Co-administration of Meningococcal Vaccine GSK134612 and Pneumococcal Vaccine GSK1024850A vs Individual Administration

NCT00758264 | Completed Phase 3 Results

• 1 other identifier: 111393
• Study Type: interventional
• Target: 363
• Locations: 2 countries
• Sites: 5

Brief Summary

The purpose of this study is to demonstrate, in 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 and pneumococcal vaccine GSK1024850A when co-administered, compared to each vaccine administered individually.

Conditions

Infections, Meningococcal

Keywords

Safety; Routine infancy vaccination; Meningococcal vaccine; Immunogenicity; Pneumococcal vaccine

Outcome Measures

Primary Outcomes (3)

• Anti-pneumococcal Antibody Concentrations

  Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). Anti-pneumococcal serotypes assessed were Anti-1, Anti-4, Anti-5, Anti-6B, Anti-7F, Anti-9V, Anti-14, Anti-18C, Anti-19F and Anti-23F via the 22F-inhibition Enzyme Linked Immunosorbent Assay (ELISA).

  At Month 1

• Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value

  The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.

  At Month 1

• rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers

  Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.

  At Month 1

Secondary Outcomes (15)

• Anti-pneumococcal Antibody Concentrations

  Before vaccination (PRE) and at one month post dose 2 (Month 2)

• Cross-reactive Anti-pneumococcal Antibody Concentrations

  Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)

• Opsonophagocytic Titers Against Pneumococcal Serotypes

  Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)

• Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes

  Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)

• Anti-protein D (Anti-PD) Antibody Concentrations

  Before vaccination (PRE), at one month post dose 1(Month 1) and at one month post dose 2 (Month 2)

Study Arms (3)

Group A

EXPERIMENTAL

Meningococcal vaccine GSK134612 co-administered with pneumococcal vaccine GSK1024850A.

Biological: Meningococcal vaccine GSK134612; Biological: Pneumococcal vaccine GSK1024850A

Group B

ACTIVE COMPARATOR

Pneumococcal vaccine GSK1024850A followed one month later by meningococcal vaccine GSK134612.

Biological: Meningococcal vaccine GSK134612; Biological: Pneumococcal vaccine GSK1024850A

Group C

ACTIVE COMPARATOR

Meningococcal vaccine GSK134612 followed one month later by pneumococcal vaccine GSK1024850A.

Biological: Meningococcal vaccine GSK134612; Biological: Pneumococcal vaccine GSK1024850A

Interventions

Meningococcal vaccine GSK134612 BIOLOGICAL

Single dose intramuscular injection.

Group A; Group B; Group C

Pneumococcal vaccine GSK1024850A BIOLOGICAL

Single dose intramuscular injection.

Group A; Group B; Group C

Eligibility Criteria

• Age: 12 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
• A male or female between, and including, 12 and 23 months of age at the time of the first booster vaccination, who previously participated in study 109661 conducted in Mexico or in study 109861 conducted in Taiwan and who received 3 doses of the GSK1024850A vaccine.
• 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.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine(s), or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine(s) and 30 days after the last dose of vaccine(s).
• 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 (pharmaceutical product or device).
• Previous vaccination with a meningococcal vaccine.
• Previous administration of a fourth dose of a pneumococcal vaccine
• Previous vaccination with tetanus toxoid within the last month (including also tetanus toxoid given as part of Hib-TT conjugate vaccine).
• History of meningococcal or pneumococcal invasive disease.
• History of reactions or allergic disease likely to be exacerbated by any component of the vaccines.
• Hypersensitivity reaction due to previous vaccination with GSK1024850A vaccine.
• History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required).
• A family history of congenital or hereditary immunodeficiency, unless the child has previously been documented, through laboratory testing, to have normal immune function.
• Major congenital defects or serious chronic illness.
• Acute disease at the time of enrolment.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (5)

GSK Investigational Site

Mexico City, 14000, Mexico

Location

GSK Investigational Site

México, 14000, Mexico

Location

GSK Investigational Site

Taipei, 100, Taiwan

Location

GSK Investigational Site

Taipei, 105, Taiwan

Location

GSK Investigational Site

Taoyuan Hsien, Taiwan

Location

Related Publications (2)

• Huang LM et al. Immunogenicity and safety of PHiD-CV coadministered with a candidate meningococcal tetanus toxoid conjugate vaccine (MenACWY-TT) in children previously primed with PHiD. Abstract presented at the 5th Asian Congress of Pediatric Infectious Diseases (ACPID). Taipei, Taiwan, 23-26 September 2010.

  BACKGROUND

• Ruiz-Palacios GM, Huang LM, Lin TY, Hernandez L, Guerrero ML, Villalobos AL, Van der Wielen M, Moreira M, Fissette L, Borys D, Miller JM. Immunogenicity and safety of a booster dose of the 10-valent pneumococcal Haemophilus influenzae protein D conjugate vaccine coadministered with the tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in toddlers: a randomized trial. Pediatr Infect Dis J. 2013 Jan;32(1):62-71. doi: 10.1097/INF.0b013e3182784143.

  PMID: 23076383 BACKGROUND

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

Condition Hierarchy (Ancestors)

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

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: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: September 25, 2008
• Study Start: October 30, 2008
• Primary Completion: June 2, 2009
• Study Completion: November 2, 2009
• Last Updated: May 9, 2018
• Results First Posted: May 9, 2018

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

TW (3); ME (2)