NCT01048190

Brief Summary

The purpose of this study is to evaluate the safety and the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2008

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
Last Updated

January 14, 2010

Status Verified

August 1, 2008

Enrollment Period

7 months

First QC Date

January 12, 2010

Last Update Submit

January 13, 2010

Conditions

Poliomyelitis

Keywords

Inactivated Poliomyelitis VaccineSabin Strainspoliomyelitis

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.

    one year

Secondary Outcomes (1)

  • To evaluate the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.

    one year

Study Arms (3)

Infants I-1

EXPERIMENTAL

Biological: Inactivated Poliomyelitis Vaccine (Sabin strains). Group I-1: 15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;

Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)

Infants I-2

EXPERIMENTAL

15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;

Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)

Infant I-3

EXPERIMENTAL

15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.

Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)

Interventions

Inactivated Poliomyelitis Vaccine (Sabin strains)BIOLOGICAL

15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.

Also known as: Sabin IPV,lot No.20080303
Infants I-1

Eligibility Criteria

Age60 Days - 90 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Males and females, age from 60 days to 60 years old;
  • Routine blood assaying (white blood cell, red blood cell, hemoglobin), liver (alanine transaminase)and kidney(blood urea nitrogen) functions are normal before vaccination;
  • Adults, 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;
  • Infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days;
  • Axillary temperature ≤37℃.

You may not qualify if:

  • Have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy;
  • Abnormal results of routine blood assaying (white blood cell, red blood cell, hemoglobin), liver (alanine transaminase)and kidney(blood urea nitrogen) functions before vaccination;
  • Low platelet or bleeding disorder do not allow vaccination into the muscle;
  • Have damaged or lower immunological function;
  • Received blood, plasma or immunoglobulin treatment since birth;
  • Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome ).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hezhou Center for Disease Prevention and Control

Hezhou, Guangxi, 542800, China

Location

MeSH Terms

Conditions

Poliomyelitis

Interventions

Poliovirus Vaccine, Inactivated

Condition Hierarchy (Ancestors)

MyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

Vaccines, InactivatedVaccinesBiological ProductsComplex MixturesPoliovirus VaccinesViral Vaccines

Study Officials

  • Liao Guoyang, PhD

    Institute of Medical Biology, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Li Rongcheng, MD

    Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control

    PRINCIPAL INVESTIGATOR

  • Li Changgui, PhD

    National Institute for the Control of Pharmaceutical and Biological Products, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2010

First Posted

January 13, 2010

Study Start

August 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

January 14, 2010

Record last verified: 2008-08

Locations

CN(1)