A Dose Ranging Study Comparing Different Combinations of Adjuvanted and Non-adjuvanted Influenza Vaccines in Healthy Children 6 to <36 Months of Age

A Phase Ib, Randomized, Observer-Blind, Multicenter, Factorial-Design Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Injections of Trivalent Inactivated Influenza Vaccine With or Without a Second Influenza B Strain in Combination With or Without One of Three Different Doses of Adjuvant in Healthy Children, Aged 6 to <36 Months

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00848887

Enrollment

410

Registered

2009-02-20

Start date

2008-10-31

Completion date

2009-05-31

Last updated

2014-01-24

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

Conditions

Influenza

Keywords

Influenza, Flu, Vaccine, Adjuvant

Brief summary

This study will evaluate the safety and immunogenicity of different combinations of influenza vaccine in healthy young children.

Interventions

BIOLOGICALAdjuvanted and un-adjuvanted influenza vaccines

16 different formulations of trivalent influenza vaccine and 1 marketed influenza vaccine comparator.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

6 Months to 35 Months

Healthy volunteers

Yes

Inclusion criteria

* Children of 6 month to \<36 month of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator.

Exclusion criteria

* History of serious disease. History of serious reaction following administration of vaccine or hypersensitivity to vaccine components. Known or suspected impairment/alteration of immune function.

Design outcomes

Primary

Measure	Time frame
Assessment of all adverse events from time of vaccination through study end will be collected to for safety assessment.	50 days

Secondary

Measure	Time frame
Strain-specific influenza antibody titers will be used to assess Immunogenicity	50 days

Countries

Belgium

Outcome results

None listed

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