Safety and Immunogenicity Study of Hib-MenCY-TT Vaccine Compared to Licensed Hib Conjugate Vaccine
NCT ID: NCT00289783
Last Updated: 2018-08-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
4441 participants
INTERVENTIONAL
2006-02-22
2008-02-26
Brief Summary
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Detailed Description
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* US Safety and Immunogenicity (Cohort 1): All immunogenicity analyses in the primary and booster phases will be evaluated in this cohort. These subjects will also contribute to the safety analyses in the primary and booster phases.
* Safety Only (Cohort 2): Only safety objectives will be assessed in the primary and booster phases for this cohort.
* Non-US Safety and Immunogenicity (Cohort 3): Only descriptive immunogenicity results in the primary and booster phases will be reported for this cohort. These subjects will also contribute to the safety analyses in the primary and booster phases.
Treatment allocation:
Primary phase: Subjects will be randomized with balanced allocation (1:1:1:1) to 1 of the 4 treatment groups and with a stratification according to the cohort. Assignment to a cohort will be based on study site.
Booster phase: Subjects who received Hib-MenCY-TT vaccine in the primary phase will receive a booster dose of Hib-MenCY-TT vaccine. Subjects who received ActHIB in the primary phase will receive a booster dose of PedvaxHIB.
During the 3-dose primary vaccination course, co-administration of Prevnar, Synagis, and/or rotavirus vaccine is permitted; co-administration of influenza vaccine is permitted at dose 3.
During the booster vaccination, co-administration of Prevnar, hepatitis A vaccine and influenza vaccine is permitted for all subjects in Cohort 1, 2 and 3; and co-administration of measles, mumps, rubella and varicella vaccine is permitted for all subjects in Cohort 2 and 3.
The study will be conducted in a double-blind fashion with regard to consistency of the 3 manufacturing lots of Hib-MenCY-TT vaccine and single-blind fashion for Hib-MenCY-TT vaccine versus monovalent Hib vaccine. The parents/guardians will be blinded up to collection of all data pertaining to the period up to one month after booster vaccination. Therefore, the extended safety follow-up after the booster dose will be conducted in an unblinded manner. The person administering the vaccines will ensure that the parent/guardian does not see the vaccine vial used in reconstituting the vaccine. Due to the differences in the presentations of the candidate Hib-MenCY-TT vaccine and control vaccines, it is not possible to blind study personnel who administer the vaccines.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Menhibrix A Group
Subjects 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.
GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine
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.
Pediarix
3-dose intramuscular injection at 2, 4 and 6 months of age.
Prevnar
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.
M-M-R II
1 booster dose by subcutaneous injection at 12 to 15 months of age.
Varivax
1 booster dose by subcutaneous injection at 12 to 15 months of age
Menhibrix B Group
Subjects 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.
GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine
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.
Pediarix
3-dose intramuscular injection at 2, 4 and 6 months of age.
Prevnar
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.
M-M-R II
1 booster dose by subcutaneous injection at 12 to 15 months of age.
Varivax
1 booster dose by subcutaneous injection at 12 to 15 months of age
Menhibrix C Group
Subjects 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.
GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine
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.
Pediarix
3-dose intramuscular injection at 2, 4 and 6 months of age.
Prevnar
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.
M-M-R II
1 booster dose by subcutaneous injection at 12 to 15 months of age.
Varivax
1 booster dose by subcutaneous injection at 12 to 15 months of age
Menhibrix Group
Subjects 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.
GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine
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.
Pediarix
3-dose intramuscular injection at 2, 4 and 6 months of age.
Prevnar
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.
M-M-R II
1 booster dose by subcutaneous injection at 12 to 15 months of age.
Varivax
1 booster dose by subcutaneous injection at 12 to 15 months of age
ActHIB Group
Subjects 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.
ActHIB
3-dose intramuscular injection at 2, 4 and 6 months of age.
PedvaxHIB
1 booster dose by intramuscular injection at 12 to 15 months of age.
Interventions
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GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis 792014 vaccine
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.
ActHIB
3-dose intramuscular injection at 2, 4 and 6 months of age.
PedvaxHIB
1 booster dose by intramuscular injection at 12 to 15 months of age.
Pediarix
3-dose intramuscular injection at 2, 4 and 6 months of age.
Prevnar
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.
M-M-R II
1 booster dose by subcutaneous injection at 12 to 15 months of age.
Varivax
1 booster dose by subcutaneous injection at 12 to 15 months of age
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
6 Weeks
15 Months
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Bryant, Arkansas, United States
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Fayetteville, Arkansas, United States
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Little Rock, Arkansas, United States
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Little Rock, Arkansas, United States
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East Artesia, California, United States
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Fountain Valley, California, United States
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Fresno, California, United States
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Fresno, California, United States
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Fresno, California, United States
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La Jolla, California, United States
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Oakland, California, United States
GSK Investigational Site
Paramount, California, United States
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Rolling Hills Estates, California, United States
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Sacramento, California, United States
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West Covina, California, United States
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Longmont, Colorado, United States
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Norwich, Connecticut, United States
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Cocoa Beach, Florida, United States
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Melbourne, Florida, United States
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Pembroke Pines, Florida, United States
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Rockledge, Florida, United States
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Nampa, Idaho, United States
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Des Moines, Iowa, United States
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Des Moines, Iowa, United States
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Arkansas City, Kansas, United States
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Kansas City, Kansas, United States
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Bardstown, Kentucky, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Bossier City, Louisiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Fall River, Massachusetts, United States
GSK Investigational Site
Jamaica Plain, Massachusetts, United States
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Kalamazoo, Michigan, United States
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Portage, Michigan, United States
GSK Investigational Site
Stevensville, Michigan, United States
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Brainerd, Minnesota, United States
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Saint Paul, Minnesota, United States
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Omaha, Nebraska, United States
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North Las Vegas, Nevada, United States
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Ithaca, New York, United States
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New Hartford, New York, United States
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Rochester, New York, United States
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Stony Brook, New York, United States
GSK Investigational Site
Syracuse, New York, United States
GSK Investigational Site
The Bronx, New York, United States
GSK Investigational Site
Durham, North Carolina, United States
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Durham, North Carolina, United States
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Raleigh, North Carolina, United States
GSK Investigational Site
Sylva, North Carolina, United States
GSK Investigational Site
Boardman, Ohio, United States
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Canton, Ohio, United States
GSK Investigational Site
Cleveland, Ohio, United States
GSK Investigational Site
Columbus, Ohio, United States
GSK Investigational Site
Huber Heights, Ohio, United States
GSK Investigational Site
South Euclid, Ohio, United States
GSK Investigational Site
Tulsa, Oklahoma, United States
GSK Investigational Site
Gresham, Oregon, United States
GSK Investigational Site
Beaver Falls, Pennsylvania, United States
GSK Investigational Site
Erie, Pennsylvania, United States
GSK Investigational Site
Greenville, Pennsylvania, United States
GSK Investigational Site
Hershey, Pennsylvania, United States
GSK Investigational Site
Philadelphia, Pennsylvania, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Sellersville, Pennsylvania, United States
GSK Investigational Site
Providence, Rhode Island, United States
GSK Investigational Site
Charleston, South Carolina, United States
GSK Investigational Site
Lexington, South Carolina, United States
GSK Investigational Site
Amarillo, Texas, United States
GSK Investigational Site
Fort Worth, Texas, United States
GSK Investigational Site
Galveston, Texas, United States
GSK Investigational Site
San Antonio, Texas, United States
GSK Investigational Site
Temple, Texas, United States
GSK Investigational Site
Layton, Utah, United States
GSK Investigational Site
Pleasant Grove, Utah, United States
GSK Investigational Site
South Jordan, Utah, United States
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St. George, Utah, United States
GSK Investigational Site
Mechanicsville, Virginia, United States
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Norfolk, Virginia, United States
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Vancouver, Washington, United States
GSK Investigational Site
La Crosse, Wisconsin, United States
GSK Investigational Site
Randwick, New South Wales, Australia
GSK Investigational Site
Herston, Queensland, Australia
GSK Investigational Site
South Brisbane, Queensland, Australia
GSK Investigational Site
Carlton, Victoria, Australia
GSK Investigational Site
Mexico City, , Mexico
Countries
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References
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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.
Bryant 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.
Bryant 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.
Bryant 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.
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.
Study Documents
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Document Type: Informed Consent Form
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Dataset Specification
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Study Protocol
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Clinical Study Report
For additional information about this study please refer to the GSK Clinical Study Register
View DocumentDocument Type: Individual Participant Data Set
For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 103813 are summarised with study 105067 on the GSK Clinical Study Register.
View DocumentRelated Links
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Other Identifiers
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105067
Identifier Type: OTHER
Identifier Source: secondary_id
103813
Identifier Type: -
Identifier Source: org_study_id
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