Back to resultsVAXCHORA Pediatric Study to Assess Safety and Immunogenicity
Primary Purpose
Cholera (Disorder)
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
VAXCHORA (Cholera Vaccine, Live, Oral)
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Cholera (Disorder)
Eligibility Criteria
Inclusion Criteria:
- Male or Female
- Between 2 and <18 years of age on Day 1
- In general good health
- Able and willing to provide informed assent for study participation
- Primary caregiver is able and willing to provide informed consent for study participation
- (for females of childbearing potential) Using an acceptable method of contraception through Day 29
Exclusion Criteria:
- Current acute gastrointestinal illness or loose stools within 3 days of Day 1 visit
- Current acute febrile illness
- History of cholera infection
- History of cholera vaccination
- History of severe allergic reaction (e.g. anaphylaxis) to any ingredient of VAXCHORA
- Congenital or acquired immunodeficiency
- Pregnancy (for females of childbearing potential)
- Any other condition that, in the opinion of the Investigator, creates an unacceptable risk to the subject
- Any other condition that, in the opinion of the Investigator, will interfere with the conduct of the study or the validity of the data
- Duration of >2 weeks of abnormal stool pattern, defined as <3 stools per week or >2 stools per day in the past 6 months
- Regular use of laxatives in the past 6 months
- History of enterotoxigenic E. coli infection
- Travel to cholera-endemic area in the previous 5 years
- Nursing/Breastfeeding
- Received or plans to receive the following from 14 days prior to the study vaccination through 11 days after vaccination: Any other licensed vaccines, antibiotics, or chloroquine
- Received or plans to receive any other investigational agent throughout the main study (Day 181)
Sites / Locations
- Emory University
- Johnson County Clin-Trials, Inc.
- Heartland Research Associates, LLC
- University of Kentucky
- Boston Medical Center
- The Center for Pharmaceutical Research
- Rochester Clinical Research, Inc.
- Aventiv Research Inc.
- Coastal Carolina Research Center
- Clinical Research Associates, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Other
Arm Label
Cohort 1 (active, 12-17 yrs)
Cohort 1 (placebo, 12 - 17 yrs)
Cohort 2 (active, 6 - 11 yrs)
Cohort 2 (placebo, 6 - 11 yrs)
Cohort 3 (active, 2 - 5 yrs)
Cohort 3 (placebo, 2 - 5 yrs)
Historical Control: Adult Bridging Population
Arm Description
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
Subjects aged 12 - 17 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-006 as a comparator bridging population for the Day 11 seroconversion. NCT02094586 PubMed ID:29317118
Outcomes
Primary Outcome Measures
Cohort 1 (12-17 Yrs) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer
Cohort 2 (6 to <12 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer.
Cohort 3 (2 to <6 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer.
Cohort 1 (12-17 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
Cohort 2 (6-11 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
Cohort 3 (2-5 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of18 and 45 years.
Secondary Outcome Measures
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 29
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 91
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 91 for all subjects
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 181
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 181 for all subjects
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 365
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 365 for all subjects
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 547
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 547 for all subjects
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 730
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 730 for all subjects
Cohort 2 (6 to <12 Years) - Seroconversion of SVA - Day 29
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
Cohort 3 (2 to <6 Years) - Seroconversion of SVA - Day 29
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
Full Information
NCT ID
NCT03220737
First Posted
July 11, 2017
Last Updated
June 26, 2023
Sponsor
Bavarian Nordic
Collaborators
Emergent BioSolutions
1. Study Identification
Unique Protocol Identification Number
NCT03220737
Brief Title
VAXCHORA Pediatric Study to Assess Safety and Immunogenicity
Official Title
A Phase 4 Study to Assess the Safety and Immunogenicity of VAXCHORA (Cholera Vaccine, Live, Oral) in Children 2 to <18 Years of Age
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 21, 2017 (Actual)
Primary Completion Date
September 10, 2019 (Actual)
Study Completion Date
March 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bavarian Nordic
Collaborators
Emergent BioSolutions
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
VAXCHORA (Cholera Vaccine, Live, Oral) is a vaccine indicated for active immunization against disease caused by Vibrio cholerae serogroup O1. VAXCHORA is approved for use in adults 18 through 64 years of age travelling to cholera-affected areas. The primary goals of this Phase 4 study are to evaluate the safety and immunogenicity of a single dose of VAXCHORA (1 x 10e9 cfu/dose) in children ages 2 years to <18 years of age in developed countries.
Detailed Description
This is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholera (Disorder)
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Model Description
This is a randomized, placebo-controlled, double-blind, single-crossover study with three age cohorts and two treatment groups within each cohort.
The main study consists of a screening period of 30 days, a treatment period from Day 1 to Day 29, and a follow-up period through Day 181. Cohort 1 has an optional sub-study consisting of a long-term follow-up period through Day 730.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The study will be conducted as a double-blind study through 181, where neither the sponsor, the statistical team, study volunteer subjects, nor clinical site personnel (except for the unblinded administration staff) will know subjects' treatment assignment. Once each subject has reached their Day 181 visit they will be individually unblinded.
Allocation
Randomized
Enrollment
550 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1 (active, 12-17 yrs)
Arm Type
Experimental
Arm Description
Subjects aged 12 - 17 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181. Cohort 1 subjects that continued in the long-term follow-up sub-study had visits on days 365, 547 and 730.
Arm Title
Cohort 1 (placebo, 12 - 17 yrs)
Arm Type
Placebo Comparator
Arm Description
Subjects aged 12 - 17 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Arm Title
Cohort 2 (active, 6 - 11 yrs)
Arm Type
Experimental
Arm Description
Subjects aged 6 - 11 were administered a 100 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
Arm Title
Cohort 2 (placebo, 6 - 11 yrs)
Arm Type
Placebo Comparator
Arm Description
Subjects aged 6 - 11 were administered a 100 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Arm Title
Cohort 3 (active, 2 - 5 yrs)
Arm Type
Experimental
Arm Description
Subjects aged 2 - 5 were administered a 50 mL oral dose of Vaxchora vaccine on Day 1, and had study visits on Day 11, 29, 91 and 181.
Arm Title
Cohort 3 (placebo, 2 - 5 yrs)
Arm Type
Placebo Comparator
Arm Description
Subjects aged 2-5 were administered a 50 mL oral dose of 0.9% saline on Day 1, and had study visits on Day 11, 29, 91 and 181.
Arm Title
Historical Control: Adult Bridging Population
Arm Type
Other
Arm Description
This arm consists of historical data from Vaxchora vaccine subjects from study PXVX-VC-200-004. The data was included in study PXVX-VC-200-006 as a comparator bridging population for the Day 11 seroconversion. NCT02094586 PubMed ID:29317118
Intervention Type
Biological
Intervention Name(s)
VAXCHORA (Cholera Vaccine, Live, Oral)
Intervention Description
VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo control for this study is normal (0.9%) saline.
Primary Outcome Measure Information:
Title
Cohort 1 (12-17 Yrs) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
Description
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer
Time Frame
Day 11
Title
Cohort 2 (6 to <12 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
Description
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer.
Time Frame
Day 11
Title
Cohort 3 (2 to <6 Years) Primary Endpoint - Seroconversion of Serum Vibriocidal Antibody Against V. Cholerae
Description
The proportion of subjects achieving seroconversion of serum vibriocidal antibody (SVA) against the classical Inaba biotype of V. cholerae at Day 11 following one dose of VAXCHORA, defined as a 4-fold or greater rise over baseline Day 1 SVA titer.
Time Frame
Day 11
Title
Cohort 1 (12-17 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
Description
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
Time Frame
Day 11
Title
Cohort 2 (6-11 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
Description
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of 18 and 45 years.
Time Frame
Day 11
Title
Cohort 3 (2-5 Yrs) Primary Endpoint - Non-inferiority of Seroconversion Rate at Day 11 Relative to Adults Aged 18 - 45 Years
Description
The seroconversion rate is defined as the percentage of subjects with a 4-fold or greater rise over baseline Day 1 Serum Vibriocidal Antibody (SVA) titer against the classical Inaba biotype of V. cholerae at Day 11 following one dose of Vaxchora vaccine. The hypothesis was that the pediatric seroconversion rate would be non-inferior to the seroconversion rate at Day 11 in adults between the ages of18 and 45 years.
Time Frame
Day 11
Secondary Outcome Measure Information:
Title
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 29
Description
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
Time Frame
Day 29
Title
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 91
Description
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 91 for all subjects
Time Frame
Day 91
Title
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 181
Description
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 181 for all subjects
Time Frame
Day 181
Title
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 365
Description
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 365 for all subjects
Time Frame
Day 365
Title
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 547
Description
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 547 for all subjects
Time Frame
Day 547
Title
Cohort 1 (12 to <18 Years) - Seroconversion of SVA - Day 730
Description
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 730 for all subjects
Time Frame
Day 730
Title
Cohort 2 (6 to <12 Years) - Seroconversion of SVA - Day 29
Description
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
Time Frame
Day 29
Title
Cohort 3 (2 to <6 Years) - Seroconversion of SVA - Day 29
Description
Seroconversion of SVA against the classical Inaba biotype of V. cholerae at Day 29 for all subjects
Time Frame
Day 29
Other Pre-specified Outcome Measures:
Title
Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 1
Description
Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 1 for the subjects in the active treatment group and the placebo crossover group
Time Frame
Day 1
Title
Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 91
Description
Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 91 for the subjects in the active treatment group and the placebo crossover group
Time Frame
Day 91
Title
Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 181
Description
Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 181 for the subjects in the active treatment group and the placebo crossover group
Time Frame
Day 181
Title
Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 365
Description
Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 365 for the subjects in the active treatment group who participate in the substudy.
Time Frame
Day 365
Title
Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 547
Description
Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 547 for the subjects in the active treatment group who participate in the substudy.
Time Frame
Day 547
Title
Cohort 1 (12 to <18 Years) Exploratory Endpoint - Anti-O1 Lipopolysaccharide Memory B Cell Concentration at Day 730
Description
Anti-O1 lipopolysaccharide (LPS) memory B cell concentration at Day 730 for the subjects in the active treatment group who participate in the substudy.
Time Frame
Day 730
Title
Safety - Solicited Adverse Events
Description
Evaluate the safety and tolerability of VAXCHORA by collecting solicited adverse events (abdominal pain, headache, lack of appetite, tiredness, diarrhea, nausea, vomiting and fever) by age cohort and overall through Day 8
Time Frame
Through Day 8
Title
Safety - Unsolicited Adverse Events
Description
Evaluate the safety and tolerability of VAXCHORA by collecting unsolicited adverse events by age cohort and overall through Day 29
Time Frame
Through Day 29
Title
Safety - Serious Adverse Events
Description
Evaluate the safety and tolerability of VAXCHORA by collecting serious adverse events by age cohort and overall through Day 181
Time Frame
Through Day 181
Title
Acceptability
Description
Evaluate the acceptability of VAXCHORA using the percent of subjects in each age cohort able to complete the dosing according to protocol.
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or Female
Between 2 and <18 years of age on Day 1
In general good health
Able and willing to provide informed assent for study participation
Primary caregiver is able and willing to provide informed consent for study participation
(for females of childbearing potential) Using an acceptable method of contraception through Day 29
Exclusion Criteria:
Current acute gastrointestinal illness or loose stools within 3 days of Day 1 visit
Current acute febrile illness
History of cholera infection
History of cholera vaccination
History of severe allergic reaction (e.g. anaphylaxis) to any ingredient of VAXCHORA
Congenital or acquired immunodeficiency
Pregnancy (for females of childbearing potential)
Any other condition that, in the opinion of the Investigator, creates an unacceptable risk to the subject
Any other condition that, in the opinion of the Investigator, will interfere with the conduct of the study or the validity of the data
Duration of >2 weeks of abnormal stool pattern, defined as <3 stools per week or >2 stools per day in the past 6 months
Regular use of laxatives in the past 6 months
History of enterotoxigenic E. coli infection
Travel to cholera-endemic area in the previous 5 years
Nursing/Breastfeeding
Received or plans to receive the following from 14 days prior to the study vaccination through 11 days after vaccination: Any other licensed vaccines, antibiotics, or chloroquine
Received or plans to receive any other investigational agent throughout the main study (Day 181)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Andre de Lame, MD
Organizational Affiliation
Emergent BioSolutions
Official's Role
Study Director
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Johnson County Clin-Trials, Inc.
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
The Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Rochester Clinical Research, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
Aventiv Research Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43123
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Clinical Research Associates, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31769402
Citation
McCarty JM, Gierman EC, Bedell L, Lock MD, Bennett S. Safety and Immunogenicity of Live Oral Cholera Vaccine CVD 103-HgR in Children and Adolescents Aged 6-17 Years. Am J Trop Med Hyg. 2020 Jan;102(1):48-57. doi: 10.4269/ajtmh.19-0241.
Results Reference
derived
Learn more about this trial
VAXCHORA Pediatric Study to Assess Safety and Immunogenicity
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