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
Sponsor study identifier
Secondary identifiers
interventional
1,274
0 countries
N/A
Study Start
April 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2010
Actual (reported)Study Completion
June 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2010
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 8, 2006
Actual (reported)February 10, 2006
Actual (reported)April 2006
Date type not reportedThis date has not been verified as actual or estimated.
June 2010
Actual (reported)June 2010
Actual (reported)July 7, 2011
Actual (reported)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
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.
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.
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.
Medical Monitor
Merck Sharp & Dohme LLC
1,274 participants (actual enrollment reported by the registry).
First Submitted
February 8, 2006
First Posted
February 10, 2006
Study Start
April 2006
Date type not reportedThis date has not been verified as actual or estimated.
Immunogenicity and Safety of I-HAV in Healthy Thai Children and Adolescents Lacking Protective Antibody After L-HAV
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™
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.
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.
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Primary Completion
June 2010
Actual (reported)Study Completion
June 2010
Actual (reported)Last Updated
April 13, 2017
Results First Posted
July 7, 2011
Record last verified: 2017-03
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
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Source: ClinicalTrials.gov.
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