Study in Children to Evaluate Non-Inferiority and Persistence up to 5 Years of GSK Bio Meningococcal Vaccine 134612

Infections, Meningococcal Clinical Trial

Official title:

Evaluate Non-Inferiority and Persistence of the Immune Response of GSK Biologicals' Meningococcal Vaccine 134612 Versus Meningitec™ or Mencevax™ ACWY in Healthy Subjects (1-10 Years of Age)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00427908
• Other study ID #: 108658
• Secondary ID: 108660 (Y1)10866
• Status: Completed
• Phase: Phase 2
• Start date: February 7, 2007
• Est. completion date: December 3, 2007

Study information

• Verified date: May 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study has 2 phases, a vaccination phase and a long-term follow-up phase. In the vaccination phase of this study, the new meningococcal vaccine 134612 will be evaluated in children using Mencevax™ ACWY (in children above 2 years) or Meningitec™ (in children below 2 years) as controls. In the long-term follow-up phase of the study, the long-term protection offered by the vaccines will be assessed up to 5 years after vaccination.

Subjects will be randomized in the primary vaccination phase of the study; no new subjects will be enrolled during the long-term follow-up phase of the study.

Description:

Subjects will be enrolled in 3 age strata. Subjects including and above two years of age will receive either GSK Biologicals meningococcal vaccine 134612 or Mencevax™ ACWY, subjects below two years of age will receive either GSK Biologicals meningococcal vaccine 134612 or Meningitec™. All subjects will have 7 blood samples taken: prior and one month after vaccination and one, two, three, four and five years after vaccination.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 613
• Est. completion date: December 3, 2007
• Est. primary completion date: December 3, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

Inclusion Criteria:

• Subjects who the investigator believes that their parent or guardian can and will comply with the requirements of the protocol.

• A male or female between, and including, 1 through 10 years of age at the time of vaccination.

• Written informed consent obtained from the parent or guardian of the subject.

• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

• Previously completed routine childhood vaccinations to the best of his/her parents/guardians' knowledge.

Exclusion Criteria:

For the primary phase:

• 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.

• Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the dose of vaccine(s).

• Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W, and/or Y (for subjects below 6 years) or within the last five previous years (for subjects 6 years old or above).

• Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroup A, C, W, and/or Y.

• Previous vaccination with tetanus toxoid containing vaccine within the last 28 days.

• History of meningococcal disease due to serogroup A, C, W, or Y.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.

• A family history of congenital or hereditary immunodeficiency.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

• Major congenital defects or serious chronic illness.

• History of any neurologic disorders or seizures.

• Acute disease at the time of enrolment.

• Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

For the long term persistence phase:

• History of meningococcal serogroup A, C, W, and/or Y disease.

• Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine not planned in the protocol.

Related Conditions & MeSH terms

• Infections, Meningococcal
• Meningococcal Infections

Intervention

Biological:
• GSK Biolgicals' meningococcal vaccine 134612 (Nimenrix)
One intramuscular dose.
• Mencevax™ ACWY
One subcutaneous dose.
• Meningitec™
One intramuscular dose.

Locations

Country	Name	City	State
Finland	GSK Investigational Site	Espoo
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Helsinki
Finland	GSK Investigational Site	Jarvenpaa
Finland	GSK Investigational Site	Lahti
Finland	GSK Investigational Site	Oulu
Finland	GSK Investigational Site	Pori
Finland	GSK Investigational Site	Tampere
Finland	GSK Investigational Site	Turku
Finland	GSK Investigational Site	Vantaa
Finland	GSK Investigational Site	Vantaa

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Finland, 

References & Publications (2)

Vesikari T, Forstén A, Boutriau D, Bianco V, Van der Wielen M, Miller JM. A randomized study to assess the immunogenicity, antibody persistence and safety of a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in children aged 2-10 years. Hum Vaccin Immunother. 2012 Dec 1;8(12):1882-91. doi: 10.4161/hv.22165. Epub 2012 Oct 2. — View Citation

Vesikari T, Forstén A, Boutriau D, Bianco V, Van der Wielen M, Miller JM. Randomized trial to assess the immunogenicity, safety and antibody persistence up to three years after a single dose of a tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine in toddlers. Hum Vaccin Immunother. 2012 Dec 1;8(12):1892-903. doi: 10.4161/hv.22166. Epub 2012 Oct 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-MenY) Antibodies Vaccine Response	Vaccine response was defined as: for initially seronegative subjects, post vaccination rSBA titer = 1:32; for initially seropositive subjects, at least 4-fold increase in rSBA titer from pre to post vaccination.	One Month after vaccination
Primary	Number of Subjects With rSBA 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. This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE) vaccination
Primary	Percentage of Subjects With rSBA 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. This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE) to vaccination
Primary	Number of Subjects With rSBA 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. This analysis was performed by the GSK Biologicals' laboratory.	One month after vaccination [PI(M1)]
Primary	Percentage of Subjects With rSBA 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. This analysis was performed by the GSK Biologicals' laboratory.	One month after vaccination [PI(M1)]
Secondary	Number of Subjects With rSBA 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 (=) 1:128. This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE) and one month after vaccination [PI(M1)]
Secondary	rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE) and one month after vaccination [PI(M1)]
Secondary	Number of Subjects With rSBA Antibody Titers = the Cut-off Values	The cut-off value for the rSBA titers were greater than or equal to = 1:8 and = 1:128. These analyses were performed by the GSK Biologicals' laboratory.	Prior to (PRE) and one month after vaccination [PI(M1)]
Secondary	rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE) and one month post vaccination [PI(M1)]
Secondary	Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations Greater Than or Equal to the Cut-off Value	The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (=) 0.3 micrograms per milliliter (µg/mL) and = 2.0 µg/mL.	Prior to (PRE) and one month after vaccination [PI(M1)]
Secondary	Anti-PS Antibody Concentrations	Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL).	Prior to (PRE) and one month after vaccination [PI(M1)]
Secondary	Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value	The cut-off value for the anti-polysaccharide concentrations were greater than or equal to (=) 0.3 micrograms per milliliter (µg/mL) and (=) 2.0 µg/mL.	Prior to (PRE) and one month after vaccination [PI(M1)]
Secondary	Anti-PS Antibody Concentrations	Antibody concentrations were presented as micrograms per milliliter (µg/mL).	Prior to (PRE) and one month post vaccination [PI(M1)]
Secondary	Number of Subjects With Anti-tetanus (Anti-TT) Antibody Concentrations Greater Than or Equal to the Cut-off Value	The cut-off value for the anti-TT concentrations was greater than or equal to (=) 0.1 international units per milliliter (IU/mL).	Prior to (PRE) and one month after vaccination [PI(M1)]
Secondary	Anti-TT Antibody Concentrations	Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).	Prior to (PRE) and one month after vaccination [PI(M1)]
Secondary	Number of Subjects With Anti-TT Antibody Concentrations	Cut-off values assessed were greater than or equal to (=) 0.1 international units per milliliter (IU/mL).	Prior to (PRE) and one month after vaccination [PI(M1)]
Secondary	Anti-TT Antibody Concentrations	Concentrations are presented as geometric mean concentrations (GMCs) expressed in international units per milliliter (IU/mL).	Prior to (PRE) and one month post vaccination [PI(M1)]
Secondary	Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitides Serogroups A, C, W-135, Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Greater Than or Equal to the Cut-off Value	The cut-off value for the hSBA titers was greater than or equal to (=) 1:4.	Prior to (PRE) and one month after vaccination [PI(M1)]
Secondary	hSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).	Prior to (PRE) and one month after vaccination [PI(M1)]
Secondary	Number of Subjects With hSBA Antibody Titers = the Cut-off Value	The cut-off value for the hSBA titers was greater than or equal to (=) 1:4.	Prior to (PRE) and one month after vaccination [PI(M1)]
Secondary	hSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).	Prior to (PRE) and one month post vaccination [PI(M1)]
Secondary	Number of Subjects With rSBA 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. This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Secondary	rSBA Antibody Titers	Antibody titers are presented as GMTs. This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Secondary	Number of Subjects With rSBA Antibody Titers = the Cut-off Value	The cut-off value for the rSBA titers was greater than or equal to (=) 1:8. This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Secondary	rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). The analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Secondary	Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value	The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (=) 0.3 micrograms per milliliter (µg/mL).	Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Secondary	Anti-PS Antibody Concentrations	Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (µg/mL).	Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Secondary	Number of Subjects With Anti-PS Antibody Concentrations = the Cut-off Value	The cut-off value for the anti-polysaccharide concentrations was = 0.3 µg/mL.	Prior to (PRE), one month after vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Secondary	Anti-PS Antibody Concentrations	Antibody concentrations are presented as GMCs and expressed in µg/mL.	Prior to (PRE), one month post vaccination [PI(M1)] and at Persistence Year 1 [PI(M12)]
Secondary	Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value	The cut-off value for the hSBA titers was greater than or equal to (=) 1:4.	Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Secondary	hSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).	Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Secondary	Number of Subjects With hSBA Antibody Titers = to the Cut-off Value	The cut-off value for the hSBA titers was greater or equal to (=) 1:4.	Prior to (PRE), one month post vaccination [PI(M1)] and Persistence Year 1 [PI(M12)]
Secondary	hSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).	Prior to (PRE), one month after vaccination [PI(M1)] and at Persistence Year 1 [PI(M12)]
Secondary	Number of Subjects With rSBA 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. This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Secondary	rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Secondary	Number of Subjects With rSBA Antibody Titers = the Cut-off Value	The cut-off value for the rSBA titers was = 1:8. This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Secondary	rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Secondary	Anti-PS Antibody Concentrations	Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL).	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Secondary	Number of Subjects With Anti-PS Antibody Concentrations Greater Than or Equal to the Cut-off Value	The cut-off value for the anti-polysaccharide concentrations was = 0.3 micrograms per milliliter (µg/mL).	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Secondary	Number of Subjects With Anti-PS Antibody Concentrations = the Cut-off Value	The cut-off value for the anti-polysaccharide concentrations was = 0.3 micrograms per milliliter (µg/mL).	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Secondary	Anti-PS Antibody Concentrations	Antibody concentrations are presented as GMCs and expressed in micrograms per milliliter (µg/mL).	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Secondary	Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value	The cut-off value for the hSBA titers was greater than or equal to (=) 1:4.	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Secondary	hSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)] and Persistence Year 2 [PI(M24)]
Secondary	Number of Subjects With rSBA 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. This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]
Secondary	rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]
Secondary	rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and at Persistence Year 3 [PI(M36)]
Secondary	Number of Subjects With rSBA Antibody Titers = the Cut-off Value	The cut-off value for the rSBA titers was greater than or equal to (=) 1:8. This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]
Secondary	Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value	The cut-off value for the hSBA titers was greater than or equal to (=) 1:4.	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]
Secondary	hSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)] and Persistence Year 3 [PI(M36)]
Secondary	Number of Subjects With rSBA 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. This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]
Secondary	rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]
Secondary	Number of Subjects With rSBA Antibody Titers = the Cut-off Value	The cut-off value for the rSBA titers was greater than or equal to (=) 1:8. This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]
Secondary	rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory.	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]
Secondary	rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.	At Persistence Year 4 [PI(M48)]
Secondary	Number of Subjects With rSBA 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. This analysis was performed by the Health Protection Agency (HPA) laboratory.	At Persistence Year 4 [PI(M48)]
Secondary	Number of Subjects With rSBA Antibody Titers = the Cut-off Value	The cut-off value for the rSBA titers was greater than or equal to (=) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.	At Persistence Year 4 [PI(M48)]
Secondary	rSBA Antibody Titers (HPA Laboratory Assay)	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.	At Persistence Year 4 [PI(M48)]
Secondary	Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value	The cut-off value for the hSBA titers was greater than or equal to (=) 1:4.	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]
Secondary	hSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]
Secondary	Number of Subjects With rSBA 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. This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]
Secondary	rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]
Secondary	Number of Subjects With rSBA Antibody Titers = the Cut-off Value	The cut-off value for the rSBA titers was greater than or equal to (=) 1:8. This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)]
Secondary	rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the GSK Biologicals' laboratory, on the ATP cohort for persistence Year 5.	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)] and Persistence Year 4 [PI(M48)]
Secondary	Number of Subjects With rSBA 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. This analysis was performed by the Health Protection Agency (HPA) laboratory.	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]
Secondary	rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).This analysis was performed by the Health Protection Agency (HPA) laboratory.	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]
Secondary	Number of Subjects With rSBA Antibody Titers = the Cut-off Value	The cut-off value for the rSBA titers was greater than or equal to (=) 1:8. This analysis was performed by the Health Protection Agency (HPA) laboratory.	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]
Secondary	rSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs). This analysis was performed by the Health Protection Agency (HPA) laboratory.	Prior to (PRE), one month after vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and at Persistence Year 5 [PI(M60)]
Secondary	Number of Subjects With hSBA Antibody Titers Greater Than or Equal to the Cut-off Value	The cut-off value for the hSBA titers was greater than or equal to (=) 1:4.	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]
Secondary	hSBA Antibody Titers	Antibody titers are presented as geometric mean titers (GMTs).	Prior to (PRE), one month post vaccination [PI(M1)], at Persistence Year 1 [PI(M12)], Persistence Year 2 [PI(M24)], Persistence Year 3 [PI(M36)], Persistence Year 4 [PI(M48)] and Persistence Year 5 [PI(M60)]
Secondary	Number of Subjects With Solicited Local Symptoms	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) (1 - < 2 years of age and 2 - < 6 years of age groups) and 50 mm (6 - < 11 years of age groups) of injection site, respectively.	During the 4-day (Day 0-3) follow-up period
Secondary	Number of Subjects With Solicited General Symptoms	Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.	During the 4-day (Day 0-3) follow-up period
Secondary	Number of Subjects With Rash	Rash assessed included hives, idiopathic thrombocytopenic purpura and petechiae.	From administration of the vaccine dose until 6 months later
Secondary	Number of Subjects With New Onset of Chronic Illnesses (NOCIs)	NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.	From administration of the vaccine dose until 6 months later
Secondary	Number of Subjects With Adverse Events (AEs) Resulting in an Emergency Room (ER) Visit	Among AEs prompting emergency room visits were: infections, injuries, skin diseases and respiratory diseases.	From administration of the vaccine dose until 6 months later
Secondary	Number of Subjects With Unsolicited AEs	An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.	During the 31-day (Days 0-30) post-vaccination period
Secondary	Number of Subjects With Serious Adverse Events (SAEs)	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	Up to 6 Months after vaccination
Secondary	Number of Subjects With SAE(s)	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	From 6 Months after vaccination up to Year 1
Secondary	Number of Subjects With SAE(s)	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	From 6 Months after vaccination up to Year 2
Secondary	Number of Subjects With SAE(s)	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	From 6 Months following vaccination up to Year 3
Secondary	Number of Subjects With SAE(s)	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	From 6 Months following vaccination up to Year 4
Secondary	Number of Subjects With SAE(s)	SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.	From 6 Months following vaccination up to Year 5

External 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.