Immuno,Safety of GSK Vaccine 134612 Given at Age of 12-15 Months 15-18 Months Post-priming With GSK Vaccine 792014

NCT00614614 | Completed Phase 3 Results

• 2 other identifiers: 110870110871
• Study Type: interventional
• Target: 1,558
• Locations: 1 country
• Sites: 56

Brief Summary

The purpose of the study is to characterize the immunogenicity \& safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in healthy toddlers primed with GSK Biological's Hib-meningococcal vaccine 792014. This study is single-blinded for the primary phase and open-label for the booster phase.

Conditions

Infections, Meningococcal

Keywords

Meningococcal disease; Toddlers; Neisseria meningitidis; Meningococcal vaccines; Immunogenicity; Human serum bactericidal assay; Safety; Vaccines, conjugate; Booster vaccination

Outcome Measures

Primary Outcomes (8)

• Number of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) Antibody Titers for N. Meningitidis Serogroups A(MenA), W-135(MenW-135), C(MenC) and Y(MenY) Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 1 Group

  The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8

  One month post vaccination at 12-15 months of age (Month 11)

• Number of Subjects With hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group

  The cut-off values assessed for hSBA-MenA, hSBA-MenW-135, hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8

  One month post vaccination at 15-18 months of age (Month 14)

• Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 1 Group

  Antibody titers were expressed as Geometric mean titers (GMTs)

  One month post vaccination at 12-15 months of age (Month 11)

• Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group

  Antibody titers were expressed as Geometric mean titers (GMTs)

  One month post vaccination at 15-18 months of age (Month 14)

• Number of Subjects With Anti-Diptheria (Anti-D) and Anti-Tetanus (Anti-T) Antibody Concentrations Greater Than or Equal to Protocol Specified Cut-off Value in Nimenrix 2 Group and ActHIB- Infanrix Group

  The cut-off value assessed for Anti-D and Anti-T were greater than or equal to (≥) 1.0 International Units per milliliter (IU/mL).

  One month post vaccination at 15-18 months of age (Month 14)

• Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Menhibrix 2 Group

  Antibody titers were expressed as Geometric mean titers (GMTs)

  One month post vaccination at 12-15 months of age (Month 11)

• Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Value in Menhibrix 2 Group

  The cut-off values assessed for hSBA-MenC and hSBA-MenY were greater than or equal to (≥) 1:8

  One month post vaccination at 12-15 months of age (Month 11)

• Geometric Mean Antibody Concentrations for Anti-PT (Pertusis Toxoid), Anti-FHA (Filamentous Hemagglutinin) and Anti-PRN (Pertactin) in Nimenrix 2 Group and ActHIB- Infanrix Group

  Concentrations were provided as Geometric mean concentrations (GMCs) and expressed as enzyme-linked immunosorbent assay units per milliliter (EL.U/mL)

  One month after vaccination at 15-18 months of age (Month 14)

Secondary Outcomes (22)

• Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group and Menhibrix 2 Group

  One month after vaccination at 12-15 months of age (Month 11)

• Number of Subjects With hSBA-MenA and hSBA MenW-135 Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 1 Group

  One month after vaccination at 12-15 months of age (Month 11)

• Geometric Mean Antibody Titers for hSBA-MenA and hSBA MenW-135 in Nimenrix 1 Group

  One month after vaccination at 12-15 months of age (Month 11)

• Geometric Mean Antibody Titers for hSBA-MenC and hSBA-MenY in Nimenrix 2 Group

  Prior to vaccination at 15-18 months of age (Month 13)

• Number of Subjects With hSBA-MenC and hSBA-MenY Antibody Titers Greater Than or Equal to Protocol Specified Cut-off Values in Nimenrix 2 Group

  Prior to vaccination at 15-18 months of age (Month 13)

Study Arms (2)

Menhibrix 1 Group

EXPERIMENTAL

Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during the Primary Vaccination Phase. For the Booster Vaccination Phase, subjects were re-randomized and received either 1 dose of Nimenrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) \[Nimenrix 1 Group\] or a fourth dose of Menhibrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) \[Menhibrix 2 Group\], or 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine (at 15-18 months of age) \[Nimenrix 2 Group\].

Biological: GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix); Biological: GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix); Biological: Infanrix®; Biological: Pediarix®

ActHIB- Infanrix Group

ACTIVE COMPARATOR

Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age and 1 booster dose of Infanrix vaccine at 15-18 months of age.

Biological: Infanrix®; Biological: ActHIB®; Biological: Pediarix®

Interventions

GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix) BIOLOGICAL

One dose in the booster phase as intramuscular injection

Also known as: Nimenrix

Menhibrix 1 Group

GSK Biologicals' Hib-meningococcal vaccine GSK 792014 (Menhibrix) BIOLOGICAL

Three doses in the priming phase and, for Menhibrix 2 Group, one dose in the booster phase as intramuscular injection

Also known as: Menhibrix

Menhibrix 1 Group

Infanrix® BIOLOGICAL

One dose as intramuscular injection

ActHIB- Infanrix Group; Menhibrix 1 Group

ActHIB® BIOLOGICAL

Three doses in the priming phase as intramuscular injection

ActHIB- Infanrix Group

Pediarix® BIOLOGICAL

Three doses in the priming phase as intramuscular injection

ActHIB- Infanrix Group; Menhibrix 1 Group

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 (+ 6 days) 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.

You may not qualify if:

• 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.
• History of Neisseria meningitidis, hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, polio or pertussis diseases.
• 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, or by 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).
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding entry into the booster phase (Visit 4), 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 entry into the booster phase (Visit 4) with the exception of Prevnar® and Hib (see the following three criteria) (Note; licensed influenza vaccine is allowed throughout the study)

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (56)

GSK Investigational Site

Birmingham, Alabama, 35205, United States

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GSK Investigational Site

Birmingham, Alabama, 35244, United States

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GSK Investigational Site

Dothan, Alabama, 36305, United States

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GSK Investigational Site

Benton, Arkansas, 72019, United States

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GSK Investigational Site

Fayetteville, Arkansas, 72703, United States

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GSK Investigational Site

Jonesboro, Arkansas, 72401, United States

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GSK Investigational Site

Little Rock, Arkansas, 72205, United States

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GSK Investigational Site

Fountain Valley, California, 92708, United States

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GSK Investigational Site

Fresno, California, 93726, United States

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GSK Investigational Site

Huntington Beach, California, 92647, United States

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GSK Investigational Site

West Covina, California, 91790, United States

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GSK Investigational Site

Plantation, Florida, 33324, United States

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GSK Investigational Site

West Palm Beach, Florida, 33407, United States

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GSK Investigational Site

Marietta, Georgia, 30062, United States

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GSK Investigational Site

Woodstock, Georgia, 30189, United States

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GSK Investigational Site

Nampa, Idaho, 208 463 3126, United States

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GSK Investigational Site

Des Moines, Iowa, 50312, United States

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GSK Investigational Site

West Des Moines, Iowa, 50266, United States

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GSK Investigational Site

Arkansas City, Kansas, 67005, United States

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GSK Investigational Site

Bardstown, Kentucky, 40004, United States

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GSK Investigational Site

Lexington, Kentucky, 40503, United States

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GSK Investigational Site

Bossier City, Louisiana, 71111, United States

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GSK Investigational Site

Boston, Massachusetts, 02130, United States

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GSK Investigational Site

Fall River, Massachusetts, 02724, United States

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GSK Investigational Site

Kalamazoo, Michigan, 49008, United States

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GSK Investigational Site

Niles, Michigan, 49120, United States

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GSK Investigational Site

Portage, Michigan, 49024, United States

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GSK Investigational Site

Richland, Michigan, 49083, United States

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GSK Investigational Site

Stevensville, Michigan, 49127, United States

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GSK Investigational Site

Saint Paul, Minnesota, 55108, United States

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GSK Investigational Site

Henderson, Nevada, 89015, United States

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GSK Investigational Site

Clyde, North Carolina, 28721, United States

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GSK Investigational Site

Raleigh, North Carolina, 27609, United States

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GSK Investigational Site

Cleveland, Ohio, 44121, United States

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GSK Investigational Site

Huber Heights, Ohio, 45424, United States

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GSK Investigational Site

Gresham, Oregon, 97030, United States

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GSK Investigational Site

Erie, Pennsylvania, 16505, United States

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GSK Investigational Site

Greenville, Pennsylvania, 16125, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15220, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15236, United States

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GSK Investigational Site

Pittsburgh, Pennsylvania, 15241, United States

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GSK Investigational Site

Uniontown, Pennsylvania, 15401, United States

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GSK Investigational Site

Charleston, South Carolina, 29406, United States

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GSK Investigational Site

Kingsport, Tennessee, 37660, United States

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GSK Investigational Site

Amarillo, Texas, 79124, United States

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GSK Investigational Site

Galveston, Texas, 77555-1119, United States

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GSK Investigational Site

Sugar Land, Texas, 77479, United States

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GSK Investigational Site

Layton, Utah, 84041, United States

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GSK Investigational Site

Ogden, Utah, 84405, United States

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GSK Investigational Site

Orem, Utah, 84057, United States

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GSK Investigational Site

Provo, Utah, 84604, United States

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GSK Investigational Site

Roy, Utah, 84067, United States

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GSK Investigational Site

South Jordan, Utah, 84095, United States

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GSK Investigational Site

St. George, Utah, 84790, United States

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GSK Investigational Site

Syracuse, Utah, 84075, United States

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GSK Investigational Site

Marshfield, Wisconsin, 54449, United States

Location

Related Publications (2)

• Leonardi M, Latiolais T, Sarpong K, Simon M, Twiggs J, Lei P, Rinderknecht S, Blatter M, Bianco V, Baine Y, Friedland LR, Baccarini C, Miller JM. Immunogenicity and reactogenicity of Infanrix when co-administered with meningococcal MenACWY-TT conjugate vaccine in toddlers primed with MenHibrix and Pediarix. Vaccine. 2015 Feb 11;33(7):924-32. doi: 10.1016/j.vaccine.2014.09.064. Epub 2014 Oct 8.

  PMID: 25305567 DERIVED

• Leonardi M, Latiolais T, Sarpong K, Simon M, Twiggs J, Lei P, Rinderknecht S, Blatter M, Bianco V, Baine Y, Friedland LR, Miller JM. Quadrivalent meningococcal (MenACWY-TT) conjugate vaccine or a fourth dose of H. influenzae-N. meningitidis C/Y conjugate vaccine (HibMenCY-TT) is immunogenic in toddlers who previously received three doses of HibMenCY-TT in infancy. Vaccine. 2015 Feb 11;33(7):933-41. doi: 10.1016/j.vaccine.2014.08.027. Epub 2014 Aug 21.

  PMID: 25152325 DERIVED

Related 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.

MeSH Terms

Conditions

Meningococcal Infections

Interventions

Hib-MenCY-TT vaccine; Diphtheria-Tetanus-acellular Pertussis Vaccines; Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate; PEDIARIX

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Pertussis Vaccine; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2008
• First Posted: February 13, 2008
• Study Start: February 13, 2008
• Primary Completion: July 31, 2009
• Study Completion: September 17, 2009
• Last Updated: September 21, 2018
• Results First Posted: July 20, 2012

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (56)