Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Conjugate Vaccine (GSK134612) When Co-administered With Boostrix® in Subjects Between 11 and 25 Years of Age

NCT01767376 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 1167052012-002737-11
• Study Type: interventional
• Target: 692
• Locations: 3 countries
• Sites: 15

Brief Summary

The purpose of this study is to assess the immunogenicity, safety and reactogenicity of the meningococcal conjugate vaccine (MenACWY-TT) co-administered with Boostrix® versus each of the two vaccines given separately in healthy adolescents and young adults.

Conditions

Infections, Meningococcal

Keywords

Young adults; Adolescents; Reactogenicity; Diphtheria; pertussis; Immunogenicity; Tetanus; Meningococcal vaccines; Safety; Neisseria meningitidis; Healthy

Outcome Measures

Primary Outcomes (3)

• Anti-Meningitis Antibody Titers by Serum Bactericidal Assay Using Rabbit Complement (rSBA)

  The analysis was performed for the serogroups -MenA, -MenC -MenW-135 and -MenY. Antibody titers tabulated as geometric mean titers (GMTs), were obtained by serum bactericidal assay using rabbit complement and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The primary outcome results only refer to Nimenrix+Boostrix Group and Nimenrix Group.

  One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)

• Number of Subjects With Anti-D and Anti-T Concentrations Above the Cut-off Value

  The antibody concentrations were calculated as geometric mean concentrations (GMCs) and expressed as international units per milliliter (IU/mL). The reference cut-off value was an antibody concentration ≥ 1 IU/mL. The primary outcome results only refer to Nimenrix+Boostrix Group and Boostrix Group.

  One month after Boostrix vaccination (i.e. Month 1)

• Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations

  The antibody concentrations were tabulated as adjusted geometric mean concentrations (GMCs) and expressed as international units per millilitre (IU/mL). The primary outcome results only refer to Nimenrix+Boostrix Group and Boostrix Group

  One month after Boostrix vaccination (i.e. Month 1)

Secondary Outcomes (11)

• Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titres Above the Cut-off Values

  Prior to (i.e. Month 0 for Nimenrix+Boostrix and Nimenrix Groups and Month 1 for Boostrix Group) and one month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)

• Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies

  One month after Nimenrix vaccination (i.e. Month 1 for Nimenrix+Boostrix and Nimenrix Groups and Month 2 for Boostrix Group)

• Anti-D Antibody Concentrations

  Prior to (PRE i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group) and one month after Boostrix vaccination (POST i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)

• Anti-T Antibody Concentrations

  Prior to (i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group), one month after Nimenrix vaccination and one month after Boostrix vaccination

• Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Above the Cut-off Value

  Prior to (i.e. Month 0 for Nimenrix + Boostrix Group and Boostrix Group and Month 1 for Nimenrix Group) and one month after Boostrix vaccination (i.e. Month 1 for Nimenrix + Boostrix Group and Boostrix Group and Month 2 for Nimenrix Group)

Study Arms (3)

Nimenrix+ Boostrix Group

EXPERIMENTAL

Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine co-administered with one dose of Boostrix vaccine, at Month 0, administered by intramuscular injection into the deltoid muscle.

Biological: Meningococcal vaccine GSK134612; Biological: Boostrix®

Nimenrix Group

EXPERIMENTAL

Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Nimenrix vaccine at Month 0 and one dose of Boostrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.

Biological: Meningococcal vaccine GSK134612; Biological: Boostrix®

Boostrix Group

EXPERIMENTAL

Healthy male or female subjects, between and including 11 and 25 years of age, who received one dose of Boostrix vaccine at Month 0 and one dose of Nimenrix vaccine at Month 1. Both vaccines were administered by intramuscular injection into the deltoid muscle.

Biological: Meningococcal vaccine GSK134612; Biological: Boostrix®

Interventions

Meningococcal vaccine GSK134612 BIOLOGICAL

One dose administered intramuscularly (IM) in the deltoid muscle of the arm.

Also known as: MenACWY-TT, Nimenrix

Boostrix Group; Nimenrix Group; Nimenrix+ Boostrix Group

Boostrix® BIOLOGICAL

One dose administered intramuscularly (IM) in the deltoid of the right arm (in Co-ad Group) and left arm (in TdapACWY and ACWYTdap Groups).

Also known as: Tdap

Boostrix Group; Nimenrix Group; Nimenrix+ Boostrix Group

Eligibility Criteria

• Age: 11 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Subjects and 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, 11 and 25 years of age at the time of the first vaccination.
• Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject.
• Written informed assent obtained from the subjects when applicable according to local regulations.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy or ovariectomy.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:
• has practiced adequate contraception for 30 days prior to vaccination, and
• has a negative pregnancy test on the day of vaccination, and
• has agreed to continue adequate contraception during the entire treatment period and for two months after completion of the vaccination series.

You may not qualify if:

• Child in care.
• Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone ≥ 10 mg/day, or equivalent. Inhaled and topical steroids are allowed.
• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine and ending 30 days after the last dose of vaccine, with the exception of licensed inactivated influenza vaccine.
• Concurrently participating 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.
• Previous vaccination with a meningococcal vaccine.
• History of meningococcal disease.
• Vaccination with a DTP-containing vaccine within the previous five years.
• History of serious allergic reaction following any other DTP-containing vaccine or any component of the study vaccines.
• History of encephalopathy within seven days following administration of a previous dose of pertussis vaccine that is not attributable to another identifiable cause.
• Temperature of ≥ 40.5°C (105°F) within 48 hours of receipt of a previous dose of DTP vaccine, not due to another identifiable cause.
• Collapse or shock-like state within 48 hours of receipt of a previous dose of DTP vaccine.
• Seizures with or without fever within three days of a previous dose of DTP vaccine.
• Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid (TT) within the previous ten years.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination during the study period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (15)

GSK Investigational Site

Santo Domingo, Distrito Nacional, Dominican Republic

Location

GSK Investigational Site

Kehl, Baden-Wurttemberg, 77694, Germany

Location

GSK Investigational Site

Tuttlingen, Baden-Wurttemberg, 78532, Germany

Location

GSK Investigational Site

Bindlach, Bavaria, 95463, Germany

Location

GSK Investigational Site

Würzburg, Bavaria, 97070, Germany

Location

GSK Investigational Site

Essen, North Rhine-Westphalia, 45359, Germany

Location

GSK Investigational Site

Goch, North Rhine-Westphalia, 47574, Germany

Location

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, 67227, Germany

Location

GSK Investigational Site

Ansan, 425-707, South Korea

Location

GSK Investigational Site

Incheon, 400 711, South Korea

Location

GSK Investigational Site

Incheon, 700-711, South Korea

Location

GSK Investigational Site

Jeonju Jeonbuk, 561-712, South Korea

Location

GSK Investigational Site

Seoul, 130-702, South Korea

Location

GSK Investigational Site

Seoul, 150-950, South Korea

Location

GSK Investigational Site

Seoul, 158-710, South Korea

Location

Related Publications (1)

• Rivera L, Schwarz TF, Kim KH, Kim YK, Behre U, Cha SH, Jo DS, Lee J, Lee JS, Cheuvart B, Jastorff A, Van der Wielen M. Immunogenicity and safety of the quadrivalent meningococcal vaccine MenACWY-TT co-administered with a combined diphtheria-tetanus-acellular pertussis vaccine versus their separate administration in adolescents and young adults: A phase III, randomized study. Vaccine. 2018 Jul 25;36(31):4750-4758. doi: 10.1016/j.vaccine.2018.04.034. Epub 2018 Jun 28.

  PMID: 29960800 DERIVED

MeSH Terms

Conditions

Meningococcal Infections; Diphtheria; Whooping Cough; Tetanus

Interventions

tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine; Boostrix

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bordetella Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Clostridium Infections

Limitations and Caveats

Due to late availability of the serology results, only safety results were posted by the initial due date.

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: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: January 14, 2013
• Study Start: January 10, 2013
• Primary Completion: January 16, 2014
• Study Completion: January 16, 2014
• Last Updated: September 6, 2017
• Results First Posted: September 6, 2017

Record last verified: 2017-08

Locations

KR (7); DO (1); DE (7)