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)
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
2 other identifiers
interventional
1,274
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2006
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2006
CompletedFirst Posted
Study publicly available on registry
February 10, 2006
CompletedStudy Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
July 7, 2011
CompletedApril 13, 2017
March 1, 2017
4.2 years
February 8, 2006
June 9, 2011
March 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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).
4 weeks after dose 2 of VAQTA™
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™.
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.
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
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.
4 weeks postvaccination with Infanrix™
Study Arms (5)
VAQTA™, PedvaxHIB™ and Infanrix™/VAQTA™ (Stage 1)
EXPERIMENTALDay 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites. Week 24: The second dose of VAQTA™ was administered.
PedvaxHIB™ and Infanrix™/VAQTA™/VAQTA™ (Stage 1)
EXPERIMENTALDay 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.
VAQTA™, PedvaxHIB™/VAQTA™ (Stage 1)
EXPERIMENTALDay 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites. Week 24: The second dose of VAQTA™ was administered.
PedvaxHIB™/VAQTA™/VAQTA™ (Stage 1)
EXPERIMENTALDay 1: PedvaxHIB™ was administered. Week 4: The first dose of VAQTA™ was administered. Week 28: The second dose of VAQTA™ was administered.
VAQTA™/VAQTA™ (Stage 2)
EXPERIMENTALDay 1: The first dose of VAQTA™ was administered. Week 24: The second dose of VAQTA™ was administered.
Interventions
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.
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.
PedvaxHIB™ (Haemophilus B Conjugate Vaccine \[Meningococcal Protein Conjugate\]). One intramuscular 0.5-mL injection of PedvaxHIB™ was administered at the first study visit.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 26308112RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Late Stage Development Group Leader
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2006
First Posted
February 10, 2006
Study Start
April 1, 2006
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
April 13, 2017
Results First Posted
July 7, 2011
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
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