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.

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

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: Pediarix/Infanrix Penta; Biological: ActHIB

Detailed Description

Pediarix/Infanrix Penta and Prevnar should be co-administered to all subjects in all study groups according to a 2, 4, and 6 month schedule concomitantly with study vaccines.

• Study Type: Interventional
• Enrollment (Actual): 4432
• 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, 35235
      • GSK Investigational Site
    • Birmingham, Alabama, United States, 35244
      • GSK Investigational Site
  • Arkansas
    • Benton, Arkansas, United States, 72015
      • GSK Investigational Site
    • Fayetteville, Arkansas, United States, 72703
      • GSK Investigational Site
    • Hot Springs, Arkansas, United States, 71913
      • GSK Investigational Site
    • Jonesboro, Arkansas, United States, 72401
      • GSK Investigational Site
    • Little Rock, Arkansas, United States, 72201
      • 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
  • Illinois
    • Oaklawn, Illinois, United States, 60453
      • 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, 02111
      • GSK Investigational Site
    • Jamaica Plain, 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
    • New Hartford, New York, United States, 13413
      • GSK Investigational Site
    • Syracuse, New York, United States, 13210
      • GSK Investigational Site
  • North Carolina
    • Clyde, North Carolina, United States, 28721
      • GSK Investigational Site
    • Deerfield, North Carolina, United States, 28607
      • GSK Investigational Site
    • Raleigh, North Carolina, United States, 27609
      • GSK Investigational Site
    • Sylva, North Carolina, United States, 28779
      • GSK Investigational Site
  • Ohio
    • Akron, Ohio, United States, 44308-1062
      • 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
    • Pittsburgh, Pennsylvania, United States, 15202
      • 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
    • 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
    • Kingsport, Tennessee, United States, 37664
      • GSK Investigational Site
  • Texas
    • Houston, Texas, United States, 77084
      • GSK Investigational Site
    • Katy, Texas, United States, 77450
      • 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
    • 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 month to 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion criteria:

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).

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 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.	Biological: GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined 792014; 3-dose intramuscular injection; Biological: Pediarix/Infanrix Penta; 3-dose intramuscular injection
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 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.	Biological: Pediarix/Infanrix Penta; 3-dose intramuscular injection; Biological: ActHIB; 3-dose intramuscular injection

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 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)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• 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

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): March 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): December 16, 2016
• Last Update Submitted That Met QC Criteria: November 3, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Humans; Safety; Infants; Prophylaxis; Neisseria meningitidis Vaccines, conjugate; Meningococcal vaccines; H. influenzae type B vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; PENTA
• Other Study ID Numbers: 105987

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. Clinical Study Report
   Information identifier: 105987
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Statistical Analysis Plan
   Information identifier: 105987
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Dataset Specification
   Information identifier: 105987
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Individual Participant Data Set
   Information identifier: 105987
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Informed Consent Form
   Information identifier: 105987
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Study Protocol
   Information identifier: 105987
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No