Infections, Meningococcal
Conditions
Brief summary
This is Phase IV, Open label, Multicenter study. Subject's parents and/or legal guardian will be provided information about the trial. If interested and if eligible, they will then be asked to provide signed informed consent. The initial study visit can occur immediately after signed informed consent has been obtained. Approximately 135 subjects will be enrolled to receive 4 doses of intramuscular MenACWY vaccine at 2, 4, 6 and 12 months of age.
Interventions
BIOLOGICALMenACWY
Four Intramuscular doses of MenACWY vaccine at 2, 4, 6 and 12 months of age followed by two blood samples at 13 and 24 months of age.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 24 Months
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male and female 2 month-old infants (55 - 89 days) on the day of consent. 2. Infants whose parents or legal guardians have voluntary given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. 3. Infants whose parents or legal guardians can comply with study procedures including follow-up
Exclusion criteria
1. Previously received any meningococcal A, C, W and Y vaccines. 2. Previous confirmed or suspected disease caused by N. meningitidis or who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection at any time since birth. 3. Progressive, unstable or uncontrolled clinical conditions. 4. A history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component, such as latex allergy. 5. Experienced significant acute or chronic infection within the previous 7 days or have experienced fever (temperature ≥ 38.0°C \[100.4°F\]) within the previous 3 days. 6. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. 7. Received treatment with systemic administration corticosteroids (PO/IV/IM) for more than 14 consecutive days from birth 8. Ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin) at any time since birth and for the full length of the study. 9. Any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw. 10. Any condition which, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study. 11. Received or are planning to receive any investigational or non-registered medicinal product from birth and throughout the study. 12. Received oral or parenteral antibiotic treatment in the 3 days prior to the scheduled blood draw (topical antibiotics are acceptable, including antibiotic eye drops). 13. Relatives of site research staff working on this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 128 Against Each N.Meningitidis Serogroup at 24 Months of Age | At 24 months of age (Visit 6) | To assess antibody persistence against N. Meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement |
| Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Within 30 minutes of each vaccination | Solicited signs and symptoms occurring within 30 minutes following each vaccination, include solicited local events (e.g. injection site erythema, induration and tenderness -threshold for Erythema and Induration: Type II- None \[\<10mm\], Any\[\>=10 mm\]), solicited systemic events (e.g. change in eating habits, sleepiness, irritability, vomiting, diarrhea, fever\[ body temperature \>=38°C measured preferably via tympanic route\]), and any other solicited event like use of analgesic/antipyretics for treatment or for prophylaxis |
| Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination | From Day 1 to Day 7 after each vaccination | Solicited local AEs reported from day 1 to day 7 after each vaccination were assessed. Assessed local symptoms include injection site erythema, injection site induration and injection site tenderness. Any = incidence of a particular symptom regardless of intensity grade.Threshold for Erythema and Induration: Type II None (\<10 mm), Any (\>=10 mm) |
| Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | From Day 1 to Day 7 after each vaccination | Solicited systemic AEs reported from day 1 to day 7 after each vaccination were assessed. Assessed systemic symptoms include change in eating habits, sleepiness, irritability, vomiting, diarrhea and fever (body temperature ≥ 38°C (100.4°F)). |
| Number of Subjects With Any Medically Attended Unsolicited AEs and AEs Leading to Premature Withdrawal | From Day 1 to Visit 6 (at 24 Months of age) | An unsolicited adverse event is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject parent(s)/legal guardian(s)\] who has signed the informed consent. All medically attended unsolicited AEs were collected from Day 1 to Visit 6. |
| Number of Subjects With Serious AEs (SAEs) | From Day 1 to Visit 6 (At 24 months of age) | Subjects reporting SAEs from day 1 to visit 6 (at 24 months of age) were assessed. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in one or more of the following: death, is life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above. |
| Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 8 Against Each N.Meningitidis Serogroup A,C,W and Y at 24 Months of Age. | At 24 months of age (Visit 6) | To assess antibody persistence against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using human serum complement. |
| Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 8, Against Each N.Meningitidis Serogroup at 24 Months of Age | At 24 months of age (Visit 6) | To assess antibody persistence against N. Meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With rSBA Titers ≥ 8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | At 13 months of age (Visit 5) | To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement. |
| Percentage of Subjects With rSBA Titers ≥ 128 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | At 13 months of age (Visit 5) | To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement. |
| hSBA Geometric Mean Titers (GMTs) Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age | At 24 months of age (Visit 6) | To assess persistence of antibody response in terms of GMTs using hSBA assay against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine. |
| rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age | At 24 months of age (Visit 6) | To assess persistence of antibody response in terms of GMTs using rSBA assay against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine. |
| hSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | At 13 months of age (Visit 5) | To assess antibody response in terms of GMTs using hSBA assay against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine. |
| rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age. | At 13 months of age (Visit 5) | To assess antibody response in terms of GMTs using rSBA assay against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine. |
| Percentage of Subjects With hSBA ≥8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | At 13 months of age (Visit 5) | To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using human serum complement. |
Countries
South Korea
Participant flow
Recruitment details
Subjects were enrolled from 6 centers in South Korea.
Pre-assignment details
All enrolled subjects were vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| MenACWY Group Healthy male and female infants approximately 2 months (55-89 days) of age on the day of consent, who received 4 doses of the GSK MenACWY Conjugate Vaccine, administered intramuscularly, at 2, 4, 6 and 12 months of age. | 128 |
| Total | 128 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 8 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | MenACWY Group |
|---|---|
| Age, Continuous | 71.7 Days STANDARD_DEVIATION 8.09 |
| Race/Ethnicity, Customized Asian | 127 Participants |
| Race/Ethnicity, Customized Unspecified | 1 Participants |
| Sex: Female, Male Female | 59 Participants |
| Sex: Female, Male Male | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 128 |
| other Total, other adverse events | 112 / 128 |
| serious Total, serious adverse events | 26 / 128 |
Outcome results
Primary
Number of Subjects With Any Medically Attended Unsolicited AEs and AEs Leading to Premature Withdrawal
An unsolicited adverse event is an adverse event that was not solicited using a Subject Diary and that was spontaneously communicated by a subject parent(s)/legal guardian(s)\] who has signed the informed consent. All medically attended unsolicited AEs were collected from Day 1 to Visit 6.
Time frame: From Day 1 to Visit 6 (at 24 Months of age)
Population: Analysis was performed on the unsolicited safety set, which included all subjects who received a study vaccination and reported any unsolicited adverse event data.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenACWY Group | Number of Subjects With Any Medically Attended Unsolicited AEs and AEs Leading to Premature Withdrawal | Any Medically Attended Unsolicited AEs | 85 Participants |
| MenACWY Group | Number of Subjects With Any Medically Attended Unsolicited AEs and AEs Leading to Premature Withdrawal | AEs leading to premature withdrawal | 0 Participants |
Primary
Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination.
Solicited signs and symptoms occurring within 30 minutes following each vaccination, include solicited local events (e.g. injection site erythema, induration and tenderness -threshold for Erythema and Induration: Type II- None \[\<10mm\], Any\[\>=10 mm\]), solicited systemic events (e.g. change in eating habits, sleepiness, irritability, vomiting, diarrhea, fever\[ body temperature \>=38°C measured preferably via tympanic route\]), and any other solicited event like use of analgesic/antipyretics for treatment or for prophylaxis
Time frame: Within 30 minutes of each vaccination
Population: Analysis was performed on the solicited safety set, which included all subjects who received a study vaccination and reported any solicited adverse event data and/or indicators of solicited adverse events.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Injection site induration, Vaccination 3, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Injection site tenderness, Vaccination 3, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Sleepiness, Vaccination 3, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Vomiting, Vaccination 3, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Fever, Vaccination 1, No | 128 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Injection site erythema, Vaccination 1, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Injection site erythema, Vaccination 2, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Injection site erythema, Vaccination 3, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Injection site erythema, Vaccination 4, Any | 1 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Injection site induration, Vaccination 1, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Injection site induration, Vaccination 2, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Injection site induration, Vaccination 4, Any | 1 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Injection site tenderness, Vaccination 1, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Injection site tenderness, Vaccination 2, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Injection site tenderness, Vaccination 4, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Change in eating habits, Vaccination 1, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Change in eating habits, Vaccination 2, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Change in eating habits, Vaccination 3, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Change in eating habits, Vaccination 4, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Diarrhea, Vaccination 1, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Diarrhea, Vaccination 2, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Diarrhea, Vaccination 3, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Diarrhea, Vaccination 4, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Irritability, Vaccination 1, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Irritability, Vaccination 2, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Irritability, Vaccination 3, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Irritability, Vaccination 4, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Sleepiness, Vaccination 1, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Sleepiness, Vaccination 2, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Sleepiness, Vaccination 4, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Vomiting, Vaccination 1, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Vomiting, Vaccination 2, Any | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Vomiting, Vaccination 4, Any | 1 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Fever, Vaccination 1, Yes | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Fever, Vaccination 2, Yes | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Fever, Vaccination 2, No | 128 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Fever, Vaccination 3, Yes | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Fever, Vaccination 3, No | 128 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Fever, Vaccination 4, Yes | 0 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Adverse Events (AEs) Within 30 Minutes After Each Vaccination. | Fever, Vaccination 4, No | 124 Participants |
Primary
Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination
Solicited local AEs reported from day 1 to day 7 after each vaccination were assessed. Assessed local symptoms include injection site erythema, injection site induration and injection site tenderness. Any = incidence of a particular symptom regardless of intensity grade.Threshold for Erythema and Induration: Type II None (\<10 mm), Any (\>=10 mm)
Time frame: From Day 1 to Day 7 after each vaccination
Population: Analysis was performed on the solicited safety set, which included all subjects who received a study vaccination and reported any solicited adverse event data and/or indicators of solicited adverse events.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenACWY Group | Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination | Injection site induration, Vaccination 2, Any | 9 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination | Injection site induration, Vaccination 3, Any | 3 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination | Injection site erythema, Vaccination 1, Any | 4 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination | Injection site erythema, Vaccination 2, Any | 6 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination | Injection site erythema, Vaccination 3, Any | 6 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination | Injection site erythema, Vaccination 4, Any | 6 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination | Injection site induration, Vaccination 1, Any | 4 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination | Injection site induration, Vaccination 4, Any | 6 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination | Injection site tenderness, Vaccination 1, Any | 17 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination | Injection site tenderness, Vaccination 2, Any | 21 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination | Injection site tenderness, Vaccination 3, Any | 14 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Local AEs From Day 1 to Day 7 After Each Vaccination | Injection site tenderness, Vaccination 4, Any | 20 Participants |
Primary
Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination.
Solicited systemic AEs reported from day 1 to day 7 after each vaccination were assessed. Assessed systemic symptoms include change in eating habits, sleepiness, irritability, vomiting, diarrhea and fever (body temperature ≥ 38°C (100.4°F)).
Time frame: From Day 1 to Day 7 after each vaccination
Population: Analysis was performed on the solicited safety set, which included all subjects who received a study vaccination and reported any solicited adverse event data and/or indicators of solicited adverse events.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Change in eating habits, Vaccination 2, Any | 21 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Change in eating habits, Vaccination 3, Any | 21 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Sleepiness, Vaccination 4, Any | 20 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Fever, Vaccination 4, No | 109 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Change in eating habits, Vaccination 1, Any | 29 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Change in eating habits, Vaccination 4, Any | 24 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Diarrhea, Vaccination 1, Any | 15 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Diarrhea, Vaccination 2, Any | 13 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Diarrhea, Vaccination 3, Any | 15 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Diarrhea, Vaccination 4, Any | 17 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Irritability, Vaccination 1, Any | 58 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Irritability, Vaccination 2, Any | 49 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Irritability, Vaccination 3, Any | 47 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Irritability, Vaccination 4, Any | 45 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Sleepiness, Vaccination 1, Any | 52 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Sleepiness, Vaccination 2, Any | 31 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Sleepiness, Vaccination 3, Any | 28 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Vomiting, Vaccination 1, Any | 26 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Vomiting, Vaccination 2, Any | 20 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Vomiting, Vaccination 3, Any | 15 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Vomiting, Vaccination 4, Any | 5 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Fever, Vaccination 1, Yes | 4 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Fever, Vaccination 1, No | 124 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Fever, Vaccination 2, Yes | 10 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Fever, Vaccination 2, No | 118 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Fever, Vaccination 3, Yes | 6 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Fever, Vaccination 3, No | 121 Participants |
| MenACWY Group | Number of Subjects With Any Solicited Systemic AEs From Day 1 to Day 7 After Each Vaccination. | Fever, Vaccination 4, Yes | 15 Participants |
Primary
Number of Subjects With Serious AEs (SAEs)
Subjects reporting SAEs from day 1 to visit 6 (at 24 months of age) were assessed. A serious adverse event (SAE) is defined as any untoward medical occurrence that at any dose results in one or more of the following: death, is life-threatening, required or prolonged hospitalization, persistent or significant disability/incapacity, congenital anomaly/or birth defect, An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based upon appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above.
Time frame: From Day 1 to Visit 6 (At 24 months of age)
Population: Analysis was performed on the overall safety set, which included all subjects who received a study vaccination and reported any solicited/unsolicited adverse event data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MenACWY Group | Number of Subjects With Serious AEs (SAEs) | 26 Participants |
Primary
Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 8 Against Each N.Meningitidis Serogroup A,C,W and Y at 24 Months of Age.
To assess antibody persistence against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using human serum complement.
Time frame: At 24 months of age (Visit 6)
Population: Analysis was performed on the Full analysis set (FAS), which included all enrolled subjects who received at least one study vaccination and provided an evaluable hSBA Visit 6 assessment, one year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age), for at least one serogroup.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY Group | Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 8 Against Each N.Meningitidis Serogroup A,C,W and Y at 24 Months of Age. | Serogroup A | 39 Percentage of subjects |
| MenACWY Group | Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 8 Against Each N.Meningitidis Serogroup A,C,W and Y at 24 Months of Age. | Serogroup C | 61 Percentage of subjects |
| MenACWY Group | Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 8 Against Each N.Meningitidis Serogroup A,C,W and Y at 24 Months of Age. | Serogroup W | 88 Percentage of subjects |
| MenACWY Group | Percentage of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 8 Against Each N.Meningitidis Serogroup A,C,W and Y at 24 Months of Age. | Serogroup Y | 89 Percentage of subjects |
Primary
Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 128 Against Each N.Meningitidis Serogroup at 24 Months of Age
To assess antibody persistence against N. Meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement
Time frame: At 24 months of age (Visit 6)
Population: Analysis was performed on the FAS, which included all enrolled subjects who receive at least one study vaccination and provided an evaluable rSBA Visit 6 assessment, one year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age), for at least one serogroup.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY Group | Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 128 Against Each N.Meningitidis Serogroup at 24 Months of Age | Serogroup A | 98 Percentage of subjects |
| MenACWY Group | Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 128 Against Each N.Meningitidis Serogroup at 24 Months of Age | Serogroup C | 30 Percentage of subjects |
| MenACWY Group | Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 128 Against Each N.Meningitidis Serogroup at 24 Months of Age | Serogroup W | 62 Percentage of subjects |
| MenACWY Group | Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 128 Against Each N.Meningitidis Serogroup at 24 Months of Age | Serogroup Y | 80 Percentage of subjects |
Primary
Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 8, Against Each N.Meningitidis Serogroup at 24 Months of Age
To assess antibody persistence against N. Meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement
Time frame: At 24 months of age (Visit 6)
Population: Analysis was performed on the FAS, which included all enrolled subjects who receive at least one study vaccination and provided an evaluable rSBA Visit 6 assessment, one year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age), for at least one serogroup.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY Group | Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 8, Against Each N.Meningitidis Serogroup at 24 Months of Age | Serogroup A | 99 Percentage of subjects |
| MenACWY Group | Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 8, Against Each N.Meningitidis Serogroup at 24 Months of Age | Serogroup C | 54 Percentage of subjects |
| MenACWY Group | Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 8, Against Each N.Meningitidis Serogroup at 24 Months of Age | Serogroup W | 69 Percentage of subjects |
| MenACWY Group | Percentage of Subjects With Rabbit Serum Bactericidal Assay (rSBA) Titers ≥ 8, Against Each N.Meningitidis Serogroup at 24 Months of Age | Serogroup Y | 90 Percentage of subjects |
Secondary
hSBA Geometric Mean Titers (GMTs) Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age
To assess persistence of antibody response in terms of GMTs using hSBA assay against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.
Time frame: At 24 months of age (Visit 6)
Population: Analysis was performed on the Full analysis set (FAS), which included all enrolled subjects who received atleast one study vaccination and provided an evaluable hSBA Visit 6 assessment, one year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age ), for atleast one serogroup.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY Group | hSBA Geometric Mean Titers (GMTs) Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age | Serogroup C | 13.04 Titers |
| MenACWY Group | hSBA Geometric Mean Titers (GMTs) Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age | Serogroup W | 53.56 Titers |
| MenACWY Group | hSBA Geometric Mean Titers (GMTs) Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age | Serogroup A | 6.80 Titers |
| MenACWY Group | hSBA Geometric Mean Titers (GMTs) Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age | Serogroup Y | 50.75 Titers |
Secondary
hSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age
To assess antibody response in terms of GMTs using hSBA assay against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.
Time frame: At 13 months of age (Visit 5)
Population: The Analysis was done on FAS hSBA 1 month, which included all enrolled subjects who received atleast one study vaccination and provided evaluable hSBA immunogenicity data at 1 month after last vaccination for atleast one serogroup.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY Group | hSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | Serogroup A | 107.90 Titers |
| MenACWY Group | hSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | Serogroup C | 201.04 Titers |
| MenACWY Group | hSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | Serogroup W | 426.74 Titers |
| MenACWY Group | hSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | Serogroup Y | 359.39 Titers |
Secondary
Percentage of Subjects With hSBA ≥8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age
To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using human serum complement.
Time frame: At 13 months of age (Visit 5)
Population: The Analysis was done on FAS hSBA 1 month, which included all enrolled subjects who received at least one study vaccination and who provided evaluable hSBA immunogenicity data at 1 month after last vaccination for at least one serogroup.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY Group | Percentage of Subjects With hSBA ≥8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | Serogroup A | 94 Percentage of subjects |
| MenACWY Group | Percentage of Subjects With hSBA ≥8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | Serogroup C | 98 Percentage of subjects |
| MenACWY Group | Percentage of Subjects With hSBA ≥8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | Serogroup W | 100 Percentage of subjects |
| MenACWY Group | Percentage of Subjects With hSBA ≥8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | Serogroup Y | 100 Percentage of subjects |
Secondary
Percentage of Subjects With rSBA Titers ≥ 128 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age
To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement.
Time frame: At 13 months of age (Visit 5)
Population: The Analysis was done on FAS rSBA 1 month, which included all enrolled subjects who received atleast one study vaccination and who provided evaluable rSBA immunogenicity data at 1 month after last vaccination for atleast one serogroup.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY Group | Percentage of Subjects With rSBA Titers ≥ 128 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | Serogroup A | 100 Percentage of subjects |
| MenACWY Group | Percentage of Subjects With rSBA Titers ≥ 128 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | Serogroup C | 92 Percentage of subjects |
| MenACWY Group | Percentage of Subjects With rSBA Titers ≥ 128 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | Serogroup W | 98 Percentage of subjects |
| MenACWY Group | Percentage of Subjects With rSBA Titers ≥ 128 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | Serogroup Y | 98 Percentage of subjects |
Secondary
Percentage of Subjects With rSBA Titers ≥ 8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age
To assess antibody response against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine as measured by serum bactericidal assay using rabbit serum complement.
Time frame: At 13 months of age (Visit 5)
Population: The Analysis was done on FAS rSBA 1 month, which included all enrolled subjects who received atleast one study vaccination and who provided evaluable rSBA immunogenicity data at 1 month after last vaccination for atleast one serogroup.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MenACWY Group | Percentage of Subjects With rSBA Titers ≥ 8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | Serogroup A | 100 Percentage of subjects |
| MenACWY Group | Percentage of Subjects With rSBA Titers ≥ 8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | Serogroup C | 99 Percentage of subjects |
| MenACWY Group | Percentage of Subjects With rSBA Titers ≥ 8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | Serogroup W | 100 Percentage of subjects |
| MenACWY Group | Percentage of Subjects With rSBA Titers ≥ 8 Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age | Serogroup Y | 100 Percentage of subjects |
Secondary
rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age.
To assess antibody response in terms of GMTs using rSBA assay against N. meningitidis serogroups A, C, W and Y at 1 month after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.
Time frame: At 13 months of age (Visit 5)
Population: The Analysis was done on FAS rSBA 1 month, which included all enrolled subjects who received atleast one study vaccination and provided evaluable rSBA immunogenicity data at 1 month after last vaccination for atleast one serogroup.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY Group | rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age. | Serogroup Y | 2226.70 Titers |
| MenACWY Group | rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age. | Serogroup A | 7394.18 Titers |
| MenACWY Group | rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age. | Serogroup C | 735.07 Titers |
| MenACWY Group | rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 13 Months of Age. | Serogroup W | 2718.69 Titers |
Secondary
rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age
To assess persistence of antibody response in terms of GMTs using rSBA assay against N. meningitidis serogroups A, C, W and Y at 1 year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age) of MenACWY vaccine.
Time frame: At 24 months of age (Visit 6)
Population: Analysis was performed on the Full analysis set (FAS), which included all enrolled subjects who received atleast one study vaccination and provided an evaluable rSBA Visit 6 assessment, one year after completion of a 4-dose infant vaccination series (2, 4, 6 and 12 months of age ), for atleast one serogroup.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MenACWY Group | rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age | Serogroup A | 2269.48 Titers |
| MenACWY Group | rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age | Serogroup C | 17.17 Titers |
| MenACWY Group | rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age | Serogroup W | 114.04 Titers |
| MenACWY Group | rSBA GMTs Against Each N. Meningitidis Serogroups A, C, W and Y at 24 Months of Age | Serogroup Y | 310.91 Titers |