Long-Term Antibody Persistence at 1, 3 and 5 Years After a Fourth Dose of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to ActHIB
A Study to Evaluate the Long-term Antibody Persistence at 1, 3 & 5 Years After the Administration of a Fourth Dose of Hib-MenCY-TT Vaccine Compared to ActHIB in Subjects Boosted in a Previous Study.
3 other identifiers
interventional
270
1 country
21
Brief Summary
This study is evaluating antibody persistence at 1, 3 \& 5 years post-fourth dose (i.e., at 2, 4 \& 6 years of age, respectively) in subjects vaccinated in a previous study. This protocol posting deals with objectives \& outcome measures of the extension phase at years 1, 3 and 5. The objectives \& outcome measures of the first four doses are presented in a separate protocol posting (NCT00129129). This protocol posting has been amended in order to comply with the FDA Amendment Act of September 26, 2007.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2006
Longer than P75 for phase_3
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2006
CompletedFirst Posted
Study publicly available on registry
August 3, 2006
CompletedStudy Start
First participant enrolled
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
July 20, 2012
CompletedDecember 16, 2016
November 1, 2016
1.2 years
July 31, 2006
June 15, 2012
November 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of Subjects With Anti- Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentrations Greater Than or Equal to 0.15 Microgram Per Milliliter
Results up to 5 years after the fourth dose are presented.
One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With Neisseria Meningitidis Serogroup C (MenC) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)
Results up to 5 years after the fourth dose are presented.
One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With Neisseria Meningitidis Serogroup Y (MenY) Antibody Titers Greater Than or Equal to 1:8 as Measured by Serum Bactericidal Assay Using Human Complement (hSBA)
Results up to 5 years after the fourth dose are presented.
One year, three years, and five years after the fourth dose vaccination.
Secondary Outcomes (6)
Anti-PRP Geometric Mean Concentrations (GMCs)
One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With Anti-PRP Antibody Concentrations Greater Than or Equal to 1.0 Microgram Per Milliliter
One year, three years, and five years after the fourth dose vaccination.
hSBA-MenC Geometric Mean Titers (GMTs)
One year, three years, and five years after the fourth dose vaccination.
Number of Subjects With hSBA-MenC Titers Greater Than or Equal to 1:4
One year, three years, and five years after the fourth dose vaccination.
hSBA-MenY Geometric Mean Titers (GMTs)
One year, three years, and five years after the fourth dose vaccination.
- +1 more secondary outcomes
Study Arms (3)
MenHibrix 4-dose group
EXPERIMENTALSubjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
ActHIB 4-dose group
ACTIVE COMPARATORSubjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
ActHIB 3-dose + MenHibrix 4th-dose group
EXPERIMENTALSubjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
Interventions
First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose
First three doses: 3 intramuscular doses Fourth dose: 1 intramuscular dose
Eligibility Criteria
You may qualify if:
- Healthy male and female children who completed the previous four dose vaccination series study (NCT00129129). The age of the child at the 3 post-fourth dose timelines are as follows:
- Year 1: 22 to 36 months of age.
- Year 3: 44 to 60 months of age.
- Year 5: 5 years post-dose 4 +/- 8 weeks
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study
- Having completed the fourth dose vaccination of study Hib-MenCY-TT-005/006
You may not qualify if:
- Children should not have:
- received more than 4 doses of Hib or meningococcal serogroup C and Y vaccine
- had a history of H. influenzae type b, meningococcal serogroup C and Y diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (21)
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Fountain Valley, California, 92708, United States
GSK Investigational Site
Norwich, Connecticut, 06360, United States
GSK Investigational Site
Marietta, Georgia, 30062, United States
GSK Investigational Site
Woodstock, Georgia, 30189, United States
GSK Investigational Site
Waukee, Iowa, 50263, United States
GSK Investigational Site
Bardstown, Kentucky, 40004, United States
GSK Investigational Site
Louisville, Kentucky, 40202, United States
GSK Investigational Site
Louisville, Kentucky, 40272, United States
GSK Investigational Site
Bossier City, Louisiana, 71111, United States
GSK Investigational Site
Boston, Massachusetts, 02118, United States
GSK Investigational Site
Fall River, Massachusetts, 02724, United States
GSK Investigational Site
Pittsford, New York, 14534, United States
GSK Investigational Site
Rochester, New York, 14620, United States
GSK Investigational Site
Boardman, Ohio, 44512, United States
GSK Investigational Site
Cleveland, Ohio, 44121, United States
GSK Investigational Site
Erie, Pennsylvania, 16505, United States
GSK Investigational Site
Greenville, Pennsylvania, 16125, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15217, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
Related Publications (5)
Bryant KA, Marshall GS. Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine for infants and toddlers. Expert Rev Vaccines. 2011 Jul;10(7):941-50. doi: 10.1586/erv.11.90.
PMID: 21806393BACKGROUNDMarshall GS, Marchant CD, Blatter M, Aris E, Boutriau D, Poolman JT, Friedland LR, Miller JM. Immune response and one-year antibody persistence after a fourth dose of a novel Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY) at 12 to 15 months of age. Pediatr Infect Dis J. 2010 May;29(5):469-71. doi: 10.1097/INF.0b013e3181cdd379.
PMID: 20072077BACKGROUNDMarshall GS et al. Antibody persistence 5 years after the fourth dose of a US-licensed Heamophilus influenzae type B and Neisseria meningitidis serogroups C and Y tetanus toxoid (HIBMENCY-TT) conjugate vaccine. Abstract presented at the 50th Annual Meeting of the Infectious Diseases Society of America - (IDSA-IDWeek), San Diego, 17-21 October 2012.
BACKGROUNDMarshall GS et al. Persistence of Immunity three years after an Investigational Haemophilus influenzae type b and Neisseria meningitidis Serogroups C and Y Tetanus Toxoid (HibMenCY-TT) Conjugate Vaccine. Abstract presented at the 45th National Immunization Conference (NIC). Washington, D.C, USA, 28-31 March 2011.
BACKGROUNDMarshall GS, Blatter M, Marchant C, Aris E, Mesaros N, Miller JM. Antibody persistence for up to 5 years after a fourth dose of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine (HibMenCY-TT) given at 12-15 months of age. Pediatr Infect Dis J. 2013 Jun;32(6):662-8. doi: 10.1097/INF.0b013e3182840e35.
PMID: 23340564DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2006
First Posted
August 3, 2006
Study Start
September 1, 2006
Primary Completion
November 1, 2007
Study Completion
May 1, 2011
Last Updated
December 16, 2016
Results First Posted
July 20, 2012
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.