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.

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.

Study Overview

• Status: Completed
• Conditions: Neisseria Meningitidis; Haemophilus Influenzae Type b
• Intervention / Treatment: Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014); Biological: Prevnar; Biological: M-M-R II; Biological: Varivax; Biological: PedvaxHIB

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)

• Study Type: Interventional
• Enrollment (Actual): 4021
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Menhibrix Group; Subjects 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.	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; Biological: M-M-R II; Single dose by subcutaneous injection; Other Names: Measles; mumps and rubella vaccine.; Biological: Varivax; Single dose by subcutaneous injection; Other Names: Varicella vaccine
Active Comparator: ActHIB Group; Subjects 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.	Biological: Prevnar; Booster dose by intramuscular injection; Biological: M-M-R II; Single dose by subcutaneous injection; Other Names: Measles; mumps and rubella vaccine.; Biological: Varivax; Single dose by subcutaneous injection; Other Names: Varicella vaccine; Biological: PedvaxHIB; Booster dose by intramuscular injection; Other Names: Monovalent Hib conjugate vaccine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Helpful Links

• Primary Study

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: June 26, 2006
• First Submitted That Met QC Criteria: June 26, 2006
• First Posted (Estimate): June 28, 2006

Study Record Updates

• Last Update Posted (Estimate): November 29, 2016
• Last Update Submitted That Met QC Criteria: October 18, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Humans; Safety; Infants; Prophylaxis; Comparative study; Neisseria meningitidis; Meningococcal vaccines; H. influenzae type B vaccine; Vaccines, conjugate
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 105988

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Informed Consent Form
   Information identifier: 105988
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Individual Participant Data Set
   Information identifier: 105988
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Statistical Analysis Plan
   Information identifier: 105988
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Study Protocol
   Information identifier: 105988
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Clinical Study Report
   Information identifier: 105988
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Annotated Case Report Form
   Information identifier: 105988
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Dataset Specification
   Information identifier: 105988
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register