Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)

Influenza Clinical Trial

Official title:

A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Pediatric Subjects 3 to < 9 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972816
• Other study ID #: V112_02
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 2, 2009
• Last updated: September 14, 2015
• Start date: September 2009
• Est. completion date: October 2010

Study information

• Verified date: September 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1357
• Est. completion date: October 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 8 Years

Eligibility

Inclusion Criteria:

• Children 3 to < 9 years 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza

Intervention

Biological:
• MF59-eH1N1
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias	Tlalpan
United States	Heartland Research Associates LLC	Arkansas City	Kansas
United States	The Portland Clinic LLP	Beaverton	Oregon
United States	PI-Coor Clinical Research	Burke	Virginia
United States	Dr. Senders and Associates, Pediatrics	Cleveland	Ohio
United States	Research Across America	Dallas	Texas
United States	Northern Illinois Research Associates	Dekalb	Illinois
United States	Premier Health Research Center, LLC	Downey	California
United States	Children's Health Care -West	Erie	Pennsylvania
United States	Prestige Clinical Research	Franklin	Ohio
United States	UPMC/Community Medicine (pediatrics)	Greenville	Pennsylvania
United States	Clinical Research Center of Nevada	Henderson	Nevada
United States	West Houston Clinical Research Service	Houston	Texas
United States	Pediatric Physicians Research, Inc.	Jefferson Hills	Pennsylvania
United States	Holston Medical Group	Kingsport	Tennessee
United States	Bluegrass Clinical Research, Inc (Brownsboro for drug shipment)	Louisville	Kentucky
United States	Madera Family Medical Group	Madera	California
United States	Pediatrics and Adolescent Medicine	Marietta	Georgia
United States	Bluegrass Clinical Research, Inc.	New Albany	Indiana
United States	Heartland Research Associates LLC	Newton	Kansas
United States	IPS Research	Oklahoma City	Oklahoma
United States	Meridien Clinical Research	Omaha	Nebraska
United States	Center for Clincal Trials, LLC	Paramount	California
United States	Center for Clinical Trials, LLC	Paramount	California
United States	Pediatric Alliance - Greentree Division (pediatrics)	Pittsburgh	Pennsylvania
United States	Capital Pediatrics and Adolescent Ctr.	Raleigh	North Carolina
United States	Virginia Commonwealth University	Richmond	Virginia
United States	J. Lewis Research, Inc./Foothill Family Clinic South	Salt Lake City	Utah
United States	J.Lewis Research, Inc./Foothill Family Clinic	Salt Lake City	Utah
United States	Rockwood Research Center	Spokane	Washington
United States	1st International Research Centers	Thornton	Colorado
United States	Pediatric Healthcare of NW Houston	Tomball	Texas
United States	Omega Clinical Research	Warwick	Rhode Island
United States	Center for Clinical Trials of San Gabriel	West Covina	California
United States	Pediatrics and Adolescent Medicine	Woodstock	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 percentages of subjects achieving seroconversion for HI antibody should be = 40% and the lower bound of the twosided 95% CI for the percentages of subjects achieving an HI antibody titer = 1:40 should be = 70%.; PPS Day 1-29 analysis set. N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H, respectively.; PPS Day 1-202 analysis set. N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H,respectively.; PPS Day 1-387 analysis set. N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H,respectively.	Day 22, Day 29, Day 43, Day 202 and Day 387	No
Secondary	Geometric Mean Titer After Each Vaccination by Vaccine Group	Immunogenicity was measured in terms of GMTs After Each Vaccination by Vaccine Group.PPS Day1-29 analysis set. N=143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F, G, and H, respectively.PPS Day 1-202 analysis set. N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H, respectively.	Day 22, Day 29, Day 43, Day 202 and Day 387	No
Secondary	Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010 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; Subgroups without recent seasonal flu vaccine: PPS Day 1, Day 1-22 and Day 1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H, respectively. PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F, G, and H, respectively.; Subgroups with recent seasonal flu vaccine: PPS Day 1-22 and Day 1-43 analysis set. N= 11, 9, 6, 8, 9, 11, 6, and 7 for Groups A, B, C, D, E, F, G,and H, respectively	Day 22, Day 29, Day 43	No
Secondary	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 Subgroups without recent seasonal flu vaccine: PPS Day 1, Day 1-22 and Day 1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H, respectively.; PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F,G, and H, respectively.; Subgroups with recent seasonal flu vaccine:PPS Day 1-22 and Day 1-43 analysis set. N= 11, 9, 6, 8, 9, 11, 6, and 7 for Groups A, B, C, D, E, F, G, and H, respectively PPS Day 1-29 analysis set. N= 11, 9, 6, 7, 9, 11, 5, and 6 for Groups A, B, C, D, E, F, G, and H,respectively.	Day 1, Day 22, Day 29, Day 43	No
Secondary	Antibody Response Based on Baseline Seropositivity	Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer = 1:10 Subgroups with baseline HI titer < 1:10: PPS Day 1-29 analysis set. N= 104, 116, 111, 107, 109, 113,120, and 103 for Groups A, B, C, D, E, F, G, and H, respectively.; Subgroups with baseline HI titer = 1:10: PPS Day 1-29 analysis set. N= 39, 33, 38, 39, 38, 34, 24, and 41 for Groups A, B, C, D, E, F, G, and H, respectively	Day 22, Day 29, Day 43	No
Secondary	Geometric Mean Titers (GMTs) Based on Baseline Seropositivity	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)	Day 1, Day 22, Day 29, Day 43	No
Secondary	Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination	Solicited local and systemic reactions were assessed after the first vaccination by vaccine group.	7 days after first vaccination	Yes
Secondary	Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination	Solicited local and systemic reactions were assessed after the second vaccination by vaccine group.	7 days after second vaccination	Yes
Secondary	Number of Participants Reporting Unsolicited Adverse Events(AEs)	Safety was measured in terms of the Number of Participants Reporting Unsolicited AEs	Safety monitoring periods were the Primary Period: Day 1 (1st vaccination) through =21 days post second vaccination, and the Follow-up Period: >21 Days post second vaccination to 12 months after second vaccination	Yes