MedTrace Logo

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

NCT04638985 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2020-12-10

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 (NCT04054882) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows:

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

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

Conditions

  • Vaccine

Interventions

BIOLOGICAL

sIPV+DTaP+MMR

sIPV+DTaP+MMR 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

MMR

MMR at the age of 18 month old

Sponsors & Collaborators

  • Jiangsu Province Centers for Disease Control and Prevention

    collaborator NETWORK

  • Anhui Provincial Center for Disease Control and Prevention

    collaborator UNKNOWN

  • Sichuan Center for Disease Control and Prevention

    collaborator OTHER_GOV

  • Beijing Institute of Biological Products Co Ltd.

    collaborator INDUSTRY

  • Chengdu Institute of Biological Products Co.,Ltd.

    collaborator INDUSTRY

  • Peking University

    collaborator OTHER

  • National Institutes for Food and Drug Control, China

    collaborator OTHER

  • China National Biotec Group Company Limited

    lead INDUSTRY

Principal Investigators

  • Fenyang Tang · Jiangsu Province Centers for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-11-13
Primary Completion
2021-09-30
Completion
2021-12-31

Countries

  • China

Study Locations

More Related Trials

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 NCT04638985 on ClinicalTrials.gov