A Phase II, Randomized, Partially Blinded Study to Assess the Safety, Tolerability and Immunogenicity of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Infants
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Infections, Meningococcal
- Sponsor
- GlaxoSmithKline
- Enrollment
- 724
- Locations
- 1
- Primary Endpoint
- Percentage of participants with solicited administration site events
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
The purpose of this study is to assess the safety, tolerability and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY-2Gen) vaccine intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups, in healthy infants 2 months of age (MoA) at enrolment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
- •Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
- •Healthy participants as established by medical history and clinical examination before entering into the study.
- •A male or female between, and including, 55 and 89 days of age (approximately 2 MoA) at the time of the first study vaccination.
- •Born after a gestation period of ≥37 weeks, with a birth weight ≥2.5 kg.
Exclusion Criteria
- •Medical conditions
- •Current or previous, confirmed or suspected disease caused by N. meningitidis.
- •Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection from birth.
- •Progressive, unstable or uncontrolled clinical conditions.
- •Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.
- •Any neuroinflammatory disorders, congenital and peripartum neurological conditions, encephalopathies, seizures.
- •Congenital or peripartum disorders resulting in a chronic condition
- •Major congenital defects, as assessed by the investigator.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product(s).
- •Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM197) and latex medicinal products or medical equipment whose use is foreseen in this study.
Outcomes
Primary Outcomes
Percentage of participants with solicited administration site events
Time Frame: During the 7 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1 and 61 and Day 301)
The solicited administration site events include tenderness, erythema, induration and swelling.
Percentage of participants with any unsolicited adverse events (AEs), including all medically attended adverse events (MAEs), serious adverse events (SAEs), AEs leading to withdrawal, and adverse events of special interest (AESIs)
Time Frame: During the 30 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1 and 61 and Day 301)
Unsolicited AEs includes any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. MAEs are defined as symptoms or illnesses requiring a hospitalization, or an emergency room visit, or visit to/by a health care provider. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.
hSBA geometric mean titers (GMTs) for each serogroup B indicator strain
Time Frame: At 1 month after the second vaccination (Day 91)
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMTs. For each serogroup B indicator strain 90% CIs for the GMTs ratio between ABCWY-2Gen low dose/ ABCWY-2Gen high dose and MenB, is created by exponentiating (base 10) the least squares means and the lower and upper limits of the 90% CIs of the log transformed titers (base 10) obtained from a 2-way Analysis of Variance (ANOVA) with factors for arms and center.
hSBA GMTs for each serogroup B indicator strain
Time Frame: At 1 month after the third vaccination (Day 331)
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMTs. For each serogroup B indicator strain 90% CIs for the GMTs ratio between ABCWY-2Gen low dose/ ABCWY-2Gen high dose and MenB, is created by exponentiating (base 10) the least squares means and the lower and upper limits of the 90% CIs of the log transformed titers (base 10) obtained from a 2-way ANOVA with factors for arms and center.
Within group hSBA geometric mean ratios (GMRs) for each serogroup B indicator strain
Time Frame: At 1 month after the third vaccination (Day 331) compared to pre-third vaccination (Day 301)
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine against serogroup B indicator strains is determined using hSBA GMRs. Within-group ratios of hSBA GMTs against each of the N.meningitidis serogroup B indicator strain at Day 331 compared to Day 301.
hSBA GMTs for each A, C, W and Y serogroup
Time Frame: At 1 month after the third vaccination (Day 331)
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine against serogroups A, C, W and Y is determined using hSBA GMTs. For each A, C, W, and Y serogroup 90% CIs for the GMTs ratio between ABCWY-2Gen low dose/ ABCWY-2Gen high dose and MenACWY-TT, is created by exponentiating (base 10) the least squares means and the lower and upper limits of the 90% CIs of the log transformed titers (base 10) obtained from a 2-way ANOVA with factors for arms and center.
Percentages of participants with MAEs, SAEs, AEs leading to withdrawal, and AESIs
Time Frame: During the study period (Day 1 through Day 481)
MAEs are defined as symptoms or illnesses requiring a hospitalization, or an emergency room visit, or visit to/by a health care provider. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.
Percentage of participants with hSBA titers ≥ LLOQ for each serogroup B indicator strain
Time Frame: At 1 month after the third vaccination (Day 331)
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine is evaluated by measuring bactericidal activity using an hSBA against all serogroup B indicator strains.
Within group hSBA GMRs for each A, C, W and Y serogroup
Time Frame: At 1 month after the third vaccination (Day 331) compared to pre-third vaccination (Day 301)
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine against serogroups A, C, W and Y is determined using hSBA GMRs. Within-group ratios of hSBA GMTs against each of the N.meningitidis A, C, W and Y serogroups at Day 331 compared to Day 301.
Percentage of participants with human serum bactericidal assay (hSBA) titers ≥ lower limit of quantitation (LLOQ) for each serogroup B indicator strain
Time Frame: At 1 month after the second vaccination (Day 91)
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenB vaccine is evaluated by measuring bactericidal activity using an hSBA against all serogroup B indicator strains.
Percentage of participants with solicited systemic events
Time Frame: During the 7 days (including the day of vaccination) after each vaccination (vaccines administered on Day 1 and 61 and Day 301)
The solicited systemic events include fever, irritability/fussiness, loss of appetite, drowsiness, vomiting and diarrhoea. Fever is defined as temperature \>38.0°C/100.4°F. The preferred location for measuring temperature will be axillary.
Percentage of participants with hSBA titers ≥ LLOQ for each A, C, W and Y serogroup
Time Frame: At 1 month after the third vaccination (Day 331)
The immune response to the MenABCWY-2Gen vaccine (low and high dose), the MenABCWY-1Gen vaccine and the MenACWY-TT vaccine is evaluated by measuring bactericidal activity using an hSBA against serogroups A, C, W and Y. The percentages of participants with hSBA titers ≥ LLOQ and the corresponding exact 2-sided 95% CIs based on Clopper-Pearson method are calculated.