Back to resultsConcomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age (V251-068)
Primary Purpose
Hepatitis A Virus
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Comparator: VAQTA™
Comparator: Infanrix™
Comparator: PedvaxHIB™
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: Stage 1) Healthy males and females 15 months of age with no active liver disease and a negative history of hepatitis A who have been vaccinated against Haemophilus influenzae type b (Hib), diphtheria, tetanus, and pertussis diseases Stage 2) Healthy males and females 12 to 17 months of age with no active liver disease and a negative history of hepatitis A Exclusion Criteria: Stage 1) Males and females previously vaccinated with hepatitis A vaccine, any immune deficiency, a history of allergy to any of the vaccine components, a history of seizure disorder or a neurologic disorder that would contraindicate pertussis vaccine, or a bleeding disorder Stage 2) Males and females previously vaccinated with hepatitis A vaccine, any immune deficiency, a history of allergy to any of the vaccine components, or a history of bleeding disorder
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
VAQTA™, PedvaxHIB™ and Infanrix™/VAQTA™ (Stage 1)
PedvaxHIB™ and Infanrix™/VAQTA™/VAQTA™ (Stage 1)
VAQTA™, PedvaxHIB™/VAQTA™ (Stage 1)
PedvaxHIB™/VAQTA™/VAQTA™ (Stage 1)
VAQTA™/VAQTA™ (Stage 2)
Arm Description
Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites. Week 24: The second dose of VAQTA™ was administered.
Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites. Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered.
Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites. Week 24: The second dose of VAQTA™ was administered.
Day 1: PedvaxHIB™ was administered. Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered.
Day 1: The first dose of VAQTA™ was administered. Week 24: The second dose of VAQTA™ was administered.
Outcomes
Primary Outcome Measures
Seropositivity Rate (SPR) to Hepatitis A
SPR is the percent of participants with Hepatitis A antibody titers >= 10 milli-International Units/milliliter (mIU/mL), 4 weeks after dose 2 of VAQTA™ regardless of their initial serostatus. Antibody titers to Hepatitis A virus (HAV) were detected in participants' serum samples using an Enzyme Immunoassay (EIA).
Antibody Response Rate to Haemophilus Influenzae Type b (Hib)
Antibodies to the Hib capsular polysaccharide (polyribosylribitol phosphate [PRP]) are assessed in participants serum using radioimmunoassay (RIA). The limit of detection (LOD) for the RIA is 6.60 ng/mL.
The antibody response rate is defined as the percentage of participants with anti-PRP titers >1.0 mcg/mL, 4 weeks postvaccination with PedvaxHIB™.
Number of Participants With Adverse Events (AE)
Systemic and injection site AEs were collected from participants receiving
VAQTA™ concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I)
VAQTA™ non-concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I)
VAQTA™ administered alone (Stage II)
Safety data was collected on a standardized Vaccination Report Card (VRC)
following each dose. Participants returned the VRC after the safety follow-up period for each dose of VAQTA™. AEs determined by the investigator to be possibly, probably or definitely related to the vaccine are reported as Vaccine-related AE.
Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™
GMTs for antibodies to PT, FHA, and PRN were measured in serum samples of participants vaccinated with Infanrix™.
IgG antibodies to PT were assessed using the anti-pertussis toxin enzyme-linked immunosorbent assay (anti-PT ELISA), with the LOD of 2.4 ELU/mL.
IgG antibodies to FHA were assessed using the anti-pertussis filamentous hemagglutinin enzyme-linked immunosorbent assay (anti-FHA ELISA), with the LOD of 2.0 ELU/mL.
IgG antibodies to PRN were assessed using the anti-pertussis pertactin enzyme-linked immunosorbent assay (anti-PRN ELISA), with the LOD of 3.3 ELU/mL.
Secondary Outcome Measures
Full Information
NCT ID
NCT00289913
First Posted
February 8, 2006
Last Updated
March 16, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00289913
Brief Title
Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age (V251-068)
Official Title
An Open, Randomized, Multicenter Study of the Safety, Tolerability, and Immunogenicity of VAQTA™ Given Concomitantly With PedvaxHIB™ and Infanrix™ in Healthy Children 15 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
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
This two-stage study evaluates the immunogenicity, safety, and tolerability of the administration of VAQTA™ (Hepatitis A Vaccine, Inactivated) concomitantly with PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]) and Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, GlaxoSmithKline) versus the administration of VAQTA™ in healthy children 15 months of age at study entry.
Detailed Description
In stage I, VAQTA™ given concomitantly with Infanrix™ and/or PedvaxHIB™ was evaluated.
In stage 2: Two (2) doses of the VAQTA™ vaccine were administered at least 6 months apart. Safety data was collected after each dose.
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
1274 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VAQTA™, PedvaxHIB™ and Infanrix™/VAQTA™ (Stage 1)
Arm Type
Experimental
Arm Description
Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered.
Arm Title
PedvaxHIB™ and Infanrix™/VAQTA™/VAQTA™ (Stage 1)
Arm Type
Experimental
Arm Description
Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered.
Arm Title
VAQTA™, PedvaxHIB™/VAQTA™ (Stage 1)
Arm Type
Experimental
Arm Description
Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.
Week 24: The second dose of VAQTA™ was administered.
Arm Title
PedvaxHIB™/VAQTA™/VAQTA™ (Stage 1)
Arm Type
Experimental
Arm Description
Day 1: PedvaxHIB™ was administered.
Week 4: The first dose of VAQTA™ was administered.
Week 28: The second dose of VAQTA™ was administered.
Arm Title
VAQTA™/VAQTA™ (Stage 2)
Arm Type
Experimental
Arm Description
Day 1: The first dose of VAQTA™ was administered.
Week 24: The second dose of VAQTA™ was administered.
Intervention Type
Biological
Intervention Name(s)
Comparator: VAQTA™
Intervention Description
VAQTA™ (Hepatitis A Vaccine, Inactivated).
Two intramuscular 0.5-mL doses of VAQTA™ were administered 24 weeks apart, with the second dose being administered prior to 24 months of age.
Intervention Type
Biological
Intervention Name(s)
Comparator: Infanrix™
Intervention Description
Infanrix™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis
Vaccine Adsorbed, GlaxoSmithKline).
One intramuscular 0.5-mL injection of Infanrix™ was administered at the first study visit.
Intervention Type
Biological
Intervention Name(s)
Comparator: PedvaxHIB™
Other Intervention Name(s)
One intramuscular 0.5-mL injection of PedvaxHIB™ was administered to all subjects at the first study, visit in all treatment groups in the study.
Intervention Description
PedvaxHIB™ (Haemophilus B Conjugate Vaccine [Meningococcal Protein Conjugate]).
One intramuscular 0.5-mL injection of PedvaxHIB™ was administered at the first study visit.
Primary Outcome Measure Information:
Title
Seropositivity Rate (SPR) to Hepatitis A
Description
SPR is the percent of participants with Hepatitis A antibody titers >= 10 milli-International Units/milliliter (mIU/mL), 4 weeks after dose 2 of VAQTA™ regardless of their initial serostatus. Antibody titers to Hepatitis A virus (HAV) were detected in participants' serum samples using an Enzyme Immunoassay (EIA).
Time Frame
4 weeks after dose 2 of VAQTA™
Title
Antibody Response Rate to Haemophilus Influenzae Type b (Hib)
Description
Antibodies to the Hib capsular polysaccharide (polyribosylribitol phosphate [PRP]) are assessed in participants serum using radioimmunoassay (RIA). The limit of detection (LOD) for the RIA is 6.60 ng/mL.
The antibody response rate is defined as the percentage of participants with anti-PRP titers >1.0 mcg/mL, 4 weeks postvaccination with PedvaxHIB™.
Time Frame
4 weeks postvaccination with PedvaxHIB™
Title
Number of Participants With Adverse Events (AE)
Description
Systemic and injection site AEs were collected from participants receiving
VAQTA™ concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I)
VAQTA™ non-concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ (Stage I)
VAQTA™ administered alone (Stage II)
Safety data was collected on a standardized Vaccination Report Card (VRC)
following each dose. Participants returned the VRC after the safety follow-up period for each dose of VAQTA™. AEs determined by the investigator to be possibly, probably or definitely related to the vaccine are reported as Vaccine-related AE.
Time Frame
Days 1 to 14 after any dose of VAQTA™ for systemic AEs, and Days 1 to 5 after any dose of VAQTA™ for injection-site AEs
Title
Geometric Mean Titers (GMTs) to Antibodies for the Pertussis Toxin (PT), Pertussis Filamentous Hemagglutinin Antibody (FHA), and Pertactin (PRN) Components of Infanrix™
Description
GMTs for antibodies to PT, FHA, and PRN were measured in serum samples of participants vaccinated with Infanrix™.
IgG antibodies to PT were assessed using the anti-pertussis toxin enzyme-linked immunosorbent assay (anti-PT ELISA), with the LOD of 2.4 ELU/mL.
IgG antibodies to FHA were assessed using the anti-pertussis filamentous hemagglutinin enzyme-linked immunosorbent assay (anti-FHA ELISA), with the LOD of 2.0 ELU/mL.
IgG antibodies to PRN were assessed using the anti-pertussis pertactin enzyme-linked immunosorbent assay (anti-PRN ELISA), with the LOD of 3.3 ELU/mL.
Time Frame
4 weeks postvaccination with Infanrix™
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
17 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Stage 1) Healthy males and females 15 months of age with no active liver disease and a negative history of hepatitis A who have been vaccinated against Haemophilus influenzae type b (Hib), diphtheria, tetanus, and pertussis diseases
Stage 2) Healthy males and females 12 to 17 months of age with no active liver disease and a negative history of hepatitis A
Exclusion Criteria:
Stage 1) Males and females previously vaccinated with hepatitis A vaccine, any immune deficiency, a history of allergy to any of the vaccine components, a history of seizure disorder or a neurologic disorder that would contraindicate pertussis vaccine, or a bleeding disorder
Stage 2) Males and females previously vaccinated with hepatitis A vaccine, any immune deficiency, a history of allergy to any of the vaccine components, or a history of bleeding 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
26308112
Citation
Petrecz M, Ramsey KP, Stek JE, Martin JC, Klopfer SO, Kuter B, Schodel FP, Lee AW. Concomitant use of VAQTA with PedvaxHIB and Infanrix in 12 to 17 month old children. Hum Vaccin Immunother. 2016;12(2):503-11. doi: 10.1080/21645515.2015.1080395.
Results Reference
result
Learn more about this trial
Concomitant Use of Hepatitis A Vaccine, Inactivated With Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Given to Healthy Children 15 Months of Age (V251-068)
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