The Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated) （Children Forms of Drug）

The Phase Ⅲ Clinical Trial Protocol for the Influenza Virus Vaccine (Split Virion, Inactivated)（Children Forms of Drug）

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01551823

Enrollment

1200

Registered

2012-03-13

Start date

2012-03-31

Completion date

2012-08-31

Last updated

2023-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Influenza Virus Vaccine (Split Virion, Inactivated), Influenza

Brief summary

The purpose of this study is to evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated)(children forms of drug) that do not contains Preservative.

Detailed description

Influenza Virus Vaccine (Split Virion, Inactivated) that do not contain Preservative. HA contents 7.5μg/0.5ml per dose include H1N1、H3N2 and B. Inactivated Split Influenza Vaccine was manufactured by Sanofi Pasteur HA contents 7.5μg/0.5ml per dose include H1N1、H3N2 and B. This is a randomized, blind phase 3 clinical trial. Total 1200 adults (ages from 6 months to 36 months ) were selected, randomized to two groups \[Influenza Virus Vaccine (Split Virion, Inactivated) and Inactivated Split Influenza Vaccine , each group n=600\], adults in each group will be vaccinated with two doses of either Influenza Virus Vaccine (Split Virion, Inactivated) or Sanof IVV respectively,21 days apart.

Interventions

BIOLOGICALInfluenza Virus Vaccine(no Preservative )

Influenza Virus Vaccine(no Preservative) 2×0.25ml intramuscular injections

BIOLOGICALInfluenza Virus Vaccine(contains Preservative)

Influenza Virus Vaccine(contains Preservative)2×0.25ml intramuscular injections

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 35 Months

Healthy volunteers

Yes

Inclusion criteria

* Males and females, age from 6 months to 35 months ; * 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 influenza or other preventive biologicals in recent 7 days; * Axillary temperature ≤37℃.

Exclusion criteria

* Have medical record of participants or their family on allergy and egg, convulsion, falling sickness, encephalopathy and psychopathy; * 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 ); * Have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, HIV.

Design outcomes

Primary

Measure	Time frame
To evaluate the safety and the immunogenicity of Influenza Virus Vaccine (Split Virion, Inactivated) （Children Forms of Drug）	six months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026