Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age.
Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GSK Biologicals' Hib-MenCY-TT Vaccine Compared to Monovalent Hib Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.
1 other identifier
interventional
4,021
2 countries
57
Brief Summary
The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age. This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579). No new recruitment will take place during this booster phase of the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2007
Shorter than P25 for phase_3
57 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
June 26, 2006
CompletedFirst Posted
Study publicly available on registry
June 28, 2006
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
July 20, 2012
CompletedNovember 29, 2016
October 1, 2016
1.2 years
June 26, 2006
June 15, 2012
October 18, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Number of Subjects Reporting Rash
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Number of Subjects With Rash
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Number of Subjects With Adverse Events Resulting in Emergency Room (ER) Visits
From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Study Arms (2)
Menhibrix Group
EXPERIMENTALSubjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
ActHIB Group
ACTIVE COMPARATORSubjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
Interventions
Booster dose by intramuscular injection
Booster dose by intramuscular injection
Single dose by subcutaneous injection
Single dose by subcutaneous injection
Eligibility Criteria
You may qualify if:
- Subjects enrolled in the primary study (NCT00345579) are eligible for participating in the booster study
You may not qualify if:
- Subjects should not be administered M-M-R II and Varivax if any of these criteria apply:
- History of measles, mumps, rubella or varicella.
- Previous vaccination against measles, mumps, rubella or varicella.
- Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
- Patients receiving immunosuppressive therapy.
- Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
- Individuals with primary and acquired immunodeficiency states.
- Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- Individuals with active tuberculosis.
- Acute disease at time of booster vaccination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (57)
GSK Investigational Site
Birmingham, Alabama, 35205, United States
GSK Investigational Site
Birmingham, Alabama, 35244, United States
GSK Investigational Site
Benton, Arkansas, 72015, United States
GSK Investigational Site
Jonesboro, Arkansas, 72401, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
Fountain Valley, California, 92708, United States
GSK Investigational Site
Fresno, California, 93710, United States
GSK Investigational Site
Fresno, California, 93726, United States
GSK Investigational Site
Madera, California, 93637, United States
GSK Investigational Site
Slinas, California, 93901, United States
GSK Investigational Site
West Covina, California, 91790, United States
GSK Investigational Site
Boulder, Colorado, 80303, United States
GSK Investigational Site
Longmont, Colorado, 80501, United States
GSK Investigational Site
Plantation, Florida, 33324, United States
GSK Investigational Site
Nampa, Idaho, 208 463 3126, United States
GSK Investigational Site
Waukee, Iowa, 50263, United States
GSK Investigational Site
West Desmoines, Iowa, 50266, United States
GSK Investigational Site
Bardstown, Kentucky, 40004, United States
GSK Investigational Site
Lexington, Kentucky, 40503, United States
GSK Investigational Site
Bossier City, Louisiana, 71111, United States
GSK Investigational Site
Boston, Massachusetts, 02130, United States
GSK Investigational Site
Nies, Michigan, 49120, United States
GSK Investigational Site
Portage, Michigan, 49024, United States
GSK Investigational Site
Stevensville, Michigan, 49127, United States
GSK Investigational Site
Saint Paul, Minnesota, 55108, United States
GSK Investigational Site
Las Vegas, Nevada, 89104, United States
GSK Investigational Site
Ithaca, New York, 14850, United States
GSK Investigational Site
New Hartford, New York, 13413, United States
GSK Investigational Site
Syracuse, New York, 13210, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Boardman, Ohio, 44512, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Cleveland, Ohio, 44121, United States
GSK Investigational Site
North Canton, Ohio, 44720, United States
GSK Investigational Site
South Euclid, 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, 15220, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15227, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Wexford, Pennsylvania, 15090, United States
GSK Investigational Site
Charleston, South Carolina, 29406, United States
GSK Investigational Site
Kingsport, Tennessee, 37660, United States
GSK Investigational Site
Layton, Utah, 84041, United States
GSK Investigational Site
Ogden, Utah, 84405, United States
GSK Investigational Site
Orem, Utah, 84057, United States
GSK Investigational Site
Pleasant Gorve, Utah, 84062, United States
GSK Investigational Site
Salt Lake City, Utah, 84109, United States
GSK Investigational Site
Salt Lake City, Utah, 84121, United States
GSK Investigational Site
South Jordan, Utah, 84095, United States
GSK Investigational Site
West Jordan, Utah, 84088, United States
GSK Investigational Site
Madison, Wisconsin, 53792, United States
GSK Investigational Site
Marshfield, Wisconsin, 54449, United States
GSK Investigational Site
Mexico City, 04530, Mexico
GSK Investigational Site
Mexico City, 06720, Mexico
Related Publications (1)
Rinderknecht S, Bryant K, Nolan T, Pavia-Ruz N, Doniz CA, Weber MA, Cohen C, Aris E, Mesaros N, Miller JM. The safety profile of Haemophilus influenzae type b-Neisseria meningitidis serogroups C and Y tetanus toxoid conjugate vaccine (HibMenCY). Hum Vaccin Immunother. 2012 Mar;8(3):304-11. doi: 10.4161/hv.18752. Epub 2012 Feb 13.
PMID: 22327493DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Only information about specific categories of AEs (SAEs, NOCIs, rash and AEs resulting in ER visits) were collected in this study.
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
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2006
First Posted
June 28, 2006
Study Start
July 1, 2007
Primary Completion
September 1, 2008
Study Completion
November 1, 2008
Last Updated
November 29, 2016
Results First Posted
July 20, 2012
Record last verified: 2016-10
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.