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Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants

Sponsor
Novartis Vaccines (Industry)
Overall Status
Completed
CT.gov ID
NCT00262002
Collaborator
Novartis (Industry)
601
Enrollment
3
Locations
7
Arms
25
Duration (Months)
200.3
Patients Per Site
8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation)
  • Biological: MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)
  • Biological: MenACWY PS (MenACWY-CRM, polysaccharide vaccine)
  • Biological: HBV (Hepatitis B vaccine)
  • 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)
  • Biological: Menjugate (Men C conjugated vaccine)
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
601 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
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
Study Start Date :
Sep 1, 2004
Actual Primary Completion Date :
Jul 1, 2005
Actual Study Completion Date :
Oct 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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 in the UK group. A fourth dose of MenACWY Ad+ was given at 12 months of age.

Biological: MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)
MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.

Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.
Experimental: 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.

Biological: MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)
MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.

Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.
Experimental: 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.

Biological: MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)
MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.

Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.

Biological: Menjugate (Men C conjugated vaccine)
Menjugate was injected IM in the anterolateral area of the right thigh.
Experimental: CA246+ (MenACWY Ad+ at 2, 4, 6 m)

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.

Biological: MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)
MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.

Biological: MenACWY PS (MenACWY-CRM, polysaccharide vaccine)
MenACWY polysaccharide vaccine was injected in the anterolateral area of the right thigh.

Biological: HBV (Hepatitis B vaccine)
Hepatitis B vaccine at 2, 4, 6 months of age administered IM in the anterolateral area of the left thigh.

Biological: Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)
Prevnar was administered IM in the anterolateral area of the left thigh.

Biological: MMR (Measles, Mumps and Rubella vaccine)
MMR at 12 month of age, administered in the left arm.

Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.
Experimental: CA24+ (MenACWY Ad+ at 2, 4 m)

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: MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)
MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.

Biological: MenACWY PS (MenACWY-CRM, polysaccharide vaccine)
MenACWY polysaccharide vaccine was injected in the anterolateral area of the right thigh.

Biological: HBV (Hepatitis B vaccine)
Hepatitis B vaccine at 2, 4, 6 months of age administered IM in the anterolateral area of the left thigh.

Biological: Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)
Prevnar was administered IM in the anterolateral area of the left thigh.

Biological: MMR (Measles, Mumps and Rubella vaccine)
MMR at 12 month of age, administered in the left arm.

Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.
Experimental: 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.

Biological: MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation)
MenACWY-CRM conjugate vaccine formulated without adjuvant was injected IM (intramuscularly) in the anterolateral area of the right thigh.

Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.
Experimental: CA24- (MenACWY Ad- at 2, 4 m)

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)
MenACWY-CRM conjugate vaccine formulated without adjuvant was injected IM (intramuscularly) in the anterolateral area of the right thigh.

Biological: MenACWY PS (MenACWY-CRM, polysaccharide vaccine)
MenACWY polysaccharide vaccine was injected in the anterolateral area of the right thigh.

Biological: HBV (Hepatitis B vaccine)
Hepatitis B vaccine at 2, 4, 6 months of age administered IM in the anterolateral area of the left thigh.

Biological: Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)
Prevnar was administered IM in the anterolateral area of the left thigh.

Biological: DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)
DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.

Outcome Measures

Primary Outcome Measures

  1. Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine [Baseline and at 1 month after the 3 dose primary vaccination series]

    Immunogenicity was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥ 1:4 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at the baseline and 1 month after primary vaccination by groups.

Secondary Outcome Measures

  1. Percentages of Subjects With hSBA Titers ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Conjugate Vaccine [Baseline and 1 month after the 3 dose primary vaccination series]

    Immunogenicity was measured by percentages of subjects With hSBA titers ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at baseline and 1 month after primary vaccination by groups.

  2. Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine [Baseline and 1 month after the 3 dose primary vaccination series]

    Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N meningitis serogroups A, C, W, and Y, at the baseline and 1 month after primary vaccination by groups.

  3. Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W, and Y Following 2 Doses of Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines [Baseline and 1 month after second vaccination]

    Immunogenicity was measured as the percentages of subjects With hSBA titers ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at Baseline and 1 month after second vaccination by groups.

  4. Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines [Baseline and 1 month after second vaccination]

    Immunogenicity was measured as hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y at baseline and 1 month after second vaccination by groups.

  5. Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 Against N. Meningitidis Serogroups A, C, W & Y After a Booster Dose of MenACWY Ad+ or Ad- Vaccine in a Subgroup of Subjects Following 2 or 3 Doses or MenACWY Ad+ or 2 Doses of MenACWY Ad- Vaccine [at 12 months of age and 1 month after booster vaccination]

    Immunogenicity was measured as the percentages of subjects with hSBA ≥ 1:4 or ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by groups.

  6. Geometric Mean hSBA Titers (GMT) After a Booster Dose of MenACWY Ad+ or Ad- Vaccine Conjugate in a Subgroup of Subjects Following Either 2 or 3 Doses of MenACWY Ad+ Vaccine or 2 Doses of MenACWY Ad- Conjugate Vaccines [at 12 months of age and 1 month after booster vaccination]

    Immunogenicity was measured as GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by group.

  7. Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 2 Doses of Novartis MenACWY Ad+ Vaccine, Novartis MenACWY Ad- Vaccine or Novartis Menjugate Vaccine [at 12 months of age]

    The persistence of immune response was measured as the percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 against N. Meningitidis serogroups A, C, W, and Y at 12 months of age by groups.

  8. Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine. [at 12 months of age]

    The persistence of immune response as measured by hSBA GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age by groups.

  9. Percentages of Subjects With hSBA Titers ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup A, C, W and Y Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine [at 12 months of age]

    The persistence of immune response as measured by percentages of subjects with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months by groups.

  10. Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine [at 12 months of age]

    The persistence of immune response as measured by hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y,at 12 months by groups.

  11. Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine [before challenge at 12 months of age and 1 month after PS challenge.]

    The induction of immunological memory was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.

  12. Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine [before challenge at 12 months of age and 1 month after PS challenge.]

    The induction of immunological memory was measured as hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.

  13. Percentages of Subjects With hSBA Titers ≥ 1:4 or ≥ 1:8 in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine [Before challenge at 12 months of age and 1 month after PS challenge.]

    The Induction of immunological memory was measured as percentage of subjects with hSBA ≥ 1:4, hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.

  14. Geometric Mean hSBA Titers (GMTs) in Subjects Challenged With a Reduced Dose of Licensed Meningococcal ACWY PS Vaccine Following Two Doses of Novartis MenACWY Ad+ or MenACWY Ad- Conjugate Vaccine [Before challenge at 12 months of age and 1 month after PS challenge.]

    Induction of immunological memory was measured by hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.

  15. Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine [Baseline and 1 month after the 2 or 3 dose primary vaccination series]

    The immunogenicity was measured as percentages of subject with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, baseline and 1 month after 2 or 3 dose primary series by groups.

  16. Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 in Subjects Challenged With a Reduced Dose of a Licensed Meningococcal ACWY PS Vaccine Following 2 or 3 Doses of MenACWY Ad+ Conjugate Vaccine [at 12 months of age and 1 month after PS challenge]

    The memory response was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after PS challenge by groups.

  17. Percentages of Subjects With Antibody Response to Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Routine Vaccines Are Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines [Baseline and 1 month after the 2 or 3 dose primary vaccination series]

    To assess the immunogenicity of routine vaccines when given concomitantly to Novartis MenACWY Ad+ or Novartis MenACWY Ad- conjugate vaccines. Hib, diphtheria, tetanus, pertussis will be evaluated as the first priority, followed by pneumococcus, polio, hepatitis B, and MMR (measles, mumps, and rubella) depending on the availability of sera.

  18. ELISA GMT Concentrations for Routine Vaccines (Hib, Diphtheria, Tetanus, Hepatitis B) When Given Concomitantly With Novartis MenACWY Ad+ or Novartis MenACWY Ad- Conjugate Vaccines for Hib, Diphtheria, Tetanus, Hepatitis B [Baseline and 1 month after the 2 or 3 dose primary vaccination series]

    To assess the Enzyme-linked immunosorbent assay (ELISA) GMT of Hib, Diphtheria, Tetanus, Hepatitis B, administered Concomitantly with Novartis MenACWY Ad+ or MenACWY Ad-conjugate vaccines, at the baseline and 1 month after primary vaccination by groups.

  19. Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 Against N. Meningitidis Serogroup C Following 2 Doses of MenACWY Ad+ or Ad- Conjugate Vaccine (Containing 5 μg of MenC Oligosaccharide) or 2 Doses of Menjugate (Containing 10 μg of MenC Oligosaccharide) [Baseline and 1 month after second vaccination]

    The immunogenicity was measured as percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroup C, at baseline and 1 month after second vaccination by groups.

  20. Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad- [7 days after each vaccination]

    Safety and tolerability of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccine when given in a 2 or 3 dose primary vaccination series concomitantly with licensed pediatric vaccines.

  21. Number of Subjects Reporting Solicited Local and Systemic Adverse Events After MenACWY Ad+ and MenACWY Ad- Booster or Polysaccharide Challenge Administered at 12 Months of Age [7 days after vaccination at 12 months of age]

    The safety profile of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccines when given at 12 months of age.

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Months to 6 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

Inclusion Criteria

Individuals eligible for enrollment in this study were male, and female infants:

  • Who were healthy 2-month old infants (55-89 days, inclusive) born after full term pregnancy with an estimated gestational age ≥ 37 weeks, and a birth weight ≥ 2.5 kg;

  • For whom a parent/legal guardian has given written informed consent after the nature of the study has been explained;

  • Who were available for all the visits scheduled in the study;

  • Who were in good health as determined by:

  • Medical history;

  • Physical examination;

  • Clinical judgment of the investigator.

Exclusion Criteria

Ineligible for the study were infants:

  • Whose parents/legal guardians were unwilling, or unable to give written informed consent for the subject to participate in the study;

  • Who previously received any meningococcal vaccine;

  • Who received prior vaccination with D, T, P (acellular, or whole cell), IPV, or OPV, HBV, H influenzae type b (Hib), or Pneumococcus;

  • Who had a previously ascertained or suspected disease caused by N meningitidis, C diphtheriae, C tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus, or B pertussis (history of laboratory-confirmed or clinical condition of spasmodic cough for a period ≥ 2 weeks associated with apnea or whooping cough);

  • Who had household contact with and/or intimate exposure to an individual with laboratory-confirmed N meningitis (serogroups A, C, W-135, or Y), B pertussis, Hib, C diphtheriae, Polio, or pneumococcal infection since birth;

  • Who had a history of any anaphylactic shock, asthma, urticaria, or other allergic reaction after previous vaccinations, or known hypersensitivity to any vaccine component;

  • Who had experienced significant acute or chronic infection within the previous 7 days, or fever (≥ 38.0°C) within the previous 3 days;

  • Who had any present, or suspected serious, acute (e.g., leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac, renal failure, or severe malnutrition, or insulin-dependent diabetes); or progressive neurological disease; or a genetic anomaly or known cytogenic disorders (e.g., Downs syndrome);

  • Who had a known or suspected autoimmune disease or impairment /alteration of immune function resulting from (for example):

  • receipt of any immunosuppressive therapy since birth;

  • receipt of immunostimulant since birth;

  • receipt of any systemic corticosteroid since birth.

  • Who had a suspected or known HIV infection, or HIV-related disease;

  • Who had ever received blood, blood products and/or plasma derivatives, or any parenteral immunoglobulin preparation;

  • Who had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;

  • Who had a history of seizure disorder:

  • Febrile seizure;

  • Any other seizure disorder.

  • Who had taken systemic antibiotics (either oral or parenteral) within the previous 14 days (EXCEPTION: subjects who received an oral or parenteral β-lactam antibiotic [examples: penicillin, amoxicillin, ceftriaxone, cefuroxime, cephalexin, etc.] may be enrolled 7 days following the last dose);

  • Who with their parents/legal guardians were planning to leave the area of the study site before the end of the study period;

  • Who had any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives;

  • Who had taken any antipyretic medication in the previous 6 hours.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vaccine Evaluation Center Vancouver British Columbia Canada
2 Clinical Trial Research Center Halifax Nova Scotia Canada
3 Oxford Vaccine Group Oxford United Kingdom

Sponsors and Collaborators

  • Novartis Vaccines
  • Novartis

Investigators

  • Study Director: Novartis Vaccines, Novartis Vaccines & Diagnostics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT00262002
Other Study ID Numbers:
  • V59P5
  • 2004-000195-13
First Posted:
Dec 6, 2005
Last Update Posted:
Jun 18, 2014
Last Verified:
Jun 1, 2014
Additional relevant MeSH terms:
Meningococcal Infections
Vaccines

Study Results

Participant Flow

Recruitment Details Participants were enrolled at two centers in Canada and one in UK.
Pre-assignment Detail 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.
Arm/Group Title UK234+ (MenACWY Ad+ at 2,3,4 m) UK24+ (MenACWY Ad+ at 2,4 m) UKMenC (Menjugate at 2,4m) CA246+ (MenACWY Ad+ at 2,4,6m) CA24+ (MenACWY Ad+ at 2,4m) UK24- (MenACWY Ad- at 2,4m) CA24- (MenACWY Ad- at 2,4m)
Arm/Group Description 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. 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. 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. 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. 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. 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. 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.
Period Title: Overall Study
STARTED 90 90 45 98 98 90 90
COMPLETED 79 84 45 93 91 83 84
NOT COMPLETED 11 6 0 5 7 7 6

Baseline Characteristics

Arm/Group Title UK234+ (MenACWY Ad+ at 2,3,4 m) UK24+ (MenACWY Ad+ at 2,4 m) UKMenC (Menjugate at 2,4m) CA246+ (MenACWY Ad+ at 2,4,6m) CA24+ (MenACWY Ad+ at 2,4m) UK24- (MenACWY Ad- at 2,4m) CA24- (MenACWY Ad- at 2,4m) Total
Arm/Group Description 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. 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. 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. 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. 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. 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. 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. Total of all reporting groups
Overall Participants 90 90 45 98 98 90 90 601
Age (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]
62.1
(5.4)
61.3
(5.0)
62.6
(6.5)
65.6
(6.9)
65.8
(6.9)
64.1
(5.5)
69.4
(10.0)
64.6
(7.3)
Sex: Female, Male (Count of Participants)
Female
44
48.9%
41
45.6%
26
57.8%
52
53.1%
49
50%
48
53.3%
44
48.9%
304
50.6%
Male
46
51.1%
49
54.4%
19
42.2%
46
46.9%
49
50%
42
46.7%
46
51.1%
297
49.4%

Outcome Measures

1. Primary Outcome
Title Percentages of Subjects With hSBA Titers ≥ 1:4 Against N. Meningitidis Serogroups A, C, W, and Y Following 3 Doses of MenACWY Ad+ Vaccine
Description Immunogenicity was measured as the percentage of subjects with human serum bactericidal assay (hSBA) titers ≥ 1:4 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at the baseline and 1 month after primary vaccination by groups.
Time Frame Baseline and at 1 month after the 3 dose primary vaccination series

Outcome Measure Data

Analysis Population Description
The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.
Arm/Group Title UK234+ (MenACWY Ad+ at 2, 3, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Arm/Group Description 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. 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.
Measure Participants 81 87
Ser A - baseline (n=69,80)
6
0
Ser A - 1 month after primary vacc (n=69,80)
93
81
Ser C - baseline (n=79,86)
18
15
Ser C - 1 month after primary vacc (n=79,86)
96
98
Ser W - baseline (n=69,78)
54
31
Ser W - 1 month after primary vacc (n=69,78)
97
99
Ser Y - baseline
21
17
Ser Y - 1 month after primary vacc
94
98
2. Secondary Outcome
Title 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
Description Immunogenicity was measured by percentages of subjects With hSBA titers ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W and Y, at baseline and 1 month after primary vaccination by groups.
Time Frame Baseline and 1 month after the 3 dose primary vaccination series

Outcome Measure Data

Analysis Population Description
The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.
Arm/Group Title UK234+ (MenACWY Ad+ at 2, 3, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6m)
Arm/Group Description 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. 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.
Measure Participants 81 87
Ser A - baseline (n=69,80)
4
0
Ser A - 1 month after primary vacc (n=69,80)
88
76
Ser C - baseline (n=79,86)
9
5
Ser C - 1 month after primary vacc (n=79,86)
92
98
Ser W - baseline (n=69,78)
46
28
Ser W - 1 month after primary vacc (n=69,78)
88
96
Ser Y - baseline
14
11
Ser Y - 1 month after primary vaccination
93
89
3. Secondary Outcome
Title Geometric Mean hSBA Titers (GMTs) Following 3 Doses of MenACWY Ad+ Conjugate Vaccine
Description Immunogenicity was measured as hSBA GMTs and associated 95% CI, against N meningitis serogroups A, C, W, and Y, at the baseline and 1 month after primary vaccination by groups.
Time Frame Baseline and 1 month after the 3 dose primary vaccination series

Outcome Measure Data

Analysis Population Description
The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.
Arm/Group Title UK234+ (MenACWY Ad+ at 2, 3, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Arm/Group Description 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. 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.
Measure Participants 81 87
Ser A - baseline (n=69,80)
2.2
2
Ser A - 1 month after primary vacc (n=69,80)
53
21
Ser C - baseline (n=79,86)
2.79
2.64
Ser C - 1 month after primary vacc (n=79,86)
79
124
Ser W - baseline (n=69,78)
5.76
4.03
Ser W - 1 month after primary vacc (n=69,78)
65
73
Ser Y - baseline
2.72
2.64
Ser Y - 1 month after primary vacc
56
2.64
4. Secondary Outcome
Title 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
Description Immunogenicity was measured as the percentages of subjects With hSBA titers ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at Baseline and 1 month after second vaccination by groups.
Time Frame Baseline and 1 month after second vaccination

Outcome Measure Data

Analysis Population Description
The analysis was performed on the MenACWY per-protocol (PP) "n" population.
Arm/Group Title UK24+ (MenACWY Ad+ at 2, 4 m) CA24+ (MenACWY Ad+ at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m)
Arm/Group Description 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. 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. 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. 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.
Measure Participants 77 79 79 85
Ser A - hSBA ≥1:4, baseline (N=68,79,78,83)
4
3
3
4
Ser A - hSBA ≥1:4, 1m after 2n vacc(N=68,79,78,83)
60
66
50
57
Ser A - hSBA ≥1:8, baseline (N=68,79,78,83)
3
1
0
1
Ser A - hSBA≥1:8, 1m after 2nd vacc(N=68,79,78,83)
54
58
44
49
Ser C - hSBA ≥1:4, baseline (N=77,74,79,85)
13
15
20
20
Ser C - hSBA ≥1:4,1m after 2nd vacc(N=77,74,79,85)
84
91
86
93
Ser C - hSBA ≥1:8, baseline (N=77,74,79,85)
9
15
5
11
Ser C - hSBA ≥1:8,1m after 2nd vacc(N=77,74,79,85)
83
85
82
89
Ser W - hSBA ≥1:4, baseline (N=73,74,72,75)
45
24
43
19
Ser W - hSBA ≥1:4,1m after 2nd vacc(N=73,74,72,75)
92
91
82
95
Ser W - hSBA ≥1:8, baseline (N=73,74,72,75)
37
19
36
16
Ser W -hSBA ≥1:8,1m after 2nd vacc(N=73,74,72,75)
84
85
75
92
Ser Y - hSBA ≥1:4, baseline (N=76,74,77,85)
18
9
35
18
Ser Y -hSBA ≥1:4,1m after 2nd vacc(N=76,74,77,85)
84
86
74
91
Ser Y - hSBA ≥1:8, baseline (N=76,74,77,85)
7
4
16
11
Ser Y -hSBA ≥1:8,1m after 2nd vacc(N=76,74,77,85)
76
80
70
86
5. Secondary Outcome
Title Geometric Mean hSBA Titer (GMTs) Following 2 Doses of MenACWY Ad+ and MenACWY Ad- Conjugate Vaccines
Description Immunogenicity was measured as hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y at baseline and 1 month after second vaccination by groups.
Time Frame Baseline and 1 month after second vaccination

Outcome Measure Data

Analysis Population Description
The analysis was performed on the MenACWY per-protocol (PP) "n" population
Arm/Group Title UK24+ (MenACWY Ad+ at 2, 4 m) CA24+ (MenACWY Ad+ at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m)
Arm/Group Description 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. 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. 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. 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.
Measure Participants 77 79 79 85
Ser A - baseline (n=68,79,78,83)
2.17
2.07
2.05
2.08
Ser A - 1 month after 2nd vacc (n=68,79,78,83)
12
11
7.3
7.16
Ser C - baseline (n=77,74,79,85)
2.54
2.77
2.48
2.87
Ser C - 1 month after 2nd vacc (n=77,74,79,85)
52
55
40
69
Ser W - baseline (n=73,74,79,75)
5.33
3.6
5.14
3.02
Ser W - 1 month after 2nd vacc (n=73,74,79,75)
48
44
29
69
Ser Y - baseline (n=76,74,77,85)
2.56
2.27
3.39
2.76
Ser Y - 1 month after 2nd vacc (n=76,74,77,85)
26
27
21
41
6. Secondary Outcome
Title 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
Description Immunogenicity was measured as the percentages of subjects with hSBA ≥ 1:4 or ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by groups.
Time Frame at 12 months of age and 1 month after booster vaccination

Outcome Measure Data

Analysis Population Description
The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.
Arm/Group Title UK24+ (MenACWY Ad+ at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) UK234+ (MenACWY Ad+ at 2, 3, 4 m) CA24+ (MenACWY Ad+ at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m)
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 67 63 65 40 40
Ser A -hSBA ≥1:4, at 12 m of age(n=64,61,62,39,38)
8
7
21
5
3
Ser A -hSBA≥1:4, 1 m after booster vacc
86
79
94
92
95
Ser A - hSBA ≥1:8, at 12 months of age
5
5
13
3
3
Ser A - hSBA ≥1:8, 1 m after booster vaccination
83
77
92
90
92
Ser C -hSBA ≥1:4, at 12 m of age(n=67,63,65,40,40)
40
33
60
48
33
Ser C-hSBA≥1:4,1 m after booster(n=57,63,65,40,40)
96
94
98
98
100
Ser C-hSBA ≥1:8, at 12 m of age(n=67,40,65,40,40)
34
27
52
35
25
Ser C-hSBA≥1:8, 1m after booster(n=67,63,65,40,40)
96
94
98
95
100
Ser W -hSBA≥1:4, at 12 m of age(n=57,41,57,35,35)
56
54
81
74
69
Ser W - hSBA≥1:4, 1m after booster vaccination
100
100
100
100
100
Ser W -hSBA≥1:8, at 12 m of age(n=57,41,40,35,35)
47
41
68
49
54
Ser W -hSBA≥1:8,1m after booster(n=57,41,57,35,35)
100
100
100
100
100
Ser Y -hSBA≥1:4, at 12m of age(n=66,63,65,40,38)
52
52
86
65
63
Ser Y - hSBA≥1:4, 1 m after booster vaccination
100
100
100
100
100
Ser Y - hSBA ≥1:8, at 12 months of age
39
41
72
45
53
Ser Y - hSBA ≥1:8, 1 m after booster vaccination
100
100
100
100
100
7. Secondary Outcome
Title 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
Description Immunogenicity was measured as GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after booster by group.
Time Frame at 12 months of age and 1 month after booster vaccination

Outcome Measure Data

Analysis Population Description
The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.
Arm/Group Title UK24+ (MenACWY Ad+ at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) UK234+ (MenACWY Ad+ at 2, 3, 4 m) CA24+ (MenACWY Ad+ at 2, 4m) CA24- (MenACWY Ad- at 2, 4 m)
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 67 63 65 40 40
Ser A - at 12 months of age (n=64,61,62,39,38)
2.31
2.22
2.97
2.18
2.07
Ser A - 1 month after booster (n=64,61,62,39,38)
47
30
134
67
59
Ser C - at 12 months of age(n=67,63,65,40,40)
5.18
3.94
7.94
4.64
4.07
Ser C - 1 month after booster(n=67,63,65,40,40)
236
129
429
216
258
Ser W - at 12 months of age(n=57,41,57,35,35)
8.1
6.49
16
8.84
11
Ser W - 1 month after booster (n=57,41,57,35,35)
503
311
792
381
402
Ser Y - at 12 months of age (n=66,63,65,40,38)
6.65
6.83
19
7.99
7.63
Ser Y- 1 month after booster(n=66,63,65,40,38)
508
438
1395
308
527
8. Secondary Outcome
Title 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
Description The persistence of immune response was measured as the percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 against N. Meningitidis serogroups A, C, W, and Y at 12 months of age by groups.
Time Frame at 12 months of age

Outcome Measure Data

Analysis Population Description
The analysis was performed on the MenACWY and Menjugate per-protocol (PP) "n" population evaluating the persistence response.
Arm/Group Title UKMenC (Menjugate 2, 4 m) UK24+ (MenACWY Ad+ at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) CA24+ (MenACWY Ad+ at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m)
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 38 69 66 77 81
Ser A - hSBA ≥1:4, at 12m of age(n=36,62,65,77,78)
0
8
6
8
5
Ser A - hSBA ≥1:8, at 12m of age(n=36,62,65,77,78)
0
5
5
5
4
Ser C - hSBA ≥1:4, at 12m of age(n=38,69,69,73,81)
89
41
32
48
35
Ser C - hSBA ≥1:8, at 12m of age(n=38,69,69,73,81)
87
33
26
40
30
Ser W - hSBA ≥1:4, at 12m of age(n=34,62,42,69,69)
9
58
57
64
75
Ser W - hSBA ≥1:8, at 12m of age(n=34,62,42,69,69)
6
48
45
52
61
Ser Y - hSBA ≥1:4, at 12m of age(n=38,69,66,73,79)
5
51
56
60
59
Ser Y - hSBA ≥1:8, at 12m of age(n=38,69,66,73,79)
3
42
45
51
46
9. Secondary Outcome
Title Geometric Mean hSBA Titers (GMTs) After 2 Doses of Novartis MenACWY Ad+ Vaccines, Novartis MenACWY Ad- Vaccine, or Novartis Menjugate Vaccine.
Description The persistence of immune response as measured by hSBA GMT and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age by groups.
Time Frame at 12 months of age

Outcome Measure Data

Analysis Population Description
The analysis was performed on the MenACWY and Menjugate per-protocol (PP) "n" population evaluating the persistence response.
Arm/Group Title UKMenC (Menjugate at 2, 4 m) UK24+ (MenACWY Ad+ at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) CA24+ (MenACWY Ad+ at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m)
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 38 69 66 77 81
Ser A - at 12 months of age (n=36,62,65,77,78)
2
2.32
2.2
2.29
2.18
Ser C - at 12 months of age (n=36,69,69,73,82)
27
5.04
3.85
5.43
4.42
Ser W - at 12 months of age (n=34,62,42,69,69)
2.42
8.38
7.02
8.15
12
Ser Y - at 12 months of age (n=38,69,66,73,79)
2.15
6.72
7.64
7.84
7.12
10. Secondary Outcome
Title 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
Description The persistence of immune response as measured by percentages of subjects with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y, at 12 months by groups.
Time Frame at 12 months of age

Outcome Measure Data

Analysis Population Description
The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.
Arm/Group Title UK234+ (MenACWY Ad+ at 2, 3, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Arm/Group Description 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 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.
Measure Participants 71 86
Ser A - hSBA ≥1:4, at 12 months of age (n=58,79)
21
35
Ser A - hSBA ≥1:8, at 12 months of age(n=58,79)
16
29
Ser C - hSBA ≥1:4, at 12 months of age(n=70,84)
59
75
Ser C - hSBA ≥1:8, at 12 months of age(n=70,84)
47
68
Ser W - hSBA ≥1:4, at 12 months of age(n=58,75)
78
89
Ser W - hSBA ≥1:8, at 12 months of age(n=58,75)
66
81
Ser Y - hSBA ≥1:4, at 12 months of age(n=71,86)
85
87
Ser Y - hSBA ≥1:8, at 12 months of age(n=71,86)
70
79
11. Secondary Outcome
Title Geometric Mean hSBA Titers (GMTs) Following 3 Doses of Novartis MenACWY Ad+ Conjugate Vaccine
Description The persistence of immune response as measured by hSBA GMTs and associated 95% CI against N. Meningitidis serogroups A, C, W, and Y,at 12 months by groups.
Time Frame at 12 months of age

Outcome Measure Data

Analysis Population Description
The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.
Arm/Group Title UK234+ (MenACWY Ad+ at 2, 3, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Arm/Group Description 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. 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.
Measure Participants 71 86
Ser A - at 12 months of age (n=58,79)
3.02
3.93
Ser C - at 12 months of age (n=70,84)
7.56
14
Ser W - at 12 months of age (n=58,75)
15
20
Ser Y - at 12 months of age (n=71,86)
18
22
12. Secondary Outcome
Title 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
Description The induction of immunological memory was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.
Time Frame before challenge at 12 months of age and 1 month after PS challenge.

Outcome Measure Data

Analysis Population Description
The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.
Arm/Group Title CA246+ (MenACWY Ad+ at 2,4,6 m)
Arm/Group Description 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.
Measure Participants 44
Ser A-hSBA≥1:4,before challenge at 12m (n=44)
27
Ser A - hSBA ≥1:4, 1 month after PS (n=44)
89
Ser A-hSBA ≥1:8,before challenge at 12m (n=44)
23
Ser A - hSBA ≥1:8, 1 month after PS (n=44)
86
Ser C-hSBA ≥1:4,before challenge at 12m (n=43)
74
Ser C - hSBA ≥1:4, 1 month after PS (n=43)
95
Ser C-hSBA ≥1:8, before challenge at 12m (n=43)
65
Ser C - hSBA ≥1:8, 1 month after PS (n=43)
91
Ser W-hSBA ≥1:4,before challenge at 12m (n=40)
83
Ser W - hSBA ≥1:4, 1 month after PS (n=40)
98
Ser W-hSBA ≥1:8,before challenge at 12m (n=40)
73
Ser W - hSBA ≥1:8, 1 month after PS (n=40)
95
Ser Y-hSBA ≥1:4,before challenge at 12m (n=44)
89
Ser Y - hSBA ≥1:4, 1 month after PS (n=44)
98
Ser Y-hSBA ≥1:8,before challenge at 12m (N=44)
77
Ser Y - hSBA ≥1:8, 1 month after PS (n=44)
98
13. Secondary Outcome
Title 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
Description The induction of immunological memory was measured as hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y , before challenge at 12 months of age and 1 month after PS challenge.
Time Frame before challenge at 12 months of age and 1 month after PS challenge.

Outcome Measure Data

Analysis Population Description
The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.
Arm/Group Title CA246+ (MenACWY Ad+ at 2, 4,6 m)
Arm/Group Description 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.
Measure Participants 44
Ser A - before challenge at 12 months of age(n=44)
3.4
Ser A - 1 month after PS challenge (n=44)
32
Ser C - before challenge at 12 months of age(n=43)
12
Ser C - 1 month after PS challenge (n=43)
82
Ser W - before challenge at 12 months of age(n=40)
17
Ser W - 1 month after PS challenge (n=40)
249
Ser Y - before challenge at 12 months of age(n=44)
19
Ser Y - 1 month after PS challenge (n=44)
186
14. Secondary Outcome
Title 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
Description The Induction of immunological memory was measured as percentage of subjects with hSBA ≥ 1:4, hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.
Time Frame Before challenge at 12 months of age and 1 month after PS challenge.

Outcome Measure Data

Analysis Population Description
The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.
Arm/Group Title CA24+ (MenACWY Ad+ at 2, 4m) CA24- (MenACWY Ad- at 2, 4m)
Arm/Group Description 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. 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.
Measure Participants 42 39
Ser A - hSBA≥1:4,before challange at 12m (n=40,39)
8
8
Ser A - hSBA ≥1:4,1 month after PS (n=40,39)
78
92
Ser A - hSBA≥1:8,before challange at 12m (n=40,39)
5
5
Ser A - hSBA ≥1:8, 1 month after PS (n=40,39)
78
87
Ser C - hSBA≥1:4,before challange at 12m (n=41,39)
44
38
Ser C - hSBA ≥1:4, 1 month after PS (n=41,39)
95
95
Ser C - hSBA≥1:8,before challange at 12m(n=41,39)
39
36
Ser C - hSBA ≥1:8, 1 month after PS (n=41,39)
93
90
Ser W - hSBA ≥1:4,before challange at 12m(n=41,38)
59
71
Ser W - hSBA ≥1:4, 1 month after PS (n=41,38)
98
100
Ser W - hSBA ≥1:8,before challange at 12m(n=41,38)
51
58
Ser W - hSBA ≥1:8, 1 month after PS (n=41,38)
98
100
Ser Y - hSBA ≥1:4,before challange at 12m(n=42,38)
55
55
Ser Y - hSBA ≥1:4, 1 month after PS (n=42,38)
98
100
Ser Y - hSBA ≥1:8,before challange at 12m (n=42,38
50
42
Ser Y - hSBA ≥1:8, 1 month after PS (n=42,38)
98
97
15. Secondary Outcome
Title 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
Description Induction of immunological memory was measured by hSBA Geometric Mean Titers (GMTs) and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, before challenge at 12 months and 1 month after PS challenge by groups.
Time Frame Before challenge at 12 months of age and 1 month after PS challenge.

Outcome Measure Data

Analysis Population Description
The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.
Arm/Group Title CA24+ (MenACWY Ad+ at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m)
Arm/Group Description 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. 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.
Measure Participants 42 39
Ser A - before challenge at 12 months (n=40,39)
2.22
2.31
Ser A - 1 month after PS challenge (n=40,39)
28
55
Ser C - before challenge at 12 months (n=41,39)
5.21
5.07
Ser C - 1 month after PS challenge (n=41,39)
140
181
Ser W - before challenge at 12 months (n=41,38)
7.48
11
Ser W - 1 month after PS challenge (n=41,38)
365
555
Ser Y - before challenge at 12 months (n=42,38)
6.73
6.79
Ser Y - 1 month after PS challenge (n=42,38)
280
288
16. Secondary Outcome
Title Percentages of Subjects With hSBA ≥ 1:4 and ≥ 1:8 of MenACWY Ad+ Conjugate Vaccine
Description The immunogenicity was measured as percentages of subject with hSBA≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, baseline and 1 month after 2 or 3 dose primary series by groups.
Time Frame Baseline and 1 month after the 2 or 3 dose primary vaccination series

Outcome Measure Data

Analysis Population Description
The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.
Arm/Group Title UK234+ (MenACWY Ad+ at 2, 3, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6m) UK24+ (MenACWY Ad+ at 2, 4 m) CA24+ (MenACWY Ad+ at 2, 4m)
Arm/Group Description 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. 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. 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. 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.
Measure Participants 81 87 77 79
Ser A - hSBA ≥1:4, baseline (n=69,80,38,79)
6
0
4
3
Ser A - hSBA≥1:4,1m after 1st vacc (n=69,80,38,79)
93
81
60
66
Ser A - hSBA ≥1:8, baseline (n=69,80,38,79)
4
0
3
1
Ser A - hSBA≥1:8,1m after 1st vacc (n=69,80,38,79)
88
76
54
58
Ser C - hSBA ≥1:4, baseline (n=79,86,40,74)
18
15
13
15
Ser C - hSBA≥1:4,1m after 1st vacc (n=79,86,40,74)
96
98
84
91
Ser C - hSBA ≥1:8, baseline (n=79,86,40,74)
9
5
9
15
Ser C - hSBA≥1:8,1m after 1st vacc (n=79,86,40,74)
92
98
83
85
Ser W - hSBA ≥1:4, baseline (n=69,78,73,74)
54
31
45
24
Ser W - hSBA≥1:4,1m after 1st vacc (n=69,78,73,74)
97
99
92
91
Ser W - hSBA ≥1:8, baseline (n=69,78,73,74)
46
28
37
19
Ser W - hSBA≥1:8,1m after 1st vacc (n=69,78,73,74)
88
96
84
85
Ser Y - hSBA ≥1:4, baseline (n=81,87,76,74)
21
17
18
9
Ser Y - hSBA≥1:4,1m after 1st vacc (n=81,87,76,74)
94
98
84
86
Ser Y - hSBA ≥1:8, baseline (n=81,87,76,74)
14
11
7
4
Ser Y - hSBA≥1:8,1m after 1st vacc (n=81,87,76,74)
93
89
76
80
17. Secondary Outcome
Title 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
Description The memory response was measured as percentages of subjects with hSBA ≥ 1:4 and hSBA ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroups A, C, W, and Y, at 12 months of age and 1 month after PS challenge by groups.
Time Frame at 12 months of age and 1 month after PS challenge

Outcome Measure Data

Analysis Population Description
The analysis was performed on the MenACWY per-protocol (PP) "n" population evaluating the persistence response.
Arm/Group Title CA246+ (MenACWY Ad+ at 2, 4, 6m) CA24+ (MenACWY Ad+ at 2, 4 m)
Arm/Group Description 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. 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.
Measure Participants 44 42
Ser A - hSBA ≥1:4, at 12 months of age (n=44,40)
27
8
Ser A - hSBA ≥1:4, at 1 month after PS (n=44,40)
89
78
Ser A - hSBA ≥1:8, at 12 months of age (n=44,40)
23
5
Ser A - hSBA ≥1:8, at 1 month after PS (n=44,40)
86
78
Ser C - hSBA ≥1:4, at 12 months of age (n=43,41)
74
44
Ser C - hSBA ≥1:4, at 1 month after PS (n=43,41)
95
95
Ser C - hSBA ≥1:8, at 12 months of age (n=43,41)
65
39
Ser C - hSBA ≥1:8, at 1 month after PS (n=43,41)
91
93
Ser W - hSBA ≥1:4, at 12 months of age (n=40,41)
83
59
Ser W - hSBA ≥1:4, at 1 month after PS (n=40,41)
98
98
Ser W - hSBA ≥1:8, at 12 months of age (n=40,41)
73
51
Ser W - hSBA ≥1:8, at 1 month after PS (n=40,41)
95
98
Ser Y - hSBA ≥1:4, at 12 months of age (n=44,42)
89
55
Ser Y - hSBA ≥1:4, at 1 month after PS (n=44,42)
98
98
Ser Y - hSBA ≥1:8, at 12 months of age (n=44,42)
77
50
Ser Y - hSBA ≥1:8, at 1 month after PS (n=44,42)
98
98
18. Secondary Outcome
Title 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
Description To assess the immunogenicity of routine vaccines when given concomitantly to Novartis MenACWY Ad+ or Novartis MenACWY Ad- conjugate vaccines. Hib, diphtheria, tetanus, pertussis will be evaluated as the first priority, followed by pneumococcus, polio, hepatitis B, and MMR (measles, mumps, and rubella) depending on the availability of sera.
Time Frame Baseline and 1 month after the 2 or 3 dose primary vaccination series

Outcome Measure Data

Analysis Population Description
The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.
Arm/Group Title CA24+ (MenACWY Ad+ at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m) UK234+ (MenACWY Ad+ at 2, 3, 4 m) UK24+ (MenACWY Ad+ at 2, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6 m)
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 70 77 70 73 72 73
Antitetanus≥0.1 IU/mL-baseline(69,71,70,67,69,72)
75
79
70
93
87
71
Antitetanus≥0.1 IU/mL -1m post (69,71,70,67,69,72)
100
100
99
100
100
100
antidipht≥0.1 IU/mL-baseline(69,71,70,67,69,72)
17
14
3
18
19
15
antidipht≥0.1 IU/mL- 1m post (69,71,70,67,69,72)
96
97
100
97
96
100
antiPRPtiter≥0.15µg/mL-baseline(70,77,69,73,72,73)
36
42
17
25
49
37
antiPRPtiter≥0.15µg/mL-1m post (70,77,69,73,72,73)
74
95
67
97
97
100
antiPRPtiter≥1.0 µg/mL-baseline(70,77,69,73,72,73)
10
17
3
7
17
11
antiPRPtiter≥1.0 µg/mL-1m post (70,77,69,73,72,73)
33
86
35
82
82
86
antiHBVtiter≥1.0 IU/mL-baseline(65,na,66,na,na,67)
23
NA
11
NA
NA
22
antiHBVtiter≥1.0 IU/mL-1m post (65,na,66,na,na,67)
85
NA
92
NA
NA
97
19. Secondary Outcome
Title 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
Description To assess the Enzyme-linked immunosorbent assay (ELISA) GMT of Hib, Diphtheria, Tetanus, Hepatitis B, administered Concomitantly with Novartis MenACWY Ad+ or MenACWY Ad-conjugate vaccines, at the baseline and 1 month after primary vaccination by groups.
Time Frame Baseline and 1 month after the 2 or 3 dose primary vaccination series

Outcome Measure Data

Analysis Population Description
The analysis was performed on the MenACWY per-protocol (PP) "n" population after primary vaccination.
Arm/Group Title UK234+ (MenACWY Ad+ at 2, 3, 4 m) UK24+ (MenACWY Ad+ at 2, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6 m) CA24+ (MenACWY Ad+ at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m)
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 70 77 70 73 72 73
Tetanus - baseline (n=69,71,70,67,69,72)
0.32
0.31
0.23
0.28
0.25
0.18
Tetanus - 1 m after 1st vacc(n=69,71,70,67,69,72)
0.7
0.92
1.4
0.6
0.97
0.68
Diphtheria - baseline (n=69,71,70,67,69,72)
0.035
0.04
0.027
0.031
0.032
0.016
Diphtheria -1m after 1st vacc(n=69,71,70,67,69,72)
1.02
1.02
1.72
1.06
0.98
1.49
Hib - baseline (n=70,77,69,73,72,73)
0.078
0.15
0.11
0.089
0.15
0.064
Hib - 1 m after 1st vacc (n=70,77,69,73,72,73)
4.63
4.55
4.53
0.47
5.67
0.42
Hepatitis B - baseline (n=65,na,66,na,na,67)
NA
NA
5.9
5.79
NA
4.21
Hepatitis B-1m after 1st vacc(n=65,na,66,na,na,67)
NA
NA
378
69
NA
133
20. Secondary Outcome
Title 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)
Description The immunogenicity was measured as percentages of subjects with hSBA ≥ 1:4 and ≥ 1:8 and associated 95% CI, directed against N. Meningitidis serogroup C, at baseline and 1 month after second vaccination by groups.
Time Frame Baseline and 1 month after second vaccination

Outcome Measure Data

Analysis Population Description
The analysis was performed on the MenACWY and Menjugate per-protocol (PP) "n" population after second vaccination.
Arm/Group Title UKMenC (Menjugate at 2, 4 m) UK24+ (MenACWY Ad+ at 2, 4 m) CA24+ (MenACWY Ad+ at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m)
Arm/Group Description 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. 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. 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. 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. 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.
Measure Participants 40 77 74 79 85
hSBA ≥1:4, baseline
23
13
15
20
20
hSBA ≥1:4, 1 month after second vaccination
98
84
91
86
93
hSBA ≥1:8, baseline
10
9
15
5
11
hSBA ≥1:8, 1 month after second vaccination
98
83
85
82
89
21. Secondary Outcome
Title Number of Subjects Reporting Solicited Local and Systemic Adverse Events After 2 or 3 Dose Primary Vaccination Series With MenACWY Ad+ or MenACWY Ad-
Description Safety and tolerability of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccine when given in a 2 or 3 dose primary vaccination series concomitantly with licensed pediatric vaccines.
Time Frame 7 days after each vaccination

Outcome Measure Data

Analysis Population Description
Analysis was done on safety dataset "n" population - subjects who received at least one study dose and had Post baseline safety data.
Arm/Group Title UK234+ (MenACWY Ad+ at 2, 3, 4 m) UK24+ (MenACWY Ad+ at 2, 4 m) UKMenC (Menjugate at 2, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6 m) CA24+ (MenACWY Ad+ at 2, 4 m) UK24- (MenACWY Ad- at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m)
Arm/Group Description 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. 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. 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. 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. 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. 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. 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.
Measure Participants 90 90 45 98 98 90 90
Tenderness
40
31
18
46
32
41
35
Erythema
69
64
34
73
67
78
66
Induration
21
24
12
36
18
40
24
Eating habit Change
28
25
9
35
27
21
20
Sleepiness
56
49
25
64
62
45
52
Persistent Crying
7
7
6
15
4
5
4
Irritability
63
71
31
80
70
61
73
Vomiting
19
26
9
23
15
14
11
Diarrhea
29
27
12
30
22
18
16
Fever (≥38°C)
7
4
1
14
7
5
5
Analgesics/Antipyretics
43
35
18
61
46
36
45
22. Secondary Outcome
Title 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
Description The safety profile of Novartis MenACWY Ad+ and MenACWY Ad- conjugate vaccines when given at 12 months of age.
Time Frame 7 days after vaccination at 12 months of age

Outcome Measure Data

Analysis Population Description
Analysis was done on safety dataset "n" population.
Arm/Group Title UK234+ (MenACWY Ad+ at 2,3,4 m) UK24+ (MenACWY Ad+ at 2, 4 m) UKMenC (Menjugate at 2, 4 m) CA246+ (MenACWY Ad+ at 2, 4, 6 m) - No Treatment CA246+ (MenACWY Ad+ at 2, 4, 6 m) - PS CA24+ (MenACWY Ad+ at 2, 4 m) - ACWY CA24+ (MenACWY Ad+ at 2, 4 m) - PS UK24- (MenACWY Ad- at 2, 4 m) CA24- (MenACWY Ad- at 2, 4 m) - ACWY CA24- (MenACWY Ad- at 2, 4 m) - PS
Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
Measure Participants 90 90 45 48 48 47 48 90 44 43
Tenderness
7
11
10
0
10
7
10
10
7
12
Erythema
62
58
36
0
21
27
30
66
21
26
Induration
21
32
18
0
12
9
9
36
10
15
Eating habit change
11
16
5
10
12
6
10
13
10
8
Sleepiness
11
14
9
10
8
7
13
16
9
7
Persistent crying
0
4
3
3
3
0
2
4
5
0
Irritability
26
32
20
24
23
19
24
28
17
20
Vomiting
4
6
4
2
7
0
4
8
5
4
Diarrhea
9
9
4
4
7
6
5
9
3
4
Fever (≥38°C)
3
7
2
3
6
1
8
14
4
1
Analgesics/Antipyretics
14
21
12
13
15
8
17
22
14
11

Adverse Events

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).
Adverse Event Reporting 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.
Arm/Group Title UK234+ (MenACWY Ad+ at 2,3,4 m) UK24+ (MenACWY Ad+ at 2,4 m) UKMenC (Menjugate at 2,4m) CA246+ (MenACWY Ad+ at 2,4,6m) CA24+ (MenACWY Ad+ at 2,4m) UK24- (MenACWY Ad- at 2,4m) CA24- (MenACWY Ad- at 2,4m)
Arm/Group Description 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. 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. 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. 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. 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. 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. 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.
All Cause Mortality
UK234+ (MenACWY Ad+ at 2,3,4 m) UK24+ (MenACWY Ad+ at 2,4 m) UKMenC (Menjugate at 2,4m) CA246+ (MenACWY Ad+ at 2,4,6m) CA24+ (MenACWY Ad+ at 2,4m) UK24- (MenACWY Ad- at 2,4m) CA24- (MenACWY Ad- at 2,4m)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
UK234+ (MenACWY Ad+ at 2,3,4 m) UK24+ (MenACWY Ad+ at 2,4 m) UKMenC (Menjugate at 2,4m) CA246+ (MenACWY Ad+ at 2,4,6m) CA24+ (MenACWY Ad+ at 2,4m) UK24- (MenACWY Ad- at 2,4m) CA24- (MenACWY Ad- at 2,4m)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 20/90 (22.2%) 17/90 (18.9%) 6/45 (13.3%) 9/98 (9.2%) 4/98 (4.1%) 10/90 (11.1%) 7/90 (7.8%)
Blood and lymphatic system disorders
IDIOPATHIC THROMBOCYTOPENIC PURPURA 1/90 (1.1%) 0/90 (0%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA 0/90 (0%) 1/90 (1.1%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
Congenital, familial and genetic disorders
CONGENITAL MEGACOLON 0/90 (0%) 1/90 (1.1%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
HYPOSPADIAS 1/90 (1.1%) 0/90 (0%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
PLAGIOCEPHALY 1/90 (1.1%) 0/90 (0%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE 0/90 (0%) 1/90 (1.1%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 1/90 (1.1%)
INGUINAL HERNIA 1/90 (1.1%) 0/90 (0%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
General disorders
VOMITING 0/90 (0%) 0/90 (0%) 0/45 (0%) 1/98 (1%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
CYST 1/90 (1.1%) 0/90 (0%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
DEVELOPMENTAL DELAY 0/90 (0%) 0/90 (0%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 2/90 (2.2%) 0/90 (0%)
Immune system disorders
FOOD ALLERGY 1/90 (1.1%) 0/90 (0%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
Infections and infestations
ARTHRITIS BACTERIAL 0/90 (0%) 0/90 (0%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 1/90 (1.1%) 0/90 (0%)
BRONCHIOLITIS 4/90 (4.4%) 3/90 (3.3%) 1/45 (2.2%) 2/98 (2%) 1/98 (1%) 2/90 (2.2%) 2/90 (2.2%)
CROUP INFECTIOUS 0/90 (0%) 1/90 (1.1%) 0/45 (0%) 0/98 (0%) 1/98 (1%) 0/90 (0%) 1/90 (1.1%)
GASTROENTERITIS 0/90 (0%) 2/90 (2.2%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
GASTROENTERITIS VIRAL 1/90 (1.1%) 0/90 (0%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 1/90 (1.1%) 0/90 (0%)
INFECTED CYST 0/90 (0%) 1/90 (1.1%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
INFLUENZA 0/90 (0%) 0/90 (0%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 1/90 (1.1%) 0/90 (0%)
LOWER RESPIRATORY TRACT INFECTION 1/90 (1.1%) 1/90 (1.1%) 1/45 (2.2%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
PNEUMONIA 0/90 (0%) 2/90 (2.2%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
RESPIRATORY SYNCYTIAL VIRUS BRONCHIOLITIS 0/90 (0%) 0/90 (0%) 0/45 (0%) 0/98 (0%) 1/98 (1%) 0/90 (0%) 0/90 (0%)
RESPIRATORY SYNCYTIAL VIRUS INFECTION 0/90 (0%) 0/90 (0%) 0/45 (0%) 1/98 (1%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
RESPIRATORY TRACT INFECTION VIRAL 0/90 (0%) 1/90 (1.1%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
SALMONELLOSIS 0/90 (0%) 0/90 (0%) 0/45 (0%) 1/98 (1%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
UPPER RESPIRATORY TRACT INFECTION 0/90 (0%) 0/90 (0%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 1/90 (1.1%) 0/90 (0%)
VARICELLA 0/90 (0%) 1/90 (1.1%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
VIRAL INFECTION 4/90 (4.4%) 2/90 (2.2%) 1/45 (2.2%) 1/98 (1%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
VIRAL RASH 0/90 (0%) 1/90 (1.1%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
Injury, poisoning and procedural complications
BURNS FIRST DEGREE 0/90 (0%) 0/90 (0%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 1/90 (1.1%) 0/90 (0%)
BURNS SECOND DEGREE 0/90 (0%) 0/90 (0%) 0/45 (0%) 1/98 (1%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
FEMUR FRACTURE 0/90 (0%) 0/90 (0%) 0/45 (0%) 1/98 (1%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
HEAD INJURY 0/90 (0%) 0/90 (0%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 1/90 (1.1%) 0/90 (0%)
INJURY 1/90 (1.1%) 0/90 (0%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
LIMB CRUSHING INJURY 0/90 (0%) 0/90 (0%) 1/45 (2.2%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
TRAUMATIC FRACTURE 0/90 (0%) 0/90 (0%) 1/45 (2.2%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
Nervous system disorders
CONVULSION 0/90 (0%) 1/90 (1.1%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
FEBRILE CONVULSION 1/90 (1.1%) 1/90 (1.1%) 0/45 (0%) 0/98 (0%) 1/98 (1%) 0/90 (0%) 0/90 (0%)
Renal and urinary disorders
URINARY RETENTION 1/90 (1.1%) 0/90 (0%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
Respiratory, thoracic and mediastinal disorders
ASTHMA 0/90 (0%) 0/90 (0%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 2/90 (2.2%)
BRONCHIAL HYPERREACTIVITY 0/90 (0%) 0/90 (0%) 0/45 (0%) 0/98 (0%) 1/98 (1%) 0/90 (0%) 1/90 (1.1%)
WHEEZING 0/90 (0%) 1/90 (1.1%) 1/45 (2.2%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME 0/90 (0%) 0/90 (0%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 1/90 (1.1%) 0/90 (0%)
PETECHIAE 0/90 (0%) 1/90 (1.1%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
RASH 0/90 (0%) 0/90 (0%) 1/45 (2.2%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
Surgical and medical procedures
ACROCHORDON EXCISION 1/90 (1.1%) 0/90 (0%) 0/45 (0%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
CIRCUMCISION 0/90 (0%) 0/90 (0%) 0/45 (0%) 1/98 (1%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
HYDROCELE OPERATION 0/90 (0%) 0/90 (0%) 0/45 (0%) 1/98 (1%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
INGUINAL HERNIA REPAIR 0/90 (0%) 0/90 (0%) 0/45 (0%) 2/98 (2%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
TENDON SHEATH INCISION 0/90 (0%) 0/90 (0%) 1/45 (2.2%) 0/98 (0%) 0/98 (0%) 0/90 (0%) 0/90 (0%)
Other (Not Including Serious) Adverse Events
UK234+ (MenACWY Ad+ at 2,3,4 m) UK24+ (MenACWY Ad+ at 2,4 m) UKMenC (Menjugate at 2,4m) CA246+ (MenACWY Ad+ at 2,4,6m) CA24+ (MenACWY Ad+ at 2,4m) UK24- (MenACWY Ad- at 2,4m) CA24- (MenACWY Ad- at 2,4m)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 90/90 (100%) 89/90 (98.9%) 45/45 (100%) 97/98 (99%) 97/98 (99%) 90/90 (100%) 89/90 (98.9%)
Eye disorders
CONJUNCTIVITIS 3/90 (3.3%) 9/90 (10%) 3/45 (6.7%) 3/98 (3.1%) 1/98 (1%) 12/90 (13.3%) 1/90 (1.1%)
Gastrointestinal disorders
CONSTIPATION 7/90 (7.8%) 1/90 (1.1%) 2/45 (4.4%) 8/98 (8.2%) 6/98 (6.1%) 1/90 (1.1%) 2/90 (2.2%)
DIARRHOEA 41/90 (45.6%) 40/90 (44.4%) 18/45 (40%) 37/98 (37.8%) 34/98 (34.7%) 36/90 (40%) 25/90 (27.8%)
VOMITING 24/90 (26.7%) 37/90 (41.1%) 13/45 (28.9%) 29/98 (29.6%) 23/98 (23.5%) 28/90 (31.1%) 20/90 (22.2%)
General disorders
CRYING 7/90 (7.8%) 11/90 (12.2%) 8/45 (17.8%) 19/98 (19.4%) 8/98 (8.2%) 14/90 (15.6%) 9/90 (10%)
INJECTION SITE ERYTHEMA 79/90 (87.8%) 79/90 (87.8%) 40/45 (88.9%) 73/98 (74.5%) 78/98 (79.6%) 84/90 (93.3%) 68/90 (75.6%)
INJECTION SITE INDURATION 39/90 (43.3%) 43/90 (47.8%) 25/45 (55.6%) 42/98 (42.9%) 25/98 (25.5%) 59/90 (65.6%) 36/90 (40%)
INJECTION SITE PAIN 42/90 (46.7%) 39/90 (43.3%) 23/45 (51.1%) 50/98 (51%) 41/98 (41.8%) 45/90 (50%) 45/90 (50%)
IRRITABILITY 69/90 (76.7%) 82/90 (91.1%) 39/45 (86.7%) 85/98 (86.7%) 85/98 (86.7%) 77/90 (85.6%) 82/90 (91.1%)
PYREXIA 11/90 (12.2%) 13/90 (14.4%) 3/45 (6.7%) 30/98 (30.6%) 22/98 (22.4%) 19/90 (21.1%) 21/90 (23.3%)
Infections and infestations
BRONCHIOLITIS 8/90 (8.9%) 4/90 (4.4%) 1/45 (2.2%) 3/98 (3.1%) 5/98 (5.1%) 3/90 (3.3%) 0/90 (0%)
CROUP INFECTIOUS 1/90 (1.1%) 0/90 (0%) 0/45 (0%) 3/98 (3.1%) 5/98 (5.1%) 1/90 (1.1%) 2/90 (2.2%)
LOWER RESPIRATORY TRACT INFECTION 9/90 (10%) 8/90 (8.9%) 0/45 (0%) 2/98 (2%) 0/98 (0%) 9/90 (10%) 0/90 (0%)
NASOPHARYNGITIS 0/90 (0%) 1/90 (1.1%) 0/45 (0%) 13/98 (13.3%) 14/98 (14.3%) 0/90 (0%) 14/90 (15.6%)
ORAL CANDIDIASIS 0/90 (0%) 1/90 (1.1%) 0/45 (0%) 2/98 (2%) 5/98 (5.1%) 1/90 (1.1%) 0/90 (0%)
OTITIS MEDIA 6/90 (6.7%) 7/90 (7.8%) 1/45 (2.2%) 9/98 (9.2%) 7/98 (7.1%) 12/90 (13.3%) 4/90 (4.4%)
RHINITIS 30/90 (33.3%) 34/90 (37.8%) 15/45 (33.3%) 2/98 (2%) 0/98 (0%) 39/90 (43.3%) 0/90 (0%)
UPPER RESPIRATORY TRACT INFECTION 7/90 (7.8%) 10/90 (11.1%) 8/45 (17.8%) 21/98 (21.4%) 25/98 (25.5%) 3/90 (3.3%) 20/90 (22.2%)
VIRAL INFECTION 6/90 (6.7%) 7/90 (7.8%) 1/45 (2.2%) 0/98 (0%) 1/98 (1%) 4/90 (4.4%) 0/90 (0%)
Nervous system disorders
SOMNOLENCE 58/90 (64.4%) 57/90 (63.3%) 29/45 (64.4%) 68/98 (69.4%) 70/98 (71.4%) 57/90 (63.3%) 63/90 (70%)
Psychiatric disorders
EATING DISORDER 34/90 (37.8%) 42/90 (46.7%) 17/45 (37.8%) 45/98 (45.9%) 42/98 (42.9%) 37/90 (41.1%) 38/90 (42.2%)
Respiratory, thoracic and mediastinal disorders
COUGH 10/90 (11.1%) 7/90 (7.8%) 9/45 (20%) 3/98 (3.1%) 6/98 (6.1%) 16/90 (17.8%) 2/90 (2.2%)
NASAL CONGESTION 0/90 (0%) 0/90 (0%) 0/45 (0%) 3/98 (3.1%) 6/98 (6.1%) 0/90 (0%) 4/90 (4.4%)
RHINORRHOEA 0/90 (0%) 0/90 (0%) 1/45 (2.2%) 5/98 (5.1%) 2/98 (2%) 0/90 (0%) 3/90 (3.3%)
Skin and subcutaneous tissue disorders
DERMATITIS DIAPER 6/90 (6.7%) 3/90 (3.3%) 1/45 (2.2%) 6/98 (6.1%) 7/98 (7.1%) 2/90 (2.2%) 1/90 (1.1%)
DRY SKIN 4/90 (4.4%) 0/90 (0%) 1/45 (2.2%) 4/98 (4.1%) 1/98 (1%) 5/90 (5.6%) 0/90 (0%)
ECZEMA 8/90 (8.9%) 13/90 (14.4%) 5/45 (11.1%) 15/98 (15.3%) 8/98 (8.2%) 8/90 (8.9%) 7/90 (7.8%)
RASH 3/90 (3.3%) 4/90 (4.4%) 3/45 (6.7%) 5/98 (5.1%) 3/98 (3.1%) 2/90 (2.2%) 8/90 (8.9%)
RASH PAPULAR 0/90 (0%) 0/90 (0%) 0/45 (0%) 5/98 (5.1%) 1/98 (1%) 0/90 (0%) 1/90 (1.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.

Results Point of Contact

Name/Title Posting Director
Organization Novartis Vaccine and Diagnostics S.r.l
Phone
Email RegistryContactVaccineUS@novartis.com
Responsible Party:
Novartis Vaccines
ClinicalTrials.gov Identifier:
NCT00262002
Other Study ID Numbers:
  • V59P5
  • 2004-000195-13
First Posted:
Dec 6, 2005
Last Update Posted:
Jun 18, 2014
Last Verified:
Jun 1, 2014