One month after the specific dose of IPV or OPV

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2015Jul 2017

First posted31 Dec 2015 (estimated)
Study startAug 2015
Primary completionMar 2017
Study completionJul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for PoliomyelitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 809 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02643446
Sponsor's protocol ID: 201526
Acronym: IPV
Status last verified: Jul 2017
First submitted: 23 Dec 2015
Last updated: 1 Aug 2017
Results posted: No
Data monitoring committee: No

Publications

Grassly NC. Immunogenicity and effectiveness of routine immunization with 1 or 2 doses of inactivated poliovirus vaccine: systematic review and meta-analysis. J Infect Dis. 2014 Nov 1;210 Suppl 1(Suppl 1):S439-46. doi: 10.1093/infdis/jit601. Epub 2014 Mar 14.
PubMed 24634499
Resik S, Tejeda A, Sutter RW, Diaz M, Sarmiento L, Alemani N, Garcia G, Fonseca M, Hung LH, Kahn AL, Burton A, Landaverde JM, Aylward RB. Priming after a fractional dose of inactivated poliovirus vaccine. N Engl J Med. 2013 Jan 31;368(5):416-24. doi: 10.1056/NEJMoa1202541.
PubMed 23363495

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
RecruitingPhase 1
Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults
Polio Immunity
Active, not recruiting
Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment
Severe Mobility Impairment, Spinal Cord Injuries (SCI)

All Poliomyelitis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Serological Survey on Monitoring the Population Immunity and Positive Rate After Vaccination of Inactivated Poliovirus Vaccine
ClinicalTrials.gov ID: NCT02643446
Acronym / sponsor ID: IPV / 201526
Conditions: Poliomyelitis
Keywords: Poliovirus Vaccine, Inactivated, Poliovirus Vaccine, Oral, Immunity, Seroconversion
Study type: Observational
Recruitment status: Completed
Enrolment: 809 participants (actual)
Lead sponsor: Centers for Disease Control and Prevention, ChinaOther government
Collaborators: World Health Organization, Tianjin Center for Disease Control and Prevention, Jilin Center for Disease Control and Prevention, Hubei Provincial Center for Disease Control and Prevention, Guangdong Center for Disease Prevention and Control, Ningxia Center for Disease Control and Prevention
Study start: Aug 2015 (actual)
Primary completion: Mar 2017 (actual)
Study completion: Jul 2017 (actual)
First posted: 31 Dec 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objective:

To evaluate the seroprotection rates after the 3 doses of primary polio vaccination among age eligible children in pilot areas where the IPV was introduced into NIP;
To evaluate the seroprotection rates after different dose(s) of polio vaccine(s) using sequential schedule.

Sample size:752

Jilin shall select 120 subjects to collect blood samples for evaluation of immune response,of whom 90 will be given OPV as second vaccine and 30 will be given IPV as second vaccine
Hubei shall select 132 subjects to collect blood samples for evaluation of immune response,of whom 102 will be given OPV as second vaccine and 30 will be given IPV as second vaccine
Ningxia shall select 260 subjects to collect blood samples for evaluation of immune response. The subject will be divided into 5 groups.
In Guangdong province,120 children will be selected as subjects , of whom 80 children will be given OPV as first vaccine and 40 children will be given IPV as first vaccine.
Tianjin shall select 120 subjects to collect blood samples for evaluation of immune response, of whom 80 will be given OPV as second vaccine and 30 will be given IPV as second vaccine

Organization Chart of the Study:

Chinese Centers for Disease Control and Prevention (China CDC) lead the overall study, and be responsible for the study design, supervise the five selected provinces, conduct field monitor, data analysis and result distribution and explanation.
The five pilot Provincial CDCs conduct the supervision and monitoring of 1-2 counties CDCs in each of pilot province.
The County CDCs organize several vaccination clinics to recruit the subjects who meet the Inclusion criteria.

Quality Assurance Plan:

China CDC and provincial CDC will monitor and supervise the field work, ensure the quality of the study.
County CDCs organize vaccination clinics to service the subjects receiving timely polio vaccines in accordance with the immunization schedule, and that the blood samples are collected in accordance with the required timeline in difference groups.
Clinic doctors will communicate and explain the purpose and procedure of the survey to parents, and the signed informed consent from by parents will be obtained before the children participate the study.
The target drop-out rate of subjects without the second blood samples in each province should be less than 10%.
The samples will be tested for polio antibody in a qualified laboratory, which should be a World Health Organization certified polio network laboratory in China.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 12

Arm	Type	Receives
G1: IPV+OPV, 1 m followup	–	Biological: IPV, Biological: OPVUsing 1 dose IPV and 2 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of IPV, another sample at 3 months of age, that is one month after the first dose of IPV and just before the first dose of OPV.
G2: IPV+OPV, 1 m+7d followup	–	Biological: IPV, Biological: OPVUsing 1 dose IPV and 2 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of IPV, another sample at 3 months and 7 days of age, that is 7 days after the first dose of OPV.
G3: IPV+OPV, 2 m followup	–	Biological: IPV, Biological: OPVUsing 1 dose IPV and 2 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of IPV, another sample at 4 months of age, that is one month after the first dose of OPV and just before the second dose of OPV.
G4: IPV+OPV, 3 m followup	–	Biological: IPV, Biological: OPVUsing 1 dose IPV and 2 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of IPV, another sample at 5 months of age, that is one month after the second dose of OPV.
G5: OPV, 3 m followup	–	Biological: OPVUsing 3 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of OPV, another sample at 5 months of age, that is one month after the third dose of OPV.
G6: OPV, 1 m followup	–	Biological: OPVUsing 3 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of OPV, another sample at 3 months of age, that is one month after the first dose of OPV and just before the second dose of OPV.
G7: OPV, 1 m+7d followup	–	Biological: OPVUsing 3 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of OPV, another sample at 3 months and 7 days of age, that is 7 days after the second dose of OPV.
G8: IPV+IPV, 1 m+7d followup	–	Biological: IPVUsing 2 dose IPV and 1 doses of OPV at 2, 3 and 4 months of age; Collecting two blood samples: one sample just before the first dose of IPV, another sample at 3 months and 7 days of age, that is 7 days after the second dose of IPV.
G9: IPV+IPV, 2 m followup	–	Biological: IPVUsing 2 doses of IPV and 1 doses of OPV at 2, 3,4 months of age; Collecting two blood samples: one sample just before the first dose of IPV, another sample at 4 months of age, that is one month after the second dose of IPV and just before the first dose of OPV.
G10: IPV+OPV, 1 m and 3 m followup	–	Biological: IPV, Biological: OPVUsing 1 dose IPV and 2 doses of OPV at 2, 3 and 4 months of age; Collecting three blood samples: one sample just before the first dose of IPV, another sample at 3 months of age, that is one month after the first dose of IPV and just before the first dose of OPV;the third sample at 5 months of age, that is one month after the second dose of OPV.
G11: IPV+OPV, 1 m+7d and 2 m followup	–	Biological: IPV, Biological: OPVUsing 1 dose IPV and 2 doses of OPV at 2, 3 and 4 months of age; Collecting three blood samples: one sample just before the first dose of IPV, another sample at 3 months and 7 days of age, that is 7 days after the first dose of OPV,the third sample at 4 months of age, that is one month after the first dose of OPV.
G12: IPV+IPV,1 m+7d and 2 m followup	–	Biological: IPVUsing 2 dose IPV and 1 doses of OPV at 2, 3 and 4 months of age; Collecting three blood samples: one sample just before the first dose of IPV, another sample at 3 months and 7 days of age, that is 7 days after the second dose of IPV,the third sample at 4 months of age, that is one month after the second dose of IPV.

Who may qualify

Ages: 2 to 6 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child
Study population: The participants will be seclected from the vaccination clinics. The study will be in five provinces, which conduct the pilot project of IPV phased introduction into national immunization program. In each province, 1-2 counties will be selected, and then selected several vaccination clinics.

Key inclusion criteria (3 listed)

Healthy children who are regular residents in the pilot counties where the immune response is evaluated in pilot provinces.
Receiving the polio vaccination at 2, 3 and 4 months old with an interval of 28-35 days between doses according to national immunization schedule. The first dose of vaccine was administered at 2 full months old and less than 3 full months old.
No rotavirus vaccine was administered during the period of primary polio vaccinations, and no vaccines of category 2 (private market) were administered simultaneously with polio vaccine. If vaccines of category 2 other than rotavirus vaccine were administered, they should be administered with a space of at least 2 weeks with polio vaccination.

Key exclusion criteria (5 listed)

The first dose of polio vaccine was administered at more than 3 months old regardless of the reasons.
Children didn't get proper type and doses of vaccine as the protocal required.
Children with known immunodeficiency conditions.
Immunosuppressive agents or blood products were used after birth.
Vaccine contraindications.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IPVIPV will be vaccinated at 2 months of age act as the first dose of poliovirus vaccine in the study group1 to group 4,group8 to group 11. IPV will be given at 3 month of age act as second vaccine in group 8,9,12	Biological	G10: IPV+OPV, 1 m and 3 m followup, G11: IPV+OPV, 1 m+7d and 2 m followup, G12: IPV+IPV,1 m+7d and 2 m followup, G1: IPV+OPV, 1 m followup, G2: IPV+OPV, 1 m+7d followup, G3: IPV+OPV, 2 m followup, G4: IPV+OPV, 3 m followup, G8: IPV+IPV, 1 m+7d followup, G9: IPV+IPV, 2 m followup
OPVOPV will be vaccinated at 3 and 4 months of age, act as the second and third dose of poliovirus vaccine in the study group 1 to group 4,group 10 to group 11. OPV will be vaccinated at 2, 3 and 4 months of age act as the full three primary immunization doses of polio virus vaccine in the study group 5 to group 7.	Biological	G10: IPV+OPV, 1 m and 3 m followup, G11: IPV+OPV, 1 m+7d and 2 m followup, G1: IPV+OPV, 1 m followup, G2: IPV+OPV, 1 m+7d followup, G3: IPV+OPV, 2 m followup, G4: IPV+OPV, 3 m followup, G5: OPV, 3 m followup, G6: OPV, 1 m followup, G7: OPV, 1 m+7d followup

Primary outcome

Seroconversion rate
Time frame: One month after the specific dose of IPV or OPV
Calculate the percentage of subjects with seroconversion after each dose of IPV or OPV vaccination

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
Background: PubMed 24634499Grassly NC. Immunogenicity and effectiveness of routine immunization with 1 or 2 doses of inactivated poliovirus vaccine: systematic review and meta-analysis. J Infect Dis. 2014 Nov 1;210 Suppl 1(Suppl 1):S439-46. doi: 10.1093/infdis/jit601. Epub 2014 Mar 14.
Background: PubMed 23363495Resik S, Tejeda A, Sutter RW, Diaz M, Sarmiento L, Alemani N, Garcia G, Fonseca M, Hung LH, Kahn AL, Burton A, Landaverde JM, Aylward RB. Priming after a fractional dose of inactivated poliovirus vaccine. N Engl J Med. 2013 Jan 31;368(5):416-24. doi: 10.1056/NEJMoa1202541.

Related trials for Poliomyelitis

Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
RecruitingPhase 1
Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults
Polio Immunity
Active, not recruiting
Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment
Severe Mobility Impairment, Spinal Cord Injuries (SCI)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Huaqing Wang, MD, PhD principal investigator

Centers for Disease Control and Prevention, China

Zhijie An, MD, MPH study director

Centers for Disease Control and Prevention, China

Zijian Feng, MD, MPH study chair

Centers for Disease Control and Prevention, China

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Poliomyelitis, run by Centers for Disease Control and Prevention, China at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroconversion rate (time frame: One month after the specific dose of IPV or OPV). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02643446, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2017.