Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine
A Phase III, Randomized, Multinational Study, Double-blinded for the Immunogenicity and Consistency Evaluation of 3 Hib-MenCY-TT Vaccine Lots and Single-blinded and Controlled for the Evaluation of Safety and Immunogenicity of GSK Biologicals' Haemophilus Influenzae Type b and Neisseria Meningitidis Serogroups C and Y-tetanus Toxoid Conjugate Vaccine Combined (Hib-MenCY-TT) Compared to Monovalent Hib Vaccine in Healthy Infants at 2, 4, 6, and 12 to 15 Months of Age.
2 other identifiers
interventional
4,441
3 countries
93
Brief Summary
This study evaluates the immunogenicity and consistency of 3 Hib-MenCY-TT vaccine lots and the safety and immunogenicity 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. The study will also evaluate the safety and immunogenicity of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with M-M-R® II and Varivax® at 12 to 15 months of age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2006
93 active sites
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 9, 2006
CompletedFirst Posted
Study publicly available on registry
February 10, 2006
CompletedStudy Start
First participant enrolled
February 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 26, 2008
CompletedResults Posted
Study results publicly available
August 6, 2012
CompletedAugust 24, 2018
November 1, 2016
1.5 years
February 9, 2006
June 15, 2012
July 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (13)
Anti-Polyribosyl Ribitol Phosphate (PRP) Antibody Concentrations
Concentrations are given as Geometric Mean Concentrations (GMCs) and are expressed in microgram per millilitre (µg/mL) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
One month after primary vaccination
Neisseria Meningitidis Serogroup C (MenC) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers
Titers were expressed as Geometric Mean Titers (GMTs) This analysis occured on the cohort 1 : Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
One month after primary vaccination
Neisseria Meningitidis Serogroup Y (MenY) Serum Bactericidal Assay Using Human Complement (hSBA) Antibody Titers
Titers are expressen as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
One month after primary vaccination
hSBA-MenC Antibody Titers
Titers are expressed as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Prior to the fourth dose vaccination and 42 days after the fourth dose
hSBA-MenY Antibody Titers
Titers are expressed as Geometric Mean Titers (GMTs) This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
Prior to the fourth dose vaccination and 42 days after the fourth dose
Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter (µg/mL)
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
One month after primary vaccination
Number of Subjects With hSBA-MenC Titer Equal to or Above 1:8
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
42 days after the fourth dose
Number of Subjects With hSBA-MenY Titer Equal to or Above 1:8
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
42 days after the fourth dose
Number of Subjects With Anti-measles Antibody Concentrations Equal to or Above 150 Milli-international Units Per Milli-liter (mIU/ML)
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 150 mIU/mL. Co-administration with MMR-II vaccine
42 days after the fourth dose
Number of Subjects With Anti-PRP Antibody Concentration Equal to or Above 1.0 Microgram Per Milliliter
This analysis occurred on the cohort 1: Cohort 1 was to include subjects in the US on which all immunogenicity analyses were to be based. These subjects also contributed to the safety analysis.
42 days after the fourth dose
Number of Subjects With Anti-mumps Titer Equal to or Above 28 Estimated Dose 50 (ED50)
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-mumps antibody titers below 28 ED50 Co-administration with MMR-II vaccine.
42 days after the fourth dose
Number of Subjects With Anti-rubella Antibody Concentrations Equal to or Above 10 International Units Per Milli-litre (IU/mL)
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody concentrations below 4 IU/mL. Co-administration with MMR-II vaccine.
42 days after the fourth dose
Number of Subjects With Anti-varicella Titer Equal to or Above 1:5
The analysis was performed on initially seronegative subjects. Seronegative subjects are subjects with anti-measles antibody titer below 1:5. Co-administration with Varivax vaccine.
42 days after the fourth dose
Secondary Outcomes (59)
Number of Subjects With Anti-tetanus (Anti-T) and Anti-diphtheria Toxoid (Anti-D) Antibody Concentrations Equal to or Above 0.1 International Units Per Millilitre (IU/mL)
One month after primary vaccination
Anti-D and Anti-T Antibody Concentrations
One month after primary vaccination
Number of Subjects With Anti Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Equal to or Above 10.0 Milli-international Units Per Millilitre (mIU/mL)
One month after primary vaccination
Anti-HBS Antibody Concentrations
One month after primary vaccination
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Hemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations Equal to or Above 5 ELISA Units Per Millilitre (EL.U/mL)
One month after primary vaccination
- +54 more secondary outcomes
Study Arms (5)
Menhibrix A Group
EXPERIMENTALSubjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
Menhibrix B Group
EXPERIMENTALSubjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
Menhibrix C Group
EXPERIMENTALSubjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
Menhibrix Group
EXPERIMENTALSubjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
ActHIB Group
ACTIVE COMPARATORSubjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
Interventions
3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.
3-dose intramuscular injection at 2, 4 and 6 months of age.
3-dose intramuscular injection at 2, 4 and 6 months of age, and 1 booster dose by intramuscular injection at 12 to 15 months of age.
1 booster dose by subcutaneous injection at 12 to 15 months of age.
1 booster dose by subcutaneous injection at 12 to 15 months of age
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 enrollment.
- 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). (Synagis® \[palivizumab, MedImmune\], Prevnar (Prevenar), rotavirus vaccine, and influenza vaccine are allowed.
- Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, and/or poliovirus; more than one previous dose of hepatitis B vaccine.
- 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 (no laboratory testing is required).
- 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).
- Additional specific criteria for the US subjects in Cohort 1. In addition, for Cohorts 2 and 3, 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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (93)
GSK Investigational Site
Birmingham, Alabama, 35216, United States
GSK Investigational Site
Birmingham, Alabama, 35235, United States
GSK Investigational Site
Phoenix, Arizona, 85003, United States
GSK Investigational Site
Bryant, Arkansas, 72011, United States
GSK Investigational Site
Fayetteville, Arkansas, 72703, United States
GSK Investigational Site
Little Rock, Arkansas, 72202, United States
GSK Investigational Site
Little Rock, Arkansas, 72205, United States
GSK Investigational Site
East Artesia, California, 90706, United States
GSK Investigational Site
Fountain Valley, California, 92708, United States
GSK Investigational Site
Fresno, California, 93710, United States
GSK Investigational Site
Fresno, California, 93720, United States
GSK Investigational Site
Fresno, California, 93726, United States
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La Jolla, California, 92037, United States
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Oakland, California, 94609, United States
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Paramount, California, 90723, United States
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Rolling Hills Estates, California, 90274, United States
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Sacramento, California, 95817, United States
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West Covina, California, 91790, United States
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Longmont, Colorado, 80501, United States
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Norwich, Connecticut, 06360, United States
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Cocoa Beach, Florida, 32931, United States
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Melbourne, Florida, 332901, United States
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Pembroke Pines, Florida, 33024, United States
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Rockledge, Florida, 32955, United States
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Nampa, Idaho, 208 463 3126, United States
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Des Moines, Iowa, 50266, United States
GSK Investigational Site
Des Moines, Iowa, 50309, United States
GSK Investigational Site
Arkansas City, Kansas, 67005, United States
GSK Investigational Site
Kansas City, Kansas, 66160, United States
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Bardstown, Kentucky, 40004, United States
GSK Investigational Site
Lexington, Kentucky, 40503, United States
GSK Investigational Site
Louisville, Kentucky, 40272, United States
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Bossier City, Louisiana, 71111, United States
GSK Investigational Site
Baltimore, Maryland, 21201, United States
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Boston, Massachusetts, 02118, United States
GSK Investigational Site
Fall River, Massachusetts, 02724, United States
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Jamaica Plain, Massachusetts, 02130, United States
GSK Investigational Site
Kalamazoo, Michigan, 49008, United States
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Portage, Michigan, 49024, United States
GSK Investigational Site
Stevensville, Michigan, 49127, United States
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Brainerd, Minnesota, 56401, United States
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Saint Paul, Minnesota, 55108, United States
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Omaha, Nebraska, 68131, United States
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North Las Vegas, Nevada, 89025, United States
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Ithaca, New York, 14850, United States
GSK Investigational Site
New Hartford, New York, 13413, United States
GSK Investigational Site
Rochester, New York, 14618, United States
GSK Investigational Site
Stony Brook, New York, 11794, United States
GSK Investigational Site
Syracuse, New York, 13210, United States
GSK Investigational Site
The Bronx, New York, 10467, United States
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Durham, North Carolina, 27705, United States
GSK Investigational Site
Durham, North Carolina, 27710, United States
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Raleigh, North Carolina, 27609, United States
GSK Investigational Site
Sylva, North Carolina, 28779, 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
Columbus, Ohio, 43205, United States
GSK Investigational Site
Huber Heights, Ohio, 45424, United States
GSK Investigational Site
South Euclid, Ohio, 44121, United States
GSK Investigational Site
Tulsa, Oklahoma, 74127, United States
GSK Investigational Site
Gresham, Oregon, 97030, United States
GSK Investigational Site
Beaver Falls, Pennsylvania, 15010, United States
GSK Investigational Site
Erie, Pennsylvania, 16501, United States
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Greenville, Pennsylvania, 16125, United States
GSK Investigational Site
Hershey, Pennsylvania, 17033-0850, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19114, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15212, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15236, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Sellersville, Pennsylvania, 18960, United States
GSK Investigational Site
Providence, Rhode Island, 02903, United States
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Charleston, South Carolina, 29406, United States
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Lexington, South Carolina, 29072, United States
GSK Investigational Site
Amarillo, Texas, 79124, United States
GSK Investigational Site
Fort Worth, Texas, 76107, United States
GSK Investigational Site
Galveston, Texas, 77555-0188, United States
GSK Investigational Site
San Antonio, Texas, 78205, United States
GSK Investigational Site
Temple, Texas, 76508, United States
GSK Investigational Site
Layton, Utah, 84041, United States
GSK Investigational Site
Pleasant Grove, Utah, 84062, United States
GSK Investigational Site
South Jordan, Utah, 84095, United States
GSK Investigational Site
St. George, Utah, 84790, United States
GSK Investigational Site
Mechanicsville, Virginia, 23111, United States
GSK Investigational Site
Norfolk, Virginia, 23510, United States
GSK Investigational Site
Vancouver, Washington, 98664, United States
GSK Investigational Site
La Crosse, Wisconsin, 54601, United States
GSK Investigational Site
Randwick, New South Wales, 2031, Australia
GSK Investigational Site
Herston, Queensland, 4029, Australia
GSK Investigational Site
South Brisbane, Queensland, 4101, Australia
GSK Investigational Site
Carlton, Victoria, 3053, Australia
GSK Investigational Site
Mexico City, 06720, Mexico
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: 21806393BACKGROUNDBryant KA, Marshall GS, Marchant CD, Pavia-Ruiz N, Nolan T, Rinderknecht S, Blatter M, Aris E, Lestrate P, Boutriau D, Friedland LR, Miller JM. Immunogenicity and safety of H influenzae type b-N meningitidis C/Y conjugate vaccine in infants. Pediatrics. 2011 Jun;127(6):e1375-85. doi: 10.1542/peds.2009-2992. Epub 2011 May 29.
PMID: 21624883BACKGROUNDBryant K, McVernon J, Marchant C, Nolan T, Marshall G, Richmond P, Marshall H, Nissen M, Lambert S, Aris E, Mesaros N, Miller J. Immunogenicity and safety of measles-mumps-rubella and varicella vaccines coadministered with a fourth dose of Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine in toddlers: a pooled analysis of randomized trials. Hum Vaccin Immunother. 2012 Aug;8(8):1036-41. doi: 10.4161/hv.20357. Epub 2012 Aug 1.
PMID: 22617844BACKGROUNDBryant KA et al. Immune response to measles, mumps, rubella (MMR) and varicella (V) vaccine coadministered with a fourth dose of Haemophilus influenzae type b - Neisseria meningitidis serogroups C and Y - tetanus toxoid conjugate (HibMenCY) vaccine in toddlers. Abstract presented at the Annual meeting of Pediatric Academic Societies (PAS). Vancouver, Canada, 1-4 May 2010.
BACKGROUNDRinderknecht 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)
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
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2006
First Posted
February 10, 2006
Study Start
February 22, 2006
Primary Completion
August 27, 2007
Study Completion
February 26, 2008
Last Updated
August 24, 2018
Results First Posted
August 6, 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.