NCT02643446

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
809

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 31, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 1, 2017

Status Verified

July 1, 2017

Enrollment Period

1.6 years

First QC Date

December 23, 2015

Last Update Submit

July 31, 2017

Conditions

Poliomyelitis

Keywords

Poliovirus Vaccine, InactivatedPoliovirus Vaccine, OralImmunitySeroconversion

Outcome Measures

Primary Outcomes (1)

  • Seroconversion rate

    Calculate the percentage of subjects with seroconversion after each dose of IPV or OPV vaccination

    One month after the specific dose of IPV or OPV

Study Arms (12)

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: IPVBiological: 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: IPVBiological: 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: IPVBiological: 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: IPVBiological: 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: IPVBiological: 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: IPVBiological: 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

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

G10: IPV+OPV, 1 m and 3 m followupG11: IPV+OPV, 1 m+7d and 2 m followupG12: IPV+IPV,1 m+7d and 2 m followupG1: IPV+OPV, 1 m followupG2: IPV+OPV, 1 m+7d followupG3: IPV+OPV, 2 m followupG4: IPV+OPV, 3 m followupG8: IPV+IPV, 1 m+7d followupG9: IPV+IPV, 2 m followup
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.

G10: IPV+OPV, 1 m and 3 m followupG11: IPV+OPV, 1 m+7d and 2 m followupG1: IPV+OPV, 1 m followupG2: IPV+OPV, 1 m+7d followupG3: IPV+OPV, 2 m followupG4: IPV+OPV, 3 m followupG5: OPV, 3 m followupG6: OPV, 1 m followupG7: OPV, 1 m+7d followup

Eligibility Criteria

Age2 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Guangdong Center for Disease Control and Prevention

Guangzhou, Guangdong, China

Location

Hubei Center for Disease Control and Prevention

Wuhan, Hubei, China

Location

Jilin Center for Disease Control and Prevention

Changchun, Jilin, China

Location

Ningxia Center for Disease Control and Prevention

Yinchuan, Ningxia, China

Location

Tianjin Center for Disease Control and Prevention

Tianjin, Tianjin Municipality, China

Location

Related Publications (2)

  • 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.

    PMID: 24634499BACKGROUND

  • 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.

    PMID: 23363495BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Whole blood

MeSH Terms

Conditions

PoliomyelitisHIV Seropositivity

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular DiseasesHIV InfectionsBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Huaqing Wang, MD, PhD

    Centers for Disease Control and Prevention, China

    PRINCIPAL INVESTIGATOR

  • Zhijie An, MD, MPH

    Centers for Disease Control and Prevention, China

    STUDY DIRECTOR

  • Zijian Feng, MD, MPH

    Centers for Disease Control and Prevention, China

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director, National Immunization Program, China CDC

Study Record Dates

First Submitted

December 23, 2015

First Posted

December 31, 2015

Study Start

August 1, 2015

Primary Completion

March 1, 2017

Study Completion

July 1, 2017

Last Updated

August 1, 2017

Record last verified: 2017-07

Locations

CN(5)