Clinical trial NCT01340898: Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine When Co-administered With Routine Vaccines in Healthy Infants and Toddlers
Official title: Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Conjugate Vaccine (GSK 134612) When Co-administered With Routine Vaccines in Healthy Infants and Toddlers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Infection
Keywords: meningococcal conjugate vaccine
serogroups A,C, W-135 or Y
meningococcal diseases
Immunogenicity
Neisseria meningitidis
co-administration
routine vaccines
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-04-25
Enrollment: 753
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 in healthy infants, when co-administered with other infant vaccines, on three different dose schedules.

Detailed description: This protocol has been updated following Protocol Amendment 1 date 26 July 2011 leading to the update of enrollment, a secondary outcome measure, intervention and exclusion criteria sections.

Eligibility criteria: Inclusion Criteria:

* Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol.
* A male or female, 6 to 12 weeks (42-90 days) of age at the time of the first vaccination.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born after a gestation period of at least 36 weeks.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product 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 of immunosuppressants or other immune-modifying drugs since birth.
* Planned administration/administration of a vaccine not foreseen by the study protocol during the period 30 days before and after each study vaccine administration, with the exception of rotavirus vaccine and seasonal or pandemic influenza vaccine.
* 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.
* Previous vaccination against diphtheria , tetanus, pertussis, polio (with the exception of a birth dose of OPV), Haemophilus influenzae type b, Streptococcus pneumonia.
* History of receipt of meningococcal vaccine.
* Subjects who received a birth dose Hepatitis B vaccines within the 30 days before the administration of the first study vaccine.
* History of or intercurrent diphtheria, tetanus, pertussis, polio, 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 th

Primary outcomes:
measure: Number of Subjects With Serum Bactericidal Assay Using Rabbit Complement (rSBA) Against Neisseria Meningitidis Serogroups Antibody Titers Greater Than or Equal to (≥) 1:8, One Month Post Dose 3 for the Nimenrix 3+1 Group
timeFrame: At Month 5 (one month post-dose 3)
Secondary outcomes:
measure: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:8 Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group
timeFrame: At Month 13 (prior booster) and at Month 14 (one month after the booster dose)
measure: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) 1:128, One Month Post-dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group
timeFrame: At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)
measure: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers One Month Post Dose 3, Prior to and One Month After the Booster Dose for the Nimenrix 3+1 Group
timeFrame: At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)
measure: Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers Greater Than or Equal to (≥) the Cut-off Values for the Nimenrix 1+1 and Nimenrix Control Groups
timeFrame: At Months 5 (one month post-primary dose for Nimenrix 1+1 Group), 13 (prior booster dose for Nimenrix 1+1 and prior primary dose for Nimenrix Control Group) and 14 (post booster dose for Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)
measure: rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers for Nimenrix 1+1 and Nimenrix Control Groups
timeFrame: At Months 5 (one month post-primary dose for Nimenrix 1+1 Group), 13 (prior booster dose for Nimenrix 1+1 and prior primary dose for Nimenrix Control Group) and 14 (post booster dose Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)
measure: Number of Subjects With Booster Responses for rSBA-MenA, C rSBA-MenC, Y rSBA-MenY and W-135 rSBA-MenW-135 in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group
timeFrame: At Month 14 (one month post-booster dose for Nimenrix 3+1 and Nimenrix 1+1 and post-primary dose for Nimenrix Control Group)
measure: Number of Subjects With Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroups A, C, W-135, Y Antibody Titers Greater Than or Equal to (≥) the Cut-off Values (One Month Post-primary for Nimenrix 3+1 and 1+1 Groups)
timeFrame: At Month 5 (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)
measure: hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (One Month Post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)) -Randomized Subset of 50% of Subjects of All Three Groups
timeFrame: At Month 5 (one month post-primary for Nimenrix 3+1 and Nimenrix 1+1 Groups)
measure: Number of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-Men-Y Titers (≥) the Cut-off Value (Pre- and Post-booster for Nimenrix 3+1 and 1+1 Groups and Pre- and Post-vaccination for Nimenrix Control)
timeFrame: At Month 13 (pre-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and pre-vaccination for Nimenrix Control), and at Month 14 (post-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and post-vaccination for Nimenrix Control)
measure: hSBA-MenA, hSBA-MenC, hSBA-MenW-135, and hSBA-Men-Y Antibody Titers (Pre-booster for Nimenrix 3+1 and 1+1 Groups and Pre-vaccination for Nimenrix Control, and Post-booster for Nimenrix 3+1 and 1+1 Groups and Post-vaccination for Nimenrix Control)
timeFrame: At Month 13 (pre-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and pre-vaccination for Nimenrix Control), and at Month 14 (post-booster for Nimenrix 3+1 and Nimenrix 1+1 Groups and post-vaccination for Nimenrix Control)
measure: Number of Subjects With Booster Responses for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY in Nimenrix 3+1 and Nimenrix 1+1 Groups and With Vaccine Response in Nimenrix Control Group
timeFrame: At Month 14 (one month after the booster dose in Nimenrix 3+1 and Nimenrix 1+1 and post-vaccination in Nimenrix Control Group)
measure: Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.15 Micrograms Per Milliliter (µg/mL).
timeFrame: At Months 5 (one month post-dose 3), Month 13 (prior booster dose) and Month 14 (one month after the booster dose)
measure: Number of Subjects With Anti-pneumococcal Antibody Concentrations Greater Than or Equal to (≥) 0.35 Micrograms Per Milliliter (µg/mL)
timeFrame: At Months 5 (one month post-dose 3), Month 13 (prior booster dose) and Month 14 (one month after the booster dose)
measure: Anti-pneumococcal Antibody Concentrations
timeFrame: At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)
measure: Number of Subjects With Anti-diphtheria (Anti-D) Antibodies
timeFrame: At Month 5 (one month post-dose 3)
measure: Concentration of Antibodies Against Diphtheria Antigens (Anti-D)
timeFrame: At Month 5 (one month post-dose 3)
measure: Concentration of Antibodies Against Diphtheria Antigens (Anti-D)
timeFrame: At Month 5 (one month post-dose 3)
measure: Concentration of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) Antigens
timeFrame: At Month 5 (one month post-dose 3)
measure: Number of Subjects With Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA), Anti-pertactin (Anti-PRN) Immunoglobulin G (IgG) Antibodies
timeFrame: At Month 5 (one month post-dose 3)
measure: Antibody Titers for Anti-polio Type 1, 2 and 3 Antibodies
timeFrame: At Month 5 (one month post-dose 3)
measure: Antibody Titers for Anti-polio Type 1, 2 and 3 Antibodies
timeFrame: At Month 5 (one month post-dose 3)
measure: Number of Subjects With Anti-tetanus (Anti-T) Antibodies
timeFrame: At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)
measure: Concentration of Antibodies Against Tetanus Antigens (Anti-T)
timeFrame: At Months 5 (one month post-dose 3), Month 13 (prior booster-dose) and Month 14 (one month after the booster dose)
measure: Number of Subjects With Anti-tetanus (Anti-T) Antibodies
timeFrame: At Months 5 (one month post-dose 3), 13 (prior booster-dose) and 14 (one month after the booster dose)
measure: Anti-PRP Antibody Concentrations (Geometric Mean Concentrations) in a Randomized Subset of 25% of the Subjects
timeFrame: At Month 5 (one month post-dose 3)
measure: Number of Subjects With Solicited Local Symptoms (Primary Phase)
timeFrame: Within 8 days (Day 0-7) post primary vaccination
measure: Number of Subjects With Solicited Local Symptoms (Booster Phase)
timeFrame: Within 8 days (Day 0-7) post booster vaccination
measure: Number of Subjects With Solicited General Symptoms (Primary Phase)
timeFrame: Within 8 days (Day 0-7) post primary vaccination
measure: Number of Subjects With Solicited General Symptoms (Booster Phase)
timeFrame: Within 8 days (Day 0-7) post booster vaccination
measure: Number of Subjects With Unsolicited Adverse Events (AEs) (Primary Phase)
timeFrame: Within 31 days (Day 0-30) post each primary vaccine dose
measure: Number of Subjects With Unsolicited Adverse Events (AEs) (Booster Phase)
timeFrame: Within 31 days (Day 0-30) post booster vaccination
measure: Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
timeFrame: From Day 0 to Month 19
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: From Day 0 to Month 19
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: GSK Investigational Site
city: Durango
country: Mexico
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Dbaibo G, Tinoco Favila JC, Traskine M, Jastorff A, Van der Wielen M. Immunogenicity and safety of MenACWY-TT, a meningococcal conjugate vaccine, co-administered with routine childhood vaccine in healthy infants: A phase III, randomized study. Vaccine. 2018 Jun 27;36(28):4102-4111. doi: 10.1016/j.vaccine.2018.05.046. Epub 2018 May 18.