Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years) - Full Text View

Purpose

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

Condition	Intervention	Phase
Novel 2009 Influenza H1N1	Biological: MF59-eH1N1_f Biological: eH1N1_f	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Randomized, Open Label, Single Center, Dose- and Regimen-Ranging 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 Children and Adults Ages 3 to 64 Years

Resource links provided by NLM:

MedlinePlus related topics: Flu

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age [ Time Frame: 21 days after each vaccination and 8 days after second vaccination ] [ Designated as safety issue: No ]
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.

The analyses were performed on the Per-Protocol Set (PPS).
Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age [ Time Frame: 7 and 21 days after each vaccination ] [ Designated as safety issue: No ]
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.

Analyses were performed on the Per-Protocol set (PPS).

Secondary Outcome Measures:

Age Distribution at Baseline [ Time Frame: During the duration of the study, day 1 to day 387 ] [ Designated as safety issue: No ]
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years [ Time Frame: 21 days after each vaccination and 7 days after the second vaccination ] [ Designated as safety issue: No ]
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.

The analyses were performed on the Per-Protocol Set (PPS).
HI GMRs, in 3 to <9 Years and 9 to 17 Years [ Time Frame: 21 days after each vaccination and 7 days after the second vaccination ] [ Designated as safety issue: No ]
Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers).

The analyses were performed on the the per-protocol set (PPS).
HI GMR, in Adults 18 to 64 Years [ Time Frame: 7days and 21 days after each vaccination ] [ Designated as safety issue: No ]
Geometric Mean Ratios (GMRs) of hemagglutination inhibition (HI) antibody assay (ratio of post-vaccination versus pre-vaccination HI titers).

The analyses were performed on the Per-Protocol Set (PPS).
Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years [ Time Frame: 7 days and 21 days after each vaccination ] [ Designated as safety issue: No ]
Seroconversion: The percentage of subjects with either a pre-vaccination HI titer < 1:10 and a post-vaccination HI titer >1:40 or a prevaccination HI titer >1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.

The analyses were performed on the per-protocol set (PPS).
Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age [ Time Frame: 7 days after each vaccination ] [ Designated as safety issue: Yes ]
Number of subjects with specified solicited local and systemic reactions in adult subjects (3 to <9 years of age).

Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set.
Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age [ Time Frame: 7 days after each vaccination ] [ Designated as safety issue: Yes ]
Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age).

The analyses were performed on the safety set.
Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age [ Time Frame: 7 days after each vaccination ] [ Designated as safety issue: Yes ]
Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age).

The analyses were performed on the safety set.

Enrollment:	784
Study Start Date:	August 2009
Study Completion Date:	October 2010
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 2x7.5adj Two doses of MF59 adjuvanted (adj) A/H1N1	Biological: MF59-eH1N1_f MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
Experimental: 7.5adj_1_8 MF59 adjuvanted (adj) A/H1N1 on days 1 and 8	Biological: MF59-eH1N1_f MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
Experimental: 7.5adj_1_22 MF59 adjuvanted (adj) A/H1N1 on study days 1 and 22	Biological: MF59-eH1N1_f MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
Experimental: 15_1_22 A/H1N1 on study days 1 and 22	Biological: eH1N1_f Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal
Experimental: 2x15_1_22 Two doses of A/H1N1 (one in each arm) on study days 1 and 22	Biological: eH1N1_f Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal

Eligibility

Ages Eligible for Study:	3 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Children, adolescents, and adults 3 to 64 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973700

Locations

Costa Rica
Instituto de Atencion Pediatrica, Avenida 0-2 Calle 22, Paseo Colon del Restaurante La, Bastilla 50 metros Sur, Edificio 5.
San Jose, Costa Rica

Sponsors and Collaborators

Novartis Vaccines

Investigators

Study Director:

Novartis Vaccines

More Information

Publications:

Arguedas A, Soley C, Abdelnour A, Sales V, Lindert K, Cioppa GD, Clemens R. Assessment of the safety, tolerability and kinetics of the immune response to A/H1N1v vaccine formulations with and without adjuvant in healthy pediatric subjects from 3 through 17 years of age. Hum Vaccin. 2011 Jan 1;7(1):58-66. Epub 2011 Jan 1.

Responsible Party:	Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:	NCT00973700 History of Changes
Other Study ID Numbers:	V112_04
Study First Received:	September 2, 2009
Results First Received:	October 20, 2010
Last Updated:	September 2, 2012
Health Authority:	Costa Rica: Ministry of Health Costa Rica United States: Food and Drug Administration

Keywords provided by Novartis:

Swine Flu
Flu
Vaccine
Adjuvant

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 23, 2013