Immunogenicity, Safety and Reactogenicity Study of GlaxoSmithKline (GSK) Biologicals' Hib-MenCY-TT Vaccine Compared to Merck & Co, Inc. PedvaxHIB Vaccine in Healthy Infants and Toddlers 12 to 15 Months of Age

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01978093
First received: October 31, 2013
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' Hib-MenCY-TT vaccine co-administered with Rotarix, Prevnar 13 and Havrix as compared to PedvaxHIB co-administered with Rotarix, Prevnar 13 and Havrix in infants and toddlers.


Condition Intervention Phase
Neisseria Meningitidis
Haemophilus Influenzae Type b
Biological: Hib-MenCY-TT vaccine (GSK792014)
Biological: Pediarix®
Biological: Rotarix®
Biological: Prevnar 13®
Biological: PedvaxHIB®
Biological: Havrix®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Hib-MenCY-TT Vaccine 792014 Compared to Merck & Co, Inc. Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) Vaccine in Healthy Infants and Toddlers

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Immunogenicity with respect to components of Hib-MenCY-TT and PedvaxHIB in terms of antibody concentrations [ Time Frame: 1 month after the fourth dose (in HibCY Group) or 1 month after third dose (in PedHIB Group) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of Rotarix in terms of antibody concentrations [ Time Frame: 2 months post-dose 2 of Rotarix ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of Havrix in terms of antibody concentrations [ Time Frame: 1 month post-dose 2 of Havrix ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of Prevnar 13 in terms of antibody concentrations [ Time Frame: 1 month post-dose 3 of Prevnar 13 ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of Prevnar 13 in terms of antibody concentrations [ Time Frame: 1 month post-dose 4 of Prevnar 13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Immunogenicity with respect to the components of the investigational vaccine in terms of antibody concentrations [ Time Frame: 2 months post-dose 2 (PedHib Group only), 1 month post-dose 3 and 1 month post-dose 4 (HibCY Group only) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of the investigational vaccine in terms of antibody concentrations [ Time Frame: 2 months post-dose 2 (PedHib Group only) and 1 month post-dose 3 (HibCY Group only) ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of the investigational vaccine in terms of antibody titers [ Time Frame: 1 month post-dose 3 and 1 month post-dose 4 ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of Rotarix in terms of antibody concentrations [ Time Frame: 2 months post-dose 2 of Rotarix ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of Havrix in terms of antibody concentrations [ Time Frame: 1 month post-dose 1 of Havrix ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of Havrix in terms of Geometric Mean Concentrations (GMCs) [ Time Frame: 1 month post-dose 2 of Havrix ] [ Designated as safety issue: No ]
  • Immunogenicity with respect to the components of Prevnar 13 in terms of antibody concentrations [ Time Frame: 1 month post-dose 3 and 1 month post-dose 4 ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: During the 4 day (Days 0-3) follow-up period after all vaccines post-primary and post-fourth dose in the HibCY and PedHIB groups ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: During the 31-day (Days 0-30) follow-up period after all vaccines post-primary and post-fourth dose ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: Day 0 to study end (Month 20) ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: February 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group HibCY
Subjects will receive Hib-MenCY-TT, Pediarix; Prevnar 13; Rotarix and Havrix.
Biological: Hib-MenCY-TT vaccine (GSK792014)
4 doses administered intramuscularly (IM) in the right upper thigh at Day 0, Month 2, Month 4 and Month 10-13.
Biological: Pediarix®
3 doses administered IM in the left upper thigh in HibCY Group at Day 0, Month 2 and Month 4. 2 doses administered IM in the left upper thigh at Day 0 and Month 2 and 1 dose administered IM in the right upper thigh at Month 4 in PedHIB Group.
Biological: Rotarix®
2 doses administered orally at Day 0 and Month 2.
Biological: Prevnar 13®
4 doses administered IM in the left lower thigh at Day 0, Month 2, Month 4 and Month 10-13.
Biological: Havrix®
2 doses administered IM in the left upper thigh at Month 10-13 and Month 16-19.
Active Comparator: Group PedHIB
Subjects will receive PedvaxHIB; Pediarix; Prevnar 13; Rotarix and Havrix.
Biological: Pediarix®
3 doses administered IM in the left upper thigh in HibCY Group at Day 0, Month 2 and Month 4. 2 doses administered IM in the left upper thigh at Day 0 and Month 2 and 1 dose administered IM in the right upper thigh at Month 4 in PedHIB Group.
Biological: Rotarix®
2 doses administered orally at Day 0 and Month 2.
Biological: Prevnar 13®
4 doses administered IM in the left lower thigh at Day 0, Month 2, Month 4 and Month 10-13.
Biological: PedvaxHIB®
3 doses administered IM in the right upper thigh at Day 0, Month 2 and Month 10-13.
Biological: Havrix®
2 doses administered IM in the left upper thigh at Month 10-13 and Month 16-19.

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, 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(s)/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born full-term (i.e. born after a gestation period of at least 37 weeks inclusive).
  • 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.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth prior to the first vaccine dose. Inhaled and topical steroids are allowed.
  • Previous vaccination against Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, rotavirus, pneumococcus, hepatitis A and/or poliovirus; more than one previous dose of hepatitis B vaccine.
  • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of vaccines. Subjects may receive inactivated influenza vaccine or pandemic influenza vaccines any time during the study according to the national recommendation. Measles, mumps, rubella and varicella vaccination are allowed 30 days before or 30 days after the final vaccination of Hib-MenCY-TT or PedvaxHIB.
  • History of Neisseria meningitidis, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, pneumococcus, hepatitis B, hepatitis A, rotavirus, 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. Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
  • Major congenital defects or serious chronic illnesses.
  • History of any neurologic disorders or seizures. A single, simple febrile seizure is allowed.
  • Subjects with history of intussusceptions or uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusceptions.
  • Acute disease and/or fever at the time of enrollment.
  • Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01978093

Locations
United States, Alabama
GSK Investigational Site
Birmingham, Alabama, United States, 35235
United States, Arkansas
GSK Investigational Site
Fayetteville, Arkansas, United States, 72703
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
United States, California
GSK Investigational Site
Fresno, California, United States, 93726
GSK Investigational Site
Huntington Beach, California, United States, 92647
GSK Investigational Site
Oakland, California, United States, 94611
GSK Investigational Site
Paramount, California, United States, 90723
GSK Investigational Site
Pleasanton, California, United States, 94588
GSK Investigational Site
Roseville, California, United States, 95661
GSK Investigational Site
Sacramento, California, United States, 95823
GSK Investigational Site
San Jose, California, United States, 95119
GSK Investigational Site
Santa Clara, California, United States, 95051
GSK Investigational Site
Walnut Creek, California, United States, 94596
United States, Massachusetts
GSK Investigational Site
Fall River, Massachusetts, United States, 02721
GSK Investigational Site
Woburn, Massachusetts, United States, 01801
United States, Michigan
GSK Investigational Site
Niles, Michigan, United States, 49120
GSK Investigational Site
Stevensville, Michigan, United States, 49127
United States, North Carolina
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44121
GSK Investigational Site
Dayton, Ohio, United States, 45406
United States, Pennsylvania
GSK Investigational Site
Hermitage, Pennsylvania, United States, 16148
United States, South Carolina
GSK Investigational Site
Charleston, South Carolina, United States, 29406
United States, Utah
GSK Investigational Site
Layton, Utah, United States, 84041
GSK Investigational Site
Murray, Utah, United States, 84124
GSK Investigational Site
Orem, Utah, United States, 84057
GSK Investigational Site
Roy, Utah, United States, 84067
GSK Investigational Site
Syracuse, Utah, United States, 84075
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01978093     History of Changes
Other Study ID Numbers: 112931, 2013-003459-39
Study First Received: October 31, 2013
Last Updated: July 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Conjugate
Immunogenicity
Hib-MenCY-TT vaccine
Haemophilus type b
Safety
Reactogenicity

Additional relevant MeSH terms:
Haemophilus Infections
Influenza, Human
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 28, 2014