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

Novel 2009 Influenza H1N1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973700
• Other study ID #: V112_04
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2009
• Last updated: October 29, 2015
• Start date: August 2009
• Est. completion date: October 2010

Study information

• Verified date: October 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Costa Rica: Ministry of Health Costa RicaUnited 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, adolescents, and adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 784
• Est. completion date: October 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Novel 2009 Influenza H1N1

Intervention

Biological:
• MF59-eH1N1_f
MF59 adjuvanted (adj) egg-derived A/H1N1 with traces of Thiomersal
• eH1N1_f
Unadjuvanted egg-derived A/H1N1 with traces of Thiomersal

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Costa Rica, 

References & Publications (1)

Arguedas A, Soley C, Abdelnour A, Sales V, Lindert K, Della Cioppa G, Clemens R; Costa Rican H1N1 Vaccine Study Group. Assessment of the safety, tolerability and kinetics of the immune response to A/H1N1v vaccine formulations with and without adjuvant in — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Seroconversion and HI Titer =1:40 in Children 3 to 17 Years of Age	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).	Day 1 to day 387	No
Primary	Percentage of Subjects With Seroconversion and HI Titer = 1:40 in Adults 18 to 64 Years of Age	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).	Day 1 to day 387	No
Secondary	Age Distribution at Baseline		Baseline	No
Secondary	Percentage of Subjects With Seroconversion and HI Titer =1:40, in 3 to <9 Years and 9 to 17 Years	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).	Day 1 to day 387	No
Secondary	HI GMRs, in 3 to <9 Years and 9 to 17 Years	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).	Day 1 to day 387	No
Secondary	HI GMR, in Adults 18 to 64 Years	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).	Day 1 to day 387	No
Secondary	Percentage of Subjects With Seroconversion and HI Titer =1:40, in Adults 18 to 64 Years	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).	7 days and 21 days after each vaccination	No
Secondary	Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age	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. Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination	7 days after each vaccination	Yes
Secondary	Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age	Number of subjects with specified solicited local and systemic reactions in adult subjects (9 to 17 years of age).; Postvac: postvaccination Analges: analgesics Antipyr: antipyretics The analyses were performed on the safety set.; Note: 1) postvac 1 = after the first vaccination and 2) postvac 2 = after the second vaccination.	7 days after each vaccination	Yes
Secondary	Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age	Number of subjects with specified solicited local and systemic reactions in adult subjects (18 to 64 years of age).; Note: 1) postvac. 1 = after the first vaccination and 2) postvac. 2 = after the second vaccination.; The analyses were performed on the safety set.	7 days after each vaccination	Yes