Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine, Given at 12 to 15 Months of Age. - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00345683

Purpose

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.

Condition	Intervention	Phase
Haemophilus Influenza b Infections Meningococcal Infection	Biological: M-M-R II Biological: Varivax Biological: PedvaxHIB Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014) Biological: Prevnar	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Caregiver), Parallel Assignment, Safety Study
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Tetanus Vaccine Rubella Vaccine Chickenpox Vaccine

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

See primary study posting (NCT00345579) [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of specific adverse events of new onset of chronic illness(es),rash, and conditions prompting emergency room visits [ Time Frame: From booster dose up to Day 30 after booster vaccination and from booster dose through the end of the 6-month safety follow-up ] [ Designated as safety issue: Yes ]
Occurrence of SAEs. [ Time Frame: From booster dose up to Day 30 after booster vaccination and from booster dose through the end of the 6-month safety follow-up ] [ Designated as safety issue: Yes ]

Enrollment:	4053
Study Start Date:	July 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group B: Active Comparator	Biological: M-M-R II Single dose by subcutaneous injection Biological: Varivax Single dose by subcutaneous injection Biological: PedvaxHIB Booster dose by intramuscular injection Biological: Prevnar Booster dose by intramuscular injection
Group A: Experimental	Biological: M-M-R II Single dose by subcutaneous injection Biological: Varivax Single dose by subcutaneous injection Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014) Booster dose by intramuscular injection Biological: Prevnar Booster dose by intramuscular injection

Detailed Description:

Hib-MenCY-TT = GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine.

The study will be conducted in a single blind manner up to 30 days after administration of the booster dose; the extended safety follow-up after the booster dose will be conducted in an unblinded manner.

All subjects will receive Prevnar, M-M-R II and Varivax as study vaccines, preferencially co-administered with the booster dose of Hib-MenCY-TT/PedvaxHIB.

Note: This protocol posting deals with the objectives & outcome measures for the booster phase of the study. The objectives & outcome measures for the primary phase are presented in a separate protocol posting (NCT00345579)

Eligibility

Ages Eligible for Study:	12 Months to 15 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects enrolled in the primary study (NCT00345579) are eligible for participating in the booster study

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345683

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Locations

United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35205
GSK Investigational Site
Birmingham, Alabama, United States, 35244
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
GSK Investigational Site
Benton, Arkansas, United States, 72015
United States, California
GSK Investigational Site
Fountain Valley, California, United States, 92708
GSK Investigational Site
West Covina, California, United States, 91790
GSK Investigational Site
Madera, California, United States, 93637
GSK Investigational Site
Fresno, California, United States, 93726
GSK Investigational Site
Fresno, California, United States, 93710
GSK Investigational Site
Slinas, California, United States, 93901
United States, Colorado
GSK Investigational Site
Longmont, Colorado, United States, 80501
GSK Investigational Site
Boulder, Colorado, United States, 80303
United States, Florida
GSK Investigational Site
Plantation, Florida, United States, 33324
United States, Idaho
GSK Investigational Site
Nampa, Idaho, United States, 208 463 3126
United States, Iowa
GSK Investigational Site
Waukee, Iowa, United States, 50263
GSK Investigational Site
West Desmoines, Iowa, United States, 50266
United States, Kentucky
GSK Investigational Site
Lexington, Kentucky, United States, 40503
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
United States, Louisiana
GSK Investigational Site
Bossier City, Louisiana, United States, 71111
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02130
United States, Michigan
GSK Investigational Site
Nies, Michigan, United States, 49120
GSK Investigational Site
Portage, Michigan, United States, 49024
GSK Investigational Site
Stevensville, Michigan, United States, 49127
United States, Minnesota
GSK Investigational Site
St. Paul, Minnesota, United States, 55108
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
United States, New York
GSK Investigational Site
Syracuse, New York, United States, 13210
GSK Investigational Site
Ithaca, New York, United States, 14850
GSK Investigational Site
New Hartford, New York, United States, 13413
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
United States, Ohio
GSK Investigational Site
Boardman, Ohio, United States, 44512
GSK Investigational Site
Canton, Ohio, United States, 44718
GSK Investigational Site
Cleveland, Ohio, United States, 44121
GSK Investigational Site
South Euclid, Ohio, United States, 44121
GSK Investigational Site
North Canton, Ohio, United States, 44720
United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15217
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15220
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
GSK Investigational Site
Wexford, Pennsylvania, United States, 15090
GSK Investigational Site
Greenville, Pennsylvania, United States, 16125
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15227
GSK Investigational Site
Erie, Pennsylvania, United States, 16505
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29406
United States, Tennessee
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
United States, Utah
GSK Investigational Site
Ogden, Utah, United States, 84405
GSK Investigational Site
Orem, Utah, United States, 84057
GSK Investigational Site
Layton, Utah, United States, 84041
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
GSK Investigational Site
South Jordan, Utah, United States, 84095
GSK Investigational Site
Pleasant Gorve, Utah, United States, 84062
GSK Investigational Site
West Jordan, Utah, United States, 84088
United States, Wisconsin
GSK Investigational Site
Marshfield, Wisconsin, United States, 54449
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Mexico
GSK Investigational Site
Mexico, D.F., Mexico, 06720
GSK Investigational Site
Mexico city, Mexico, 04530

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Additional Information:

Primary Study This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	105988
Study First Received:	June 26, 2006
Last Updated:	September 28, 2009
ClinicalTrials.gov Identifier:	NCT00345683 History of Changes
Health Authority:	Mexico: Federal Commission for Protection Against Health Risks; United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Comparative study
Infants
Humans
H. influenzae type B vaccine
Meningococcal vaccines

Neisseria meningitidis
Vaccines, conjugate
Safety
Prophylaxis

Additional relevant MeSH terms:

Bacterial Infections
Virus Diseases
Communicable Diseases
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections

Meningococcal Infections
Influenza, Human
Orthomyxoviridae Infections
Infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on November 25, 2009