CompletedNCT02643446IPVUpdated Aug 1, 2017

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

An observational study in Poliomyelitis, sponsored by Centers for Disease Control and Prevention, China. Completed at 5 sites in China. Open to participants aged 2 Months to 6 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-01.

Sponsored by Centers for Disease Control and Prevention, China · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 809
Ages: 2 Months to 6 Months
Sex: All

Study 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 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 studied

Poliomyelitis

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Poliomyelitis 222

Keywords

Poliovirus Vaccine, Inactivated
Poliovirus Vaccine, Oral
Immunity
Seroconversion

In context

Poliomyelitis

222 studies on the registry are indexed under Poliomyelitis; 11 are open to participants now.

This study's enrollment of 809 is above the median of 450 across 19 observational studies indexed under Poliomyelitis.

Browse Poliomyelitis studies →

Lead sponsor

Centers for Disease Control and Prevention, China is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Months to 6 Months
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

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.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 809 participants (actual)
Patient registry: No
Biospecimen retention: Samples with dna

Groups and cohorts

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Biological: IPV

Interventions

BiologicalIPV
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
BiologicalOPV
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.

What researchers measure

Primary outcomes

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

Study locations

5 sites

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

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02643446
Lead sponsor: Centers for Disease Control and Prevention, China
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
Responsible party: Huaqing Wang (Deputy Director, National Immunization Program, China CDC, Centers for Disease Control and Prevention, China) — Principal investigator
First posted: Dec 31, 2015
Start date: Aug 2015
Primary completion: Mar 2017
Completion: Jul 2017
Last update: Aug 1, 2017

Study contacts

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

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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