Study of the Safety and Immune Response of a Meningococca... | NCT00262002 | Trialant
NCT00262002
Sponsor
Novartis Vaccines
Status
Completed
Last Update Posted
Jun 18, 2014Estimated
Enrollment
601Actual
Phase
Phase 2
Conditions
Prevention of Meningococcal Disease
Interventions
MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation)
MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)
MenACWY PS (MenACWY-CRM, polysaccharide vaccine)
HBV (Hepatitis B vaccine)
Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)
MMR (Measles, Mumps and Rubella vaccine)
DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
Menjugate (Men C conjugated vaccine)
Countries
Canada
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT00262002
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
V59P5
Secondary IDs
ID
Type
Description
Link
2004-000195-13
Brief Title
Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants
Official Title
A Phase II, Randomized, Open Label, Controlled, Multicenter Study to Evaluate the Safety, Immunogenicity and Induction of Immunological Memory After Two or Three Doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants at 2, 3, 4 or 2, 4, 6 Months of Age
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Jun 2014
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 2004
Primary Completion Date
Jul 2005Actual
Completion Date
Oct 2006Actual
First Submitted Date
Dec 2, 2005
First Submission Date that Met QC Criteria
Dec 2, 2005
First Posted Date
Dec 6, 2005Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 2, 2013
Results First Submitted that Met QC Criteria
Jun 16, 2014
Results First Posted Date
Jun 18, 2014Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 16, 2014
Last Update Posted Date
Jun 18, 2014Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis VaccinesINDUSTRY
Collaborators
Name
Class
Novartis
INDUSTRY
Oversight Module
No data available
No data is available for this block.
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Prevention of Meningococcal Disease
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
601Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
Experimental
Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age in the UK group. A fourth dose of MenACWY Ad+ was given at 12 months of age.
Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
UK24+ (MenACWY Ad+ at 2, 4 m)
Experimental
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.
Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
UKMenC (Menjugate at 2, 4 m)
Experimental
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.
Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
Biological: Menjugate (Men C conjugated vaccine)
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Experimental
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 of the Canadian group (Prevnar at 6 months was optional and was given if available).One subgroup of subjects was given a reduced dose (1/5) 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.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation)
Biological
MenACWY-CRM conjugate vaccine formulated without adjuvant was injected IM (intramuscularly) in the anterolateral area of the right thigh.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
Baseline and at 1 month after the 3 dose primary vaccination series
Secondary Outcomes
Measure
Description
Time Frame
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.
Baseline and 1 month after the 3 dose primary vaccination series
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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.
Snape MD, Perrett KP, Ford KJ, John TM, Pace D, Yu LM, Langley JM, McNeil S, Dull PM, Ceddia F, Anemona A, Halperin SA, Dobson S, Pollard AJ. Immunogenicity of a tetravalent meningococcal glycoconjugate vaccine in infants: a randomized controlled trial. JAMA. 2008 Jan 9;299(2):173-84. doi: 10.1001/jama.2007.29-c.
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.
Recruitment Details
Participants were enrolled at two centers in Canada and one in UK.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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.
Biological: Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)
Biological: MMR (Measles, Mumps and Rubella vaccine)
Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
CA24+ (MenACWY Ad+ at 2, 4 m)
Experimental
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 (1/5) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Biological: Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)
Biological: MMR (Measles, Mumps and Rubella vaccine)
Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
UK24- (MenACWY Ad- at 2, 4 m)
Experimental
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.
Biological: MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation)
Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
CA24- (MenACWY Ad- at 2, 4 m)
Experimental
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.
Biological: MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation)
Biological: Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)
Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
CA24- (MenACWY Ad- at 2, 4 m)
UK24- (MenACWY Ad- at 2, 4 m)
MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)
Biological
MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.
CA24+ (MenACWY Ad+ at 2, 4 m)
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
UK24+ (MenACWY Ad+ at 2, 4 m)
UKMenC (Menjugate at 2, 4 m)
MenACWY PS (MenACWY-CRM, polysaccharide vaccine)
Biological
MenACWY polysaccharide vaccine was injected in the anterolateral area of the right thigh.
CA24+ (MenACWY Ad+ at 2, 4 m)
CA24- (MenACWY Ad- at 2, 4 m)
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
HBV (Hepatitis B vaccine)
Biological
Hepatitis B vaccine at 2, 4, 6 months of age administered IM in the anterolateral area of the left thigh.
CA24+ (MenACWY Ad+ at 2, 4 m)
CA24- (MenACWY Ad- at 2, 4 m)
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)
Biological
Prevnar was administered IM in the anterolateral area of the left thigh.
CA24+ (MenACWY Ad+ at 2, 4 m)
CA24- (MenACWY Ad- at 2, 4 m)
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
MMR (Measles, Mumps and Rubella vaccine)
Biological
MMR at 12 month of age, administered in the left arm.
CA24+ (MenACWY Ad+ at 2, 4 m)
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
Biological
DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.
CA24+ (MenACWY Ad+ at 2, 4 m)
CA24- (MenACWY Ad- at 2, 4 m)
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
UK24+ (MenACWY Ad+ at 2, 4 m)
UK24- (MenACWY Ad- at 2, 4 m)
UKMenC (Menjugate at 2, 4 m)
Menjugate (Men C conjugated vaccine)
Biological
Menjugate was injected IM in the anterolateral area of the right thigh.
UKMenC (Menjugate at 2, 4 m)
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.
Baseline and 1 month after the 3 dose primary vaccination series
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.
Baseline and 1 month after second vaccination
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.
Baseline and 1 month after second vaccination
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.
at 12 months of age and 1 month after booster vaccination
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.
at 12 months of age and 1 month after booster vaccination
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.
at 12 months of age
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.
at 12 months of age
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.
at 12 months of age
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.
at 12 months of age
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.
before challenge at 12 months of age and 1 month after PS challenge.
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.
before challenge at 12 months of age and 1 month after PS challenge.
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.
Before challenge at 12 months of age and 1 month after PS challenge.
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.
Before challenge at 12 months of age and 1 month after PS challenge.
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.
Baseline and 1 month after the 2 or 3 dose primary vaccination series
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.
at 12 months of age and 1 month after PS challenge
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.
Baseline and 1 month after the 2 or 3 dose primary vaccination series
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.
Baseline and 1 month after the 2 or 3 dose primary vaccination series
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.
Baseline and 1 month after second vaccination
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.
7 days after each vaccination
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.
7 days after vaccination at 12 months of age
Halifax
Nova Scotia
Canada
Oxford Vaccine Group
Oxford
United Kingdom
Perrett KP, Snape MD, Ford KJ, John TM, Yu LM, Langley JM, McNeil S, Dull PM, Ceddia F, Anemona A, Halperin SA, Dobson S, Pollard AJ. Immunogenicity and immune memory of a nonadjuvanted quadrivalent meningococcal glycoconjugate vaccine in infants. Pediatr Infect Dis J. 2009 Mar;28(3):186-93. doi: 10.1097/INF.0b013e31818e037d.
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.
FG002
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.
FG003
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.
FG004
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.
FG005
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.
FG006
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.
FG00090 subjects
FG00190 subjects
FG00245 subjects
FG00398 subjects
FG00498 subjects
FG00590 subjects
FG00690 subjects
COMPLETED
FG00079 subjects
FG00184 subjects
FG00245 subjects
FG00393 subjects
FG00491 subjects
FG00583 subjects
FG00684 subjects
NOT COMPLETED
FG00011 subjects
FG0016 subjects
FG0020 subjects
FG0035 subjects
FG0047 subjects
FG0057 subjects
FG0066 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Withdrawal by Subject
FG0004 subjects
FG0012 subjects
FG0020 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
Inapropriate enrollment
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0003 subjects
FG0012 subjects
FG0020 subjects
FG0032 subjects
FG004
Unable to classify
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
BG001
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.
BG002
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.
BG003
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.
BG004
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.
BG005
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.
BG006
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.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00090
BG00190
BG00245
BG00398
BG00498
BG00590
BG00690
BG007601
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
days
Title
Denominators
Categories
Title
Measurements
BG00062.1± 5.4
BG00161.3± 5.0
BG00262.6± 6.5
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00044
BG00141
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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.
The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.
Posted
Number
95% Confidence Interval
percentages of subjects
Baseline and at 1 month after the 3 dose primary vaccination series
ID
Title
Description
OG000
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
Three doses of MenACWY conjugate vaccine with adjuvant 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.
OG001
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant 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.
Units
Counts
Participants
OG00081
OG00187
Title
Denominators
Categories
Ser A - baseline (n=69,80)
Title
Measurements
OG0006(2 to 14)
OG0010(0 to 5)
Ser A - 1 month after primary vacc (n=69,80)
Title
Measurements
OG000
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.
The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.
Posted
Number
95% Confidence Interval
percentages of subjects
Baseline and 1 month after the 3 dose primary vaccination series
ID
Title
Description
OG000
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
Three doses of MenACWY conjugate vaccine with adjuvant 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.
OG001
CA246+ (MenACWY Ad+ at 2, 4, 6m)
Three doses of MenACWY conjugate vaccine with adjuvant 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.
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.
The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.
Posted
Geometric Mean
95% Confidence Interval
titers
Baseline and 1 month after the 3 dose primary vaccination series
ID
Title
Description
OG000
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
Three doses of MenACWY conjugate vaccine with adjuvant 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.
OG001
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant 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.
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.
The analysis was performed on the MenACWY per-protocol (PP) "n" population.
Posted
Number
95% Confidence Interval
percentages of subjects
Baseline and 1 month after second vaccination
ID
Title
Description
OG000
UK24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG001
CA24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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 (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
OG002
UK24- (MenACWY Ad- at 2, 4 m)
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.
The analysis was performed on the MenACWY per-protocol (PP) "n" population
Posted
Geometric Mean
95% Confidence Interval
titers
Baseline and 1 month after second vaccination
ID
Title
Description
OG000
UK24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG001
CA24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG002
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
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.
The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.
Posted
Number
95% Confidence Interval
percentages of subjects
at 12 months of age and 1 month after booster vaccination
ID
Title
Description
OG000
UK24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG001
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
OG002
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
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.
The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.
Posted
Geometric Mean
95% Confidence Interval
titers
at 12 months of age and 1 month after booster vaccination
ID
Title
Description
OG000
UK24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG001
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
OG002
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
Three doses of MenACWY conjugate vaccine with adjuvant 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.
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.
The analysis was performed on the MenACWY and Menjugate per-protocol (PP) "n" population evaluating the persistence response.
Posted
Number
95% Confidence Interval
percentages of subjects
at 12 months of age
ID
Title
Description
OG000
UKMenC (Menjugate 2, 4 m)
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.
OG001
UK24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG002
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
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.
The analysis was performed on the MenACWY and Menjugate per-protocol (PP) "n" population evaluating the persistence response.
Posted
Geometric Mean
95% Confidence Interval
titers
at 12 months of age
ID
Title
Description
OG000
UKMenC (Menjugate at 2, 4 m)
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.
OG001
UK24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG002
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
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.
The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.
Posted
Number
95% Confidence Interval
percentages of subjects
at 12 months of age
ID
Title
Description
OG000
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
Three doses of MenACWY conjugate vaccine with adjuvant 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
OG001
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant 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.
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.
The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.
Posted
Geometric Mean
95% Confidence Interval
Titers
at 12 months of age
ID
Title
Description
OG000
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
Three doses of MenACWY conjugate vaccine with adjuvant 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.
OG001
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant 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.
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.
The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.
Posted
Number
95% Confidence Interval
percentages of subjects
before challenge at 12 months of age and 1 month after PS challenge.
ID
Title
Description
OG000
CA246+ (MenACWY Ad+ at 2,4,6 m)
Three doses of MenACWY conjugate vaccine with adjuvant 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.
Units
Counts
Participants
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.
The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.
Posted
Geometric Mean
95% Confidence Interval
titers
before challenge at 12 months of age and 1 month after PS challenge.
ID
Title
Description
OG000
CA246+ (MenACWY Ad+ at 2, 4,6 m)
Three doses of MenACWY conjugate vaccine with adjuvant 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.
Units
Counts
Participants
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.
The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.
Posted
Number
95% Confidence Interval
percentages of subjects
Before challenge at 12 months of age and 1 month after PS challenge.
ID
Title
Description
OG000
CA24+ (MenACWY Ad+ at 2, 4m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG001
CA24- (MenACWY Ad- at 2, 4m)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
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.
The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.
Posted
Geometric Mean
95% Confidence Interval
titers
Before challenge at 12 months of age and 1 month after PS challenge.
ID
Title
Description
OG000
CA24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG001
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
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.
The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.
Posted
Number
95% Confidence Interval
percentages of subjects
Baseline and 1 month after the 2 or 3 dose primary vaccination series
ID
Title
Description
OG000
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
Three doses of MenACWY conjugate vaccine with adjuvant 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.
OG001
CA246+ (MenACWY Ad+ at 2, 4, 6m)
Three doses of MenACWY conjugate vaccine with adjuvant 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 to be 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.
OG002
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.
The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.
Posted
Number
95% Confidence Interval
percentages of subjects
at 12 months of age and 1 month after PS challenge
ID
Title
Description
OG000
CA246+ (MenACWY Ad+ at 2, 4, 6m)
Three doses of MenACWY conjugate vaccine with adjuvant 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.
OG001
CA24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
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.
The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.
Posted
Number
95% Confidence Interval
percentages of subjects
Baseline and 1 month after the 2 or 3 dose primary vaccination series
ID
Title
Description
OG000
CA24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG001
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
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.
The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.
Posted
Geometric Mean
95% Confidence Interval
titers
Baseline and 1 month after the 2 or 3 dose primary vaccination series
ID
Title
Description
OG000
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
Three doses of MenACWY conjugate vaccine with adjuvant 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.
OG001
UK24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG002
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
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.
The analysis was performed on the MenACWY and Menjugate per-protocol (PP) "n" population after second vaccination.
Posted
Number
95% Confidence Interval
percentages of subjects
Baseline and 1 month after second vaccination
ID
Title
Description
OG000
UKMenC (Menjugate at 2, 4 m)
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.
OG001
UK24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG002
CA24+ (MenACWY Ad+ at 2, 4 m)
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.
Analysis was done on safety dataset "n" population - subjects who received at least one study dose and had Post baseline safety data.
Posted
Number
subjects
7 days after each vaccination
ID
Title
Description
OG000
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
Three doses of MenACWY conjugate vaccine with adjuvant 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.
OG001
UK24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG002
UKMenC (Menjugate at 2, 4 m)
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.
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.
Analysis was done on safety dataset "n" population.
Posted
Number
subjects
7 days after vaccination at 12 months of age
ID
Title
Description
OG000
UK234+ (MenACWY Ad+ at 2,3,4 m)
Three doses of MenACWY conjugate vaccine with adjuvant 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.
OG001
UK24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG002
UKMenC (Menjugate at 2, 4 m)
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.
Time Frame
All solicited adverse events (AEs) were collected upto Day 7 after each vaccination. All SAEs and unsolicited AEs were collected throughout the study (22 months in total).
Description
Information on all AEs was to be collected for 7 days following each vaccination, after which information on only SAEs and AEs necessitating a physician's visit and/or resulting in premature withdrawal of subjects from the study was collected until the next study visit and recorded by study personnel.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
UK234+ (MenACWY Ad+ at 2,3,4 m)
Three doses of MenACWY Ad+ vaccine were to be given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was to be given at 12 months of age.
20
90
90
90
EG001
UK24+ (MenACWY Ad+ at 2,4 m)
Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was to be given at 12 months of age.
17
90
89
90
EG002
UKMenC (Menjugate at 2,4m)
Two doses of Menjugate® were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was to be given at 12 months of age.
6
45
45
45
EG003
CA246+ (MenACWY Ad+ at 2,4,6m)
Three doses of MenACWY Ad+ vaccine were to be 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 to be given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was to be administered one dose of MMR (and Prevnar, if available) at 12 months of age.
9
98
97
98
EG004
CA24+ (MenACWY Ad+ at 2,4m)
Two doses of MenACWY Ad+ vaccine were to be 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 (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
4
98
97
98
EG005
UK24- (MenACWY Ad- at 2,4m)
Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was to be given at 12 months of age.
10
90
90
90
EG006
CA24- (MenACWY Ad- at 2,4m)
Two doses of MenACWY Ad- vaccine were to be 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 (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
7
90
89
90
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
IDIOPATHIC THROMBOCYTOPENIC PURPURA
Blood and lymphatic system disorders
Non-systematic Assessment
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG0030 affected98 at risk
EG004
SUPRAVENTRICULAR TACHYCARDIA
Cardiac disorders
Non-systematic Assessment
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected45 at risk
EG003
CONGENITAL MEGACOLON
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected45 at risk
EG003
HYPOSPADIAS
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
PLAGIOCEPHALY
Congenital, familial and genetic disorders
Non-systematic Assessment
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
Non-systematic Assessment
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected45 at risk
EG003
INGUINAL HERNIA
Gastrointestinal disorders
Non-systematic Assessment
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
VOMITING
General disorders
Systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
CYST
General disorders
Non-systematic Assessment
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
DEVELOPMENTAL DELAY
General disorders
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
FOOD ALLERGY
Immune system disorders
Non-systematic Assessment
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
ARTHRITIS BACTERIAL
Infections and infestations
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
BRONCHIOLITIS
Infections and infestations
Non-systematic Assessment
EG0004 affected90 at risk
EG0013 affected90 at risk
EG0021 affected45 at risk
EG003
CROUP INFECTIOUS
Infections and infestations
Non-systematic Assessment
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected45 at risk
EG003
GASTROENTERITIS
Infections and infestations
Non-systematic Assessment
EG0000 affected90 at risk
EG0012 affected90 at risk
EG0020 affected45 at risk
EG003
GASTROENTERITIS VIRAL
Infections and infestations
Non-systematic Assessment
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
INFECTED CYST
Infections and infestations
Non-systematic Assessment
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected45 at risk
EG003
INFLUENZA
Infections and infestations
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
LOWER RESPIRATORY TRACT INFECTION
Infections and infestations
Non-systematic Assessment
EG0001 affected90 at risk
EG0011 affected90 at risk
EG0021 affected45 at risk
EG003
PNEUMONIA
Infections and infestations
Non-systematic Assessment
EG0000 affected90 at risk
EG0012 affected90 at risk
EG0020 affected45 at risk
EG003
RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS
Infections and infestations
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
RESPIRATORY SYNCYTIAL VIRUS INFECTION
Infections and infestations
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
RESPIRATORY TRACT INFECTION VIRAL
Infections and infestations
Non-systematic Assessment
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected45 at risk
EG003
SALMONELLOSIS
Infections and infestations
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
VARICELLA
Infections and infestations
Non-systematic Assessment
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected45 at risk
EG003
VIRAL INFECTION
Infections and infestations
Non-systematic Assessment
EG0004 affected90 at risk
EG0012 affected90 at risk
EG0021 affected45 at risk
EG003
VIRAL RASH
Infections and infestations
Non-systematic Assessment
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected45 at risk
EG003
BURNS FIRST DEGREE
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
BURNS SECOND DEGREE
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
FEMUR FRACTURE
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
HEAD INJURY
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
INJURY
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
LIMB CRUSHING INJURY
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0021 affected45 at risk
EG003
TRAUMATIC FRACTURE
Injury, poisoning and procedural complications
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0021 affected45 at risk
EG003
CONVULSION
Nervous system disorders
Non-systematic Assessment
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected45 at risk
EG003
FEBRILE CONVULSION
Nervous system disorders
Non-systematic Assessment
EG0001 affected90 at risk
EG0011 affected90 at risk
EG0020 affected45 at risk
EG003
URINARY RETENTION
Renal and urinary disorders
Non-systematic Assessment
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
ASTHMA
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
BRONCHIAL HYPERREACTIVITY
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
WHEEZING
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0021 affected45 at risk
EG003
ERYTHEMA MULTIFORME
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
PETECHIAE
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected45 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0021 affected45 at risk
EG003
ACROCHORDON EXCISION
Surgical and medical procedures
Non-systematic Assessment
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
CIRCUMCISION
Surgical and medical procedures
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
HYDROCELE OPERATION
Surgical and medical procedures
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
INGUINAL HERNIA REPAIR
Surgical and medical procedures
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
TENDON SHEATH INCISION
Surgical and medical procedures
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0021 affected45 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
CONJUNCTIVITIS
Eye disorders
Non-systematic Assessment
EG0003 affected90 at risk
EG0019 affected90 at risk
EG0023 affected45 at risk
EG0033 affected98 at risk
EG0041 affected98 at risk
EG00512 affected90 at risk
EG0061 affected90 at risk
CONSTIPATION
Gastrointestinal disorders
Non-systematic Assessment
EG0007 affected90 at risk
EG0011 affected90 at risk
EG0022 affected45 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
Systematic Assessment
EG00041 affected90 at risk
EG00140 affected90 at risk
EG00218 affected45 at risk
EG003
VOMITING
Gastrointestinal disorders
Systematic Assessment
EG00024 affected90 at risk
EG00137 affected90 at risk
EG00213 affected45 at risk
EG003
CRYING
General disorders
Systematic Assessment
EG0007 affected90 at risk
EG00111 affected90 at risk
EG0028 affected45 at risk
EG003
INJECTION SITE ERYTHEMA
General disorders
Systematic Assessment
EG00079 affected90 at risk
EG00179 affected90 at risk
EG00240 affected45 at risk
EG003
INJECTION SITE INDURATION
General disorders
Systematic Assessment
EG00039 affected90 at risk
EG00143 affected90 at risk
EG00225 affected45 at risk
EG003
INJECTION SITE PAIN
General disorders
Systematic Assessment
EG00042 affected90 at risk
EG00139 affected90 at risk
EG00223 affected45 at risk
EG003
IRRITABILITY
General disorders
Systematic Assessment
EG00069 affected90 at risk
EG00182 affected90 at risk
EG00239 affected45 at risk
EG003
PYREXIA
General disorders
Systematic Assessment
EG00011 affected90 at risk
EG00113 affected90 at risk
EG0023 affected45 at risk
EG003
BRONCHIOLITIS
Infections and infestations
Non-systematic Assessment
EG0008 affected90 at risk
EG0014 affected90 at risk
EG0021 affected45 at risk
EG003
CROUP INFECTIOUS
Infections and infestations
Non-systematic Assessment
EG0001 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
LOWER RESPIRATORY TRACT INFECTION
Infections and infestations
Non-systematic Assessment
EG0009 affected90 at risk
EG0018 affected90 at risk
EG0020 affected45 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
Non-systematic Assessment
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected45 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
Non-systematic Assessment
EG0000 affected90 at risk
EG0011 affected90 at risk
EG0020 affected45 at risk
EG003
OTITIS MEDIA
Infections and infestations
Non-systematic Assessment
EG0006 affected90 at risk
EG0017 affected90 at risk
EG0021 affected45 at risk
EG003
RHINITIS
Infections and infestations
Non-systematic Assessment
EG00030 affected90 at risk
EG00134 affected90 at risk
EG00215 affected45 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
Non-systematic Assessment
EG0007 affected90 at risk
EG00110 affected90 at risk
EG0028 affected45 at risk
EG003
VIRAL INFECTION
Infections and infestations
Non-systematic Assessment
EG0006 affected90 at risk
EG0017 affected90 at risk
EG0021 affected45 at risk
EG003
SOMNOLENCE
Nervous system disorders
Systematic Assessment
EG00058 affected90 at risk
EG00157 affected90 at risk
EG00229 affected45 at risk
EG003
EATING DISORDER
Psychiatric disorders
Systematic Assessment
EG00034 affected90 at risk
EG00142 affected90 at risk
EG00217 affected45 at risk
EG003
COUGH
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG00010 affected90 at risk
EG0017 affected90 at risk
EG0029 affected45 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0021 affected45 at risk
EG003
DERMATITIS DIAPER
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0006 affected90 at risk
EG0013 affected90 at risk
EG0021 affected45 at risk
EG003
DRY SKIN
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0004 affected90 at risk
EG0010 affected90 at risk
EG0021 affected45 at risk
EG003
ECZEMA
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0008 affected90 at risk
EG00113 affected90 at risk
EG0025 affected45 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0003 affected90 at risk
EG0014 affected90 at risk
EG0023 affected45 at risk
EG003
RASH PAPULAR
Skin and subcutaneous tissue disorders
Non-systematic Assessment
EG0000 affected90 at risk
EG0010 affected90 at risk
EG0020 affected45 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigators from publishing. Any publications from a single site are postponed until the publication of the pool data (i.e., data from all sites) in the clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
Posting Director
Novartis Vaccine and Diagnostics S.r.l
RegistryContactVaccineUS@novartis.com
ID
Term
D017325
Hepatitis B Vaccines
D000069443
Heptavalent Pneumococcal Conjugate Vaccine
D012411
Rubella Vaccine
D013745
Tetanus Toxoid
Ancestor Terms
ID
Term
D014761
Viral Hepatitis Vaccines
D014765
Viral Vaccines
D014612
Vaccines
D001688
Biological Products
D045424
Complex Mixtures
D022242
Pneumococcal Vaccines
D022541
Streptococcal Vaccines
D001428
Bacterial Vaccines
D017778
Vaccines, Combined
D014121
Toxoids
Browse Leaves
Not provided
Browse Branches
Not provided
2 subjects
FG0052 subjects
FG0062 subjects
0 subjects
FG0051 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
5 subjects
FG0053 subjects
FG0062 subjects
0 subjects
FG0050 subjects
FG0062 subjects
65.6
± 6.9
BG00465.8± 6.9
BG00564.1± 5.5
BG00669.4± 10.0
BG00764.6± 7.3
26
BG00352
BG00449
BG00548
BG00644
BG007304
Male
BG00046
BG00149
BG00219
BG00346
BG00449
BG00542
BG00646
BG007297
93
(84 to 98)
OG00181(71 to 89)
Ser C - baseline (n=79,86)
Title
Measurements
OG00018(10 to 28)
OG00115(8 to 24)
Ser C - 1 month after primary vacc (n=79,86)
Title
Measurements
OG00096(89 to 99)
OG00198(92 to 100)
Ser W - baseline (n=69,78)
Title
Measurements
OG00054(41 to 66)
OG00131(21 to 42)
Ser W - 1 month after primary vacc (n=69,78)
Title
Measurements
OG00097(90 to 100)
OG00199(93 to 100)
Ser Y - baseline
Title
Measurements
OG00021(13 to 31)
OG00117(10 to 27)
Ser Y - 1 month after primary vacc
Title
Measurements
OG00094(86 to 98)
OG00198(92 to 100)
Units
Counts
Participants
OG00081
OG00187
Title
Denominators
Categories
Ser A - baseline (n=69,80)
Title
Measurements
OG0004(1 to 12)
OG0010(0 to 5)
Ser A - 1 month after primary vacc (n=69,80)
Title
Measurements
OG00088(78 to 95)
OG00176(65 to 85)
Ser C - baseline (n=79,86)
Title
Measurements
OG0009(4 to 17)
OG0015(1 to 11)
Ser C - 1 month after primary vacc (n=79,86)
Title
Measurements
OG00092(84 to 97)
OG00198(92 to 100)
Ser W - baseline (n=69,78)
Title
Measurements
OG00046(34 to 59)
OG00128(19 to 40)
Ser W - 1 month after primary vacc (n=69,78)
Title
Measurements
OG00088(78 to 95)
OG00196(89 to 99)
Ser Y - baseline
Title
Measurements
OG00014(7 to 23)
OG00111(6 to 20)
Ser Y - 1 month after primary vaccination
Title
Measurements
OG00093(85 to 97)
OG00189(80 to 94)
Units
Counts
Participants
OG00081
OG00187
Title
Denominators
Categories
Ser A - baseline (n=69,80)
Title
Measurements
OG0002.2(2.04 to 2.38)
OG0012(1.86 to 2.15)
Ser A - 1 month after primary vacc (n=69,80)
Title
Measurements
OG00053(38 to 74)
OG00121(15 to 29)
Ser C - baseline (n=79,86)
Title
Measurements
OG0002.79(2.36 to 3.31)
OG0012.64(2.25 to 3.11)
Ser C - 1 month after primary vacc (n=79,86)
Title
Measurements
OG00079(56 to 112)
OG001124(89 to 172)
Ser W - baseline (n=69,78)
Title
Measurements
OG0005.76(4.39 to 7.57)
OG0014.03(3.12 to 5.21)
Ser W - 1 month after primary vacc (n=69,78)
Title
Measurements
OG00065(46 to 92)
OG00173(53 to 102)
Ser Y - baseline
Title
Measurements
OG0002.72(2.34 to 3.17)
OG0012.64(2.28 to 3.05)
Ser Y - 1 month after primary vacc
Title
Measurements
OG00056(41 to 77)
OG0012.64(2.28 to 3.05)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
OG003
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant 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 (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
Units
Counts
Participants
OG00077
OG00179
OG00279
OG00385
Title
Denominators
Categories
Ser A - hSBA ≥1:4, baseline (N=68,79,78,83)
Title
Measurements
OG0004(1 to 12)
OG0013(0 to 9)
OG0023(0 to 9)
OG0034(1 to 10)
Ser A - hSBA ≥1:4, 1m after 2n vacc(N=68,79,78,83)
Title
Measurements
OG00060(48 to 72)
OG00166(54 to 76)
OG00250(38 to 62)
OG003
Ser A - hSBA ≥1:8, baseline (N=68,79,78,83)
Title
Measurements
OG0003(0 to 10)
OG0011(0.032 to 7)
OG0020(0 to 5)
OG003
Ser A - hSBA≥1:8, 1m after 2nd vacc(N=68,79,78,83)
Title
Measurements
OG00054(42 to 67)
OG00158(47 to 69)
OG00244(32 to 55)
OG003
Ser C - hSBA ≥1:4, baseline (N=77,74,79,85)
Title
Measurements
OG00013(6 to 23)
OG00115(8 to 25)
OG00220(12 to 31)
OG003
Ser C - hSBA ≥1:4,1m after 2nd vacc(N=77,74,79,85)
Title
Measurements
OG00084(74 to 92)
OG00191(81 to 96)
OG00286(76 to 93)
OG003
Ser C - hSBA ≥1:8, baseline (N=77,74,79,85)
Title
Measurements
OG0009(4 to 18)
OG00115(8 to 25)
OG0025(1 to 12)
OG003
Ser C - hSBA ≥1:8,1m after 2nd vacc(N=77,74,79,85)
Title
Measurements
OG00083(73 to 91)
OG00185(75 to 92)
OG00282(72 to 90)
OG003
Ser W - hSBA ≥1:4, baseline (N=73,74,72,75)
Title
Measurements
OG00045(34 to 57)
OG00124(15 to 36)
OG00243(31 to 55)
OG003
Ser W - hSBA ≥1:4,1m after 2nd vacc(N=73,74,72,75)
Title
Measurements
OG00092(83 to 97)
OG00191(81 to 96)
OG00282(71 to 90)
OG003
Ser W - hSBA ≥1:8, baseline (N=73,74,72,75)
Title
Measurements
OG00037(26 to 49)
OG00119(11 to 30)
OG00236(25 to 48)
OG003
Ser W -hSBA ≥1:8,1m after 2nd vacc(N=73,74,72,75)
Title
Measurements
OG00084(73 to 91)
OG00185(75 to 92)
OG00275(63 to 84)
OG003
Ser Y - hSBA ≥1:4, baseline (N=76,74,77,85)
Title
Measurements
OG00018(10 to 29)
OG0019(4 to 19)
OG00235(25 to 47)
OG003
Ser Y -hSBA ≥1:4,1m after 2nd vacc(N=76,74,77,85)
Title
Measurements
OG00084(74 to 92)
OG00186(77 to 93)
OG00274(63 to 83)
OG003
Ser Y - hSBA ≥1:8, baseline (N=76,74,77,85)
Title
Measurements
OG0007(2 to 15)
OG0014(1 to 11)
OG00216(8 to 26)
OG003
Ser Y -hSBA ≥1:8,1m after 2nd vacc(N=76,74,77,85)
Title
Measurements
OG00076(65 to 85)
OG00180(69 to 88)
OG00270(59 to 80)
OG003
OG003
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
Units
Counts
Participants
OG00077
OG00179
OG00279
OG00385
Title
Denominators
Categories
Ser A - baseline (n=68,79,78,83)
Title
Measurements
OG0002.17(2.01 to 2.35)
OG0012.07(1.93 to 2.23)
OG0022.05(1.91 to 2.21)
OG0032.08(1.94 to 2.23)
Ser A - 1 month after 2nd vacc (n=68,79,78,83)
Title
Measurements
OG00012(8.36 to 16)
OG00111(7.91 to 15)
OG0027.3(5.31 to 10)
OG003
Ser C - baseline (n=77,74,79,85)
Title
Measurements
OG0002.54(2.14 to 3.02)
OG0012.77(2.33 to 3.31)
OG0022.48(2.09 to 2.94)
OG003
Ser C - 1 month after 2nd vacc (n=77,74,79,85)
Title
Measurements
OG00052(37 to 74)
OG00155(38 to 79)
OG00240(28 to 57)
OG003
Ser W - baseline (n=73,74,79,75)
Title
Measurements
OG0005.33(4.09 to 6.94)
OG0013.6(2.77 to 4.69)
OG0025.14(3.94 to 6.71)
OG003
Ser W - 1 month after 2nd vacc (n=73,74,79,75)
Title
Measurements
OG00048(34 to 67)
OG00144(31 to 61)
OG00229(20 to 40)
OG003
Ser Y - baseline (n=76,74,77,85)
Title
Measurements
OG0002.56(2.19 to 2.99)
OG0012.27(1.94 to 2.66)
OG0023.39(2.9 to 3.96)
OG003
Ser Y - 1 month after 2nd vacc (n=76,74,77,85)
Title
Measurements
OG00026(19 to 37)
OG00127(19 to 38)
OG00221(15 to 29)
OG003
Three doses of MenACWY conjugate vaccine with adjuvant 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.
OG003
CA24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG004
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
Units
Counts
Participants
OG00067
OG00163
OG00265
OG00340
OG00440
Title
Denominators
Categories
Ser A -hSBA ≥1:4, at 12 m of age(n=64,61,62,39,38)
Title
Measurements
OG0008(3 to 17)
OG0017(2 to 16)
OG00221(12 to 33)
OG0035(1 to 17)
OG0043(0.067 to 14)
Ser A -hSBA≥1:4, 1 m after booster vacc
Title
Measurements
OG00086(75 to 93)
OG00179(66 to 88)
OG00294(84 to 98)
OG003
Ser A - hSBA ≥1:8, at 12 months of age
Title
Measurements
OG0005(1 to 13)
OG0015(1 to 14)
OG00213(6 to 24)
OG003
Ser A - hSBA ≥1:8, 1 m after booster vaccination
Title
Measurements
OG00083(71 to 91)
OG00177(65 to 87)
OG00292(82 to 97)
OG003
Ser C -hSBA ≥1:4, at 12 m of age(n=67,63,65,40,40)
Title
Measurements
OG00040(28 to 53)
OG00133(22 to 46)
OG00260(47 to 72)
OG003
Ser C-hSBA≥1:4,1 m after booster(n=57,63,65,40,40)
Title
Measurements
OG00096(87 to 99)
OG00194(85 to 98)
OG00298(92 to 100)
OG003
Ser C-hSBA ≥1:8, at 12 m of age(n=67,40,65,40,40)
Title
Measurements
OG00034(23 to 47)
OG00127(17 to 40)
OG00252(40 to 65)
OG003
Ser C-hSBA≥1:8, 1m after booster(n=67,63,65,40,40)
Title
Measurements
OG00096(87 to 99)
OG00194(85 to 98)
OG00298(92 to 100)
OG003
Ser W -hSBA≥1:4, at 12 m of age(n=57,41,57,35,35)
Title
Measurements
OG00056(42 to 69)
OG00154(37 to 69)
OG00281(68 to 90)
OG003
Ser W - hSBA≥1:4, 1m after booster vaccination
Title
Measurements
OG000100(94 to 100)
OG001100(91 to 100)
OG002100(94 to 100)
OG003
Ser W -hSBA≥1:8, at 12 m of age(n=57,41,40,35,35)
Title
Measurements
OG00047(34 to 61)
OG00141(26 to 58)
OG00268(55 to 80)
OG003
Ser W -hSBA≥1:8,1m after booster(n=57,41,57,35,35)
Title
Measurements
OG000100(94 to 100)
OG001100(91 to 100)
OG002100(94 to 100)
OG003
Ser Y -hSBA≥1:4, at 12m of age(n=66,63,65,40,38)
Title
Measurements
OG00052(39 to 64)
OG00152(39 to 65)
OG00286(75 to 93)
OG003
Ser Y - hSBA≥1:4, 1 m after booster vaccination
Title
Measurements
OG000100(95 to 100)
OG001100(94 to 100)
OG002100(94 to 100)
OG003
Ser Y - hSBA ≥1:8, at 12 months of age
Title
Measurements
OG00039(28 to 52)
OG00141(29 to 54)
OG00272(60 to 83)
OG003
Ser Y - hSBA ≥1:8, 1 m after booster vaccination
Title
Measurements
OG000100(95 to 100)
OG001100(94 to 100)
OG002100(94 to 100)
OG003
OG003
CA24+ (MenACWY Ad+ at 2, 4m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG004
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
Units
Counts
Participants
OG00067
OG00163
OG00265
OG00340
OG00440
Title
Denominators
Categories
Ser A - at 12 months of age (n=64,61,62,39,38)
Title
Measurements
OG0002.31(2 to 2.66)
OG0012.22(1.92 to 2.57)
OG0022.97(2.57 to 3.44)
OG0032.18(1.74 to 2.73)
OG0042.07(1.65 to 2.6)
Ser A - 1 month after booster (n=64,61,62,39,38)
Title
Measurements
OG00047(31 to 72)
OG00130(19 to 47)
OG002134(87 to 207)
OG003
Ser C - at 12 months of age(n=67,63,65,40,40)
Title
Measurements
OG0005.18(3.83 to 7.02)
OG0013.94(2.88 to 5.39)
OG0027.94(5.84 to 11)
OG003
Ser C - 1 month after booster(n=67,63,65,40,40)
Title
Measurements
OG000236(159 to 349)
OG001129(86 to 194)
OG002429(288 to 639)
OG003
Ser W - at 12 months of age(n=57,41,57,35,35)
Title
Measurements
OG0008.1(5.76 to 11)
OG0016.49(4.34 to 9.7)
OG00216(11 to 23)
OG003
Ser W - 1 month after booster (n=57,41,57,35,35)
Title
Measurements
OG000503(347 to 732)
OG001311(200 to 485)
OG002792(544 to 1154)
OG003
Ser Y - at 12 months of age (n=66,63,65,40,38)
Title
Measurements
OG0006.65(4.88 to 9.06)
OG0016.83(4.98 to 9.37)
OG00219(14 to 26)
OG003
Ser Y- 1 month after booster(n=66,63,65,40,38)
Title
Measurements
OG000508(358 to 723)
OG001438(305 to 628)
OG0021395(979 to 1989)
OG003
OG003
CA24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG004
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
Units
Counts
Participants
OG00038
OG00169
OG00266
OG00377
OG00481
Title
Denominators
Categories
Ser A - hSBA ≥1:4, at 12m of age(n=36,62,65,77,78)
Title
Measurements
OG0000(0 to 10)
OG0018(3 to 18)
OG0026(2 to 15)
OG0038(3 to 16)
OG0045(1 to 13)
Ser A - hSBA ≥1:8, at 12m of age(n=36,62,65,77,78)
Title
Measurements
OG0000(0 to 10)
OG0015(1 to 13)
OG0025(1 to 13)
OG003
Ser C - hSBA ≥1:4, at 12m of age(n=38,69,69,73,81)
Title
Measurements
OG00089(75 to 97)
OG00141(29 to 53)
OG00232(21 to 44)
OG003
Ser C - hSBA ≥1:8, at 12m of age(n=38,69,69,73,81)
Title
Measurements
OG00087(72 to 96)
OG00133(22 to 46)
OG00226(16 to 38)
OG003
Ser W - hSBA ≥1:4, at 12m of age(n=34,62,42,69,69)
Title
Measurements
OG0009(2 to 24)
OG00158(45 to 70)
OG00257(41 to 72)
OG003
Ser W - hSBA ≥1:8, at 12m of age(n=34,62,42,69,69)
Title
Measurements
OG0006(1 to 20)
OG00148(35 to 61)
OG00245(30 to 61)
OG003
Ser Y - hSBA ≥1:4, at 12m of age(n=38,69,66,73,79)
Title
Measurements
OG0005(1 to 18)
OG00151(38 to 63)
OG00256(43 to 68)
OG003
Ser Y - hSBA ≥1:8, at 12m of age(n=38,69,66,73,79)
Title
Measurements
OG0003(0.067 to 14)
OG00142(30 to 55)
OG00245(33 to 58)
OG003
OG003
CA24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG004
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
Units
Counts
Participants
OG00038
OG00169
OG00266
OG00377
OG00481
Title
Denominators
Categories
Ser A - at 12 months of age (n=36,62,65,77,78)
Title
Measurements
OG0002(1.62 to 2.48)
OG0012.32(1.97 to 2.73)
OG0022.2(1.88 to 2.58)
OG0032.29(1.98 to 2.65)
OG0042.18(1.89 to 2.52)
Ser C - at 12 months of age (n=36,69,69,73,82)
Title
Measurements
OG00027(18 to 40)
OG0015.04(3.73 to 6.81)
OG0023.85(2.85 to 5.21)
OG003
Ser W - at 12 months of age (n=34,62,42,69,69)
Title
Measurements
OG0002.42(1.55 to 3.78)
OG0018.38(6.03 to 12)
OG0027.02(4.71 to 10)
OG003
Ser Y - at 12 months of age (n=38,69,66,73,79)
Title
Measurements
OG0002.15(1.41 to 3.28)
OG0016.72(4.92 to 9.18)
OG0027.64(5.55 to 11)
OG003
Units
Counts
Participants
OG00071
OG00186
Title
Denominators
Categories
Ser A - hSBA ≥1:4, at 12 months of age (n=58,79)
Title
Measurements
OG00021(11 to 33)
OG00135(25 to 47)
Ser A - hSBA ≥1:8, at 12 months of age(n=58,79)
Title
Measurements
OG00016(7 to 27)
OG00129(19 to 40)
Ser C - hSBA ≥1:4, at 12 months of age(n=70,84)
Title
Measurements
OG00059(46 to 70)
OG00175(64 to 84)
Ser C - hSBA ≥1:8, at 12 months of age(n=70,84)
Title
Measurements
OG00047(35 to 59)
OG00168(57 to 78)
Ser W - hSBA ≥1:4, at 12 months of age(n=58,75)
Title
Measurements
OG00078(65 to 87)
OG00189(80 to 95)
Ser W - hSBA ≥1:8, at 12 months of age(n=58,75)
Title
Measurements
OG00066(52 to 78)
OG00181(71 to 89)
Ser Y - hSBA ≥1:4, at 12 months of age(n=71,86)
Title
Measurements
OG00085(74 to 92)
OG00187(78 to 93)
Ser Y - hSBA ≥1:8, at 12 months of age(n=71,86)
Title
Measurements
OG00070(58 to 81)
OG00179(69 to 87)
Units
Counts
Participants
OG00071
OG00186
Title
Denominators
Categories
Ser A - at 12 months of age (n=58,79)
Title
Measurements
OG0003.02(2.55 to 3.57)
OG0013.93(3.4 to 4.54)
Ser C - at 12 months of age (n=70,84)
Title
Measurements
OG0007.56(5.61 to 10)
OG00114(10 to 18)
Ser W - at 12 months of age (n=58,75)
Title
Measurements
OG00015(10 to 21)
OG00120(15 to 27)
Ser Y - at 12 months of age (n=71,86)
Title
Measurements
OG00018(13 to 24)
OG00122(17 to 29)
OG00044
Title
Denominators
Categories
Ser A-hSBA≥1:4,before challenge at 12m (n=44)
Title
Measurements
OG00027(15 to 43)
Ser A - hSBA ≥1:4, 1 month after PS (n=44)
Title
Measurements
OG00089(75 to 96)
Ser A-hSBA ≥1:8,before challenge at 12m (n=44)
Title
Measurements
OG00023(11 to 38)
Ser A - hSBA ≥1:8, 1 month after PS (n=44)
Title
Measurements
OG00086(73 to 95)
Ser C-hSBA ≥1:4,before challenge at 12m (n=43)
Title
Measurements
OG00074(59 to 86)
Ser C - hSBA ≥1:4, 1 month after PS (n=43)
Title
Measurements
OG00095(84 to 99)
Ser C-hSBA ≥1:8, before challenge at 12m (n=43)
Title
Measurements
OG00065(49 to 79)
Ser C - hSBA ≥1:8, 1 month after PS (n=43)
Title
Measurements
OG00091(78 to 97)
Ser W-hSBA ≥1:4,before challenge at 12m (n=40)
Title
Measurements
OG00083(67 to 93)
Ser W - hSBA ≥1:4, 1 month after PS (n=40)
Title
Measurements
OG00098(87 to 100)
Ser W-hSBA ≥1:8,before challenge at 12m (n=40)
Title
Measurements
OG00073(56 to 85)
Ser W - hSBA ≥1:8, 1 month after PS (n=40)
Title
Measurements
OG00095(83 to 99)
Ser Y-hSBA ≥1:4,before challenge at 12m (n=44)
Title
Measurements
OG00089(75 to 96)
Ser Y - hSBA ≥1:4, 1 month after PS (n=44)
Title
Measurements
OG00098(88 to 100)
Ser Y-hSBA ≥1:8,before challenge at 12m (N=44)
Title
Measurements
OG00077(62 to 89)
Ser Y - hSBA ≥1:8, 1 month after PS (n=44)
Title
Measurements
OG00098(88 to 100)
OG00044
Title
Denominators
Categories
Ser A - before challenge at 12 months of age(n=44)
Title
Measurements
OG0003.4(2.75 to 4.2)
Ser A - 1 month after PS challenge (n=44)
Title
Measurements
OG00032(21 to 48)
Ser C - before challenge at 12 months of age(n=43)
Title
Measurements
OG00012(8.41 to 18)
Ser C - 1 month after PS challenge (n=43)
Title
Measurements
OG00082(50 to 133)
Ser W - before challenge at 12 months of age(n=40)
Title
Measurements
OG00017(11 to 25)
Ser W - 1 month after PS challenge (n=40)
Title
Measurements
OG000249(152 to 410)
Ser Y - before challenge at 12 months of age(n=44)
Title
Measurements
OG00019(13 to 28)
Ser Y - 1 month after PS challenge (n=44)
Title
Measurements
OG000186(117 to 294)
Units
Counts
Participants
OG00042
OG00139
Title
Denominators
Categories
Ser A - hSBA≥1:4,before challange at 12m (n=40,39)
Title
Measurements
OG0008(2 to 20)
OG0018(2 to 21)
Ser A - hSBA ≥1:4,1 month after PS (n=40,39)
Title
Measurements
OG00078(62 to 89)
OG00192(79 to 98)
Ser A - hSBA≥1:8,before challange at 12m (n=40,39)
Title
Measurements
OG0005(1 to 17)
OG0015(1 to 17)
Ser A - hSBA ≥1:8, 1 month after PS (n=40,39)
Title
Measurements
OG00078(62 to 89)
OG00187(73 to 96)
Ser C - hSBA≥1:4,before challange at 12m (n=41,39)
Title
Measurements
OG00044(28 to 60)
OG00138(23 to 55)
Ser C - hSBA ≥1:4, 1 month after PS (n=41,39)
Title
Measurements
OG00095(83 to 99)
OG00195(83 to 99)
Ser C - hSBA≥1:8,before challange at 12m(n=41,39)
Title
Measurements
OG00039(24 to 55)
OG00136(21 to 53)
Ser C - hSBA ≥1:8, 1 month after PS (n=41,39)
Title
Measurements
OG00093(80 to 98)
OG00190(76 to 97)
Ser W - hSBA ≥1:4,before challange at 12m(n=41,38)
Title
Measurements
OG00059(42 to 74)
OG00171(54 to 85)
Ser W - hSBA ≥1:4, 1 month after PS (n=41,38)
Title
Measurements
OG00098(87 to 100)
OG001100(91 to 100)
Ser W - hSBA ≥1:8,before challange at 12m(n=41,38)
Title
Measurements
OG00051(35 to 67)
OG00158(41 to 74)
Ser W - hSBA ≥1:8, 1 month after PS (n=41,38)
Title
Measurements
OG00098(87 to 100)
OG001100(91 to 100)
Ser Y - hSBA ≥1:4,before challange at 12m(n=42,38)
Title
Measurements
OG00055(39 to 70)
OG00155(38 to 71)
Ser Y - hSBA ≥1:4, 1 month after PS (n=42,38)
Title
Measurements
OG00098(87 to 100)
OG001100(91 to 100)
Ser Y - hSBA ≥1:8,before challange at 12m (n=42,38
Title
Measurements
OG00050(34 to 66)
OG00142(26 to 59)
Ser Y - hSBA ≥1:8, 1 month after PS (n=42,38)
Title
Measurements
OG00098(87 to 100)
OG00197(86 to 100)
Units
Counts
Participants
OG00042
OG00139
Title
Denominators
Categories
Ser A - before challenge at 12 months (n=40,39)
Title
Measurements
OG0002.22(1.77 to 2.76)
OG0012.31(1.84 to 2.89)
Ser A - 1 month after PS challenge (n=40,39)
Title
Measurements
OG00028(18 to 44)
OG00155(35 to 86)
Ser C - before challenge at 12 months (n=41,39)
Title
Measurements
OG0005.21(3.51 to 7.72)
OG0015.07(3.38 to 7.59)
Ser C - 1 month after PS challenge (n=41,39)
Title
Measurements
OG000140(85 to 231)
OG001181(109 to 301)
Ser W - before challenge at 12 months (n=41,38)
Title
Measurements
OG0007.48(4.94 to 11)
OG00111(7.08 to 17)
Ser W - 1 month after PS challenge (n=41,38)
Title
Measurements
OG000365(224 to 597)
OG001555(333 to 924)
Ser Y - before challenge at 12 months (n=42,38)
Title
Measurements
OG0006.73(4.51 to 10)
OG0016.79(4.45 to 10)
Ser Y - 1 month after PS challenge (n=42,38)
Title
Measurements
OG000280(175 to 448)
OG001288(176 to 472)
UK24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG003
CA24+ (MenACWY Ad+ at 2, 4m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
Units
Counts
Participants
OG00081
OG00187
OG00277
OG00379
Title
Denominators
Categories
Ser A - hSBA ≥1:4, baseline (n=69,80,38,79)
Title
Measurements
OG0006(2 to 14)
OG0010(0 to 5)
OG0024(1 to 12)
OG0033(0 to 9)
Ser A - hSBA≥1:4,1m after 1st vacc (n=69,80,38,79)
Title
Measurements
OG00093(84 to 98)
OG00181(71 to 89)
OG00260(48 to 72)
OG003
Ser A - hSBA ≥1:8, baseline (n=69,80,38,79)
Title
Measurements
OG0004(1 to 12)
OG0010(0 to 5)
OG0023(0 to 10)
OG003
Ser A - hSBA≥1:8,1m after 1st vacc (n=69,80,38,79)
Title
Measurements
OG00088(78 to 95)
OG00176(65 to 85)
OG00254(42 to 67)
OG003
Ser C - hSBA ≥1:4, baseline (n=79,86,40,74)
Title
Measurements
OG00018(10 to 28)
OG00115(8 to 24)
OG00213(6 to 23)
OG003
Ser C - hSBA≥1:4,1m after 1st vacc (n=79,86,40,74)
Title
Measurements
OG00096(89 to 99)
OG00198(92 to 100)
OG00284(74 to 92)
OG003
Ser C - hSBA ≥1:8, baseline (n=79,86,40,74)
Title
Measurements
OG0009(4 to 17)
OG0015(1 to 11)
OG0029(4 to 18)
OG003
Ser C - hSBA≥1:8,1m after 1st vacc (n=79,86,40,74)
Title
Measurements
OG00092(84 to 97)
OG00198(92 to 100)
OG00283(73 to 91)
OG003
Ser W - hSBA ≥1:4, baseline (n=69,78,73,74)
Title
Measurements
OG00054(41 to 66)
OG00131(21 to 42)
OG00245(34 to 57)
OG003
Ser W - hSBA≥1:4,1m after 1st vacc (n=69,78,73,74)
Title
Measurements
OG00097(90 to 100)
OG00199(93 to 100)
OG00292(83 to 97)
OG003
Ser W - hSBA ≥1:8, baseline (n=69,78,73,74)
Title
Measurements
OG00046(34 to 59)
OG00128(19 to 40)
OG00237(26 to 49)
OG003
Ser W - hSBA≥1:8,1m after 1st vacc (n=69,78,73,74)
Title
Measurements
OG00088(78 to 95)
OG00196(89 to 99)
OG00284(73 to 91)
OG003
Ser Y - hSBA ≥1:4, baseline (n=81,87,76,74)
Title
Measurements
OG00021(13 to 31)
OG00117(10 to 27)
OG00218(10 to 29)
OG003
Ser Y - hSBA≥1:4,1m after 1st vacc (n=81,87,76,74)
Title
Measurements
OG00094(86 to 98)
OG00198(92 to 100)
OG00284(74 to 92)
OG003
Ser Y - hSBA ≥1:8, baseline (n=81,87,76,74)
Title
Measurements
OG00014(7 to 23)
OG00111(6 to 20)
OG0027(2 to 15)
OG003
Ser Y - hSBA≥1:8,1m after 1st vacc (n=81,87,76,74)
Title
Measurements
OG00093(85 to 97)
OG00189(80 to 94)
OG00276(65 to 85)
OG003
Units
Counts
Participants
OG00044
OG00142
Title
Denominators
Categories
Ser A - hSBA ≥1:4, at 12 months of age (n=44,40)
Title
Measurements
OG00027(15 to 43)
OG0018(2 to 20)
Ser A - hSBA ≥1:4, at 1 month after PS (n=44,40)
Title
Measurements
OG00089(75 to 96)
OG00178(62 to 89)
Ser A - hSBA ≥1:8, at 12 months of age (n=44,40)
Title
Measurements
OG00023(11 to 38)
OG0015(1 to 17)
Ser A - hSBA ≥1:8, at 1 month after PS (n=44,40)
Title
Measurements
OG00086(73 to 95)
OG00178(62 to 89)
Ser C - hSBA ≥1:4, at 12 months of age (n=43,41)
Title
Measurements
OG00074(59 to 86)
OG00144(28 to 60)
Ser C - hSBA ≥1:4, at 1 month after PS (n=43,41)
Title
Measurements
OG00095(84 to 99)
OG00195(83 to 99)
Ser C - hSBA ≥1:8, at 12 months of age (n=43,41)
Title
Measurements
OG00065(49 to 79)
OG00139(24 to 55)
Ser C - hSBA ≥1:8, at 1 month after PS (n=43,41)
Title
Measurements
OG00091(78 to 97)
OG00193(80 to 98)
Ser W - hSBA ≥1:4, at 12 months of age (n=40,41)
Title
Measurements
OG00083(67 to 93)
OG00159(42 to 74)
Ser W - hSBA ≥1:4, at 1 month after PS (n=40,41)
Title
Measurements
OG00098(87 to 100)
OG00198(87 to 100)
Ser W - hSBA ≥1:8, at 12 months of age (n=40,41)
Title
Measurements
OG00073(56 to 85)
OG00151(35 to 67)
Ser W - hSBA ≥1:8, at 1 month after PS (n=40,41)
Title
Measurements
OG00095(83 to 99)
OG00198(87 to 100)
Ser Y - hSBA ≥1:4, at 12 months of age (n=44,42)
Title
Measurements
OG00089(75 to 96)
OG00155(39 to 70)
Ser Y - hSBA ≥1:4, at 1 month after PS (n=44,42)
Title
Measurements
OG00098(88 to 100)
OG00198(87 to 100)
Ser Y - hSBA ≥1:8, at 12 months of age (n=44,42)
Title
Measurements
OG00077(62 to 89)
OG00150(34 to 66)
Ser Y - hSBA ≥1:8, at 1 month after PS (n=44,42)
Title
Measurements
OG00098(88 to 100)
OG00198(87 to 100)
OG002
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
OG003
UK234+ (MenACWY Ad+ at 2, 3, 4 m)
Three doses of MenACWY conjugate vaccine with adjuvant 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.
OG004
UK24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG005
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant 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.
OG001NA(NA to NA)not performed due to insufficient sera
OG00211(4 to 21)
OG003
antiHBVtiter≥1.0 IU/mL-1m post (65,na,66,na,na,67)
Title
Measurements
OG00085(74 to 92)
OG001NA(NA to NA)not performed due to insufficient sera
OG00292(83 to 97)
OG003
Three doses of MenACWY conjugate vaccine with adjuvant 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.
OG003
CA24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG004
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
OG005
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
Units
Counts
Participants
OG00070
OG00177
OG00270
OG00373
OG00472
OG00573
Title
Denominators
Categories
Tetanus - baseline (n=69,71,70,67,69,72)
Title
Measurements
OG0000.32(0.24 to 0.41)
OG0010.31(0.24 to 0.4)
OG0020.23(0.18 to 0.29)
OG0030.28(0.22 to 0.37)
OG0040.25(0.19 to 0.32)
OG0050.18(0.14 to 0.23)
Tetanus - 1 m after 1st vacc(n=69,71,70,67,69,72)
Title
Measurements
OG0000.7(0.57 to 0.87)
OG0010.92(0.75 to 1.13)
OG0021.4(1.14 to 1.72)
OG003
Diphtheria - baseline (n=69,71,70,67,69,72)
Title
Measurements
OG0000.035(0.026 to 0.047)
OG0010.04(0.03 to 0.053)
OG0020.027(0.02 to 0.035)
OG003
Diphtheria -1m after 1st vacc(n=69,71,70,67,69,72)
Title
Measurements
OG0001.02(0.81 to 1.29)
OG0011.02(0.82 to 1.28)
OG0021.72(1.38 to 2.14)
OG003
Hib - baseline (n=70,77,69,73,72,73)
Title
Measurements
OG0000.078(0.056 to 0.11)
OG0010.15(0.11 to 0.21)
OG0020.11(0.078 to 0.15)
OG003
Hib - 1 m after 1st vacc (n=70,77,69,73,72,73)
Title
Measurements
OG0004.63(3.14 to 6.83)
OG0014.55(3.08 to 6.72)
OG0024.53(3.07 to 6.68)
OG003
Hepatitis B - baseline (n=65,na,66,na,na,67)
Title
Measurements
OG000NA(NA to NA)not performed due to insufficient sera
OG001NA(NA to NA)not performed due to insufficient sera
OG0025.9(4.25 to 8.2)
OG003
Hepatitis B-1m after 1st vacc(n=65,na,66,na,na,67)
Title
Measurements
OG000NA(NA to NA)not performed due to insufficient sera
OG001NA(NA to NA)not performed due to insufficient sera
OG002378(258 to 554)
OG003
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG003
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
OG004
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
Units
Counts
Participants
OG00040
OG00177
OG00274
OG00379
OG00485
Title
Denominators
Categories
hSBA ≥1:4, baseline
Title
Measurements
OG00023(11 to 38)
OG00113(6 to 23)
OG00215(8 to 25)
OG00320(12 to 31)
OG00420(12 to 30)
hSBA ≥1:4, 1 month after second vaccination
Title
Measurements
OG00098(87 to 100)
OG00184(74 to 92)
OG00291(81 to 96)
OG003
hSBA ≥1:8, baseline
Title
Measurements
OG00010(3 to 24)
OG0019(4 to 18)
OG00215(8 to 25)
OG003
hSBA ≥1:8, 1 month after second vaccination
Title
Measurements
OG00098(87 to 100)
OG00183(73 to 91)
OG00285(75 to 92)
OG003
OG003
CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Three doses of MenACWY conjugate vaccine with adjuvant 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.
OG004
CA24+ (MenACWY Ad+ at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG005
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
OG006
CA24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine without adjuvant 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.
Units
Counts
Participants
OG00090
OG00190
OG00245
OG00398
OG00498
OG00590
OG00690
Title
Denominators
Categories
Tenderness
Title
Measurements
OG00040
OG00131
OG00218
OG00346
OG00432
OG00541
OG00635
Erythema
Title
Measurements
OG00069
OG00164
OG00234
OG003
Induration
Title
Measurements
OG00021
OG00124
OG00212
OG003
Eating habit Change
Title
Measurements
OG00028
OG00125
OG0029
OG003
Sleepiness
Title
Measurements
OG00056
OG00149
OG00225
OG003
Persistent Crying
Title
Measurements
OG0007
OG0017
OG0026
OG003
Irritability
Title
Measurements
OG00063
OG00171
OG00231
OG003
Vomiting
Title
Measurements
OG00019
OG00126
OG0029
OG003
Diarrhea
Title
Measurements
OG00029
OG00127
OG00212
OG003
Fever (≥38°C)
Title
Measurements
OG0007
OG0014
OG0021
OG003
Analgesics/Antipyretics
Title
Measurements
OG00043
OG00135
OG00218
OG003
OG003
CA246+ (MenACWY Ad+ at 2, 4, 6 m) - No Treatment
Three doses of MenACWY conjugate vaccine with adjuvant 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.
OG004
CA246+ (MenACWY Ad+ at 2, 4, 6 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG005
CA24+ (MenACWY Ad+ at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG006
CA24+ (MenACWY Ad+ at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG007
UK24- (MenACWY Ad- at 2, 4 m)
Two doses of MenACWY conjugate vaccine with adjuvant 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.
OG008
CA24- (MenACWY Ad- at 2, 4 m) - ACWY
Two doses of MenACWY conjugate vaccine with adjuvant 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 (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
OG009
CA24- (MenACWY Ad- at 2, 4 m) - PS
Two doses of MenACWY conjugate vaccine with adjuvant 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.
Units
Counts
Participants
OG00090
OG00190
OG00245
OG00348
OG00448
OG00547
OG00648
OG00790
OG00844
OG00943
Title
Denominators
Categories
Tenderness
Title
Measurements
OG0007
OG00111
OG00210
OG0030
OG00410
OG0057
OG00610
OG00710
OG0087
OG00912
Erythema
Title
Measurements
OG00062
OG00158
OG00236
OG003
Induration
Title
Measurements
OG00021
OG00132
OG00218
OG003
Eating habit change
Title
Measurements
OG00011
OG00116
OG0025
OG003
Sleepiness
Title
Measurements
OG00011
OG00114
OG0029
OG003
Persistent crying
Title
Measurements
OG0000
OG0014
OG0023
OG003
Irritability
Title
Measurements
OG00026
OG00132
OG00220
OG003
Vomiting
Title
Measurements
OG0004
OG0016
OG0024
OG003
Diarrhea
Title
Measurements
OG0009
OG0019
OG0024
OG003
Fever (≥38°C)
Title
Measurements
OG0003
OG0017
OG0022
OG003
Analgesics/Antipyretics
Title
Measurements
OG00014
OG00121
OG00212
OG003
0 affected
98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0061 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
1 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0052 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0051 affected90 at risk
EG0060 affected90 at risk
2 affected
98 at risk
EG0041 affected98 at risk
EG0052 affected90 at risk
EG0062 affected90 at risk
0 affected
98 at risk
EG0041 affected98 at risk
EG0050 affected90 at risk
EG0061 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0051 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0051 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0041 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
1 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
1 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0051 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
1 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0051 affected90 at risk
EG0060 affected90 at risk
1 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
1 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0051 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0041 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0062 affected90 at risk
0 affected
98 at risk
EG0041 affected98 at risk
EG0050 affected90 at risk
EG0061 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0051 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
1 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
1 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
2 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
0 affected
98 at risk
EG0040 affected98 at risk
EG0050 affected90 at risk
EG0060 affected90 at risk
8 affected
98 at risk
EG0046 affected98 at risk
EG0051 affected90 at risk
EG0062 affected90 at risk
37 affected
98 at risk
EG00434 affected98 at risk
EG00536 affected90 at risk
EG00625 affected90 at risk
29 affected
98 at risk
EG00423 affected98 at risk
EG00528 affected90 at risk
EG00620 affected90 at risk
19 affected
98 at risk
EG0048 affected98 at risk
EG00514 affected90 at risk
EG0069 affected90 at risk
73 affected
98 at risk
EG00478 affected98 at risk
EG00584 affected90 at risk
EG00668 affected90 at risk
42 affected
98 at risk
EG00425 affected98 at risk
EG00559 affected90 at risk
EG00636 affected90 at risk
50 affected
98 at risk
EG00441 affected98 at risk
EG00545 affected90 at risk
EG00645 affected90 at risk
85 affected
98 at risk
EG00485 affected98 at risk
EG00577 affected90 at risk
EG00682 affected90 at risk
30 affected
98 at risk
EG00422 affected98 at risk
EG00519 affected90 at risk
EG00621 affected90 at risk
3 affected
98 at risk
EG0045 affected98 at risk
EG0053 affected90 at risk
EG0060 affected90 at risk
3 affected
98 at risk
EG0045 affected98 at risk
EG0051 affected90 at risk
EG0062 affected90 at risk
2 affected
98 at risk
EG0040 affected98 at risk
EG0059 affected90 at risk
EG0060 affected90 at risk
13 affected
98 at risk
EG00414 affected98 at risk
EG0050 affected90 at risk
EG00614 affected90 at risk
2 affected
98 at risk
EG0045 affected98 at risk
EG0051 affected90 at risk
EG0060 affected90 at risk
9 affected
98 at risk
EG0047 affected98 at risk
EG00512 affected90 at risk
EG0064 affected90 at risk
2 affected
98 at risk
EG0040 affected98 at risk
EG00539 affected90 at risk
EG0060 affected90 at risk
21 affected
98 at risk
EG00425 affected98 at risk
EG0053 affected90 at risk
EG00620 affected90 at risk
0 affected
98 at risk
EG0041 affected98 at risk
EG0054 affected90 at risk
EG0060 affected90 at risk
68 affected
98 at risk
EG00470 affected98 at risk
EG00557 affected90 at risk
EG00663 affected90 at risk
45 affected
98 at risk
EG00442 affected98 at risk
EG00537 affected90 at risk
EG00638 affected90 at risk
3 affected
98 at risk
EG0046 affected98 at risk
EG00516 affected90 at risk
EG0062 affected90 at risk
3 affected
98 at risk
EG0046 affected98 at risk
EG0050 affected90 at risk
EG0064 affected90 at risk
5 affected
98 at risk
EG0042 affected98 at risk
EG0050 affected90 at risk
EG0063 affected90 at risk
6 affected
98 at risk
EG0047 affected98 at risk
EG0052 affected90 at risk
EG0061 affected90 at risk
4 affected
98 at risk
EG0041 affected98 at risk
EG0055 affected90 at risk
EG0060 affected90 at risk
15 affected
98 at risk
EG0048 affected98 at risk
EG0058 affected90 at risk
EG0067 affected90 at risk
5 affected
98 at risk
EG0043 affected98 at risk
EG0052 affected90 at risk
EG0068 affected90 at risk
5 affected
98 at risk
EG0041 affected98 at risk
EG0050 affected90 at risk
EG0061 affected90 at risk
57
(45 to 67)
1
(0.03 to 7)
49
(38 to 61)
20
(12 to 30)
93
(85 to 97)
11
(5 to 19)
89
(81 to 95)
19
(11 to 29)
95
(87 to 99)
16
(9 to 26)
92
(83 to 97)
18
(10 to 27)
91
(82 to 96)
11
(5 to 19)
86
(77 to 92)
7.16
(5.26 to 9.73)
2.87
(2.44 to 3.39)
69
(49 to 96)
3.02
(2.33 to 3.93)
69
(50 to 96)
2.76
(2.38 to 3.21)
41
(30 to 56)
92
(79 to 98)
OG00495(82 to 99)
3
(0.065 to 13)
OG0043(0.067 to 14)
90
(76 to 97)
OG00492(79 to 98)
48
(32 to 64)
OG00433(19 to 49)
98
(87 to 100)
OG004100(91 to 100)
35
(21 to 52)
OG00425(13 to 41)
95
(83 to 99)
OG004100(91 to 100)
74
(57 to 88)
OG00469(51 to 83)
100
(90 to 100)
OG004100(90 to 100)
49
(31 to 66)
OG00454(37 to 71)
100
(90 to 100)
OG004100(90 to 100)
65
(48 to 79)
OG00463(46 to 78)
100
(91 to 100)
OG004100(91 to 100)
45
(29 to 62)
OG00453(36 to 69)
100
(91 to 100)
OG004100(91 to 100)
67
(43 to 106)
OG00459(38 to 93)
4.64
(3.11 to 6.91)
OG0044.07(2.73 to 6.06)
216
(130 to 356)
OG004258(56 to 426)
8.84
(5.63 to 14)
OG00411(7.04 to 17)
381
(224 to 650)
OG004402(236 to 684)
7.99
(5.29 to 12)
OG0047.63(5 to 12)
308
(191 to 499)
OG004527(322 to 862)
5
(1 to 13)
OG0044(1 to 11)
48
(36 to 60)
OG00435(24 to 46)
40
(28 to 52)
OG00430(20 to 41)
64
(51 to 75)
OG00475(64 to 85)
52
(40 to 64)
OG00461(48 to 72)
60
(48 to 72)
OG00459(48 to 70)
51
(39 to 63)
OG00446(34 to 57)
5.43
(4.05 to 7.27)
OG0044.42(3.35 to 5.84)
8.15
(5.97 to 11)
OG00412(8.81 to 16)
7.84
(5.79 to 11)
OG0047.12(5.32 to 9.54)
66
(54 to 76)
1
(0.032 to 7)
58
(47 to 69)
15
(8 to 25)
91
(81 to 96)
15
(8 to 25)
85
(75 to 92)
24
(15 to 36)
91
(81 to 96)
19
(11 to 30)
85
(75 to 92)
9
(4 to 19)
86
(77 to 93)
4
(1 to 11)
80
(69 to 88)
100
(95 to 100)
OG004100(95 to 100)
OG005100(95 to 100)
18
(10 to 29)
OG00419(10 to 30)
OG00515(8 to 26)
97
(90 to 100)
OG00496(88 to 99)
OG005100(95 to 100)
25
(15 to 36)
OG00449(37 to 61)
OG00537(26 to 49)
97
(90 to 100)
OG00497(90 to 100)
OG005100(95 to 100)
7
(2 to 15)
OG00417(9 to 27)
OG00511(5 to 20)
82
(71 to 90)
OG00482(71 to 90)
OG00586(76 to 93)
NA
(NA to NA)
not performed due to insufficient sera
OG004NA(NA to NA)not performed due to insufficient sera
OG00522(13 to 34)
NA
(NA to NA)
not performed due to insufficient sera
OG004NA(NA to NA)not performed due to insufficient sera
OG00597(90 to 100)
0.6
(0.48 to 0.73)
OG0040.97(0.79 to 1.19)
OG0050.68(0.55 to 0.83)
0.031
(0.024 to 0.042)
OG0040.032(0.024 to 0.042)
OG0050.016(0.012 to 0.021)
1.06
(0.84 to 1.32)
OG0040.98(0.78 to 1.22)
OG0051.49(1.19 to 1.87)
0.089
(0.063 to 0.12)
OG0040.15(0.11 to 0.21)
OG0050.064(0.045 to 0.09)
0.47
(0.32 to 0.7)
OG0045.67(3.89 to 8.28)
OG0050.42(0.28 to 0.63)
5.79
(4.15 to 8.09)
OG004NA(NA to NA)not performed due to insufficient sera
OG0054.21(3.03 to 5.87)
69
(47 to 102)
OG004NA(NA to NA)not performed due to insufficient sera