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Evaluation of Safety and Immunogenicity of Combined Immunization of sIPV, DTaP and HepA

NCT04636827 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2020-11-19

No results posted yet for this study

Summary

Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04053010) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows:

1. Group 1: sIPV + DTaP + HepA,
2. Group 2: sIPV only,
3. Group 3: DTaP only,
4. Group 4: HepA only.

The immunogenicity and safety of the 4 groups will be compared and analyzed before and 30-40 days after vaccination.

Conditions

  • Vaccination

Interventions

BIOLOGICAL

sIPV+DTaP+HepA

sIPV+DTaP+HepA at the age of 18 month old

BIOLOGICAL

sIPV

sIPV at the age of 18 month old

BIOLOGICAL

DTaP

DTaP at the age of 18 month old

BIOLOGICAL

HepA

HepA at the age of 18 month old

Sponsors & Collaborators

  • Shaanxi Provincial Center for Disease Control and Prevention

    collaborator OTHER

  • Hubei Provincial Center for Disease Control and Prevention

    collaborator OTHER

  • Beijing Institute of Biological Products Co Ltd.

    collaborator INDUSTRY

  • China National Biotec Group Company Limited

    lead INDUSTRY

Principal Investigators

  • Shaobai Shaobai · Shaanxi Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
19 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-11
Primary Completion
2021-08-31
Completion
2021-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04636827 on ClinicalTrials.gov