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

NCT ID: NCT00614614

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1558 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-13
• Study Completion Date: 2009-09-17

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.

Detailed Description

The purpose of this study is to evaluate the titer of antibody for serogroups A, C, Y and W-135 and the safety of a booster dose of GSK Biologicals' meningococcal vaccine 134612 given to toddlers who were primed with GSK Biological's Hib-meningococcal vaccine 792014. In addition, this study will provide immunogenicity and safety data on the co-administration of Infanrix with meningococcal vaccine 134612 as compared to Infanrix administered alone.

Depending on the group the subject is assigned to, one or two blood samples will be taken out of the subject's arm during the study.

The protocol posting has been updated following a protocol amendment.

Conditions

Infections, Meningococcal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Menhibrix 1 Group

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) \[Nimenrix 2 Group\].

Group Type: EXPERIMENTAL

GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)

Intervention Type: BIOLOGICAL

One dose in the booster phase as intramuscular injection

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

Intervention Type: BIOLOGICAL

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

Infanrix®

Intervention Type: BIOLOGICAL

One dose as intramuscular injection

Pediarix®

Intervention Type: BIOLOGICAL

Three doses in the priming phase as intramuscular injection

ActHIB- Infanrix Group

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.

Group Type: ACTIVE_COMPARATOR

Infanrix®

Intervention Type: BIOLOGICAL

One dose as intramuscular injection

ActHIB®

Intervention Type: BIOLOGICAL

Three doses in the priming phase as intramuscular injection

Pediarix®

Intervention Type: BIOLOGICAL

Three doses in the priming phase as intramuscular injection

Interventions

GSK Biologicals' Meningococcal vaccine GSK134612 (Nimenrix)

One dose in the booster phase as intramuscular injection

Intervention Type: BIOLOGICAL

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

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

Intervention Type: BIOLOGICAL

Infanrix®

One dose as intramuscular injection

Intervention Type: BIOLOGICAL

ActHIB®

Three doses in the priming phase as intramuscular injection

Intervention Type: BIOLOGICAL

Pediarix®

Three doses in the priming phase as intramuscular injection

Intervention Type: BIOLOGICAL

Other Intervention Names

Nimenrix; Menhibrix

Eligibility Criteria

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 (+ 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.
• For inclusion in the booster phase, subjects must have received all three doses in the primary phase.

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.
• 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)
• Planned administration/administration of a fourth dose of Prevnar® within 30 days of a booster dose of Infanrix®
• Previous administration of a booster dose of Hib prior to entry to the booster phase.
• Previous administration of a primary dose of Hib vaccine that is not part of the study protocol.
• Previous vaccination against Neisseria meningitidis that is not part of the study protocol.
• Previous vaccination with diphtheria, tetanus and pertussis antigens outside of the primary phase of the study.
• History of Neisseria meningitidis, Hib, diphtheria, tetanus 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 within the past 3 months 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).

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 12 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Dothan, Alabama, United States

GSK Investigational Site

Benton, Arkansas, United States

GSK Investigational Site

Fayetteville, Arkansas, United States

GSK Investigational Site

Jonesboro, Arkansas, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Fountain Valley, California, United States

GSK Investigational Site

Fresno, California, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

West Covina, California, United States

GSK Investigational Site

Plantation, Florida, United States

GSK Investigational Site

West Palm Beach, Florida, United States

GSK Investigational Site

Marietta, Georgia, United States

GSK Investigational Site

Woodstock, Georgia, United States

GSK Investigational Site

Nampa, Idaho, United States

GSK Investigational Site

Des Moines, Iowa, United States

GSK Investigational Site

West Des Moines, Iowa, United States

GSK Investigational Site

Arkansas City, Kansas, United States

GSK Investigational Site

Bardstown, Kentucky, United States

GSK Investigational Site

Lexington, Kentucky, United States

GSK Investigational Site

Bossier City, Louisiana, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Fall River, Massachusetts, United States

GSK Investigational Site

Kalamazoo, Michigan, United States

GSK Investigational Site

Niles, Michigan, United States

GSK Investigational Site

Portage, Michigan, United States

GSK Investigational Site

Richland, Michigan, United States

GSK Investigational Site

Stevensville, Michigan, United States

GSK Investigational Site

Saint Paul, Minnesota, United States

GSK Investigational Site

Henderson, Nevada, United States

GSK Investigational Site

Clyde, North Carolina, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Cleveland, Ohio, United States

GSK Investigational Site

Huber Heights, Ohio, United States

GSK Investigational Site

Gresham, Oregon, United States

GSK Investigational Site

Erie, Pennsylvania, United States

GSK Investigational Site

Greenville, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

GSK Investigational Site

Uniontown, Pennsylvania, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Kingsport, Tennessee, United States

GSK Investigational Site

Amarillo, Texas, United States

GSK Investigational Site

Galveston, Texas, United States

GSK Investigational Site

Sugar Land, Texas, United States

GSK Investigational Site

Layton, Utah, United States

GSK Investigational Site

Ogden, Utah, United States

GSK Investigational Site

Orem, Utah, United States

GSK Investigational Site

Provo, Utah, United States

GSK Investigational Site

Roy, Utah, United States

GSK Investigational Site

South Jordan, Utah, United States

GSK Investigational Site

St. George, Utah, United States

GSK Investigational Site

Syracuse, Utah, United States

GSK Investigational Site

Marshfield, Wisconsin, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25305567 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25152325 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

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Other Identifiers

110871

Identifier Type: OTHER

Identifier Source: secondary_id

110870

Identifier Type: -

Identifier Source: org_study_id