Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 2, 4, 6 and 12 to 15 Months of Age
A Single-blind, Randomized, Controlled, Multinational Study for the Evaluation of Safety of GlaxoSmithKline (GSK) Biologicals' Investigational Vaccination Regimen Compared to Monovalent Haemophilus Influenzae Type b (Hib) Control Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.
1 other identifier
interventional
4,432
2 countries
63
Brief Summary
The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. This protocol posting deals with objectives \& outcome measures of the primary phase of the study. The objectives \& outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683). 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 Sep 2006
63 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
September 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedResults Posted
Study results publicly available
July 20, 2012
CompletedDecember 16, 2016
November 1, 2016
1.1 years
June 26, 2006
June 15, 2012
November 3, 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 Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
Number of Subjects Reporting Rash
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.
From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER)
From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
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 Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Number of Subjects With Rash
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Number of Subjects With Adverse Events Resulting in Emergency Room (ER)
From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
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 and a fourth dose of Menhibrix vaccine at 12-15 months of age in the study NCT00345683. 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 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. 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
3-dose intramuscular injection
Eligibility Criteria
You may qualify if:
- Subjects for whom the investigator believes that parents/guardians can and will comply with the requirements of the protocol.
- A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- 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.
- Born after 36 weeks gestation.
- Infants who have not received a previous dose of hepatitis B vaccine or those who have received only 1 dose of hepatitis B vaccine administered at least 30 days prior to enrolment.
- Infants may have received a birth dose of Bacillus Calmette-Guérin (BCG) vaccine.
You may not qualify if:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine(s).
- Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
- In country(ies) where Prevnar will be provided by GSK Biologicals, previous vaccination with Prevnar.
- History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, hepatitis B, and/or poliovirus disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including dry natural latex rubber.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at time of enrollment.
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- Concurrent participation in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (63)
GSK Investigational Site
Birmingham, Alabama, 35235, United States
GSK Investigational Site
Birmingham, Alabama, 35244, United States
GSK Investigational Site
Benton, Arkansas, 72015, United States
GSK Investigational Site
Fayetteville, Arkansas, 72703, United States
GSK Investigational Site
Hot Springs, Arkansas, 71913, United States
GSK Investigational Site
Jonesboro, Arkansas, 72401, United States
GSK Investigational Site
Little Rock, Arkansas, 72201, 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
Oak Lawn, Illinois, 60453, 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, 02111, United States
GSK Investigational Site
Jamaica Plain, 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
New Hartford, New York, 13413, United States
GSK Investigational Site
Syracuse, New York, 13210, United States
GSK Investigational Site
Clyde, North Carolina, 28721, United States
GSK Investigational Site
Deerfield, North Carolina, 28607, United States
GSK Investigational Site
Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Sylva, North Carolina, 28779, United States
GSK Investigational Site
Akron, Ohio, 44308-1062, 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
Pittsburgh, Pennsylvania, 15202, 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
Kingsport, Tennessee, 37664, United States
GSK Investigational Site
Houston, Texas, 77084, United States
GSK Investigational Site
Katy, Texas, 77450, 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
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 (2)
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: 21806393BACKGROUNDRinderknecht 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: 22327493BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Solicited symptoms and unslocited AEs were not collected during this study. 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
- PARTICIPANT
- 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
September 1, 2006
Primary Completion
October 1, 2007
Study Completion
March 1, 2008
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.