Clinical trial NCT00973700: Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children, Adolescents and Adults (3 to 64 Years)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Novel 2009 Influenza H1N1
Keywords: Swine Flu
Flu
Vaccine
Adjuvant
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-09-09
Enrollment: 784
Sex: ALL
Minimum age (years): 3
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age
timeFrame: Day 1 to day 387
measure: Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age
timeFrame: Day 1 to day 387
Secondary outcomes:
measure: Age Distribution at Baseline
timeFrame: Baseline
measure: Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years
timeFrame: Day 1 to day 387
measure: HI GMRs, in 3 to <9 Years and 9 to 17 Years
timeFrame: Day 1 to day 387
measure: HI GMR, in Adults 18 to 64 Years
timeFrame: Day 1 to day 387
measure: Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in Adults 18 to 64 Years
timeFrame: 7 days and 21 days after each vaccination
measure: Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age
timeFrame: 7 days after each vaccination
measure: Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age
timeFrame: 7 days after each vaccination
measure: Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age
timeFrame: 7 days after each vaccination
Other outcomes:
Locations:
city: San Jose
country: Costa Rica
facility: Instituto de Atencion Pediatrica, Avenida 0-2 Calle 22, Paseo Colon del Restaurante La, Bastilla 50 metros Sur, Edificio 5.
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_DIRECTOR
References:
citation: 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 healthy pediatric subjects from 3 through 17 years of age. Hum Vaccin. 2011 Jan 1;7(1):58-66. doi: 10.4161/hv.7.1.13411. Epub 2011 Jan 1.