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

• ClinicalTrials.gov Identifier: NCT00973700
• Recruitment Status: Completed
• First Posted: September 9, 2009
• Results First Posted: May 23, 2011
• Last Update Posted: December 2, 2015
• Sponsor: Novartis Vaccines
• Information provided by (Responsible Party): Novartis ( Novartis Vaccines )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Novel 2009 Influenza H1N1	Biological: MF59-eH1N1_f; Biological: eH1N1_f	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 784 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: August 2009
• Actual Primary Completion Date: October 2009
• Actual Study Completion Date: October 2010

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Percentage of Subjects With Seroconversion and HI Titer ≥1:40 in Children 3 to 17 Years of Age [ Time Frame: Day 1 to day 387 ]

   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).

2. Percentage of Subjects With Seroconversion and HI Titer ≥ 1:40 in Adults 18 to 64 Years of Age [ Time Frame: Day 1 to day 387 ]

   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 :

1. Age Distribution at Baseline [ Time Frame: Baseline ]
2. Percentage of Subjects With Seroconversion and HI Titer ≥1:40, in 3 to <9 Years and 9 to 17 Years [ Time Frame: Day 1 to day 387 ]

   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).

3. HI GMRs, in 3 to <9 Years and 9 to 17 Years [ Time Frame: Day 1 to day 387 ]

   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).

4. HI GMR, in Adults 18 to 64 Years [ Time Frame: Day 1 to day 387 ]

   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).

5. 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 ]

   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).

6. Number of Subjects With at Least One Reactogenicity Sign, in 3 to <9 Years of Age [ Time Frame: 7 days after each vaccination ]

   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. Number of Subjects With at Least One Reactogenicity Sign, in 9 to 17 Years of Age [ Time Frame: 7 days after each vaccination ]

   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.

8. Number of Subjects With at Least One Reactogenicity Sign, in 18 to 64 Years of Age [ Time Frame: 7 days after each vaccination ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 3 Years to 64 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

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; Novartis Vaccines

More Information

Publications of Results:

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. Epub 2011 Jan 1.

• Responsible Party: Novartis Vaccines
• ClinicalTrials.gov Identifier: NCT00973700
• Other Study ID Numbers: V112_04
• First Posted: September 9, 2009
• Results First Posted: May 23, 2011
• Last Update Posted: December 2, 2015
• Last Verified: October 2015

Keywords provided by Novartis ( Novartis Vaccines ):

Swine Flu; Flu; Vaccine; Adjuvant

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases