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

Phase 2

Completed

• Conditions: Influenza
• Interventions: Biological: MF59-eH1N1_f

• Registration Number: NCT00996307
• Lead Sponsor: Novartis Vaccines

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Primary Completion: 2009-12
• Disposition First Submitted: 2010-10-08
• Study Completion: 2010-12
• Disposition First Submitted QC: 2010-12-10
• Disposition First Posted: 2010-12-15
• Results First Submitted: 2011-04-28
• Results First Submitted QC: 2011-04-28
• Results First Posted: 2011-05-25
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-19
• Last Update Posted: 2017-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 654

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
15_(0)MF59	MF59-eH1N1_f	15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
7.5_(0)MF59	MF59-eH1N1_f	7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
3.75_(50)MF59	MF59-eH1N1_f	3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
7.5_(50)MF59	MF59-eH1N1_f	7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.

Primary Outcome Measures

Name	Time	Method
Antibody Responses After the First and Second Vaccinations	21 days after each vaccination	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%.
Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination	Day 1 to 7	Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination.
Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination	Day 22 to 28	Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination.

Secondary Outcome Measures

Name	Time	Method
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity	Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)	Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer \< 1:10 and prevaccination HI antibody titer ≥ 1:10 Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline (Day 1 (pre-vaccination)) as compared to those who are seronegative (HI titer \< 1:10).
Antibody Persistence by Geometric Mean Titers (GMT)	6 months (Day 202) and 12 months (Day 387) after second vaccination	Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination.
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010	Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)	Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010	Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)	Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.
Antibody Response Based on Baseline Seropositivity	Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)	Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer \< 1:10 and prevaccination HI antibody titer ≥ 1:10
Immunogenicity Measurement by Geometric Mean Titers (GMT)	21 days after each vaccination	Immunogenicity was measured in terms of the GMT at 21 days after each vaccination.