Study to Evaluate Persistence of Antibodies After Vaccination With Meningococcal Vaccine GSK 134612

Persistence of Antibodies After Vaccination With GSK Biologicals' Meningococcal Vaccine GSK134612 in Adolescents and Young Adults

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00974363

Enrollment

697

Registered

2009-09-10

Start date

2009-09-30

Completion date

2013-05-31

Last updated

2017-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Meningococcal

Keywords

meningococcal vaccine GSK 134612

Brief summary

Subjects were previously vaccinated at 11 to 17 years of age. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new subjects will be enrolled.

Detailed description

Subjects were previously vaccinated at 11 to 17 months of age with GSK Biologicals' meningococcal vaccine 134612 or with Mencevax™. This extension phase starts 24 months after vaccination and the subjects who were vaccinated in the primary study will be enrolled in this extension phase. No new studies will be enrolled. The subjects will have 4 blood samples taken: at 24, 36, 48 and 60 months after vaccination.

Interventions

PROCEDUREBlood Sampling

A blood sample will be taken yearly at each long-term follow-up visit (i.e. Year 2 through Year 5) after vaccination during the primary study. No vaccines are administered in the long-term follow-up study

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

11 Years to 17 Years

Healthy volunteers

Yes

Inclusion criteria

* Subjects who the investigator believes that they and/or their parent(s)/guardian(s) can and will comply with the requirements of the protocol should be enrolled in the study. * A male or female having been vaccinated with a meningococcal vaccine in the primary study 109069. * Written informed consent obtained from parent(s)/guardian(s) of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday. * Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion criteria

* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the subject's first visit. * History of meningococcal disease; such cases will be documented. * Administration of a meningococcal polysaccharide or a meningococcal polysaccharide conjugate vaccine since previous vaccination in study 109069. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history. * Administration of immunoglobulins and/or any blood products within the three months preceding the subject's first visit. * Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy * Subjects who withdrew consent to be contacted for follow-up studies.

Design outcomes

Primary

Measure	Time frame	Description
Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups	At Month 24 post primary dose	A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the GSK Biologicals' laboratory.

Secondary

Measure	Time frame	Description
Number of Seropositive Subjects Against the Vaccine Meningococcal Serogroups	At Months 24, 36, 48 and 60 post primary dose	A seropositive subject was defined as a subject who had the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:128. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory.
Antibody Titers Against the Vaccine Meningococcal Serogroups	At Months 24, 36, 48 and 60 post primary dose	Seropositivity status was defined as the anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) titers equal to or above the cut-off value of 1:128. Antibody titers were presented as geometric mean titers (GMTs). The blood analyses were performed at the Public Health of England's (PHE) laboratory and at GSK Biologicals' laboratory.
Number of Subjects With Antibody Concentrations Against the Vaccine Polysaccharides	At Month 24 post primary dose	Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).
Antibody Concentrations Against the Vaccine Polysaccharides	At Month 24 post primary dose	Antibody concentrations against polysaccharide A (anti-PSA), polysaccharide C (anti-PSC), polysaccharide W-135 (anti-PSW-135) and polysaccharide Y (anti-PSY) assessed were equal to or above (≥) the cut-off values of 0.3 micrograms/milliliter (µg/mL ) and 2.0 micrograms/milliliter (µg/mL). Concentration of antibodies was determined by enzyme-linked immunosorbent assay (ELISA).

Countries

India, Philippines

Participant flow

Recruitment details

Out of the 697 subjects enrolled in this study, only 689 were vaccinated and hence started the study.

Pre-assignment details

During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Participants by arm

Arm	Count
Nimenrix™ Group Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.	521
Mencevax™ Group Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.	168
Total	689

Baseline characteristics

Characteristic	Nimenrix™ Group	Mencevax™ Group	Total
Age, Continuous	16.4 Years STANDARD_DEVIATION 1.94	16.4 Years STANDARD_DEVIATION 2	16.4 Years STANDARD_DEVIATION 1.95
Sex: Female, Male Female	273 Participants	86 Participants	359 Participants
Sex: Female, Male Male	248 Participants	82 Participants	330 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 521	0 / 168
serious Total, serious adverse events	0 / 521	0 / 168

Outcome results

Primary

Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups

A seroprotected subject was defined as a subject who had anti-meningococcal serogroups A (MenA), C (MenC), W-135 (MenW-135) and Y (MenY) antibody titers equal to or above (≥) the cut-off value of 1:8. The persistence of serum bactericidal antibodies was evaluated using baby rabbit complement (rSBA) titers. The blood analyses were performed at the GSK Biologicals' laboratory.

Time frame: At Month 24 post primary dose

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for persistence, which included all evaluable subjects for whom assay results were available for at least one tested antigen.

Arm	Measure	Group	Value (NUMBER)
Nimenrix™ Group	Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups	rSBA- MenW-135, GSK laboratory [N=407;131]	405 Subjects
Nimenrix™ Group	Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups	rSBA- MenA, GSK laboratory [N=405;132]	404 Subjects
Nimenrix™ Group	Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups	rSBA- MenY, GSK laboratory [N=407;130]	407 Subjects
Nimenrix™ Group	Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups	rSBA- MenC, GSK laboratory [N=407;132]	404 Subjects
Mencevax™ Group	Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups	rSBA- MenY, GSK laboratory [N=407;130]	126 Subjects
Mencevax™ Group	Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups	rSBA- MenA, GSK laboratory [N=405;132]	132 Subjects
Mencevax™ Group	Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups	rSBA- MenW-135, GSK laboratory [N=407;131]	124 Subjects
Mencevax™ Group	Number of Seroprotected Subjects Against the Vaccine Meningococcal Serogroups	rSBA- MenC, GSK laboratory [N=407;132]	131 Subjects

Primary