Back to resultsConcomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children (V251-067)
Primary Purpose
Hepatitis A Virus
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Comparator: VAQTA™ (Hepatitis A vaccine)
Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)
Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)
Sponsored by
About this trial
This is an interventional prevention trial for Hepatitis A Virus focused on measuring Hepatitis A Virus
Eligibility Criteria
Inclusion Criteria: 12- to 15-month-old males and females with no active liver disease A negative history of hepatitis A, measles, mumps, rubella, chickenpox, and/or zoster Exclusion Criteria: Males and females previously vaccinated with hepatitis A, measles, mumps, rubella, and/or chickenpox vaccine Any immune deficiency History of allergy to any of the vaccine components History of any seizure disorder
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Arm 1: VAQTA™ 0.5 mL injection (2 doses 6 months apart), ProQuad™ 0.5 mL injection (2 doses 6 months apart), Prevnar™ 0.5 mL injection (one dose), all vaccines administered concomitantly. 28 weeks of study duration.
Arm 2: ProQuad™ 0.5 mL injection (2 doses ~8 months apart), Prevnar™ 0.5 mL injection (one dose), both administered concomitantly, VAQTA™ 0.5 mL injection (2 doses 6 months apart) administered alone. 34 weeks of study duration.
Outcomes
Primary Outcome Measures
Antibody Response to Hepatitis A - Participants With a Serological Response
Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus
Antibody Response to Varicella - Participants With a Serological Response
Participants with varicella baseline antibody titer <1.25 gpELISA units/mL and Postdose 1 titers ≥1.25 gpELISA units/mL (seroconversion) and ≥5 gpELISA units/mL (seroprotection)
Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers
Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay
Participants With 1 or More Systemic Adverse Experience
Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 6 week study period.
Participants With 1 or More Systemic Adverse Experience
Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 4 week study period.
Participants With 1 or More Systemic Adverse Experience.
Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. Collected the first 14 days after each of the 2 doses of hepatitis A vaccine (VAQTA™) (Days 1 to 14), given 6 months apart
Participants With 1 or More Injection-site Adverse Experience
Injection-site adverse experiences collected the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.
Participants With 1 or More Injection-site Adverse Experience
Injection-site adverse experiences collected the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.
Participants With 1 or More Injection-site Adverse Experience
Injection-site adverse experiences collected the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
Elevated temperatures measured the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
Elevated temperatures measured the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
Elevated temperatures measured the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.
Participants With 1 or More Serious Vaccine-related Adverse Experience
Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Participants With 1 or More Serious Vaccine-related Adverse Experience
Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Participants With 1 or More Serious Vaccine-related Adverse Experience
Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00312858
Brief Title
Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children (V251-067)
Official Title
An Open, Randomized, Multicenter Study of the Safety, Tolerability, & Immunogenicity of VAQTA™ Given Concomitantly With PROQUAD™ and PREVNAR™ in Healthy Children 12 Months of Age
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hepatitis A vaccine will be given either alone or together with measles, mumps, rubella, and varicella vaccine and pneumococcal 7-valent conjugate vaccine at the first dose and together with measles, mumps, rubella, and varicella [Oka/Merck] virus vaccine at the second dose. Immunogenicity and safety data will be collected after each dose of vaccine.
Detailed Description
Vaccines: V251, Hepatitis A Vaccine, Inactivated (VAQTA™) administered with Measles, Mumps, Rubella and Varicella Vaccine (ProQuad™) and Pneumococcal 7-Valent Conjugate Vaccine (Prevnar™) will have a Duration of Treatment: 2 Doses, 6 months apart.
Vaccine: Hepatitis A Vaccine, Inactivated (VAQTA™), administered alone will have a Duration of Treatment: 2 Doses, 6 months apart.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis A Virus
Keywords
Hepatitis A Virus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
653 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Arm 1: VAQTA™ 0.5 mL injection (2 doses 6 months apart), ProQuad™ 0.5 mL injection (2 doses 6 months apart), Prevnar™ 0.5 mL injection (one dose), all vaccines administered concomitantly. 28 weeks of study duration.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Arm 2: ProQuad™ 0.5 mL injection (2 doses ~8 months apart), Prevnar™ 0.5 mL injection (one dose), both administered concomitantly, VAQTA™ 0.5 mL injection (2 doses 6 months apart) administered alone. 34 weeks of study duration.
Intervention Type
Biological
Intervention Name(s)
Comparator: VAQTA™ (Hepatitis A vaccine)
Intervention Description
VAQTA™ 0.5 mL injection
Intervention Type
Biological
Intervention Name(s)
Comparator: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)
Intervention Description
ProQuad™ 0.5 mL injection
Intervention Type
Biological
Intervention Name(s)
Comparator: Prevnar™ (Pneumococcal 7-Valent Conjugate vaccine)
Intervention Description
Prevnar™ 0.5 mL injection
Primary Outcome Measure Information:
Title
Antibody Response to Hepatitis A - Participants With a Serological Response
Description
Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus
Time Frame
4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)
Title
Antibody Response to Varicella - Participants With a Serological Response
Description
Participants with varicella baseline antibody titer <1.25 gpELISA units/mL and Postdose 1 titers ≥1.25 gpELISA units/mL (seroconversion) and ≥5 gpELISA units/mL (seroprotection)
Time Frame
6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)
Title
Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers
Description
Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay
Time Frame
6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Title
Participants With 1 or More Systemic Adverse Experience
Description
Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 6 week study period.
Time Frame
6 weeks post dose 1
Title
Participants With 1 or More Systemic Adverse Experience
Description
Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 4 week study period.
Time Frame
4 weeks post dose 2
Title
Participants With 1 or More Systemic Adverse Experience.
Description
Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. Collected the first 14 days after each of the 2 doses of hepatitis A vaccine (VAQTA™) (Days 1 to 14), given 6 months apart
Time Frame
6 months
Title
Participants With 1 or More Injection-site Adverse Experience
Description
Injection-site adverse experiences collected the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.
Time Frame
6 weeks post dose 1
Title
Participants With 1 or More Injection-site Adverse Experience
Description
Injection-site adverse experiences collected the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.
Time Frame
4 weeks post dose 2
Title
Participants With 1 or More Injection-site Adverse Experience
Description
Injection-site adverse experiences collected the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.
Time Frame
6 months
Title
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
Description
Elevated temperatures measured the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.
Time Frame
6 weeks post dose 1
Title
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
Description
Elevated temperatures measured the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.
Time Frame
4 weeks post dose 2
Title
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
Description
Elevated temperatures measured the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.
Time Frame
6 months
Title
Participants With 1 or More Serious Vaccine-related Adverse Experience
Description
Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Time Frame
6 weeks post dose 1
Title
Participants With 1 or More Serious Vaccine-related Adverse Experience
Description
Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Time Frame
4 weeks post dose 2
Title
Participants With 1 or More Serious Vaccine-related Adverse Experience
Description
Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Antibody Response to Hepatitis A - Geometric Mean Titer
Description
Geometric Mean Titer of hepatitis A antibody, regardless of initial serostatus
Time Frame
4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)
Title
Antibody Response to Varicella - Geometric Mean Titer
Description
Geometric Mean Titer of varicella antibody, baseline antibody titer was <1.25 gpELISA units/mL
Time Frame
6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)
Title
Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response
Description
Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 4
Time Frame
6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Title
Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response
Description
Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 6B
Time Frame
6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Title
Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response
Description
Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 9V
Time Frame
6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Title
Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response
Description
Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 14
Time Frame
6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Title
Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response
Description
Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 18C
Time Frame
6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Title
Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response
Description
Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 19F
Time Frame
6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
Title
Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response
Description
Number of participants with a postvaccination titer >=0.2 mcg/mL for S. pneumoniae serotype 23F
Time Frame
6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
15 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
12- to 15-month-old males and females with no active liver disease
A negative history of hepatitis A, measles, mumps, rubella, chickenpox, and/or zoster
Exclusion Criteria:
Males and females previously vaccinated with hepatitis A, measles, mumps, rubella, and/or chickenpox vaccine
Any immune deficiency
History of allergy to any of the vaccine components
History of any seizure disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
23744509
Citation
Yetman RJ, Shepard JS, Duke A, Stek JE, Petrecz M, Klopfer SO, Kuter BJ, Schodel FP, Lee AW. Concomitant administration of hepatitis A vaccine with measles/mumps/rubella/varicella and pneumococcal vaccines in healthy 12- to 23-month-old children. Hum Vaccin Immunother. 2013 Aug;9(8):1691-7. doi: 10.4161/hv.24873. Epub 2013 Jun 6.
Results Reference
derived
Learn more about this trial
Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children (V251-067)
We'll reach out to this number within 24 hrs