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Novel Influenza A/H1N1 Split- Virion Vaccine in Healthy Children Aged 6 to 35 Month

NCT01040078 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2009-12-30

No results posted yet for this study

Summary

The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.

Conditions

Interventions

BIOLOGICAL

7.5ug H1N1 Influenza vaccine

0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21

BIOLOGICAL

15ug H1N1 vaccine

0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21

BIOLOGICAL

seasonal influenza vaccine

0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and day 21

Sponsors & Collaborators

  • Centers for Disease Control and Prevention, China

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-02-28
Completion
2010-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT01040078 on ClinicalTrials.gov