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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00649883

Enrollment

360

Registered

2008-04-01

Start date

2008-01-31

Completion date

2008-10-31

Last updated

2017-04-07

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

Conditions

Influenza

Keywords

Influenza, vaccine, children

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.

Interventions

BIOLOGICALInfluenza Trivalent Inactivated vaccines Novartis

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.

BIOLOGICALInfluenza Trivalent Inactivated vaccines

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

6 Months to 59 Months

Healthy volunteers

Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Guatemala

Outcome results

None listed

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