Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months

Novartis Vaccines654 enrolled

Overview

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

654

Conditions

Influenza

Interventions

MF59-eH1N1_fBIOLOGICAL

3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.

MF59-eH1N1_fBIOLOGICAL

7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.

MF59-eH1N1_fBIOLOGICAL

15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 35 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Children 6 to 35 months of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months 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. * Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination For additional entry criteria, please refer to protocol

Locations (29)

Unnamed facility

Bentonville, Arkansas, United States

Outcomes

Primary Outcomes

Antibody Responses After the First and Second Vaccinations

CBER guidance (\<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.

Time frame: 21 days after each vaccination

Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination

Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination.

Time frame: Day 1 to 7

Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination

Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination.

Time frame: Day 22 to 28

Secondary Outcomes

Immunogenicity Measurement by Geometric Mean Titers (GMT)

Immunogenicity was measured in terms of the GMT at 21 days after each vaccination.

Time frame: 21 days after each vaccination

Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010

Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.

Time frame: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)

Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010

Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.

Data from ClinicalTrials.gov

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