Infections, MeningococcalPhase 3NCT01144663
Immunogenicity and Safety of Meningococcal Vaccine GSK 134612 Co-administered With Pneumococcal and DTPa-HBV-IPV/Hib Vaccines
A Phase 3 study testing Nimenrix™, Menjugate® and NeisVac-CTM in people with Infections, Meningococcal and Meningococcal Vaccines, run by GlaxoSmithKline at 44 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2 months of age. Pneumococcal conjugate vaccine and DTPa-HBV-IPV/Hib vaccines will be co-administered. Read more about this study
- Who is it for?
- Ages 6 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Infections, Meningococcal, Meningococcal Vaccines
- What is being tested?
- Nimenrix™, Menjugate® and NeisVac-CTM
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,095 participants
- Where
- 44 sitesin 3 countries
- Study dates
- 1 Jul 2010to 10 Sep 2013
- 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 6 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All subjects must satisfy ALL the following criteria at study entry:
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
- A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s) or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of at least 36 weeks.
Who cannot join
- Child in care.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Extended administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the first dose of vaccine(s) until 30 days after the last dose of vaccine(s) (i.e. booster dose), with the exception of rotavirus vaccine which can be administered at any time during the study, according to the national immunisation recommendations. MMR(V) vaccine, if recommended in national immunisation programs, can be given after the last blood sampling time point i.e. after Visit 6. Seasonal or pandemic influenza vaccine can be given at any time during the study, and according to the Summary of Product Characteristics and national 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 product (pharmaceutical product or device).
- Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, Streptococcus pneumoniae, Neisseria meningitidis serogroups A, C, W-135 or Y with the exception of vaccines where the first dose may be given within the first two weeks of life according to the national recommendations (for example hepatitis B and BCG).
Show all 15Show fewer
- History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease, pneumococcal and/or meningococcal disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, 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(s).
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures (history of a single, simple febrile seizure is permitted).
- Acute disease and/or fever at the time of enrolment. (Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic setting, or ≥ 38.0°C (100.4°F) on rectal setting).
- (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 since birth or planned administration during the study period.
Trial locations and contacts
44 sites in 3 countries.
44 sites in 3 countries
Germany28 sites
GSK Investigational Site
Bad Lobenstein, Thuringia, 07356
GSK Investigational Site
Baunatal-Grossenritte, Hesse, 34225
GSK Investigational Site
Berchtesgaden, Bavaria, 83471
GSK Investigational Site
Berlin, 12157
GSK Investigational Site
Berlin, 13055
GSK Investigational Site
Berlin, 14197
GSK Investigational Site
Bindlach, Bavaria, 95463
GSK Investigational Site
Detmold, North Rhine-Westphalia, 32756
GSK Investigational Site
Eschwege, Hesse, 37269
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227
GSK Investigational Site
Gilching, Bavaria, 82205
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694
GSK Investigational Site
Kirchheim, Bavaria, 85551
GSK Investigational Site
Kleve-Materborn, North Rhine-Westphalia, 47533
GSK Investigational Site
Leipzig, Saxony, 04178
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131
GSK Investigational Site
Munich, Bavaria, 81241
GSK Investigational Site
Porta Westfalica, North Rhine-Westphalia, 32457
GSK Investigational Site
Schwäbisch Hall, Baden-Wurttemberg, 74523
GSK Investigational Site
Solingen, North Rhine-Westphalia, 42719
GSK Investigational Site
Trier, Rhineland-Palatinate, 54290
GSK Investigational Site
Vellmar, Hesse, 34246
GSK Investigational Site
Wanzleben, Saxony-Anhalt, 39164
GSK Investigational Site
Weilheim, Bavaria, 82362
GSK Investigational Site
Weißenfels, Saxony-Anhalt, 06667
GSK Investigational Site
Worms, Rhineland-Palatinate, 67547
GSK Investigational Site
Wurzen, Saxony, 04808
Spain11 sites
GSK Investigational Site
Almería, 04009
GSK Investigational Site
Antequera/Málaga, 29200
GSK Investigational Site
Badalona, 08916
GSK Investigational Site
Blanes (Girona), 17300
GSK Investigational Site
Burgos, 09006
GSK Investigational Site
Ciudad Real, 13005
GSK Investigational Site
Manlleu, 08560
GSK Investigational Site
Seville, 41014
GSK Investigational Site
Valencia, 46026
GSK Investigational Site
Valladolid, 47012
GSK Investigational Site
Vic, 08500
Estonia5 sites
GSK Investigational Site
Haabneeme, 74001
GSK Investigational Site
Tallinn, 10117
GSK Investigational Site
Tallinn, 10617
GSK Investigational Site
Tallinn
GSK Investigational Site
Tartu, 51014
About this study
Official title: Immunogenicity and Safety of GSK Biologicals' Meningococcal Vaccine (GSK 134612) When Co-administered With a Pneumococcal Conjugate Vaccine and Infanrix Hexa™ in Healthy Infants
The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2 months of age. Pneumococcal conjugate vaccine and DTPa-HBV-IPV/Hib vaccines will be co-administered.
Read the detailed description
The study consists of a primary vaccination phase and a booster vaccination phase. The Protocol Posting has been updated due to protocol amendment 2.
- Conditions
- Infections, Meningococcal, Meningococcal Vaccines
- Being tested
- Nimenrix™, Menjugate®, NeisVac-CTM, Infanrix™ hexa, Synflorix™
- Keywords
- Infants, conjugate vaccine, immunogenicity, meningococcal vaccine, non-inferiority, co-administration
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nimenrix™Biological
4- or 3-dose intramuscular injection
Menjugate®Biological
3-dose intramuscular injection
NeisVac-CTMBiological
3-dose intramuscular injection
Infanrix™ hexaBiological
Also called Infanrix hexa™
4-dose intramuscular injection
Synflorix™Biological
4-dose intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| Nimenrix 3 Group | Experimental | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age. Receives: Biological: Nimenrix™; Biological: Infanrix™ hexa; Biological: Synflorix™ |
| Nimenrix 2 Group | Experimental | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age. Receives: Biological: Nimenrix™; Biological: Infanrix™ hexa; Biological: Synflorix™ |
| Menjugate Group | Active comparator | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age. Receives: Biological: Menjugate®; Biological: Infanrix™ hexa; Biological: Synflorix™ |
| NeisVac-C Group | Active comparator | Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age. Receives: Biological: NeisVac-CTM; Biological: Infanrix™ hexa; Biological: Synflorix™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value.
The cut-off value for the rSBA-MenA, rSBA-MenW-135 and rSBA-Y titers was greater than or equal to (≥) 1:8.
Indication of the immunogenicity of the 2-dose and 3-dose schedules: the lower limit of the two-sided exact 95% CI for the percentage of subjects with post-primary vaccination rSBA antibody titre ≥ 1:8 is greater than or equal to the pre-defined clinical limit of 80%.
Measured: One month after the final primary vaccination at Month 3
Number of Subjects With rSBA-MenC Antibody Titers ≥ the Cut-off Value
The cut-off value for rSBA-MenC titers was ≥ 1:8.
Measured: One month after the final primary vaccination at Month 3
Secondary outcomes (47)
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values
The cut-off values for rSBA-Men antibody titers were greater than or equal to (≥) 1:8 and ≥ 1:128 at pre-vaccination
Measured: Pre-primary vaccination at Month 0
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Measured: Pre-primary vaccination at Month 0
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values
The cut-off values for the rSBA-Men antibody titers were greater than or equal to (≥) 1:8 and ≥ 1:128.
Measured: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Measured: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values
The cut-off values for hSBA antibody titers were greater than or equal to (≥) 1:4 and ≥ 1:8.
Measured: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Measured: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values
The cut-off values for hSBA antibody titers were greater than or equal to (≥) 1:4 and ≥ 1:8.
Measured: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Measured: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
The cut-off values for anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F concentrations were greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL) and ≥ 0.35 µg/mL
Measured: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in µg/mL.
Measured: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
The cut-off values for anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F concentrations were ≥ 0.15 µg/mL and ≥ 0.35 µg/mL
Measured: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-pneumococcal Serotypes Antibody Concentrations
Anti-1, anti-4, anti-5, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19F and anti-23F antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in µg/mL.
Measured: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off Value
The cut-off value for anti-D and anti-T concentrations was greater than or equal to (≥) 0.1 IU/mL
Measured: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Measured: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value
The cut-off value for anti-D and anti-T concentrations was greater than or equal to (≥) 0.1 IU/mL
Measured: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL).
Measured: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off Value
The cut-off value for anti-PT, anti-FHA and anti-PRN concentrations was greater than or equal to (≥) 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Measured: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in EL.U/mL.
Measured: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off Value
The cut-off value for anti-PT, anti-FHA and anti-PRN concentrations was greater than or equal to (≥) 5 EL.U/mL.
Measured: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in EL.U/mL.
Measured: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Values
The cut-off values for anti-HBs concentrations were greater than or equal to (≥) 10 milli-international units per milliliter (mIU/mL) and ≥ 100 mIU/mL.
Measured: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
Measured: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Values
The cut-off values for anti-HBs concentrations were greater than or equal to (≥) 10 mIU/mL and ≥ 100 mIU/mL.
Measured: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL).
Measured: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off Values
The cut-off values for anti-PRP antibody concentrations were greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL) and ≥ 1.0 µg/mL.
Measured: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL).
Measured: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off Values
The cut-off values for anti-PRP antibody concentrations were greater than or equal to (≥) 0.15 µg/mL and ≥ 1.0 µg/mL.
Measured: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL).
Measured: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value
The cut-off value for anti-poliovirus type 1, 2 and 3 antibody concentrations was greater than or equal to (≥) 1:8.
Measured: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-polio Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Measured: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value
The cut-off value for anti-poliovirus type 1, 2 and 3 antibody concentrations was greater than or equal to (≥) 1:8.
Measured: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-polio Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Measured: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
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. For the Nimenrix 2, Menjugate and NeisVac-C groups, results corresponding to Dose 2 are for Infanrix hexa and Synflorix vaccination at Visit 2 (Month 1), while results corresponding to Dose 3 refer to the vaccination at Visit 3 (Month 2).
Measured: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
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: During the 8-day (Days 0-7) post-meningococcal vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
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: During the 8-day (Days 0-7) post-Infanrix hexa vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
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: During the 8-day (Days 0-7) post-Synflorix vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
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: During the 8-day (Days 0-7) post-meningococcal booster vaccination period
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
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: During the 8-day (Days 0-7) post-Infanrix™ hexa booster vaccination period
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 31-days (Days 0-30) post-each primary vaccination dose
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ Vaccination
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: During the 8-day (Days 0-7) post-Synflorix™ booster vaccination period
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 rectal temperature greater than or equal to (≥) 38 degrees Celsius (°C)]. Any = occurrence of any general symptoms, regardless of their intensity grade or relationship to study vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Not eating at all. Grade 3 Temperature= temperature above 40.0 (°C). Related = symptom assessed by the investigator as related to the vaccination. For the Nimenrix 2, Menjugate and NeisVac-C groups, results corresponding to Dose 2 are for Infanrix™ hexa and Synflorix™ vaccination at Visit 2 (Month 1), while results corresponding to Dose 3 refer to the vaccination at Visit 3 (Month 2).
Measured: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)
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 rectal temperature greater than or equal to (≥) 38 degrees Celsius (°C)]. Any = occurrence of any general symptoms, regardless of their intensity grade or relationship to study vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Not eating at all. Grade 3 Temperature= temperature above 40.0 (°C). Related = symptom assessed by the investigator as related to the vaccination.
Measured: During the 8-day (Days 0-7) post-booster vaccination period
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 31-days (Days 0-30) post-booster vaccination period
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 (from Day 0 to Month 16)
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: From Booster vaccination (Month 10) up to Extended Safety Follow-Up (ESFU) (Month 16)
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
NOCIs assessed included asthma, autoimmune disorders, type 1 diabetes and allergies.
Measured: During 31-days (Days 0-30) post-each primary vaccination dose (Day 0 to Month 3) and from primary vaccination up to ESFU (Month 16)
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
NOCIs assessed included asthma, autoimmune disorders, type 1 diabetes and allergies.
Measured: From Booster vaccination (Month 10 to Month 11) up to ESFU (Month 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study start1 Jul 2010
- Primary completion22 Jun 2012
- Study completion10 Sep 2013
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
- 2,095 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144663
- Sponsor's protocol ID
- 113369
- Other IDs
- 2009-016841-24, 2009
- Status last verified
- Dec 2020
- First submitted
- 3 Jun 2010
- Last updated
- 31 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Merino Arribas JM, Carmona Martinez A, Horn M, Perez Porcuna XM, Otero Reigada MD, Mares Bermudez J, Centeno Malfaz F, Miranda M, Mendez M, Garcia Cabezas MA, Wittermann C, Bleckmann G, Fischbach T, Kolhe D, van der Wielen M, Baine Y. Safety and Immunogenicity of the Quadrivalent Meningococcal Serogroups A, C, W and Y Tetanus Toxoid Conjugate Vaccine Coadministered With Routine Childhood Vaccines in European Infants: An Open, Randomized Trial. Pediatr Infect Dis J. 2017 Apr;36(4):e98-e107. doi: 10.1097/INF.0000000000001484.
PubMed 28002359Merino Arribas JM, Carmona Martinez A, Horn M, Perez Porcuna XM, Otero Reigada MDC, Mares Bermudez J, Centeno Malfaz F, Miranda M, Mendez M, Garcia Cabezas MA, Christoph W, Bleckmann G, Fischbach T, Kolhe D, Van der Wielen M, Baine Y. Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib and PHiD-CV When Coadministered With MenACWY-TT in Infants: Results of an Open, Randomized Trial. Pediatr Infect Dis J. 2018 Jul;37(7):704-714. doi: 10.1097/INF.0000000000002061.
PubMed 29620722
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of GSK Biologicals' Meningococcal Vaccine (GSK 134612) When Co-administered With a Pneumococcal Conjugate Vaccine and Infanrix Hexa™ in Healthy Infants
- ClinicalTrials.gov ID
- NCT01144663
- Acronym / sponsor ID
- 113369
- Conditions
- Infections, Meningococcal, Meningococcal Vaccines
- Keywords
- Infants, conjugate vaccine, immunogenicity, meningococcal vaccine, non-inferiority, co-administration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,095 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2010 (actual)
- Primary completion
- 22 Jun 2012 (actual)
- Study completion
- 10 Sep 2013 (actual)
- First posted
- 15 Jun 2010 (estimated)
- Results
- Posted 1 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate immunogenicity and safety of meningococcal conjugate vaccine GSK134612 compared to the licensed vaccines MenC-CRM197 and MenC-TT in infants of 2 months of age. Pneumococcal conjugate vaccine and DTPa-HBV-IPV/Hib vaccines will be co-administered.
Detailed description
The study consists of a primary vaccination phase and a booster vaccination phase. The Protocol Posting has been updated due to protocol amendment 2.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nimenrix 3 Group | Experimental | Biological: Nimenrix™, Biological: Infanrix™ hexa, Biological: Synflorix™Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 3 primary doses of Nimenrix™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 3, 4 and 12 months of age. |
| Nimenrix 2 Group | Experimental | Biological: Nimenrix™, Biological: Infanrix™ hexa, Biological: Synflorix™Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Nimenrix™ vaccine at 2 and 4 months of age, followed by a booster dose of Nimenrix™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age. |
| Menjugate Group | Active comparator | Biological: Menjugate®, Biological: Infanrix™ hexa, Biological: Synflorix™Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of Menjugate® vaccine at 2 and 4 months of age, followed by a booster dose of Menjugate® vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age. |
| NeisVac-C Group | Active comparator | Biological: NeisVac-CTM, Biological: Infanrix™ hexa, Biological: Synflorix™Healthy male or female subjects aged between and including, 6 and 12 weeks of age, intramuscularly received 2 primary doses of NeisVac-C™ vaccine at 2 and 4 months of age, followed by a booster dose of NeisVac-C™ vaccine at 12 months of age. Subjects were also administered intramuscular injections of Infanrix™ hexa and Synflorix™ vaccines at 2, 4 and 12 months of age. |
Who may qualify
- Ages
- 6 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visit).
- A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.
- Written informed consent obtained from the parent(s) or guardian of the subject.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- Born after a gestation period of at least 36 weeks.
Key exclusion criteria (15 listed)
- Child in care.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Extended administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone >= 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the first dose of vaccine(s) until 30 days after the last dose of vaccine(s) (i.e. booster dose), with the exception of rotavirus vaccine which can be administered at any time during the study, according to the national immunisation recommendations. MMR(V) vaccine, if recommended in national immunisation programs, can be given after the last blood sampling time point i.e. after Visit 6. Seasonal or pandemic influenza vaccine can be given at any time during the study, and according to the Summary of Product Characteristics and national 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 product (pharmaceutical product or device).
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 |
|---|---|---|
| Nimenrix™4- or 3-dose intramuscular injection | Biological | Nimenrix 2 Group, Nimenrix 3 Group |
| Menjugate®3-dose intramuscular injection | Biological | Menjugate Group |
| NeisVac-CTM3-dose intramuscular injection | Biological | NeisVac-C Group |
| Infanrix™ hexaAlso: Infanrix hexa™4-dose intramuscular injection | Biological | Menjugate Group, NeisVac-C Group, Nimenrix 2 Group, Nimenrix 3 Group |
| Synflorix™4-dose intramuscular injection | Biological | Menjugate Group, NeisVac-C Group, Nimenrix 2 Group, Nimenrix 3 Group |
Primary outcome
Percentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value.
Time frame: One month after the final primary vaccination at Month 3
The cut-off value for the rSBA-MenA, rSBA-MenW-135 and rSBA-Y titers was greater than or equal to (≥) 1:8. Indication of the immunogenicity of the 2-dose and 3-dose schedules: the lower limit of the two-sided exact 95% CI for the percentage of subjects with post-primary vaccination rSBA antibody titre ≥ 1:8 is greater than or equal to the pre-defined clinical limit of 80%.
Number of Subjects With rSBA-MenC Antibody Titers ≥ the Cut-off Value
Time frame: One month after the final primary vaccination at Month 3
The cut-off value for rSBA-MenC titers was ≥ 1:8.
47 secondary outcomes
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Cut-off Values
Time frame: Pre-primary vaccination at Month 0
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Time frame: Pre-primary vaccination at Month 0
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Antibody Titers Above the Cut-off Values
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Meningococcal Serogroups (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibody Titers Above the Cut-off Values
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers Above the Cut-off Values
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Anti-pneumococcal Serotypes (Anti-P) Antibody Concentrations Above the Cut-off Values
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-pneumococcal Serotypes Antibody Concentrations
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With Anti-pneumococcal Serotypes Antibody Concentrations Above the Cut-off Values
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-pneumococcal Serotypes Antibody Concentrations
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Concentrations ≥ the Cut-off Value
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-D and Anti-T Antibody Concentrations
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-D and Anti-T Antibody Concentrations
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Concentrations ≥ the Cut-off Value
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With Anti-PT, Anti-FHA and Anti-PRN Concentrations ≥ the Cut-off Value
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above the Cut-off Values
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-HBs Antibody Concentrations
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With Anti-HBs Antibody Concentrations Above the Cut-off Values
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-HBs Antibody Concentrations
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Concentrations ≥ the Cut-off Values
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-PRP Antibody Concentrations
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With Anti-PRP Antibody Concentrations Above the Cut-off Values
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-PRP Antibody Concentrations
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Anti-poliovirus Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Anti-polio Type 1, 2 and 3 Antibody Titers
Time frame: Pre-primary vaccination at Month 0 and one month after final primary vaccination at Month 3
Number of Subjects With Anti-polio Type 1, 2 and 3 Antibody Concentrations ≥ the Cut-off Value
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Anti-polio Type 1, 2 and 3 Antibody Titers
Time frame: Pre-Booster dose at Month 10 and one month post-Booster dose at Month 11
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 8-day (Days 0-7) post-vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Time frame: During the 8-day (Days 0-7) post-meningococcal vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Time frame: During the 8-day (Days 0-7) post-Infanrix hexa vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix Vaccination
Time frame: During the 8-day (Days 0-7) post-Synflorix vaccination period following each dose and across doses from Day 0 to Month 3 (Primary Vaccination)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-meningococcal Vaccination
Time frame: During the 8-day (Days 0-7) post-meningococcal booster vaccination period
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Infanrix™ Hexa Vaccination
Time frame: During the 8-day (Days 0-7) post-Infanrix™ hexa booster vaccination period
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: Within 31-days (Days 0-30) post-each primary vaccination dose
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Post-Synflorix™ Vaccination
Time frame: During the 8-day (Days 0-7) post-Synflorix™ booster vaccination period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28002359Merino Arribas JM, Carmona Martinez A, Horn M, Perez Porcuna XM, Otero Reigada MD, Mares Bermudez J, Centeno Malfaz F, Miranda M, Mendez M, Garcia Cabezas MA, Wittermann C, Bleckmann G, Fischbach T, Kolhe D, van der Wielen M, Baine Y. Safety and Immunogenicity of the Quadrivalent Meningococcal Serogroups A, C, W and Y Tetanus Toxoid Conjugate Vaccine Coadministered With Routine Childhood Vaccines in European Infants: An Open, Randomized Trial. Pediatr Infect Dis J. 2017 Apr;36(4):e98-e107. doi: 10.1097/INF.0000000000001484.
- Background: PubMed 29620722Merino Arribas JM, Carmona Martinez A, Horn M, Perez Porcuna XM, Otero Reigada MDC, Mares Bermudez J, Centeno Malfaz F, Miranda M, Mendez M, Garcia Cabezas MA, Christoph W, Bleckmann G, Fischbach T, Kolhe D, Van der Wielen M, Baine Y. Immunogenicity and Reactogenicity of DTPa-HBV-IPV/Hib and PHiD-CV When Coadministered With MenACWY-TT in Infants: Results of an Open, Randomized Trial. Pediatr Infect Dis J. 2018 Jul;37(7):704-714. doi: 10.1097/INF.0000000000002061.
Related trials for Infections, Meningococcal
Not yet recruitingPhase 4
Single-center, Open-label Study: Immunogenicity and Safety Observation After Vaccination With ACYW135 Meningococcal Polysaccharide Vaccine in Junior High School Students Aged 13-15 Years
Meningococcal Disease; Meningococcal Meningitis
RecruitingPhase 3
Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Infants and Toddlers in China
Meningococcal Infection, Healthy Volunteers
Active, not recruitingPhase 2
Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents
Meningitis, Meningococcal
RecruitingObservational study
A Study to Learn About the Safety of PENBRAYA During Pregnancy
Meningococcal Disease
RecruitingPhase 3
Phase Ⅲ Trial of Group ACYW135 Meningococcal Conjugate Vaccine in Children Aged 3-5 Months
Epidemic Meningitis, Meningococcal Vaccines
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
44 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nimenrix™, Menjugate® and NeisVac-CTM in people with Infections, Meningococcal and Meningococcal Vaccines, run by GlaxoSmithKline at 44 sites in 3 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 6 inclusion and 15 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 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Germany, Spain, Estonia. 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 1 Feb 2019). 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?
Percentage of Subjects With Serum Bactericidal Assay Using Baby Rabbit Complement Against Meningococcal Serogroups A, W-135 and Y (rSBA-MenA, rSBA-MenW-135 and rSBA-Y) Antibody Titers Greater Than or Equal to (≥) the Cut-off Value. (time frame: One month after the final primary vaccination at Month 3). The study lists 2 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 NCT01144663, 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 31 Dec 2020.