Prevention of Meningococcal Disease
Conditions
Brief summary
The purpose of this study is to evaluate the safety, immunogenicity and induction of immune memory after two or three doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy infants.
Interventions
BIOLOGICALMenACWY Ad- (MenACWY-CRM, non adjuvanted formulation)
MenACWY-CRM conjugate vaccine formulated without adjuvant was injected IM (intramuscularly) in the anterolateral area of the right thigh.
BIOLOGICALMenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)
MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.
BIOLOGICALMenACWY PS (MenACWY-CRM, polysaccharide vaccine)
MenACWY polysaccharide vaccine was injected in the anterolateral area of the right thigh.
BIOLOGICALHBV (Hepatitis B vaccine)
Hepatitis B vaccine at 2, 4, 6 months of age administered IM in the anterolateral area of the left thigh.
BIOLOGICALPrevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)
Prevnar was administered IM in the anterolateral area of the left thigh.
BIOLOGICALMMR (Measles, Mumps and Rubella vaccine)
MMR at 12 month of age, administered in the left arm.
BIOLOGICALDTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.
BIOLOGICALMenjugate (Men C conjugated vaccine)
Menjugate was injected IM in the anterolateral area of the right thigh.
Sponsors
Novartis
Novartis Vaccines
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Months to 6 Months
Healthy volunteers
Yes
Inclusion criteria
Individuals eligible for enrollment in this study were male, and female infants: * Who were healthy 2-month old infants (55-89 days, inclusive) born after full term pregnancy with an estimated gestational age ≥ 37 weeks, and a birth weight ≥ 2.5 kg; * For whom a parent/legal guardian has given written informed consent after the nature of the study has been explained; * Who were available for all the visits scheduled in the study; * Who were in good health as determined by: * Medical history; * Physical examination; * Clinical judgment of the investigator.
Exclusion criteria
Ineligible for the study were infants: * Whose parents/legal guardians were unwilling, or unable to give written informed consent for the subject to participate in the study; * Who previously received any meningococcal vaccine; * Who received prior vaccination with D, T, P (acellular, or whole cell), IPV, or OPV, HBV, H influenzae type b (Hib), or Pneumococcus; * Who had a previously ascertained or suspected disease caused by N meningitidis, C diphtheriae, C tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus, or B pertussis (history of laboratory-confirmed or clinical condition of spasmodic cough for a period ≥ 2 weeks associated with apnea or whooping cough); * Who had household contact with and/or intimate exposure to an individual with laboratory-confirmed N meningitis (serogroups A, C, W-135, or Y), B pertussis, Hib, C diphtheriae, Polio, or pneumococcal infection since birth; * Who had a history of any anaphylactic shock, asthma, urticaria, or other allergic reaction after previous vaccinations, or known hypersensitivity to any vaccine component; * Who had experienced significant acute or chronic infection within the previous 7 days, or fever (≥ 38.0°C) within the previous 3 days; * Who had any present, or suspected serious, acute (e.g., leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac, renal failure, or severe malnutrition, or insulin-dependent diabetes); or progressive neurological disease; or a genetic anomaly or known cytogenic disorders (e.g., Downs syndrome); * Who had a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example): * receipt of any immunosuppressive therapy since birth; * receipt of immunostimulant since birth; * receipt of any systemic corticosteroid since birth. * Who had a suspected or known HIV infection, or HIV-related disease; * Who had ever received blood, blood products and/or plasma derivatives, or any parenteral immunoglobulin preparation; * Who had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time; * Who had a history of seizure disorder: * Febrile seizure; * Any other seizure disorder. * Who had taken systemic antibiotics (either oral or parenteral) within the previous 14 days (EXCEPTION: subjects who received an oral or parenteral β-lactam antibiotic \[examples: penicillin, amoxicillin, ceftriaxone, cefuroxime, cephalexin, etc.\] may be enrolled 7 days following the last dose); * Who with their parents/legal guardians were planning to leave the area of the study site before the end of the study period; * Who had any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives; * Who had taken any antipyretic medication in the previous 6 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine | Baseline and at 1 month after the 3 dose primary vaccination series | Immunogenicity was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥ 1:4 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at the baseline and 1 month after primary vaccination by groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Baseline and 1 month after the 3 dose primary vaccination series | Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N meningitis serogroups A, C, W, and Y, at the baseline and 1 month after primary vaccination by groups. |
| Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Baseline and 1 month after second vaccination | Immunogenicity was measured as the percentages of subjects With hSBA titers ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at Baseline and 1 month after second vaccination by groups. |
| Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Baseline and 1 month after second vaccination | Immunogenicity was measured as hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y at baseline and 1 month after second vaccination by groups. |
| Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | at 12 months of age and 1 month after booster vaccination | Immunogenicity was measured as the percentages of subjects with hSBA ≥ 1:4 or ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by groups. |
| Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | at 12 months of age and 1 month after booster vaccination | Immunogenicity was measured as GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by group. |
| Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | at 12 months of age | The persistence of immune response was measured as the percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 against N. Meningitidis serogroups A, C, W, and Y at 12 months of age by groups. |
| Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | at 12 months of age | The persistence of immune response as measured by hSBA GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age by groups. |
| Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | at 12 months of age | The persistence of immune response as measured by percentages of subjects with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months by groups. |
| Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | at 12 months of age | The persistence of immune response as measured by hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y,at 12 months by groups. |
| Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | before challenge at 12 months of age and 1 month after PS challenge. | The induction of immunological memory was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge. |
| Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Baseline and 1 month after the 3 dose primary vaccination series | Immunogenicity was measured by percentages of subjects With hSBA titers ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at baseline and 1 month after primary vaccination by groups. |
| Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Before challenge at 12 months of age and 1 month after PS challenge. | The Induction of immunological memory was measured as percentage of subjects with hSBA ≥ 1:4, hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups. |
| Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Before challenge at 12 months of age and 1 month after PS challenge. | Induction of immunological memory was measured by hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups. |
| Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Baseline and 1 month after the 2 or 3 dose primary vaccination series | The immunogenicity was measured as percentages of subject with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, baseline and 1 month after 2 or 3 dose primary series by groups. |
| Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | at 12 months of age and 1 month after PS challenge | The memory response was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after PS challenge by groups. |
| Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Baseline and 1 month after the 2 or 3 dose primary vaccination series | To assess the immunogenicity of routine vaccines when given concomitantly to Novartis MenACWY Ad+ or Novartis MenACWY Ad- conjugate vaccines. Hib, diphtheria, tetanus, pertussis will be evaluated as the first priority, followed by pneumococcus, polio, hepatitis B, and MMR (measles, mumps, and rubella) depending on the availability of sera. |
| ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Baseline and 1 month after the 2 or 3 dose primary vaccination series | To assess the Enzyme-linked immunosorbent assay (ELISA) GMT of Hib, Diphtheria, Tetanus, Hepatitis B, administered Concomitantly with Novartis MenACWY Ad+ or MenACWY Ad-conjugate vaccines, at the baseline and 1 month after primary vaccination by groups. |
| Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | Baseline and 1 month after second vaccination | The immunogenicity was measured as percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroup C, at baseline and 1 month after second vaccination by groups. |
| Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | 7 days after each vaccination | Safety and tolerability of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccine when given in a 2 or 3 dose primary vaccination series concomitantly with licensed pediatric vaccines. |
| Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | 7 days after vaccination at 12 months of age | The safety profile of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccines when given at 12 months of age. |
| Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | before challenge at 12 months of age and 1 month after PS challenge. | The induction of immunological memory was measured as hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge. |
Countries
Canada, United Kingdom
Participant flow
Recruitment details
Participants were enrolled at two centers in Canada and one in UK.
Pre-assignment details
The two selected countries provided data on different infant vaccination schedules (at 2 and 4 months of age; at 2, 3, and 4 months of age: and at 2, 4, and 6 months of age), and on different recommended concomitant vaccinations.
Participants by arm
| Arm | Count |
|---|---|
| UK234+ (MenACWY Ad+ at 2,3,4 m) Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age. | 90 |
| UK24+ (MenACWY Ad+ at 2,4 m) Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age. | 90 |
| UKMenC (Menjugate at 2,4m) Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age. | 45 |
| CA246+ (MenACWY Ad+ at 2,4,6m) Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age. | 98 |
| CA24+ (MenACWY Ad+ at 2,4m) Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age. | 98 |
| UK24- (MenACWY Ad- at 2,4m) Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age. | 90 |
| CA24- (MenACWY Ad- at 2,4m) Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age. | 90 |
| Total | 601 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 1 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Inapropriate enrollment | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 0 | 0 | 2 | 0 | 1 | 0 |
| Overall Study | Protocol Violation | 3 | 2 | 0 | 2 | 5 | 3 | 2 |
| Overall Study | Unable to classify | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 2 | 0 | 1 | 2 | 2 | 2 |
Baseline characteristics
| Characteristic | UK234+ (MenACWY Ad+ at 2,3,4 m) | UK24+ (MenACWY Ad+ at 2,4 m) | UKMenC (Menjugate at 2,4m) | CA246+ (MenACWY Ad+ at 2,4,6m) | CA24+ (MenACWY Ad+ at 2,4m) | UK24- (MenACWY Ad- at 2,4m) | CA24- (MenACWY Ad- at 2,4m) | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 62.1 days STANDARD_DEVIATION 5.4 | 61.3 days STANDARD_DEVIATION 5 | 62.6 days STANDARD_DEVIATION 6.5 | 65.6 days STANDARD_DEVIATION 6.9 | 65.8 days STANDARD_DEVIATION 6.9 | 64.1 days STANDARD_DEVIATION 5.5 | 69.4 days STANDARD_DEVIATION 10 | 64.6 days STANDARD_DEVIATION 7.3 |
| Sex: Female, Male Female | 44 Participants | 41 Participants | 26 Participants | 52 Participants | 49 Participants | 48 Participants | 44 Participants | 304 Participants |
| Sex: Female, Male Male | 46 Participants | 49 Participants | 19 Participants | 46 Participants | 49 Participants | 42 Participants | 46 Participants | 297 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 90 / 90 | 89 / 90 | 45 / 45 | 97 / 98 | 97 / 98 | 90 / 90 | 89 / 90 |
| serious Total, serious adverse events | 20 / 90 | 17 / 90 | 6 / 45 | 9 / 98 | 4 / 98 | 10 / 90 | 7 / 90 |
Outcome results
Primary
Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine
Immunogenicity was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥ 1:4 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at the baseline and 1 month after primary vaccination by groups.
Time frame: Baseline and at 1 month after the 3 dose primary vaccination series
Population: The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine | Ser A - baseline (n=69,80) | 6 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine | Ser A - 1 month after primary vacc (n=69,80) | 93 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine | Ser C - baseline (n=79,86) | 18 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine | Ser C - 1 month after primary vacc (n=79,86) | 96 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine | Ser W - baseline (n=69,78) | 54 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine | Ser W - 1 month after primary vacc (n=69,78) | 97 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine | Ser Y - baseline | 21 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine | Ser Y - 1 month after primary vacc | 94 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine | Ser Y - 1 month after primary vacc | 98 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine | Ser A - baseline (n=69,80) | 0 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine | Ser W - baseline (n=69,78) | 31 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine | Ser A - 1 month after primary vacc (n=69,80) | 81 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine | Ser Y - baseline | 17 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine | Ser C - baseline (n=79,86) | 15 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine | Ser W - 1 month after primary vacc (n=69,78) | 99 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine | Ser C - 1 month after primary vacc (n=79,86) | 98 percentages of subjects |
Secondary
ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B
To assess the Enzyme-linked immunosorbent assay (ELISA) GMT of Hib, Diphtheria, Tetanus, Hepatitis B, administered Concomitantly with Novartis MenACWY Ad+ or MenACWY Ad-conjugate vaccines, at the baseline and 1 month after primary vaccination by groups.
Time frame: Baseline and 1 month after the 2 or 3 dose primary vaccination series
Population: The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Diphtheria - baseline (n=69,71,70,67,69,72) | 0.035 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Tetanus - 1 m after 1st vacc(n=69,71,70,67,69,72) | 0.7 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Tetanus - baseline (n=69,71,70,67,69,72) | 0.32 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Diphtheria -1m after 1st vacc(n=69,71,70,67,69,72) | 1.02 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hib - baseline (n=70,77,69,73,72,73) | 0.078 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hib - 1 m after 1st vacc (n=70,77,69,73,72,73) | 4.63 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hepatitis B - baseline (n=65,na,66,na,na,67) | NA titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hepatitis B-1m after 1st vacc(n=65,na,66,na,na,67) | NA titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Diphtheria -1m after 1st vacc(n=69,71,70,67,69,72) | 1.02 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hepatitis B-1m after 1st vacc(n=65,na,66,na,na,67) | NA titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Tetanus - baseline (n=69,71,70,67,69,72) | 0.31 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hepatitis B - baseline (n=65,na,66,na,na,67) | NA titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hib - 1 m after 1st vacc (n=70,77,69,73,72,73) | 4.55 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Diphtheria - baseline (n=69,71,70,67,69,72) | 0.04 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Tetanus - 1 m after 1st vacc(n=69,71,70,67,69,72) | 0.92 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hib - baseline (n=70,77,69,73,72,73) | 0.15 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Tetanus - 1 m after 1st vacc(n=69,71,70,67,69,72) | 1.4 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Diphtheria - baseline (n=69,71,70,67,69,72) | 0.027 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Diphtheria -1m after 1st vacc(n=69,71,70,67,69,72) | 1.72 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hepatitis B-1m after 1st vacc(n=65,na,66,na,na,67) | 378 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hib - baseline (n=70,77,69,73,72,73) | 0.11 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hib - 1 m after 1st vacc (n=70,77,69,73,72,73) | 4.53 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hepatitis B - baseline (n=65,na,66,na,na,67) | 5.9 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Tetanus - baseline (n=69,71,70,67,69,72) | 0.23 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hepatitis B - baseline (n=65,na,66,na,na,67) | 5.79 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hib - 1 m after 1st vacc (n=70,77,69,73,72,73) | 0.47 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hib - baseline (n=70,77,69,73,72,73) | 0.089 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Tetanus - baseline (n=69,71,70,67,69,72) | 0.28 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Diphtheria - baseline (n=69,71,70,67,69,72) | 0.031 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Diphtheria -1m after 1st vacc(n=69,71,70,67,69,72) | 1.06 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hepatitis B-1m after 1st vacc(n=65,na,66,na,na,67) | 69 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Tetanus - 1 m after 1st vacc(n=69,71,70,67,69,72) | 0.6 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hepatitis B-1m after 1st vacc(n=65,na,66,na,na,67) | NA titers |
| CA24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Tetanus - baseline (n=69,71,70,67,69,72) | 0.25 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hib - baseline (n=70,77,69,73,72,73) | 0.15 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hib - 1 m after 1st vacc (n=70,77,69,73,72,73) | 5.67 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hepatitis B - baseline (n=65,na,66,na,na,67) | NA titers |
| CA24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Tetanus - 1 m after 1st vacc(n=69,71,70,67,69,72) | 0.97 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Diphtheria - baseline (n=69,71,70,67,69,72) | 0.032 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Diphtheria -1m after 1st vacc(n=69,71,70,67,69,72) | 0.98 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hepatitis B-1m after 1st vacc(n=65,na,66,na,na,67) | 133 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hib - baseline (n=70,77,69,73,72,73) | 0.064 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Diphtheria - baseline (n=69,71,70,67,69,72) | 0.016 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Diphtheria -1m after 1st vacc(n=69,71,70,67,69,72) | 1.49 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hib - 1 m after 1st vacc (n=70,77,69,73,72,73) | 0.42 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Tetanus - 1 m after 1st vacc(n=69,71,70,67,69,72) | 0.68 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Hepatitis B - baseline (n=65,na,66,na,na,67) | 4.21 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B | Tetanus - baseline (n=69,71,70,67,69,72) | 0.18 titers |
Secondary
Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines
Immunogenicity was measured as hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y at baseline and 1 month after second vaccination by groups.
Time frame: Baseline and 1 month after second vaccination
Population: The analysis was performed on the MenACWY per-protocol (PP) n population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser A - 1 month after 2nd vacc (n=68,79,78,83) | 12 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser Y - 1 month after 2nd vacc (n=76,74,77,85) | 26 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser C - baseline (n=77,74,79,85) | 2.54 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser C - 1 month after 2nd vacc (n=77,74,79,85) | 52 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser W - baseline (n=73,74,79,75) | 5.33 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser A - baseline (n=68,79,78,83) | 2.17 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser W - 1 month after 2nd vacc (n=73,74,79,75) | 48 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser Y - baseline (n=76,74,77,85) | 2.56 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser W - 1 month after 2nd vacc (n=73,74,79,75) | 44 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser Y - baseline (n=76,74,77,85) | 2.27 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser C - 1 month after 2nd vacc (n=77,74,79,85) | 55 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser A - 1 month after 2nd vacc (n=68,79,78,83) | 11 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser W - baseline (n=73,74,79,75) | 3.6 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser Y - 1 month after 2nd vacc (n=76,74,77,85) | 27 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser C - baseline (n=77,74,79,85) | 2.77 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser A - baseline (n=68,79,78,83) | 2.07 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser A - 1 month after 2nd vacc (n=68,79,78,83) | 7.3 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser C - baseline (n=77,74,79,85) | 2.48 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser C - 1 month after 2nd vacc (n=77,74,79,85) | 40 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser A - baseline (n=68,79,78,83) | 2.05 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser W - 1 month after 2nd vacc (n=73,74,79,75) | 29 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser Y - baseline (n=76,74,77,85) | 3.39 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser Y - 1 month after 2nd vacc (n=76,74,77,85) | 21 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser W - baseline (n=73,74,79,75) | 5.14 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser Y - 1 month after 2nd vacc (n=76,74,77,85) | 41 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser A - baseline (n=68,79,78,83) | 2.08 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser C - baseline (n=77,74,79,85) | 2.87 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser C - 1 month after 2nd vacc (n=77,74,79,85) | 69 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser W - baseline (n=73,74,79,75) | 3.02 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser W - 1 month after 2nd vacc (n=73,74,79,75) | 69 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser Y - baseline (n=76,74,77,85) | 2.76 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines | Ser A - 1 month after 2nd vacc (n=68,79,78,83) | 7.16 titers |
Secondary
Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines
Immunogenicity was measured as GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by group.
Time frame: at 12 months of age and 1 month after booster vaccination
Population: The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser A - at 12 months of age (n=64,61,62,39,38) | 2.31 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser A - 1 month after booster (n=64,61,62,39,38) | 47 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser C - at 12 months of age(n=67,63,65,40,40) | 5.18 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser C - 1 month after booster(n=67,63,65,40,40) | 236 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser W - at 12 months of age(n=57,41,57,35,35) | 8.1 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser W - 1 month after booster (n=57,41,57,35,35) | 503 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser Y - at 12 months of age (n=66,63,65,40,38) | 6.65 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser Y- 1 month after booster(n=66,63,65,40,38) | 508 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser C - at 12 months of age(n=67,63,65,40,40) | 3.94 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser W - 1 month after booster (n=57,41,57,35,35) | 311 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser A - at 12 months of age (n=64,61,62,39,38) | 2.22 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser C - 1 month after booster(n=67,63,65,40,40) | 129 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser A - 1 month after booster (n=64,61,62,39,38) | 30 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser Y- 1 month after booster(n=66,63,65,40,38) | 438 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser W - at 12 months of age(n=57,41,57,35,35) | 6.49 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser Y - at 12 months of age (n=66,63,65,40,38) | 6.83 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser Y - at 12 months of age (n=66,63,65,40,38) | 19 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser Y- 1 month after booster(n=66,63,65,40,38) | 1395 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser C - 1 month after booster(n=67,63,65,40,40) | 429 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser W - 1 month after booster (n=57,41,57,35,35) | 792 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser C - at 12 months of age(n=67,63,65,40,40) | 7.94 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser A - 1 month after booster (n=64,61,62,39,38) | 134 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser A - at 12 months of age (n=64,61,62,39,38) | 2.97 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser W - at 12 months of age(n=57,41,57,35,35) | 16 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser A - 1 month after booster (n=64,61,62,39,38) | 67 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser C - at 12 months of age(n=67,63,65,40,40) | 4.64 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser C - 1 month after booster(n=67,63,65,40,40) | 216 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser W - at 12 months of age(n=57,41,57,35,35) | 8.84 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser W - 1 month after booster (n=57,41,57,35,35) | 381 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser Y- 1 month after booster(n=66,63,65,40,38) | 308 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser A - at 12 months of age (n=64,61,62,39,38) | 2.18 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser Y - at 12 months of age (n=66,63,65,40,38) | 7.99 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser C - 1 month after booster(n=67,63,65,40,40) | 258 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser Y- 1 month after booster(n=66,63,65,40,38) | 527 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser C - at 12 months of age(n=67,63,65,40,40) | 4.07 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser Y - at 12 months of age (n=66,63,65,40,38) | 7.63 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser A - at 12 months of age (n=64,61,62,39,38) | 2.07 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser W - 1 month after booster (n=57,41,57,35,35) | 402 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser A - 1 month after booster (n=64,61,62,39,38) | 59 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines | Ser W - at 12 months of age(n=57,41,57,35,35) | 11 titers |
Secondary
Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine.
The persistence of immune response as measured by hSBA GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age by groups.
Time frame: at 12 months of age
Population: The analysis was performed on the MenACWY and Menjugate per-protocol (PP) n population evaluating the persistence response.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | Ser A - at 12 months of age (n=36,62,65,77,78) | 2 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | Ser C - at 12 months of age (n=36,69,69,73,82) | 27 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | Ser W - at 12 months of age (n=34,62,42,69,69) | 2.42 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | Ser Y - at 12 months of age (n=38,69,66,73,79) | 2.15 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | Ser A - at 12 months of age (n=36,62,65,77,78) | 2.32 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | Ser Y - at 12 months of age (n=38,69,66,73,79) | 6.72 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | Ser C - at 12 months of age (n=36,69,69,73,82) | 5.04 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | Ser W - at 12 months of age (n=34,62,42,69,69) | 8.38 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | Ser Y - at 12 months of age (n=38,69,66,73,79) | 7.64 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | Ser C - at 12 months of age (n=36,69,69,73,82) | 3.85 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | Ser W - at 12 months of age (n=34,62,42,69,69) | 7.02 titers |
| UK24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | Ser A - at 12 months of age (n=36,62,65,77,78) | 2.2 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | Ser A - at 12 months of age (n=36,62,65,77,78) | 2.29 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | Ser C - at 12 months of age (n=36,69,69,73,82) | 5.43 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | Ser Y - at 12 months of age (n=38,69,66,73,79) | 7.84 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | Ser W - at 12 months of age (n=34,62,42,69,69) | 8.15 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | Ser Y - at 12 months of age (n=38,69,66,73,79) | 7.12 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | Ser W - at 12 months of age (n=34,62,42,69,69) | 12 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | Ser C - at 12 months of age (n=36,69,69,73,82) | 4.42 titers |
| CA24- (MenACWY Ad- at 2, 4 m) | Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. | Ser A - at 12 months of age (n=36,62,65,77,78) | 2.18 titers |
Secondary
Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N meningitis serogroups A, C, W, and Y, at the baseline and 1 month after primary vaccination by groups.
Time frame: Baseline and 1 month after the 3 dose primary vaccination series
Population: The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser A - baseline (n=69,80) | 2.2 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser A - 1 month after primary vacc (n=69,80) | 53 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser C - baseline (n=79,86) | 2.79 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser C - 1 month after primary vacc (n=79,86) | 79 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser W - baseline (n=69,78) | 5.76 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser W - 1 month after primary vacc (n=69,78) | 65 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser Y - baseline | 2.72 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser Y - 1 month after primary vacc | 56 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser Y - 1 month after primary vacc | 2.64 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser A - baseline (n=69,80) | 2 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser W - baseline (n=69,78) | 4.03 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser A - 1 month after primary vacc (n=69,80) | 21 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser Y - baseline | 2.64 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser C - baseline (n=79,86) | 2.64 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser W - 1 month after primary vacc (n=69,78) | 73 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser C - 1 month after primary vacc (n=79,86) | 124 titers |
Secondary
Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
The persistence of immune response as measured by hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y,at 12 months by groups.
Time frame: at 12 months of age
Population: The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser A - at 12 months of age (n=58,79) | 3.02 Titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser C - at 12 months of age (n=70,84) | 7.56 Titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser W - at 12 months of age (n=58,75) | 15 Titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser Y - at 12 months of age (n=71,86) | 18 Titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser Y - at 12 months of age (n=71,86) | 22 Titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser A - at 12 months of age (n=58,79) | 3.93 Titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser W - at 12 months of age (n=58,75) | 20 Titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser C - at 12 months of age (n=70,84) | 14 Titers |
Secondary
Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
The induction of immunological memory was measured as hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.
Time frame: before challenge at 12 months of age and 1 month after PS challenge.
Population: The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser A - before challenge at 12 months of age(n=44) | 3.4 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser A - 1 month after PS challenge (n=44) | 32 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser C - before challenge at 12 months of age(n=43) | 12 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser C - 1 month after PS challenge (n=43) | 82 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser W - before challenge at 12 months of age(n=40) | 17 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser W - 1 month after PS challenge (n=40) | 249 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser Y - before challenge at 12 months of age(n=44) | 19 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser Y - 1 month after PS challenge (n=44) | 186 titers |
Secondary
Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
Induction of immunological memory was measured by hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.
Time frame: Before challenge at 12 months of age and 1 month after PS challenge.
Population: The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser A - before challenge at 12 months (n=40,39) | 2.22 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser A - 1 month after PS challenge (n=40,39) | 28 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser C - before challenge at 12 months (n=41,39) | 5.21 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser C - 1 month after PS challenge (n=41,39) | 140 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser W - before challenge at 12 months (n=41,38) | 7.48 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser W - 1 month after PS challenge (n=41,38) | 365 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser Y - before challenge at 12 months (n=42,38) | 6.73 titers |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser Y - 1 month after PS challenge (n=42,38) | 280 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser Y - 1 month after PS challenge (n=42,38) | 288 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser A - before challenge at 12 months (n=40,39) | 2.31 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser W - before challenge at 12 months (n=41,38) | 11 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser A - 1 month after PS challenge (n=40,39) | 55 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser Y - before challenge at 12 months (n=42,38) | 6.79 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser C - before challenge at 12 months (n=41,39) | 5.07 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser W - 1 month after PS challenge (n=41,38) | 555 titers |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser C - 1 month after PS challenge (n=41,39) | 181 titers |
Secondary
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad-
Safety and tolerability of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccine when given in a 2 or 3 dose primary vaccination series concomitantly with licensed pediatric vaccines.
Time frame: 7 days after each vaccination
Population: Analysis was done on safety dataset n population - subjects who received at least one study dose and had Post baseline safety data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Diarrhea | 29 subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Tenderness | 40 subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Sleepiness | 56 subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Fever (≥38°C) | 7 subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Induration | 21 subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Vomiting | 19 subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Persistent Crying | 7 subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Analgesics/Antipyretics | 43 subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Eating habit Change | 28 subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Erythema | 69 subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Irritability | 63 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Irritability | 71 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Persistent Crying | 7 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Analgesics/Antipyretics | 35 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Erythema | 64 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Fever (≥38°C) | 4 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Induration | 24 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Tenderness | 31 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Diarrhea | 27 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Eating habit Change | 25 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Vomiting | 26 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Sleepiness | 49 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Vomiting | 9 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Fever (≥38°C) | 1 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Sleepiness | 25 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Eating habit Change | 9 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Tenderness | 18 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Diarrhea | 12 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Analgesics/Antipyretics | 18 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Induration | 12 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Persistent Crying | 6 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Irritability | 31 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Erythema | 34 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Persistent Crying | 15 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Tenderness | 46 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Erythema | 73 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Induration | 36 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Sleepiness | 64 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Eating habit Change | 35 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Irritability | 80 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Vomiting | 23 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Diarrhea | 30 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Fever (≥38°C) | 14 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Analgesics/Antipyretics | 61 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Sleepiness | 62 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Eating habit Change | 27 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Irritability | 70 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Vomiting | 15 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Induration | 18 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Analgesics/Antipyretics | 46 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Diarrhea | 22 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Erythema | 67 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Fever (≥38°C) | 7 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Tenderness | 32 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Persistent Crying | 4 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Vomiting | 14 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Induration | 40 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Tenderness | 41 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Sleepiness | 45 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Diarrhea | 18 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Erythema | 78 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Persistent Crying | 5 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Analgesics/Antipyretics | 36 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Fever (≥38°C) | 5 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Irritability | 61 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Eating habit Change | 21 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Induration | 24 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Persistent Crying | 4 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Analgesics/Antipyretics | 45 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Erythema | 66 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Sleepiness | 52 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Fever (≥38°C) | 5 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Irritability | 73 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Diarrhea | 16 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Eating habit Change | 20 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Vomiting | 11 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- | Tenderness | 35 subjects |
Secondary
Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age
The safety profile of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccines when given at 12 months of age.
Time frame: 7 days after vaccination at 12 months of age
Population: Analysis was done on safety dataset n population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Eating habit change | 11 subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Diarrhea | 9 subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Persistent crying | 0 subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Tenderness | 7 subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Fever (≥38°C) | 3 subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Analgesics/Antipyretics | 14 subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Erythema | 62 subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Sleepiness | 11 subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Irritability | 26 subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Induration | 21 subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Vomiting | 4 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Induration | 32 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Diarrhea | 9 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Eating habit change | 16 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Fever (≥38°C) | 7 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Vomiting | 6 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Analgesics/Antipyretics | 21 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Erythema | 58 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Persistent crying | 4 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Tenderness | 11 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Irritability | 32 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Sleepiness | 14 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Sleepiness | 9 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Irritability | 20 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Analgesics/Antipyretics | 12 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Erythema | 36 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Tenderness | 10 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Fever (≥38°C) | 2 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Induration | 18 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Eating habit change | 5 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Diarrhea | 4 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Vomiting | 4 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Persistent crying | 3 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Induration | 0 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Erythema | 0 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Vomiting | 2 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Persistent crying | 3 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Analgesics/Antipyretics | 13 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Fever (≥38°C) | 3 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Irritability | 24 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Diarrhea | 4 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Sleepiness | 10 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Tenderness | 0 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Eating habit change | 10 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Irritability | 23 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Eating habit change | 12 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Tenderness | 10 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Persistent crying | 3 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Induration | 12 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Vomiting | 7 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Fever (≥38°C) | 6 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Erythema | 21 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Sleepiness | 8 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Analgesics/Antipyretics | 15 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Diarrhea | 7 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Persistent crying | 0 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Tenderness | 7 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Erythema | 27 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Induration | 9 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Eating habit change | 6 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Sleepiness | 7 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Irritability | 19 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Vomiting | 0 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Diarrhea | 6 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Fever (≥38°C) | 1 subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Analgesics/Antipyretics | 8 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Fever (≥38°C) | 8 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Persistent crying | 2 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Irritability | 24 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Induration | 9 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Sleepiness | 13 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Eating habit change | 10 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Erythema | 30 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Tenderness | 10 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Analgesics/Antipyretics | 17 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Diarrhea | 5 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Vomiting | 4 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Diarrhea | 9 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Fever (≥38°C) | 14 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Induration | 36 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Erythema | 66 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Vomiting | 8 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Tenderness | 10 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Persistent crying | 4 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Eating habit change | 13 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Irritability | 28 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Analgesics/Antipyretics | 22 subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Sleepiness | 16 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - ACWY | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Erythema | 21 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - ACWY | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Irritability | 17 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - ACWY | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Sleepiness | 9 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - ACWY | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Vomiting | 5 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - ACWY | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Eating habit change | 10 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - ACWY | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Induration | 10 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - ACWY | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Diarrhea | 3 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - ACWY | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Analgesics/Antipyretics | 14 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - ACWY | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Fever (≥38°C) | 4 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - ACWY | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Tenderness | 7 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - ACWY | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Persistent crying | 5 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - PS | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Fever (≥38°C) | 1 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - PS | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Induration | 15 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - PS | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Tenderness | 12 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - PS | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Irritability | 20 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - PS | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Vomiting | 4 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - PS | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Eating habit change | 8 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - PS | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Persistent crying | 0 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - PS | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Analgesics/Antipyretics | 11 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - PS | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Erythema | 26 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - PS | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Diarrhea | 4 subjects |
| CA24- (MenACWY Ad- at 2, 4 m) - PS | Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age | Sleepiness | 7 subjects |
Secondary
Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
To assess the immunogenicity of routine vaccines when given concomitantly to Novartis MenACWY Ad+ or Novartis MenACWY Ad- conjugate vaccines. Hib, diphtheria, tetanus, pertussis will be evaluated as the first priority, followed by pneumococcus, polio, hepatitis B, and MMR (measles, mumps, and rubella) depending on the availability of sera.
Time frame: Baseline and 1 month after the 2 or 3 dose primary vaccination series
Population: The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiHBVtiter≥1.0 IU/mL-1m post (65,na,66,na,na,67) | 85 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiHBVtiter≥1.0 IU/mL-baseline(65,na,66,na,na,67) | 23 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥1.0 µg/mL-1m post (70,77,69,73,72,73) | 33 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥0.15µg/mL-baseline(70,77,69,73,72,73) | 36 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antidipht≥0.1 IU/mL-baseline(69,71,70,67,69,72) | 17 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Antitetanus≥0.1 IU/mL -1m post (69,71,70,67,69,72) | 100 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥0.15µg/mL-1m post (70,77,69,73,72,73) | 74 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antidipht≥0.1 IU/mL- 1m post (69,71,70,67,69,72) | 96 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Antitetanus≥0.1 IU/mL-baseline(69,71,70,67,69,72) | 75 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥1.0 µg/mL-baseline(70,77,69,73,72,73) | 10 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiHBVtiter≥1.0 IU/mL-baseline(65,na,66,na,na,67) | NA percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥0.15µg/mL-1m post (70,77,69,73,72,73) | 95 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥1.0 µg/mL-baseline(70,77,69,73,72,73) | 17 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥1.0 µg/mL-1m post (70,77,69,73,72,73) | 86 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Antitetanus≥0.1 IU/mL-baseline(69,71,70,67,69,72) | 79 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥0.15µg/mL-baseline(70,77,69,73,72,73) | 42 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antidipht≥0.1 IU/mL- 1m post (69,71,70,67,69,72) | 97 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antidipht≥0.1 IU/mL-baseline(69,71,70,67,69,72) | 14 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Antitetanus≥0.1 IU/mL -1m post (69,71,70,67,69,72) | 100 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiHBVtiter≥1.0 IU/mL-1m post (65,na,66,na,na,67) | NA percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiHBVtiter≥1.0 IU/mL-baseline(65,na,66,na,na,67) | 11 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥0.15µg/mL-baseline(70,77,69,73,72,73) | 17 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥0.15µg/mL-1m post (70,77,69,73,72,73) | 67 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥1.0 µg/mL-baseline(70,77,69,73,72,73) | 3 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥1.0 µg/mL-1m post (70,77,69,73,72,73) | 35 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antidipht≥0.1 IU/mL- 1m post (69,71,70,67,69,72) | 100 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiHBVtiter≥1.0 IU/mL-1m post (65,na,66,na,na,67) | 92 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Antitetanus≥0.1 IU/mL-baseline(69,71,70,67,69,72) | 70 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Antitetanus≥0.1 IU/mL -1m post (69,71,70,67,69,72) | 99 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antidipht≥0.1 IU/mL-baseline(69,71,70,67,69,72) | 3 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥1.0 µg/mL-baseline(70,77,69,73,72,73) | 7 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥0.15µg/mL-1m post (70,77,69,73,72,73) | 97 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥0.15µg/mL-baseline(70,77,69,73,72,73) | 25 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Antitetanus≥0.1 IU/mL-baseline(69,71,70,67,69,72) | 93 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥1.0 µg/mL-1m post (70,77,69,73,72,73) | 82 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Antitetanus≥0.1 IU/mL -1m post (69,71,70,67,69,72) | 100 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiHBVtiter≥1.0 IU/mL-baseline(65,na,66,na,na,67) | NA percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiHBVtiter≥1.0 IU/mL-1m post (65,na,66,na,na,67) | NA percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antidipht≥0.1 IU/mL-baseline(69,71,70,67,69,72) | 18 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antidipht≥0.1 IU/mL- 1m post (69,71,70,67,69,72) | 97 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥1.0 µg/mL-baseline(70,77,69,73,72,73) | 17 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiHBVtiter≥1.0 IU/mL-baseline(65,na,66,na,na,67) | NA percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antidipht≥0.1 IU/mL-baseline(69,71,70,67,69,72) | 19 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiHBVtiter≥1.0 IU/mL-1m post (65,na,66,na,na,67) | NA percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥0.15µg/mL-1m post (70,77,69,73,72,73) | 97 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Antitetanus≥0.1 IU/mL-baseline(69,71,70,67,69,72) | 87 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥0.15µg/mL-baseline(70,77,69,73,72,73) | 49 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antidipht≥0.1 IU/mL- 1m post (69,71,70,67,69,72) | 96 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Antitetanus≥0.1 IU/mL -1m post (69,71,70,67,69,72) | 100 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥1.0 µg/mL-1m post (70,77,69,73,72,73) | 82 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥1.0 µg/mL-baseline(70,77,69,73,72,73) | 11 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Antitetanus≥0.1 IU/mL -1m post (69,71,70,67,69,72) | 100 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antidipht≥0.1 IU/mL-baseline(69,71,70,67,69,72) | 15 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antidipht≥0.1 IU/mL- 1m post (69,71,70,67,69,72) | 100 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiHBVtiter≥1.0 IU/mL-1m post (65,na,66,na,na,67) | 97 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥0.15µg/mL-1m post (70,77,69,73,72,73) | 100 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥0.15µg/mL-baseline(70,77,69,73,72,73) | 37 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiHBVtiter≥1.0 IU/mL-baseline(65,na,66,na,na,67) | 22 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | antiPRPtiter≥1.0 µg/mL-1m post (70,77,69,73,72,73) | 86 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Antitetanus≥0.1 IU/mL-baseline(69,71,70,67,69,72) | 71 percentages of subjects |
Secondary
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide)
The immunogenicity was measured as percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroup C, at baseline and 1 month after second vaccination by groups.
Time frame: Baseline and 1 month after second vaccination
Population: The analysis was performed on the MenACWY and Menjugate per-protocol (PP) n population after second vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | hSBA ≥1:4, baseline | 23 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | hSBA ≥1:4, 1 month after second vaccination | 98 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | hSBA ≥1:8, baseline | 10 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | hSBA ≥1:8, 1 month after second vaccination | 98 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | hSBA ≥1:4, baseline | 13 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | hSBA ≥1:8, 1 month after second vaccination | 83 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | hSBA ≥1:4, 1 month after second vaccination | 84 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | hSBA ≥1:8, baseline | 9 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | hSBA ≥1:8, 1 month after second vaccination | 85 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | hSBA ≥1:4, 1 month after second vaccination | 91 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | hSBA ≥1:8, baseline | 15 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | hSBA ≥1:4, baseline | 15 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | hSBA ≥1:4, baseline | 20 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | hSBA ≥1:4, 1 month after second vaccination | 86 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | hSBA ≥1:8, 1 month after second vaccination | 82 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | hSBA ≥1:8, baseline | 5 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | hSBA ≥1:8, 1 month after second vaccination | 89 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | hSBA ≥1:8, baseline | 11 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | hSBA ≥1:4, 1 month after second vaccination | 93 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) | hSBA ≥1:4, baseline | 20 percentages of subjects |
Secondary
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine
The memory response was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after PS challenge by groups.
Time frame: at 12 months of age and 1 month after PS challenge
Population: The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:4, at 12 months of age (n=44,40) | 27 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:4, at 1 month after PS (n=44,40) | 89 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:8, at 12 months of age (n=44,40) | 23 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:8, at 1 month after PS (n=44,40) | 86 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:4, at 12 months of age (n=43,41) | 74 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:4, at 1 month after PS (n=43,41) | 95 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:8, at 12 months of age (n=43,41) | 65 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:8, at 1 month after PS (n=43,41) | 91 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:4, at 12 months of age (n=40,41) | 83 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:4, at 1 month after PS (n=40,41) | 98 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:8, at 12 months of age (n=40,41) | 73 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:8, at 1 month after PS (n=40,41) | 95 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:4, at 12 months of age (n=44,42) | 89 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:4, at 1 month after PS (n=44,42) | 98 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:8, at 12 months of age (n=44,42) | 77 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:8, at 1 month after PS (n=44,42) | 98 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:8, at 1 month after PS (n=44,42) | 98 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:4, at 12 months of age (n=44,40) | 8 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:4, at 12 months of age (n=40,41) | 59 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:4, at 1 month after PS (n=44,40) | 78 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:4, at 12 months of age (n=44,42) | 55 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:8, at 12 months of age (n=44,40) | 5 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:4, at 1 month after PS (n=40,41) | 98 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:8, at 1 month after PS (n=44,40) | 78 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:8, at 12 months of age (n=44,42) | 50 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:4, at 12 months of age (n=43,41) | 44 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:8, at 12 months of age (n=40,41) | 51 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:4, at 1 month after PS (n=43,41) | 95 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:4, at 1 month after PS (n=44,42) | 98 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:8, at 12 months of age (n=43,41) | 39 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:8, at 1 month after PS (n=40,41) | 98 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:8, at 1 month after PS (n=43,41) | 93 percentages of subjects |
Secondary
Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine
The immunogenicity was measured as percentages of subject with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, baseline and 1 month after 2 or 3 dose primary series by groups.
Time frame: Baseline and 1 month after the 2 or 3 dose primary vaccination series
Population: The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:4, baseline (n=79,86,40,74) | 18 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:4, baseline (n=69,80,38,79) | 6 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA≥1:4,1m after 1st vacc (n=69,80,38,79) | 93 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:8, baseline (n=69,80,38,79) | 4 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA≥1:8,1m after 1st vacc (n=69,80,38,79) | 88 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA≥1:4,1m after 1st vacc (n=79,86,40,74) | 96 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:8, baseline (n=79,86,40,74) | 9 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA≥1:8,1m after 1st vacc (n=79,86,40,74) | 92 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:4, baseline (n=69,78,73,74) | 54 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA≥1:4,1m after 1st vacc (n=69,78,73,74) | 97 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:8, baseline (n=69,78,73,74) | 46 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA≥1:8,1m after 1st vacc (n=69,78,73,74) | 88 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:4, baseline (n=81,87,76,74) | 21 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA≥1:4,1m after 1st vacc (n=81,87,76,74) | 94 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:8, baseline (n=81,87,76,74) | 14 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA≥1:8,1m after 1st vacc (n=81,87,76,74) | 93 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:4, baseline (n=79,86,40,74) | 15 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:4, baseline (n=69,78,73,74) | 31 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA≥1:8,1m after 1st vacc (n=81,87,76,74) | 89 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:4, baseline (n=81,87,76,74) | 17 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:8, baseline (n=81,87,76,74) | 11 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA≥1:4,1m after 1st vacc (n=69,78,73,74) | 99 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA≥1:8,1m after 1st vacc (n=69,80,38,79) | 76 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA≥1:8,1m after 1st vacc (n=69,78,73,74) | 96 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:8, baseline (n=79,86,40,74) | 5 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:8, baseline (n=69,78,73,74) | 28 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA≥1:4,1m after 1st vacc (n=81,87,76,74) | 98 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:8, baseline (n=69,80,38,79) | 0 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA≥1:4,1m after 1st vacc (n=69,80,38,79) | 81 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA≥1:8,1m after 1st vacc (n=79,86,40,74) | 98 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA≥1:4,1m after 1st vacc (n=79,86,40,74) | 98 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:4, baseline (n=69,80,38,79) | 0 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:4, baseline (n=69,80,38,79) | 4 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:4, baseline (n=79,86,40,74) | 13 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA≥1:4,1m after 1st vacc (n=79,86,40,74) | 84 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA≥1:4,1m after 1st vacc (n=81,87,76,74) | 84 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:8, baseline (n=79,86,40,74) | 9 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA≥1:8,1m after 1st vacc (n=79,86,40,74) | 83 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA≥1:8,1m after 1st vacc (n=81,87,76,74) | 76 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:4, baseline (n=69,78,73,74) | 45 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA≥1:4,1m after 1st vacc (n=69,78,73,74) | 92 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:8, baseline (n=81,87,76,74) | 7 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:8, baseline (n=69,78,73,74) | 37 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA≥1:8,1m after 1st vacc (n=69,78,73,74) | 84 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:4, baseline (n=81,87,76,74) | 18 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA≥1:4,1m after 1st vacc (n=69,80,38,79) | 60 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:8, baseline (n=69,80,38,79) | 3 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA≥1:8,1m after 1st vacc (n=69,80,38,79) | 54 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA≥1:8,1m after 1st vacc (n=81,87,76,74) | 80 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:4, baseline (n=69,78,73,74) | 24 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA≥1:8,1m after 1st vacc (n=79,86,40,74) | 85 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA≥1:4,1m after 1st vacc (n=81,87,76,74) | 86 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:4, baseline (n=69,80,38,79) | 3 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA≥1:4,1m after 1st vacc (n=79,86,40,74) | 91 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:4, baseline (n=79,86,40,74) | 15 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA≥1:4,1m after 1st vacc (n=69,80,38,79) | 66 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:4, baseline (n=81,87,76,74) | 9 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:8, baseline (n=79,86,40,74) | 15 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA≥1:8,1m after 1st vacc (n=69,80,38,79) | 58 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:8, baseline (n=69,78,73,74) | 19 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:8, baseline (n=81,87,76,74) | 4 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA≥1:4,1m after 1st vacc (n=69,78,73,74) | 91 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:8, baseline (n=69,80,38,79) | 1 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA≥1:8,1m after 1st vacc (n=69,78,73,74) | 85 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
The persistence of immune response as measured by percentages of subjects with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months by groups.
Time frame: at 12 months of age
Population: The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:4, at 12 months of age (n=58,79) | 21 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:8, at 12 months of age(n=58,79) | 16 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:4, at 12 months of age(n=70,84) | 59 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:8, at 12 months of age(n=70,84) | 47 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:4, at 12 months of age(n=58,75) | 78 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:8, at 12 months of age(n=58,75) | 66 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:4, at 12 months of age(n=71,86) | 85 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:8, at 12 months of age(n=71,86) | 70 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:8, at 12 months of age(n=71,86) | 79 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:4, at 12 months of age (n=58,79) | 35 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:4, at 12 months of age(n=58,75) | 89 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:8, at 12 months of age(n=58,79) | 29 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:4, at 12 months of age(n=71,86) | 87 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:4, at 12 months of age(n=70,84) | 75 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:8, at 12 months of age(n=58,75) | 81 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:8, at 12 months of age(n=70,84) | 68 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine
The persistence of immune response was measured as the percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 against N. Meningitidis serogroups A, C, W, and Y at 12 months of age by groups.
Time frame: at 12 months of age
Population: The analysis was performed on the MenACWY and Menjugate per-protocol (PP) n population evaluating the persistence response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser A - hSBA ≥1:4, at 12m of age(n=36,62,65,77,78) | 0 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser A - hSBA ≥1:8, at 12m of age(n=36,62,65,77,78) | 0 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser C - hSBA ≥1:4, at 12m of age(n=38,69,69,73,81) | 89 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser C - hSBA ≥1:8, at 12m of age(n=38,69,69,73,81) | 87 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser W - hSBA ≥1:4, at 12m of age(n=34,62,42,69,69) | 9 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser W - hSBA ≥1:8, at 12m of age(n=34,62,42,69,69) | 6 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser Y - hSBA ≥1:4, at 12m of age(n=38,69,66,73,79) | 5 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser Y - hSBA ≥1:8, at 12m of age(n=38,69,66,73,79) | 3 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser C - hSBA ≥1:4, at 12m of age(n=38,69,69,73,81) | 41 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser W - hSBA ≥1:8, at 12m of age(n=34,62,42,69,69) | 48 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser A - hSBA ≥1:4, at 12m of age(n=36,62,65,77,78) | 8 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser C - hSBA ≥1:8, at 12m of age(n=38,69,69,73,81) | 33 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser A - hSBA ≥1:8, at 12m of age(n=36,62,65,77,78) | 5 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser Y - hSBA ≥1:8, at 12m of age(n=38,69,66,73,79) | 42 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser W - hSBA ≥1:4, at 12m of age(n=34,62,42,69,69) | 58 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser Y - hSBA ≥1:4, at 12m of age(n=38,69,66,73,79) | 51 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser Y - hSBA ≥1:4, at 12m of age(n=38,69,66,73,79) | 56 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser Y - hSBA ≥1:8, at 12m of age(n=38,69,66,73,79) | 45 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser C - hSBA ≥1:8, at 12m of age(n=38,69,69,73,81) | 26 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser W - hSBA ≥1:8, at 12m of age(n=34,62,42,69,69) | 45 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser C - hSBA ≥1:4, at 12m of age(n=38,69,69,73,81) | 32 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser A - hSBA ≥1:8, at 12m of age(n=36,62,65,77,78) | 5 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser A - hSBA ≥1:4, at 12m of age(n=36,62,65,77,78) | 6 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser W - hSBA ≥1:4, at 12m of age(n=34,62,42,69,69) | 57 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser A - hSBA ≥1:8, at 12m of age(n=36,62,65,77,78) | 5 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser C - hSBA ≥1:4, at 12m of age(n=38,69,69,73,81) | 48 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser C - hSBA ≥1:8, at 12m of age(n=38,69,69,73,81) | 40 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser W - hSBA ≥1:4, at 12m of age(n=34,62,42,69,69) | 64 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser W - hSBA ≥1:8, at 12m of age(n=34,62,42,69,69) | 52 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser Y - hSBA ≥1:8, at 12m of age(n=38,69,66,73,79) | 51 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser A - hSBA ≥1:4, at 12m of age(n=36,62,65,77,78) | 8 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser Y - hSBA ≥1:4, at 12m of age(n=38,69,66,73,79) | 60 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser C - hSBA ≥1:8, at 12m of age(n=38,69,69,73,81) | 30 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser Y - hSBA ≥1:8, at 12m of age(n=38,69,66,73,79) | 46 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser C - hSBA ≥1:4, at 12m of age(n=38,69,69,73,81) | 35 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser Y - hSBA ≥1:4, at 12m of age(n=38,69,66,73,79) | 59 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser A - hSBA ≥1:4, at 12m of age(n=36,62,65,77,78) | 5 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser W - hSBA ≥1:8, at 12m of age(n=34,62,42,69,69) | 61 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser A - hSBA ≥1:8, at 12m of age(n=36,62,65,77,78) | 4 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine | Ser W - hSBA ≥1:4, at 12m of age(n=34,62,42,69,69) | 75 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines
Immunogenicity was measured as the percentages of subjects With hSBA titers ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at Baseline and 1 month after second vaccination by groups.
Time frame: Baseline and 1 month after second vaccination
Population: The analysis was performed on the MenACWY per-protocol (PP) n population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser C - hSBA ≥1:4, baseline (N=77,74,79,85) | 13 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser A - hSBA ≥1:4, 1m after 2n vacc(N=68,79,78,83) | 60 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser A - hSBA ≥1:8, baseline (N=68,79,78,83) | 3 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser A - hSBA≥1:8, 1m after 2nd vacc(N=68,79,78,83) | 54 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser A - hSBA ≥1:4, baseline (N=68,79,78,83) | 4 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser C - hSBA ≥1:4,1m after 2nd vacc(N=77,74,79,85) | 84 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser C - hSBA ≥1:8, baseline (N=77,74,79,85) | 9 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser C - hSBA ≥1:8,1m after 2nd vacc(N=77,74,79,85) | 83 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser W - hSBA ≥1:4, baseline (N=73,74,72,75) | 45 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser W - hSBA ≥1:4,1m after 2nd vacc(N=73,74,72,75) | 92 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser W - hSBA ≥1:8, baseline (N=73,74,72,75) | 37 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser W -hSBA ≥1:8,1m after 2nd vacc(N=73,74,72,75) | 84 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser Y - hSBA ≥1:4, baseline (N=76,74,77,85) | 18 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser Y -hSBA ≥1:4,1m after 2nd vacc(N=76,74,77,85) | 84 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser Y - hSBA ≥1:8, baseline (N=76,74,77,85) | 7 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser Y -hSBA ≥1:8,1m after 2nd vacc(N=76,74,77,85) | 76 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser C - hSBA ≥1:4,1m after 2nd vacc(N=77,74,79,85) | 91 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser W - hSBA ≥1:4, baseline (N=73,74,72,75) | 24 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser Y -hSBA ≥1:8,1m after 2nd vacc(N=76,74,77,85) | 80 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser W -hSBA ≥1:8,1m after 2nd vacc(N=73,74,72,75) | 85 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser Y - hSBA ≥1:8, baseline (N=76,74,77,85) | 4 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser W - hSBA ≥1:4,1m after 2nd vacc(N=73,74,72,75) | 91 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser A - hSBA ≥1:8, baseline (N=68,79,78,83) | 1 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser W - hSBA ≥1:8, baseline (N=73,74,72,75) | 19 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser C - hSBA ≥1:4, baseline (N=77,74,79,85) | 15 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser C - hSBA ≥1:8, baseline (N=77,74,79,85) | 15 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser A - hSBA≥1:8, 1m after 2nd vacc(N=68,79,78,83) | 58 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser A - hSBA ≥1:4, 1m after 2n vacc(N=68,79,78,83) | 66 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser Y - hSBA ≥1:4, baseline (N=76,74,77,85) | 9 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser C - hSBA ≥1:8,1m after 2nd vacc(N=77,74,79,85) | 85 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser Y -hSBA ≥1:4,1m after 2nd vacc(N=76,74,77,85) | 86 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser A - hSBA ≥1:4, baseline (N=68,79,78,83) | 3 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser C - hSBA ≥1:4,1m after 2nd vacc(N=77,74,79,85) | 86 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser C - hSBA ≥1:4, baseline (N=77,74,79,85) | 20 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser Y -hSBA ≥1:4,1m after 2nd vacc(N=76,74,77,85) | 74 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser C - hSBA ≥1:8, baseline (N=77,74,79,85) | 5 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser C - hSBA ≥1:8,1m after 2nd vacc(N=77,74,79,85) | 82 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser Y -hSBA ≥1:8,1m after 2nd vacc(N=76,74,77,85) | 70 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser W - hSBA ≥1:4, baseline (N=73,74,72,75) | 43 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser W - hSBA ≥1:4,1m after 2nd vacc(N=73,74,72,75) | 82 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser Y - hSBA ≥1:8, baseline (N=76,74,77,85) | 16 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser W - hSBA ≥1:8, baseline (N=73,74,72,75) | 36 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser W -hSBA ≥1:8,1m after 2nd vacc(N=73,74,72,75) | 75 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser A - hSBA ≥1:4, baseline (N=68,79,78,83) | 3 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser A - hSBA ≥1:4, 1m after 2n vacc(N=68,79,78,83) | 50 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser Y - hSBA ≥1:4, baseline (N=76,74,77,85) | 35 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser A - hSBA ≥1:8, baseline (N=68,79,78,83) | 0 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser A - hSBA≥1:8, 1m after 2nd vacc(N=68,79,78,83) | 44 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser Y -hSBA ≥1:8,1m after 2nd vacc(N=76,74,77,85) | 86 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser C - hSBA ≥1:8,1m after 2nd vacc(N=77,74,79,85) | 89 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser A - hSBA ≥1:8, baseline (N=68,79,78,83) | 1 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser A - hSBA ≥1:4, baseline (N=68,79,78,83) | 4 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser Y -hSBA ≥1:4,1m after 2nd vacc(N=76,74,77,85) | 91 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser C - hSBA ≥1:8, baseline (N=77,74,79,85) | 11 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser Y - hSBA ≥1:4, baseline (N=76,74,77,85) | 18 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser A - hSBA ≥1:4, 1m after 2n vacc(N=68,79,78,83) | 57 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser C - hSBA ≥1:4, baseline (N=77,74,79,85) | 20 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser W - hSBA ≥1:4,1m after 2nd vacc(N=73,74,72,75) | 95 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser C - hSBA ≥1:4,1m after 2nd vacc(N=77,74,79,85) | 93 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser W - hSBA ≥1:8, baseline (N=73,74,72,75) | 16 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser Y - hSBA ≥1:8, baseline (N=76,74,77,85) | 11 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser W - hSBA ≥1:4, baseline (N=73,74,72,75) | 19 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser A - hSBA≥1:8, 1m after 2nd vacc(N=68,79,78,83) | 49 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines | Ser W -hSBA ≥1:8,1m after 2nd vacc(N=73,74,72,75) | 92 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine
Immunogenicity was measured as the percentages of subjects with hSBA ≥ 1:4 or ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by groups.
Time frame: at 12 months of age and 1 month after booster vaccination
Population: The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser W -hSBA≥1:4, at 12 m of age(n=57,41,57,35,35) | 56 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser C-hSBA≥1:8, 1m after booster(n=67,63,65,40,40) | 96 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser C-hSBA ≥1:8, at 12 m of age(n=67,40,65,40,40) | 34 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser C -hSBA ≥1:4, at 12 m of age(n=67,63,65,40,40) | 40 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser A -hSBA≥1:4, 1 m after booster vacc | 86 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser C-hSBA≥1:4,1 m after booster(n=57,63,65,40,40) | 96 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser Y - hSBA ≥1:8, 1 m after booster vaccination | 100 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser Y -hSBA≥1:4, at 12m of age(n=66,63,65,40,38) | 52 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser W -hSBA≥1:8,1m after booster(n=57,41,57,35,35) | 100 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser A - hSBA ≥1:8, at 12 months of age | 5 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser Y - hSBA ≥1:8, at 12 months of age | 39 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser A -hSBA ≥1:4, at 12 m of age(n=64,61,62,39,38) | 8 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser W -hSBA≥1:8, at 12 m of age(n=57,41,40,35,35) | 47 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser W - hSBA≥1:4, 1m after booster vaccination | 100 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser A - hSBA ≥1:8, 1 m after booster vaccination | 83 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser Y - hSBA≥1:4, 1 m after booster vaccination | 100 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser W -hSBA≥1:8, at 12 m of age(n=57,41,40,35,35) | 41 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser A -hSBA ≥1:4, at 12 m of age(n=64,61,62,39,38) | 7 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser A -hSBA≥1:4, 1 m after booster vacc | 79 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser A - hSBA ≥1:8, at 12 months of age | 5 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser A - hSBA ≥1:8, 1 m after booster vaccination | 77 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser C -hSBA ≥1:4, at 12 m of age(n=67,63,65,40,40) | 33 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser C-hSBA≥1:4,1 m after booster(n=57,63,65,40,40) | 94 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser C-hSBA ≥1:8, at 12 m of age(n=67,40,65,40,40) | 27 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser C-hSBA≥1:8, 1m after booster(n=67,63,65,40,40) | 94 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser W -hSBA≥1:4, at 12 m of age(n=57,41,57,35,35) | 54 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser W - hSBA≥1:4, 1m after booster vaccination | 100 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser W -hSBA≥1:8,1m after booster(n=57,41,57,35,35) | 100 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser Y -hSBA≥1:4, at 12m of age(n=66,63,65,40,38) | 52 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser Y - hSBA≥1:4, 1 m after booster vaccination | 100 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser Y - hSBA ≥1:8, at 12 months of age | 41 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser Y - hSBA ≥1:8, 1 m after booster vaccination | 100 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser Y -hSBA≥1:4, at 12m of age(n=66,63,65,40,38) | 86 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser Y - hSBA ≥1:8, at 12 months of age | 72 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser A - hSBA ≥1:8, at 12 months of age | 13 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser W -hSBA≥1:8, at 12 m of age(n=57,41,40,35,35) | 68 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser A - hSBA ≥1:8, 1 m after booster vaccination | 92 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser Y - hSBA ≥1:8, 1 m after booster vaccination | 100 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser W -hSBA≥1:8,1m after booster(n=57,41,57,35,35) | 100 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser A -hSBA≥1:4, 1 m after booster vacc | 94 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser C-hSBA≥1:4,1 m after booster(n=57,63,65,40,40) | 98 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser W -hSBA≥1:4, at 12 m of age(n=57,41,57,35,35) | 81 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser C-hSBA≥1:8, 1m after booster(n=67,63,65,40,40) | 98 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser C -hSBA ≥1:4, at 12 m of age(n=67,63,65,40,40) | 60 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser Y - hSBA≥1:4, 1 m after booster vaccination | 100 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser A -hSBA ≥1:4, at 12 m of age(n=64,61,62,39,38) | 21 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser W - hSBA≥1:4, 1m after booster vaccination | 100 percentages of subjects |
| UK24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser C-hSBA ≥1:8, at 12 m of age(n=67,40,65,40,40) | 52 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser Y - hSBA≥1:4, 1 m after booster vaccination | 100 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser A - hSBA ≥1:8, 1 m after booster vaccination | 90 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser Y - hSBA ≥1:8, at 12 months of age | 45 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser C-hSBA≥1:8, 1m after booster(n=67,63,65,40,40) | 95 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser W -hSBA≥1:4, at 12 m of age(n=57,41,57,35,35) | 74 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser W - hSBA≥1:4, 1m after booster vaccination | 100 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser A - hSBA ≥1:8, at 12 months of age | 3 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser W -hSBA≥1:8, at 12 m of age(n=57,41,40,35,35) | 49 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser W -hSBA≥1:8,1m after booster(n=57,41,57,35,35) | 100 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser A -hSBA≥1:4, 1 m after booster vacc | 92 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser Y -hSBA≥1:4, at 12m of age(n=66,63,65,40,38) | 65 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser Y - hSBA ≥1:8, 1 m after booster vaccination | 100 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser C-hSBA ≥1:8, at 12 m of age(n=67,40,65,40,40) | 35 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser A -hSBA ≥1:4, at 12 m of age(n=64,61,62,39,38) | 5 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser C -hSBA ≥1:4, at 12 m of age(n=67,63,65,40,40) | 48 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser C-hSBA≥1:4,1 m after booster(n=57,63,65,40,40) | 98 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser A -hSBA ≥1:4, at 12 m of age(n=64,61,62,39,38) | 3 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser C-hSBA ≥1:8, at 12 m of age(n=67,40,65,40,40) | 25 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser A - hSBA ≥1:8, at 12 months of age | 3 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser C-hSBA≥1:4,1 m after booster(n=57,63,65,40,40) | 100 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser Y - hSBA≥1:4, 1 m after booster vaccination | 100 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser A - hSBA ≥1:8, 1 m after booster vaccination | 92 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser C-hSBA≥1:8, 1m after booster(n=67,63,65,40,40) | 100 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser C -hSBA ≥1:4, at 12 m of age(n=67,63,65,40,40) | 33 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser A -hSBA≥1:4, 1 m after booster vacc | 95 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser W -hSBA≥1:4, at 12 m of age(n=57,41,57,35,35) | 69 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser W -hSBA≥1:8,1m after booster(n=57,41,57,35,35) | 100 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser Y - hSBA ≥1:8, 1 m after booster vaccination | 100 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser W -hSBA≥1:8, at 12 m of age(n=57,41,40,35,35) | 54 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser W - hSBA≥1:4, 1m after booster vaccination | 100 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser Y - hSBA ≥1:8, at 12 months of age | 53 percentages of subjects |
| CA24- (MenACWY Ad- at 2, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine | Ser Y -hSBA≥1:4, at 12m of age(n=66,63,65,40,38) | 63 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
The induction of immunological memory was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.
Time frame: before challenge at 12 months of age and 1 month after PS challenge.
Population: The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser A-hSBA≥1:4,before challenge at 12m (n=44) | 27 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:4, 1 month after PS (n=44) | 89 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser A-hSBA ≥1:8,before challenge at 12m (n=44) | 23 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser A - hSBA ≥1:8, 1 month after PS (n=44) | 86 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser C-hSBA ≥1:4,before challenge at 12m (n=43) | 74 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:4, 1 month after PS (n=43) | 95 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser C-hSBA ≥1:8, before challenge at 12m (n=43) | 65 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser C - hSBA ≥1:8, 1 month after PS (n=43) | 91 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser W-hSBA ≥1:4,before challenge at 12m (n=40) | 83 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:4, 1 month after PS (n=40) | 98 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser W-hSBA ≥1:8,before challenge at 12m (n=40) | 73 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser W - hSBA ≥1:8, 1 month after PS (n=40) | 95 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser Y-hSBA ≥1:4,before challenge at 12m (n=44) | 89 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:4, 1 month after PS (n=44) | 98 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser Y-hSBA ≥1:8,before challenge at 12m (N=44) | 77 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine | Ser Y - hSBA ≥1:8, 1 month after PS (n=44) | 98 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine
The Induction of immunological memory was measured as percentage of subjects with hSBA ≥ 1:4, hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.
Time frame: Before challenge at 12 months of age and 1 month after PS challenge.
Population: The analysis was performed on the MenACWY per-protocol (PP) n population evaluating the persistence response.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser A - hSBA≥1:4,before challange at 12m (n=40,39) | 8 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser A - hSBA ≥1:4,1 month after PS (n=40,39) | 78 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser A - hSBA≥1:8,before challange at 12m (n=40,39) | 5 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser A - hSBA ≥1:8, 1 month after PS (n=40,39) | 78 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser C - hSBA≥1:4,before challange at 12m (n=41,39) | 44 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser C - hSBA ≥1:4, 1 month after PS (n=41,39) | 95 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser C - hSBA≥1:8,before challange at 12m(n=41,39) | 39 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser C - hSBA ≥1:8, 1 month after PS (n=41,39) | 93 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser W - hSBA ≥1:4,before challange at 12m(n=41,38) | 59 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser W - hSBA ≥1:4, 1 month after PS (n=41,38) | 98 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser W - hSBA ≥1:8,before challange at 12m(n=41,38) | 51 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser W - hSBA ≥1:8, 1 month after PS (n=41,38) | 98 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser Y - hSBA ≥1:4,before challange at 12m(n=42,38) | 55 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser Y - hSBA ≥1:4, 1 month after PS (n=42,38) | 98 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser Y - hSBA ≥1:8,before challange at 12m (n=42,38 | 50 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser Y - hSBA ≥1:8, 1 month after PS (n=42,38) | 98 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser Y - hSBA ≥1:8, 1 month after PS (n=42,38) | 97 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser A - hSBA≥1:4,before challange at 12m (n=40,39) | 8 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser W - hSBA ≥1:4,before challange at 12m(n=41,38) | 71 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser A - hSBA ≥1:4,1 month after PS (n=40,39) | 92 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser Y - hSBA ≥1:4,before challange at 12m(n=42,38) | 55 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser A - hSBA≥1:8,before challange at 12m (n=40,39) | 5 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser W - hSBA ≥1:4, 1 month after PS (n=41,38) | 100 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser A - hSBA ≥1:8, 1 month after PS (n=40,39) | 87 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser Y - hSBA ≥1:8,before challange at 12m (n=42,38 | 42 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser C - hSBA≥1:4,before challange at 12m (n=41,39) | 38 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser W - hSBA ≥1:8,before challange at 12m(n=41,38) | 58 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser C - hSBA ≥1:4, 1 month after PS (n=41,39) | 95 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser Y - hSBA ≥1:4, 1 month after PS (n=42,38) | 100 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser C - hSBA≥1:8,before challange at 12m(n=41,39) | 36 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser W - hSBA ≥1:8, 1 month after PS (n=41,38) | 100 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine | Ser C - hSBA ≥1:8, 1 month after PS (n=41,39) | 90 percentages of subjects |
Secondary
Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Immunogenicity was measured by percentages of subjects With hSBA titers ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at baseline and 1 month after primary vaccination by groups.
Time frame: Baseline and 1 month after the 3 dose primary vaccination series
Population: The analysis was performed on the MenACWY per-protocol (PP) n population after primary vaccination.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser A - baseline (n=69,80) | 4 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser A - 1 month after primary vacc (n=69,80) | 88 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser C - baseline (n=79,86) | 9 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser C - 1 month after primary vacc (n=79,86) | 92 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser W - baseline (n=69,78) | 46 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser W - 1 month after primary vacc (n=69,78) | 88 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser Y - baseline | 14 percentages of subjects |
| UK234+ (MenACWY Ad+ at 2, 3, 4 m) | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser Y - 1 month after primary vaccination | 93 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser Y - 1 month after primary vaccination | 89 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser A - baseline (n=69,80) | 0 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser W - baseline (n=69,78) | 28 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser A - 1 month after primary vacc (n=69,80) | 76 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser Y - baseline | 11 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser C - baseline (n=79,86) | 5 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser W - 1 month after primary vacc (n=69,78) | 96 percentages of subjects |
| CA246+ (MenACWY Ad+ at 2, 4, 6 m) | Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine | Ser C - 1 month after primary vacc (n=79,86) | 98 percentages of subjects |