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

NCT00996307 | Completed Phase 2 Results DMC

• 1 other identifier: V112_06
• Study Type: interventional
• Target: 654
• Locations: 2 countries
• Sites: 29

Brief Summary

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

Conditions

Influenza

Keywords

Swine Flu; Flu; Vaccine; Children; Adjuvant; A/H1N1 2009 Influenza

Outcome Measures

Primary Outcomes (3)

• 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%.

  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.

  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.

  Day 22 to 28

Secondary Outcomes (6)

• Immunogenicity Measurement by Geometric Mean Titers (GMT)

  21 days after each 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)

• 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)

• Antibody Response Based on Baseline Seropositivity

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

• Geometric Mean Titers (GMTs) Based on Baseline Seropositivity

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

Study Arms (4)

3.75_(50)MF59

EXPERIMENTAL

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

Biological: MF59-eH1N1_f

7.5_(0)MF59

EXPERIMENTAL

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

Biological: MF59-eH1N1_f

7.5_(50)MF59

EXPERIMENTAL

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

Biological: MF59-eH1N1_f

15_(0)MF59

EXPERIMENTAL

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

Biological: MF59-eH1N1_f

Interventions

MF59-eH1N1_f BIOLOGICAL

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

3.75_(50)MF59

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Vaccines: lead
• Novartis: collaborator

Study Sites (29)

Unknown Facility

Bentonville, Arkansas, 72712, United States

Location

Unknown Facility

Fort Smith, Arkansas, 72903, United States

Location

Unknown Facility

Canoga Park, California, 91306, United States

Location

Unknown Facility

Dinuba, California, 93618, United States

Location

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Fresno, California, 93703, United States

Location

Unknown Facility

Long Beach, California, 90806, United States

Location

Unknown Facility

Los Angeles, California, 90015, United States

Location

Unknown Facility

Madera, California, 93637, United States

Location

Unknown Facility

Torrance, California, 90503, United States

Location

Unknown Facility

New Albany, Indiana, 47150, United States

Location

Unknown Facility

Newton, Kansas, 67114, United States

Location

Unknown Facility

Wichita, Kansas, 67207, United States

Location

Unknown Facility

Bardstown, Kentucky, 40004, United States

Location

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Woburn, Massachusetts, 01801, United States

Location

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Fargo, North Dakota, 58104, United States

Location

Unknown Facility

Dayton, Ohio, 45406, United States

Location

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Huber Heights, Ohio, 45424, United States

Location

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Oklahoma City, Oklahoma, 73103, United States

Location

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Charleston, South Carolina, 29406, United States

Location

Unknown Facility

Spartanburg, South Carolina, 29303, United States

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Unknown Facility

Lebanon, Tennessee, 37087, United States

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Dallas, Texas, 75230, United States

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Houston, Texas, 77055, United States

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Provo, Utah, 84604, United States

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South Jordan, Utah, 84095, United States

Location

Unknown Facility

St. George, Utah, 84790, United States

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West Jordan, Utah, 84088, United States

Location

Unknown Facility

Charlottesville, Virginia, 22902, United States

Location

Unknown Facility

Tlalpan, Mexico City, 14000, Mexico

Location

MeSH Terms

Conditions

Influenza, Human; Orthomyxoviridae Infections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines and Diagnostics

  Novartis

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: October 16, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: May 30, 2017
• Results First Posted: May 25, 2011

Record last verified: 2017-04

Locations

US (28); ME (1)