NCT00649883|CompletedPhase 2

Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Two Different Influenza Vaccines in Healthy Children Aged 6 to <60 Months

A Phase II, Observer-Blind, Randomized, Multi-center Study to Evaluate the Safety and Immunogenicity of Two 0.25 mL or 0.5 mL Doses of Investigational Vaccine and Active Influenza Vaccine in Healthy Children Aged 6 to <60 Months

Novartis ClinicalTrials.gov

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1 other identifier

V70P6

Study Type

interventional

Target

360

Locations

1 country

Sites

Timeline

RegisteredApr 2008

StartedJan 2008

CompletionOct 2008

Brief Summary

This a multicenter phase II trial will evaluate safety and immunogenicity of two 0.25 mL or 0.5 mL doses of investigational influenza vaccine and active control influenza vaccine in healthy children aged 6 to \<60 months.

Trial Health

On Track

Trial Health Score

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

Enrollment

360

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jan 2008

Shorter than P25 for phase_2

Geographic Reach

1 country

5 active sites

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

9 months study duration

Study Start

First participant enrolled

January 1, 2008

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed

7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2008

Completed

Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed

Last Updated

April 7, 2017

Status Verified

April 1, 2017

Enrollment Period

3 months

First QC Date

March 25, 2008

Last Update Submit

April 5, 2017

Conditions

Influenza

Keywords

Influenzavaccinechildren

Outcome Measures

Primary Outcomes (1)

To evaluate the safety and tolerability of one and two doses of investigational vaccines or active control influenza vaccine in unprimed healthy children aged 6 months to <36 months.
211 days

Secondary Outcomes (1)

To evaluate the immunogenicity of two doses of investigational influenza vaccine or active control influenza vaccines, as measured by HI assay in children aged 36 to <60 months.
211 days

Study Arms (2)

1

EXPERIMENTAL

Biological: Influenza Trivalent Inactivated vaccines Novartis

2

ACTIVE COMPARATOR

Biological: Influenza Trivalent Inactivated vaccines

Interventions

Influenza Trivalent Inactivated vaccines NovartisBIOLOGICAL

Children 6 to \<36 months of age will receive two 0.25 mL doses, and children 36 to \<60 months of age will receive two 0.5 mL doses of investigational influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.

Influenza Trivalent Inactivated vaccinesBIOLOGICAL

Children 6 to \<36 months of age will receive two 0.25 mL doses, and children 36 to \<60 months of age will receive two 0.5 mL doses of active control influenza vaccine, administered four weeks apart intramuscularly (IM) in the deltoid muscle preferably of the non-dominant arm.

Eligibility Criteria

Age6 Months - 59 Months

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

Children of 6 to \<60 months of age, whose parents/legal guardians have given written informed consent prior to study entry.
In good health as determined by: medical history, physical examination, clinical judgment of the investigator.
Able to comply with all study procedure

You may not qualify if:

Any serious disease, such as: cancer,autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic and renal disease, acute or progressive neurological or neuromuscular disease;
History of any anaphylaxis or serious reaction following administration of vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, or any other vaccine component, chemically related substance, or component of the potential packaging materials;
Known or suspected impairment/alteration of immune function, including: immunosuppressive therapy, cancer chemotherapy, receipt of immunostimulants within 60 days prior to Visit 1, receipt of parenteral immunoglobulin known HIV infection or HIV-related disease;
Bleeding diathesis;
Surgery planned during the study period;
Receipt of another investigational agent within 90 days
Laboratory-confirmed influenza disease within 6 months prior to Visit 1;
Ever received two doses of an influenza vaccine before the study
Receipt of an influenza vaccine within 6 months prior to Visit 1;
Experienced a temperature 38.0°C within 3 days prior to Visit 1

Contact the study team to confirm eligibility.