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Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MF59-eH1N1
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Swine Flu, Flu, Vaccine, Children, Adjuvant

Eligibility Criteria

3 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children 3 to < 9 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.

Sites / Locations

  • Premier Health Research Center, LLC
  • Madera Family Medical Group
  • Center for Clincal Trials, LLC
  • Center for Clinical Trials, LLC
  • Center for Clinical Trials of San Gabriel
  • 1st International Research Centers
  • Pediatrics and Adolescent Medicine
  • Pediatrics and Adolescent Medicine
  • Northern Illinois Research Associates
  • Bluegrass Clinical Research, Inc.
  • Heartland Research Associates LLC
  • Heartland Research Associates LLC
  • Bluegrass Clinical Research, Inc (Brownsboro for drug shipment)
  • Meridien Clinical Research
  • Clinical Research Center of Nevada
  • Capital Pediatrics and Adolescent Ctr.
  • Dr. Senders and Associates, Pediatrics
  • Prestige Clinical Research
  • IPS Research
  • The Portland Clinic LLP
  • Children's Health Care -West
  • UPMC/Community Medicine (pediatrics)
  • Pediatric Physicians Research, Inc.
  • Pediatric Alliance - Greentree Division (pediatrics)
  • Omega Clinical Research
  • Holston Medical Group
  • Research Across America
  • West Houston Clinical Research Service
  • Pediatric Healthcare of NW Houston
  • J.Lewis Research, Inc./Foothill Family Clinic
  • J. Lewis Research, Inc./Foothill Family Clinic South
  • PI-Coor Clinical Research
  • Virginia Commonwealth University
  • Rockwood Research Center
  • Instituto Nacional de Ciencias

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

3.75_(50)MF59

7.5_(0) MF59

7.5_(50) MF59

7.5_(100) MF59

15_(0) MF59

15_(50)MF59

15_(100) MF59

30_(0) MF59

Arm Description

3.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22

7.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22

7.5 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22

7.5 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22

15 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22

15 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22

15 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22

30 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22

Outcomes

Primary Outcome Measures

Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for <65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity. PPS Day 1-29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively. PPS Day 1-202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively.

Secondary Outcome Measures

Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group
Immunogenicity was measured in terms of GMTs After each vaccination by vaccine Group. PPS Day1-29 analysis set: N=143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-202 analysis set. N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Committee for Medicinal Products for Human Use (CHMP) guidance: in adults ages 18 to 60 years are:The percentage of subjects with seroconversion or significant increase in HI antibody is > 40%.The percentage of subjects achieving an HI titer ≥ 40 is > 70% and The GMR is > 2.5. All 3 criteria (seroconversion/significant increase, HI antibody titer ≥ 40, and GMR) had to be fulfilled to establish immunogenicity.Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.Subgroups without recent seasonal flu vaccine:PPS Day1, Day 1-22 and Day1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F, G,and H respectively.
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Immunogenicity was measured in terms of GMTs of Subgroups with receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines Subgroups without recent seasonal flu vaccine: PPS Day 1, Day 1-22 and Day 1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F,G, and H respectively. Subgroups with recent seasonal flu vaccine:PPS Day 1-22 and Day 1-43 analysis set. N= 11, 9, 6, 8, 9, 11, 6, and 7 for Groups A, B, C, D, E, F, G,and H respectively. PPS Day 1-29 analysis set. N= 11, 9, 6, 7, 9, 11, 5, and 6 for Groups A, B, C, D, E, F, G, and H respectively
Antibody Response Based on Baseline Seropositivity
Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline. Subgroups with baseline HI titer < 1:10: PPS Day 1-29 analysis set. N= 104, 116, 111, 107, 109, 113,120, and 103 for Groups A, B, C, D, E, F, G, and H respectively. Subgroups with baseline HI titer ≥ 1:10: PPS Day 1-29 analysis set. N= 39, 33, 38, 39, 38, 34, 24, and 41 for Groups A, B, C, D, E, F, G, and H respectively.
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline. Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline [Day 1 (pre-vaccination)] as compared to those who are seronegative (HI titer < 1:10).
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Solicited local and systemic reactions were assessed after the first vaccination by vaccine group. Source Vocabulary Name: MedDRA (13.1).
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Solicited local and systemic reactions were assessed after the second vaccination by vaccine group.Source Vocabulary Name: MedDRA (13.1)
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Safety was measured in terms of the Number of Participants Reporting Unsolicited AEs. Source Vocabulary Name: MedDRA (13.1)

Full Information

First Posted
September 2, 2009
Last Updated
March 14, 2016
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT00972816
Brief Title
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)
Official Title
A Pivotal Randomized, Single-Blind, Dose-Finding 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 Pediatric Subjects 3 to < 9 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Swine Flu, Flu, Vaccine, Children, Adjuvant

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1357 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3.75_(50)MF59
Arm Type
Experimental
Arm Description
3.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
Arm Title
7.5_(0) MF59
Arm Type
Experimental
Arm Description
7.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
Arm Title
7.5_(50) MF59
Arm Type
Experimental
Arm Description
7.5 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
Arm Title
7.5_(100) MF59
Arm Type
Experimental
Arm Description
7.5 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
Arm Title
15_(0) MF59
Arm Type
Experimental
Arm Description
15 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
Arm Title
15_(50)MF59
Arm Type
Experimental
Arm Description
15 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
Arm Title
15_(100) MF59
Arm Type
Experimental
Arm Description
15 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
Arm Title
30_(0) MF59
Arm Type
Experimental
Arm Description
30 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
Intervention Type
Biological
Intervention Name(s)
MF59-eH1N1
Intervention Description
MF59 adjuvanted with egg-derived A/H1N1 antigen. MF59-eH1N1 vaccine is the same vaccine as A/H1N1-SOIV (Swine Origin A/H1N1 Influenza Virus).
Primary Outcome Measure Information:
Title
Antibody Responses According to the Hemagglutinin Inhibition (HI) Assay After the First and Second Vaccinations
Description
HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Center for Biologics Evaluation and Research (CBER) guidance for <65 years of age: The lower bound of the two-sided 95% Confidence Interval (CI) for the percentages of subjects achieving seroconversion for HI antibody should be ≥ 40% and the lower bound of the two-sided 95% CI for the percentages of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%. Both criteria (seroconversion and HI antibody titer ≥ 40) had to be fulfilled to establish immunogenicity. PPS Day 1-29 analysis set: N= 143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F,G,and H respectively. PPS Day 1-202 analysis set: N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-387 analysis set: N= 55, 63, 61, 58, 61, 65, 59, and 63 for Groups A, B, C, D, E, F, G, and H respectively.
Time Frame
Day 22, Day 29, Day 43, Day 202 and Day 387
Secondary Outcome Measure Information:
Title
Geometric Mean Titer (GMT) After Each Vaccination by Vaccine Group
Description
Immunogenicity was measured in terms of GMTs After each vaccination by vaccine Group. PPS Day1-29 analysis set: N=143, 149, 149, 146, 147, 147, 144, and 144 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-202 analysis set. N= 82, 85, 84, 84, 86, 87, 82, and 79 for Groups A, B, C, D, E, F, G, and H respectively.
Time Frame
Day 22, Day 29, Day 43, Day 202 and Day 387
Title
Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010.
Description
HI antibody assay (used to assess immune responses in subjects following vaccination) according to the Committee for Medicinal Products for Human Use (CHMP) guidance: in adults ages 18 to 60 years are:The percentage of subjects with seroconversion or significant increase in HI antibody is > 40%.The percentage of subjects achieving an HI titer ≥ 40 is > 70% and The GMR is > 2.5. All 3 criteria (seroconversion/significant increase, HI antibody titer ≥ 40, and GMR) had to be fulfilled to establish immunogenicity.Subgroup analysis based on receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.Subgroups without recent seasonal flu vaccine:PPS Day1, Day 1-22 and Day1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F, G,and H respectively.
Time Frame
Day 22, Day 29, Day 43
Title
Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Description
Immunogenicity was measured in terms of GMTs of Subgroups with receipt of recent seasonal vaccination. Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines Subgroups without recent seasonal flu vaccine: PPS Day 1, Day 1-22 and Day 1-43 analysis set. N= 141, 147, 150, 148, 146, 146, 150, and 146 for Groups A, B, C, D, E, F, G, and H respectively. PPS Day 1-29 analysis set. N= 132, 140, 143, 139, 138, 136, 139, and 138 for Groups A, B, C, D, E, F,G, and H respectively. Subgroups with recent seasonal flu vaccine:PPS Day 1-22 and Day 1-43 analysis set. N= 11, 9, 6, 8, 9, 11, 6, and 7 for Groups A, B, C, D, E, F, G,and H respectively. PPS Day 1-29 analysis set. N= 11, 9, 6, 7, 9, 11, 5, and 6 for Groups A, B, C, D, E, F, G, and H respectively
Time Frame
Day 1, Day 22, Day 29, Day 43
Title
Antibody Response Based on Baseline Seropositivity
Description
Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline. Subgroups with baseline HI titer < 1:10: PPS Day 1-29 analysis set. N= 104, 116, 111, 107, 109, 113,120, and 103 for Groups A, B, C, D, E, F, G, and H respectively. Subgroups with baseline HI titer ≥ 1:10: PPS Day 1-29 analysis set. N= 39, 33, 38, 39, 38, 34, 24, and 41 for Groups A, B, C, D, E, F, G, and H respectively.
Time Frame
Day 22, Day 29 and Day 43
Title
Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
Description
Subgroup analysis based on Subjects with seropositivity (pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10) at baseline. Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline [Day 1 (pre-vaccination)] as compared to those who are seronegative (HI titer < 1:10).
Time Frame
Day 1, Day 22, Day 29, Day 43
Title
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the First Vaccination
Description
Solicited local and systemic reactions were assessed after the first vaccination by vaccine group. Source Vocabulary Name: MedDRA (13.1).
Time Frame
7 days after first vaccination
Title
Number of Subjects Reporting Solicited Local and Systemic Symptoms After the Second Vaccination
Description
Solicited local and systemic reactions were assessed after the second vaccination by vaccine group.Source Vocabulary Name: MedDRA (13.1)
Time Frame
7 days after second vaccination
Title
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Description
Safety was measured in terms of the Number of Participants Reporting Unsolicited AEs. Source Vocabulary Name: MedDRA (13.1)
Time Frame
Safety monitoring periods were the Primary Period: Day 1 (1st vaccination) through ≤21 days post second vaccination, and the Follow-up Period: >21 Days post second vaccination to 12 months after second vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children 3 to < 9 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines and Diagnostics
Organizational Affiliation
Novartis
Official's Role
Study Director
Facility Information:
Facility Name
Premier Health Research Center, LLC
City
Downey
State/Province
California
ZIP/Postal Code
90241-4982
Country
United States
Facility Name
Madera Family Medical Group
City
Madera
State/Province
California
ZIP/Postal Code
93637
Country
United States
Facility Name
Center for Clincal Trials, LLC
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Center for Clinical Trials, LLC
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Center for Clinical Trials of San Gabriel
City
West Covina
State/Province
California
ZIP/Postal Code
91790
Country
United States
Facility Name
1st International Research Centers
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80233
Country
United States
Facility Name
Pediatrics and Adolescent Medicine
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
Facility Name
Pediatrics and Adolescent Medicine
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Northern Illinois Research Associates
City
Dekalb
State/Province
Illinois
ZIP/Postal Code
60115
Country
United States
Facility Name
Bluegrass Clinical Research, Inc.
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Heartland Research Associates LLC
City
Arkansas City
State/Province
Kansas
ZIP/Postal Code
67005
Country
United States
Facility Name
Heartland Research Associates LLC
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Bluegrass Clinical Research, Inc (Brownsboro for drug shipment)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
Meridien Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Clinical Research Center of Nevada
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89015
Country
United States
Facility Name
Capital Pediatrics and Adolescent Ctr.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Dr. Senders and Associates, Pediatrics
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
Prestige Clinical Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
IPS Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
The Portland Clinic LLP
City
Beaverton
State/Province
Oregon
ZIP/Postal Code
97006
Country
United States
Facility Name
Children's Health Care -West
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
Facility Name
UPMC/Community Medicine (pediatrics)
City
Greenville
State/Province
Pennsylvania
ZIP/Postal Code
16125
Country
United States
Facility Name
Pediatric Physicians Research, Inc.
City
Jefferson Hills
State/Province
Pennsylvania
ZIP/Postal Code
15025
Country
United States
Facility Name
Pediatric Alliance - Greentree Division (pediatrics)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15220
Country
United States
Facility Name
Omega Clinical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
West Houston Clinical Research Service
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Pediatric Healthcare of NW Houston
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
J.Lewis Research, Inc./Foothill Family Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research, Inc./Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
PI-Coor Clinical Research
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Rockwood Research Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Instituto Nacional de Ciencias
City
Tlalpan
ZIP/Postal Code
14000
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)

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