A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years

Phase 2

Completed

• Conditions: Influenza; Swine-origin A/H1N1 Influenza
• Interventions: Biological: Monovalent Subvirion A/H1N1 Influenza vaccine; Biological: Normal saline solution (placebo)

• Registration Number: NCT00952419
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children.

Primary Objectives:

* To describe the immunogenicity of the candidate vaccines after each injection.

* To describe the safety of the candidate vaccines after each injection.

Detailed Description

Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-03
• Study First Submitted QC: 2009-08-04
• Study First Posted: 2009-08-06
• Primary Completion: 2010-03
• Study Completion: 2010-06
• Results First Submitted: 2011-06-08
• Results First Submitted QC: 2011-06-08
• Results First Posted: 2011-07-11
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 474

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A/H1N1 Vaccine Group 1	Monovalent Subvirion A/H1N1 Influenza vaccine	Participants will receive A/H1N1 vaccine formulation 1
A/H1N1 Vaccine Group 2	Monovalent Subvirion A/H1N1 Influenza vaccine	Participants will receive A/H1N1 vaccine formulation 2
Placebo Group	Normal saline solution (placebo)	Participants will receive a placebo vaccine

Primary Outcome Measures

Name	Time	Method
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months	Pre-vaccination (Day 0) and 21 days post-vaccination	Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months	Pre-vaccination (Day 0) and 21 days post-vaccination	Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years	Pre-vaccination (Day 0) and Day 21 post-vaccination	Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years	Days 0 to 7 post vaccination	Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months	Days 0 to 7 post-vaccination	Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months	Days 0 to 7 post-vaccination	Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months	Pre-vaccination (Day 0) and Day 21 post-vaccination	Seroprotection: Antibody titer of ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years	Pre-vaccination (Day 0) and Day 21 post-vaccination	Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years	Pre-vaccination (Day 0) and 21 days post-vaccination	Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.