CompletedNCT01777308Updated Jan 25, 2019Results posted

Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' MenACWY-TT Vaccine Administered 6 Years Post-MenC Primary Vaccination in Healthy Subjects Who Were 12-18 Months at Primary Vaccination

A Phase 3 interventional study of Meningococcal conjugate vaccine GSK134612 in Infections, Meningococcal, sponsored by GlaxoSmithKline. Completed at 8 sites in Australia. Open to participants aged 84 Months to 95 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-25.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 156
Allocation: Non-randomized
Ages: 84 Months to 95 Months
Sex: All

Study summary

The purpose of this study is to evaluate the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' MenACWY-TT vaccine administered at 6 years post-primary vaccination with either GSK Biologicals' Hib-MenC-TT vaccine (Menitorix™) or Hiberix™ and Meningitec™, in healthy subjects aged 12-18 months at primary vaccination and to evaluate the long-term antibody persistence at 2 years after MenACWY-TT booster vaccination.

This is an extension study of the Hib-MenC-TT-016 study (NCT number: NCT00326118).

Conditions studied

Infections, Meningococcal

Browse trials for

Meningococcal Infections 219

Keywords

Immunogenicity
Booster
Healthy
Vaccine response
Safety
Neisseria meningiditis
Antibody persistence
Meningococcal conjugate vaccine

In context

Meningococcal Infections

219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.

This study's enrollment of 156 is below the median of 450 across 190 interventional studies indexed under Meningococcal Infections.

Browse Meningococcal Infections studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 84 Months to 95 Months
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Subjects' parent(s)/Legally Acceptable Representative(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, 84 and 95 months of age at the time of the booster vaccination.
Written informed consent obtained from the parent(s)/LAR(s) of the subject and written informed assent obtained from the subject in accordance with local laws and regulations.
Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
Having completed the vaccination in the study [Hib-MenC-TT-016 (106445)] as per protocol.

Exclusion criteria

Exclusion Criteria:

Child in care.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the 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 vaccine dose. For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
Administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the study vaccine dose, with the exception of a licensed inactivated influenza vaccine which can be administered at any time during the study according to the local recommendations.
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 vaccine/product.
Previous vaccination with meningococcal vaccine except the meningococcal vaccination received in the Hib-MenC-TT-016 study.
History of meningococcal disease.
Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including Human Immunodeficiency Virus (HIV)infection, based on medical history and physical examination (no laboratory testing required).
Family history of congenital or hereditary immunodeficiency.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, and history of serious allergic reaction (anaphylaxis) following the administration of vaccine(s).
Major congenital defects or serious chronic illness.
History of any neurological disorders or seizures, including GBS. History of a simple, single febrile seizure is permitted.
Acute disease and/or fever at the time of enrollment.
- Fever is defined as temperature ≥ 37.5°C for oral, axillary or tympanic route, or ≥ 38.0°C for rectal route. The preferred route for recording temperature in this study will be oral.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
Administration of immunoglobulins and/or any blood products within the 3 months preceding the study vaccination or planned administration during the booster vaccination phase of the study (i.e. between Visit 1 and Visit 2) and within 3 months preceding the blood sampling at Visit 3.

The following criteria should be checked for the long-term persistence phase at two years after booster vaccination (Visit 3):

In case an exclusion criterion becomes applicable, the subject will not enter the long-term follow-up and the reason will be documented.

Previous administration of a meningococcal vaccine with the exception of the meningococcal vaccination given in the primary study and the booster vaccination in this particular study.
History of meningococcal disease.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 156 participants (actual)

Study arms

Experimental
Menitorix Group
Subjects who were primed with Menitorix™ (Hib-MenC-TT) + Priorix™ (MMR) vaccines in the primary study HIB-MENC-TT-016 (NCT00326118) received one dose of Nimenrix™ (MenACWY-TT) booster vaccine at Month 72 post primary vaccination (booster visit 1). The MenACWY-TT vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
Biological: Meningococcal conjugate vaccine GSK134612
Experimental
Meningitec + Hiberix Group
Subjects who were primed with Meningitec™ (MCC) + Hiberix™ (Hib) + Priorix™ (MMR) vaccine in the primary study HIB-MENC-TT-016 (NCT00326118) received one dose of Nimenrix™ (MenACWY-TT) booster vaccine at Month 72 post primary vaccination (booster visit 1). The MenACWY-TT vaccine was administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
Biological: Meningococcal conjugate vaccine GSK134612

Interventions

BiologicalMeningococcal conjugate vaccine GSK134612
Single dose to be administrated intramuscularly in the deltoid of the non-dominant arm

What researchers measure

Primary outcomes

Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroup A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY)
Vaccine response was defined as: For initially seronegative subjects (pre-vaccination rSBA titer below 1:8), antibody titer greater than or equal to (≥) 1:32 at post-vaccination; for initially seropositive subjects, antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer.
Time frame: At Month 73, one month post-booster vaccination

Secondary outcomes

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
The cut-off values for the rSBA titers were greater than or equal to (≥) 1:8 and 1:128.
Time frame: At Month 73, one month post-booster vaccination
Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: At Month 73, one month post-booster vaccination
Number of Subjects With Anti-tetanus (Anti-T) Concentrations ≥ the Predefined Cut-off Values
The cut-off values for anti-T concentrations were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.
Time frame: At Month 73, one month post-booster vaccination
Antibody Concentrations Against Tetanus (Anti-T) Antigen
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Time frame: At Month 73, one month post-booster vaccination
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
The cut-off values for the rSBA titers were greater than or equal to (≥) 1:8 and 1:128.
Time frame: At Month 96, 24 months post-booster vaccination
Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY
Antibody titers were presented as geometric mean titers (GMTs).
Time frame: At Month 96, 24 months post-booster vaccination
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms included pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) post-booster vaccination period at Month 72
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, and fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 4-day (Days 0-3) post-booster vaccination period at Month 72
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: During the 31-day (Days 0-30) post-booster vaccination period at Month 72
Number of Subjects With Any Unsolicited Adverse Events (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.
Time frame: During the 31-day (Days 0-30) post-booster vaccination period at Month 72
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.
Time frame: During the 31-day (Days 0-30) post-booster vaccination period at Month 72
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.
Time frame: From Month 72 up to study end, at Month 96

Results

Posted Jan 25, 2019

Participant flow

Participant flow — Overall Study
Milestone	Menitorix Group	Meningitec + Hiberix Group
Started	119	37
Completed up to month 73	118	37
Completed	105	34
Not completed	14	3
Withdrew: Withdrawal by subject	5	1
Withdrew: Migrated/moved from study area	1	0
Withdrew: Lost to follow-up	7	2
Withdrew: Blood draw refusal at visit 3	1	0

Outcome measures

PrimaryNumber of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroup A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY)

Vaccine response was defined as: For initially seronegative subjects (pre-vaccination rSBA titer below 1:8), antibody titer greater than or equal to (≥) 1:32 at post-vaccination; for initially seropositive subjects, antibody titer at post-vaccination ≥ 4 fold the pre-vaccination antibody titer.

Time frame:: At Month 73, one month post-booster vaccination
Reported as:: Count of participants · Participants

Number of Subjects With Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroup A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY)
Participants	Menitorix Group	Meningitec + Hiberix Group
rSBA-MenA	102	33
rSBA-MenC	101	33
rSBA-MenW-135	102	33
rSBA-MenY	101	33

SecondaryNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values

The cut-off values for the rSBA titers were greater than or equal to (≥) 1:8 and 1:128.

Time frame:: At Month 73, one month post-booster vaccination
Reported as:: Count of participants · Participants

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
Participants	Menitorix Group	Meningitec + Hiberix Group
rSBA-MenA, ≥ 1:8	102	35
rSBA-MenA, ≥ 1:128	102	35
rSBA-MenC, ≥ 1:8	102	35
rSBA-MenC, ≥ 1:128	102	34
rSBA-MenW-135, ≥ 1:8	102	35
rSBA-MenW-135, ≥ 1:128	102	35
rSBA-MenY, ≥ 1:8	103	34
rSBA-MenY, ≥ 1:128	103	34

SecondaryAntibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY

Antibody titers were presented as geometric mean titers (GMTs).

Time frame:: At Month 73, one month post-booster vaccination
Reported as:: Geometric mean · Titer

Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY
Titer	Menitorix Group	Meningitec + Hiberix Group
rSBA-MenA	3421.4 (2659.3 to 4402)	2925.1 (1949.5 to 4389)
rSBA-MenC	11819.2 (9026.4 to 15476.1)	7419.7 (4543.2 to 12117.3)
rSBA-MenW-135	17166.5 (12745.9 to 23120.3)	15747.7 (10033 to 24717.7)
rSBA-MenY	4871 (3932.7 to 6033.1)	3495.9 (2126.6 to 5746.8)

SecondaryNumber of Subjects With Anti-tetanus (Anti-T) Concentrations ≥ the Predefined Cut-off Values

The cut-off values for anti-T concentrations were greater than or equal to (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL.

Time frame:: At Month 73, one month post-booster vaccination
Reported as:: Count of participants · Participants

Number of Subjects With Anti-tetanus (Anti-T) Concentrations ≥ the Predefined Cut-off Values
Participants	Menitorix Group	Meningitec + Hiberix Group
Anti-T ≥ 0.1 IU/mL	103	34
Anti-T ≥ 1 IU/mL	102	33

SecondaryAntibody Concentrations Against Tetanus (Anti-T) Antigen

Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).

Time frame:: At Month 73, one month post-booster vaccination
Reported as:: Geometric mean · IU/mL

Antibody Concentrations Against Tetanus (Anti-T) Antigen
IU/mL	Menitorix Group	Meningitec + Hiberix Group
Antibody Concentrations Against Tetanus (Anti-T) Antigen	15.6 (13.1 to 18.6)	12.5 (8.4 to 18.7)

SecondaryNumber of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values

The cut-off values for the rSBA titers were greater than or equal to (≥) 1:8 and 1:128.

Time frame:: At Month 96, 24 months post-booster vaccination
Reported as:: Count of participants · Participants

Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Predefined Cut-off Values
Participants	Menitorix Group	Meningitec + Hiberix Group
rSBA-MenA, ≥ 1:8	72	21
rSBA-MenA, ≥ 1:128	67	17
rSBA-MenC, ≥ 1:8	100	31
rSBA-MenC, ≥ 1:128	90	26
rSBA-MenW-135, ≥ 1:8	96	30
rSBA-MenW-135, ≥ 1:128	96	30
rSBA-MenY, ≥ 1:8	95	29
rSBA-MenY, ≥ 1:128	95	29

SecondaryAntibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY

Antibody titers were presented as geometric mean titers (GMTs).

Time frame:: At Month 96, 24 months post-booster vaccination
Reported as:: Geometric mean · Titers

Antibody Titers Against rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBa-MenY
Titers	Menitorix Group	Meningitec + Hiberix Group
rSBA-MenA	174.9 (102.4 to 298.7)	79.0 (29.6 to 210.4)
rSBA-MenC	333.1 (278.3 to 398.8)	175.4 (104.1 to 295.5)
rSBA-MenW-135	1002.9 (742.1 to 1355.5)	941.5 (448.4 to 1976.9)
rSBA-MenY	929.3 (678.0 to 1273.7)	512.0 (250.1 to 1048.3)

SecondaryNumber of Subjects With Any Solicited Local Symptoms

Assessed solicited local symptoms included pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

Time frame:: During the 4-day (Days 0-3) post-booster vaccination period at Month 72
Reported as:: Count of participants · Participants

Number of Subjects With Any Solicited Local Symptoms
Participants	Menitorix Group	Meningitec + Hiberix Group
Any Pain	69	15
Any Redness	56	19
Any Swelling	30	8

SecondaryNumber of Subjects With Any Solicited General Symptoms

Assessed solicited general symptoms were fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain), headache, and fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.

Time frame:: During the 4-day (Days 0-3) post-booster vaccination period at Month 72
Reported as:: Count of participants · Participants

Number of Subjects With Any Solicited General Symptoms
Participants	Menitorix Group	Meningitec + Hiberix Group
Any Fatigue	31	10
Any Gastrointestinal symptoms	29	5
Any Headache	29	6
Any Fever	6	1

SecondaryNumber of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)

NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.

Time frame:: During the 31-day (Days 0-30) post-booster vaccination period at Month 72
Reported as:: Count of participants · Participants

Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
Participants	Menitorix Group	Meningitec + Hiberix Group
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)	0	0

SecondaryNumber of Subjects With Any Unsolicited Adverse Events (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.

Time frame:: During the 31-day (Days 0-30) post-booster vaccination period at Month 72
Reported as:: Count of participants · Participants

Number of Subjects With Any Unsolicited Adverse Events (AEs)
Participants	Menitorix Group	Meningitec + Hiberix Group
Number of Subjects With Any Unsolicited Adverse Events (AEs)	36	7

SecondaryNumber 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.

Time frame:: During the 31-day (Days 0-30) post-booster vaccination period at Month 72
Reported as:: Count of participants · Participants

Number of Subjects With Serious Adverse Events (SAEs)
Participants	Menitorix Group	Meningitec + Hiberix Group
Number of Subjects With Serious Adverse Events (SAEs)	0	0

SecondaryNumber 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.

Time frame:: From Month 72 up to study end, at Month 96
Reported as:: Count of participants · Participants

Number of Subjects With Serious Adverse Events (SAEs)
Participants	Menitorix Group	Meningitec + Hiberix Group
Number of Subjects With Serious Adverse Events (SAEs)	0	0

Adverse events

Collected over Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period; Solicited and unsolicited symptoms: during the 31-day (Days 0-30) post-vaccination period; SAEs: up to study end at Month 96.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Menitorix Group	0/119 (0%)	0/119 (0%)	95/119 (79.8%)
Meningitec + Hiberix Group	0/37 (0%)	0/37 (0%)	28/37 (75.7%)

Most frequent other events

Most frequent other events
Event	Menitorix Group	Meningitec + Hiberix Group
PainGeneral disorders	69/119	15/37
ErythemaSkin and subcutaneous tissue disorders	56/119	19/37
FatigueGeneral disorders	31/119	10/37
HeadacheNervous system disorders	30/119	7/37
SwellingGeneral disorders	30/119	8/37
Gastrointestinal disorderGastrointestinal disorders	29/119	5/37
Upper respiratory tract infectionInfections and infestations	7/119	2/37
PyrexiaGeneral disorders	6/119	2/37

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Menitorix Group	Meningitec + Hiberix Group	Total
Mean	7.0 ± 0.2	7.0 ± 0.0	7.0 ± 0.17

Sex: Female, Male
Sex: Female, Male(Participants)	Menitorix Group	Meningitec + Hiberix Group	Total
Female	57	14	71
Male	62	23	85

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Menitorix Group	Meningitec + Hiberix Group	Total
Geographic ancestry — Asian-East Asian Heritage	1	1	2
Geographic ancestry — Asian-South East Asian Heritage	1	0	1
Geographic ancestry — White-Caucasian/European Heritage	109	36	145
Geographic ancestry — Asian - Central/South Asian Heritage	1	0	1
Geographic ancestry — Unspecified	7	0	7

Study locations

8 sites

GSK Investigational Site
Garran, Australian Capital Territory 2606, Australia
GSK Investigational Site
Randwick, New South Wales 2031, Australia
GSK Investigational Site
Westmead, New South Wales 2145, Australia
GSK Investigational Site
Herston, Queensland 4029, Australia
GSK Investigational Site
Sherwood, Queensland 4075, Australia
GSK Investigational Site
North Adelaide, South Australia 5006, Australia
GSK Investigational Site
Carlton, Victoria 3053, Australia
GSK Investigational Site
Subiaco, Western Australia 6008, Australia

References and documents

Publications

Nolan T, Booy R, Marshall HS, Richmond P, Nissen M, Ziegler JB, Baine Y, Traskine M, Jastorff A, Van der Wielen M. Immunogenicity and Safety of a Quadrivalent Meningococcal ACWY-tetanus Toxoid Conjugate Vaccine 6 Years After MenC Priming as Toddlers. Pediatr Infect Dis J. 2019 Jun;38(6):643-650. doi: 10.1097/INF.0000000000002334. PubMed 31116180 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01777308
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Jan 28, 2013
Start date: May 3, 2013
Primary completion: Jul 3, 2014
Completion: Apr 20, 2016
Results posted: Jan 25, 2019
Last update: Jan 25, 2019

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

View the source record on ClinicalTrials.gov ↗

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