Infections, MeningococcalPhase 3NCT00758264

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

A Phase 3 study testing Meningococcal vaccine GSK134612 and Pneumococcal vaccine GSK1024850A in people with Infections, Meningococcal, run by GlaxoSmithKline at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 12 to 23 monthsHealthy volunteers can take part
Conditions the study is for: Infections, Meningococcal
What is being tested?: Meningococcal vaccine GSK134612 and Pneumococcal vaccine GSK1024850A
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 363 participants
Where: 5 sitesin 2 countries
Study dates: 30 Oct 2008to 2 Nov 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 23 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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

Show all 16Show fewer

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.
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.

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

Taiwan3 sites

GSK Investigational Site
Taipei, 100
GSK Investigational Site
Taipei, 105
GSK Investigational Site
Taoyuan Hsien

Other trials in Taiwan

Mexico2 sites

GSK Investigational Site
México, 14000
GSK Investigational Site
Mexico City, 14000

Other trials in Mexico

About this study

Official title: Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When Co-administered With GSK Biologicals' Pneumococcal Vaccine GSK1024850A in Healthy 12-23-month-old Children Previously Primed With GSK1024850A

Read the detailed description

Multi-center study with 3 parallel groups. One group will receive 2 vaccines injections at the same visit (pneumococcal+ meningococcal), one group will receive a pneumococcal vaccine followed one month later by a meningococcal vaccine, and the last group will receive the meningococcal vaccine followed one month later by the pneumococcal vaccine.

All subjects will have one blood sample taken before vaccination and one blood sample taken one month after each vaccination (i.e. the first group will have 2 blood samples taken, and the other two groups will have 3 blood sample taken)

Conditions: Infections, Meningococcal
Being tested: Meningococcal vaccine GSK134612, Pneumococcal vaccine GSK1024850A
Keywords: Safety, Routine infancy vaccination, Meningococcal vaccine, Immunogenicity, Pneumococcal vaccine
Medical subject headings: Meningococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Meningococcal vaccine GSK134612Biological
Single dose intramuscular injection.
Pneumococcal vaccine GSK1024850ABiological
Single dose intramuscular injection.

Study groups in NCT00758264
Study group	Role	What they receive
Group A	Experimental	Meningococcal vaccine GSK134612 co-administered with pneumococcal vaccine GSK1024850A. Receives: Biological: Meningococcal vaccine GSK134612; Biological: Pneumococcal vaccine GSK1024850A
Group B	Active comparator	Pneumococcal vaccine GSK1024850A followed one month later by meningococcal vaccine GSK134612. Receives: Biological: Meningococcal vaccine GSK134612; Biological: Pneumococcal vaccine GSK1024850A
Group C	Active comparator	Meningococcal vaccine GSK134612 followed one month later by pneumococcal vaccine GSK1024850A. Receives: Biological: Meningococcal vaccine GSK134612; Biological: Pneumococcal vaccine GSK1024850A

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: At Month 1

Secondary outcomes (15)

Anti-pneumococcal Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) via 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Measured: Before vaccination (PRE) and at one month post dose 2 (Month 2)
Cross-reactive Anti-pneumococcal Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in µg/mL. The pneumococcal serotypes assessed were 6A and 19A (anti-6A and anti-19A) via the 22F-inhibition ELISA. GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Measured: 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
Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPSONO-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Measured: 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
Opsonophagocytic titers are presented as geometric mean titers (GMTs). The pneumococcal serotypes assessed were 6A and 19A (OPSONO-6A and OPSONO-19A). GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Measured: 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
Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Measured: Before vaccination (PRE), at one month post dose 1(Month 1) and at one month post dose 2 (Month 2)
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers
Antibody titers are presented as geometric mean titers (GMTs) and measured in titers. GMTs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Measured: Before vaccination (PRE) and at one month post dose 2 (Month 2)
Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Measured: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Anti-tetanus (Anti-T) Antibody Concentrations
Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). GMCs post Dose 2 are not presented for Nimenrix + Synflorix Group, as they received only one study vaccination dose.
Measured: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Measured: Within the 4-day (Days 0-3) post-vaccination period after each dose
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as rectally temperature equal to or above (≥) 38.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 drowsiness = drowsiness that prevented normal activities. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever higher than (>) 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Measured: Within the 4-day (Days 0-3) post-vaccination period after each dose
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.
Measured: Within the 31-day (Day 0-30) post-vaccination period after each dose
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: Throughout the entire study duration (Day 0-Month 7)
Number of Subjects Reporting Rash
Rash-like symptoms assessed were hives, idiopathic thrombocytopenic purpura, petechiae.
Measured: Throughout the entire study duration (Day 0-Month 7)
Number of Subjects With New Onset Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Measured: Throughout the entire study duration (Day 0-Month 7)
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Among AEs prompting emergency room visits were: infections, injuries, skin diseases, gastrointestinal symptoms.
Measured: Throughout the entire study duration (Day 0-Month 7)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 20082 Nov 2009

First posted25 Sep 2008 (estimated)
Study start30 Oct 2008
Primary completion2 Jun 2009
Study completion2 Nov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Infections, MeningococcalStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 363 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00758264
Sponsor's protocol ID: 111393
Status last verified: Apr 2017
First submitted: 23 Sep 2008
Last updated: 9 May 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

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.
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.
PubMed 23076383

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When Co-administered With GSK Biologicals' Pneumococcal Vaccine GSK1024850A in Healthy 12-23-month-old Children Previously Primed With GSK1024850A
ClinicalTrials.gov ID: NCT00758264
Acronym / sponsor ID: 111393
Conditions: Infections, Meningococcal
Keywords: Safety, Routine infancy vaccination, Meningococcal vaccine, Immunogenicity, Pneumococcal vaccine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 363 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 30 Oct 2008
Primary completion: 2 Jun 2009 (actual)
Study completion: 2 Nov 2009 (actual)
First posted: 25 Sep 2008 (estimated)
Results: Posted 9 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group A	Experimental	Biological: Meningococcal vaccine GSK134612, Biological: Pneumococcal vaccine GSK1024850AMeningococcal vaccine GSK134612 co-administered with pneumococcal vaccine GSK1024850A.
Group B	Active comparator	Biological: Meningococcal vaccine GSK134612, Biological: Pneumococcal vaccine GSK1024850APneumococcal vaccine GSK1024850A followed one month later by meningococcal vaccine GSK134612.
Group C	Active comparator	Biological: Meningococcal vaccine GSK134612, Biological: Pneumococcal vaccine GSK1024850AMeningococcal vaccine GSK134612 followed one month later by pneumococcal vaccine GSK1024850A.

Who may qualify

Ages: 12 to 23 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Meningococcal vaccine GSK134612Single dose intramuscular injection.	Biological	Group A, Group B, Group C
Pneumococcal vaccine GSK1024850ASingle dose intramuscular injection.	Biological	Group A, Group B, Group C

Primary outcome

Anti-pneumococcal Antibody Concentrations
Time frame: At Month 1
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).
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
Time frame: At Month 1
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers
Time frame: At Month 1
Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers.

15 secondary outcomes

Anti-pneumococcal Antibody Concentrations
Time frame: Before vaccination (PRE) and at one month post dose 2 (Month 2)
Cross-reactive Anti-pneumococcal Antibody Concentrations
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Before vaccination (PRE), at one month post dose 1(Month 1) and at one month post dose 2 (Month 2)
rSBA-MenA, rSBA-MenC, rSBA-MenW -135 and rSBA-Men-Y Antibody Titers
Time frame: Before vaccination (PRE) and at one month post dose 2 (Month 2)
Anti-meningococcal Polysaccharide (Anti-PS) Antibody Concentrations
Time frame: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Anti-tetanus (Anti-T) Antibody Concentrations
Time frame: Before vaccination (PRE), at one month post dose 1 (Month 1) and at one month post dose 2 (Month 2)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: Within the 4-day (Days 0-3) post-vaccination period after each dose
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: Within the 4-day (Days 0-3) post-vaccination period after each dose
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: Within the 31-day (Day 0-30) post-vaccination period after each dose
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: Throughout the entire study duration (Day 0-Month 7)
Number of Subjects Reporting Rash
Time frame: Throughout the entire study duration (Day 0-Month 7)
Number of Subjects With New Onset Chronic Illnesses (NOCIs)
Time frame: Throughout the entire study duration (Day 0-Month 7)
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Time frame: Throughout the entire study duration (Day 0-Month 7)

Results and safety

Results posted to the registry on 9 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nimenrix + Synflorix Group	182	181
Nimenrix Group	91	91
Synflorix Group	90	85

Primary outcome: Anti-pneumococcal Antibody Concentrations

Time frame: At Month 1. Geometric mean (95% Confidence Interval). Unit: μg/mL

Measure	Nimenrix + Synflorix Group n = 175	Nimenrix Group n = 81	Synflorix Group n = 81
Anti-1	3.43 (3.06 to 3.85)	0.33 (0.27 to 0.41)	3.60 (2.96 to 4.38)
Anti-4	6.86 (6.06 to 7.76)	0.52 (0.41 to 0.65)	6.98 (5.82 to 8.37)
Anti-5	4.97 (4.40 to 5.62)	0.54 (0.43 to 0.67)	5.07 (4.34 to 5.93)
Anti-6B	2.91 (2.48 to 3.41)	0.53 (0.41 to 0.68)	3.14 (2.55 to 3.85)
Anti-7F	5.32 (4.75 to 5.95)	0.88 (0.74 to 1.04)	5.10 (4.26 to 6.10)
Anti-9V	4.70 (4.15 to 5.32)	0.79 (0.64 to 0.98)	4.74 (3.96 to 5.67)
Anti-14	8.89 (7.65 to 10.33)	1.16 (0.88 to 1.51)	9.00 (7.40 to 10.95)
Anti-18C	9.81 (8.40 to 11.45)	0.73 (0.56 to 0.94)	19.48 (15.20 to 24.97)

Nimenrix + Synflorix Group vs Synflorix Group: Adjusted GMC ratio: 0.87 (95% CI 0.72 to 1.05)
Nimenrix + Synflorix Group vs Synflorix Group: Adjusted GMC ratio: 1.03 (95% CI 0.84 to 1.26)
Nimenrix + Synflorix Group vs Synflorix Group: Adjusted GMC ratio: 0.90 (95% CI 0.74 to 1.10)

Population analysed: The analysis was done on the According-to-protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. The primary outcome concerns the Nimenrix + Synflorix Group and the Synflorix Group.

Primary outcome: 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

Time frame: At Month 1. Count of participants. Unit: Participants

Measure	Nimenrix + Synflorix Group n = 174	Nimenrix Group n = 80	Synflorix Group n = 79
rSBA-MenA	173	78	23
rSBA-MenC	173	79	9
rSBA-MenW-135	174	79	40
rSBA-MenY	173	80	48

Nimenrix + Synflorix Group vs Nimenrix Group: Difference in percentage: 1.93 (95% CI -1.09 to 8.15)
Nimenrix + Synflorix Group vs Nimenrix Group: Difference in percentage: 0.68 (95% CI -2.11 to 6.22)
Nimenrix + Synflorix Group vs Nimenrix Group: Difference in percentage: 1.25 (95% CI -0.94 to 6.76)

Primary outcome: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-Men-Y Antibody Titers

Time frame: At Month 1. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Nimenrix + Synflorix Group n = 174	Nimenrix Group n = 80	Synflorix Group n = 79
rSBA-MenA	6673.7 (5680.7 to 7840.4)	5016.6 (3594.8 to 7000.8)	23.5 (12.7 to 43.5)
rSBA-MenC	2496.6 (2096.5 to 2973.0)	2044.0 (1522.8 to 2743.6)	6.4 (4.7 to 8.7)
rSBA-MenW- 135	11731.0 (10270.7 to 13398.9)	8407.7 (6225.4 to 11355.0)	35.8 (21.5 to 59.6)
rSBA-MenY	6797.8 (6014.4 to 7683.4)	5606.2 (4484.5 to 7008.3)	68.4 (39.9 to 117.2)

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local/general symptoms: during the 4-day post-vaccination period (Days 0-3). Unsolicited AEs: during the 31-day post-vaccination period (Days 0-30). SAEs: during the entire study period (from Day 0 up to Month 7).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nimenrix + Synflorix Group	6 of 182 (3.3%)	154 of 182 (84.6%)	0 of 182
Nimenrix Group	3 of 91 (3.3%)	81 of 91 (89%)	0 of 91
Synflorix Group	4 of 90 (4.4%)	76 of 90 (84.4%)	0 of 90

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundHuang 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: PubMed 23076383Ruiz-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.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Meningococcal vaccine GSK134612 and Pneumococcal vaccine GSK1024850A in people with Infections, Meningococcal, run by GlaxoSmithKline at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Taiwan, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anti-pneumococcal Antibody Concentrations (time frame: At Month 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00758264, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.