A Study of Swine-origin A/H1N1 Influenza Vaccines in Healthy Europeans Children Aged 6 to 35 Months

NCT00956046 | Completed Phase 2

• 3 other identifiers: GPF09UTN: U1111-1111-50292009-013858-32
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration. Primary objectives:

• To describe the immune response to vaccines 21 days after each vaccination in all participants.
• To describe the antibody persistence eight months after the first vaccine administration using hemagglutination inhibition (HAI) method in a subset of participants who received two half-doses of either formulation 1 or 2.
• To describe the immune response against the A/H1N1 strain using the HAI method 21 days after last vaccination with the 2010-2011 NH seasonal Trivalent Influenza Vaccine (TIV) administered 13 months after the first vaccination in a subset of subjects who received two half-doses of either t either formulation 1 or 2 of the A/H1N1 influenza vaccines as primary series.
• To describe the safety profile of each vaccine in all participants.

Conditions

Influenza; Swine-origin A/H1N1 Influenza

Keywords

Influenza; Pandemic Flu; Swine-origin A/H1N1 Influenza; Swine-origin Influenza Virus; Infants

Outcome Measures

Primary Outcomes (2)

• Immunogenicity: To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccines

  21 days post vaccination

• Safety: To provide information concerning the safety in terms of solicited injection site and systemic reactions of Swine A/H1N1 influenza vaccines.

  0-7 days post-vaccination and entire study duration

Study Arms (3)

A/H1N1 Vaccine Group 1

EXPERIMENTAL

All participants will receive A/H1N1 Influenza vaccine formulation 1 at Visits 1 and 2; and a subset will receive a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset)

Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)

A/H1N1 Vaccine Group 2

EXPERIMENTAL

All participants will receive A/H1N1 Influenza vaccine formulation 2 at Visits 1 and 2; and a subset will receive a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset).

Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)

A/H1N1 Vaccine Group 3

EXPERIMENTAL

Participants will receive A/H1N1 Influenza vaccine formulation 3

Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated + adjuvant)

Interventions

Swine A/H1N1 influenza vaccine (split virion, inactivated) BIOLOGICAL

0.5 mL, Intramuscular on Day 0 and Day 21 (all participants); and 0.5 mL of a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset).

A/H1N1 Vaccine Group 1

Swine A/H1N1 influenza vaccine (split virion, inactivated + adjuvant) BIOLOGICAL

0.5 mL, Intramuscular on Day 0 and Day 21 (all participants); and 0.5 mL of a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset)

A/H1N1 Vaccine Group 2

Eligibility Criteria

• Age: 6 Months - 35 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All subjects
• Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
• Subject and parent/legal representative are able to attend all scheduled visits and to comply with all trial procedures
• Completion of vaccination according to the national immunization schedule.
• Subjects ≥ 6 to \< 24 months of age - Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
• At Month 8 for antibody persistence assessment:
• Having received two half-doses of either the formulation 1 or 2 of the vaccine
• Addendum 1 to Informed Consent Form has been signed and dated by the parents or other legally acceptable representative.
• At Visit 06, for subjects eligible for the Antibody persistence evaluation who will receive the Trivalent Influenza Vaccine (TIV):
• \- Addendum 2 to Informed Consent Form has been signed by the subject's parents/legal representative.

You may not qualify if:

• All subjects
• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
• Planned participation in another clinical trial during the present trial period
• Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
• Planned receipt of any vaccine prior to the Day 42 blood sample
• Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
• Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• Seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B antigen, or Hepatitis C as reported by parents/legal representative
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
• Thrombocytopenia contraindicating intramuscular (IM) vaccination as reported by parents/legal representative
• Chronic illness that in the opinion of the Investigator is at a stage where it might interfere with trial conduct or completion
• Family members of the employees or the Investigator
• Previous participation in a trial investigating a vaccine with the swine-origin A/H1N1 influenza strain
• Confirmed infection with the swine-origin A/H1N1 influenza strain (different from the seasonal strain) in 2009
• Febrile illness (temperature ≥ 38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (15)

Unknown Facility

Espoo, FIN-02100, Finland

Location

Unknown Facility

Helsinki, FIN-00100, Finland

Location

Unknown Facility

Helsinki, FIN-00930, Finland

Location

Unknown Facility

Jarvenpaa, FIN-04400, Finland

Location

Unknown Facility

Kokkola, 67100, Finland

Location

Unknown Facility

Kotka, FIN-48600, Finland

Location

Unknown Facility

Kuopio, FIN-70100, Finland

Location

Unknown Facility

Lahti, FIN-15140, Finland

Location

Unknown Facility

Oulu, FIN-90220, Finland

Location

Unknown Facility

Pori, FIN-28100, Finland

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Unknown Facility

Seinäjoki, 60100, Finland

Location

Unknown Facility

Tampere, FIN-33100, Finland

Location

Unknown Facility

Turku, FIN-20520, Finland

Location

Unknown Facility

Vantaa, FIN-01300, Finland

Location

Unknown Facility

Vantaa, FIN-01600, Finland

Location

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Adjuvants, Pharmaceutic

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Medical Monitor

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2009
• First Posted: August 11, 2009
• Study Start: September 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: June 1, 2011
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

FI (15)