A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.

Official Title
-----------------
A Phase 3, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

Conditions
-----------------
Meningitis, Meningococcal

Intervention / Treatment
-----------------
* Biological: Meningococcal ACWY Conjugate Vaccine
* Biological: DTaP-IPV-HBV
* Biological: Hib
* Biological: Rotavirus
* Biological: Pneumococcal 7-valent Conjugate Vaccine
* Biological: HAV
* Biological: MMR-V
* Biological: DTaP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy term 2-month-old infants for whom a parent/legal representative has given written informed consent. Exclusion Criteria: Subjects with a previous or suspected disease caused by Neisseria meningitidis, Corynebacterium diphtheriae, Clostridium tetani, Poliovirus, Hepatitis B, Haemophilus influenzae type b (Hib), Pneumococcus or Bordetella pertussis; previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) or prior vaccination with Diptheria, Tetanus, Pertussis (acellular or whole cell), inactivated polio vaccineIPV or oral polio vaccineOPV, H. influenzae type b (Hib) or Pneumococcus; who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W-135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth; Any serious acute, chronic or progressive disease

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 2 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: US1A (MenACWY-CRM + Infant Vaccines)<br>Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months | Biological: Meningococcal ACWY Conjugate Vaccine<br> <br> * Other names: Menveo;Biological: DTaP-IPV-HBV<br> <br> * Other names: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined;Biological: Hib<br> <br> * Other names: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine);Biological: Rotavirus<br> <br> * Other names: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent;Biological: Pneumococcal 7-valent Conjugate Vaccine<br> <br> * Other names: Prevnar®;Biological: HAV<br> <br> * Other names: Havrix® (Hepatitis A Vaccine, Inactivated);Biological: MMR-V<br> <br> * Other names: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine);|
| Experimental: US1B (MenACWY-CRM + Infant Vaccines)<br>Received vaccines: MenACWY: 2, 4, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months | Biological: Meningococcal ACWY Conjugate Vaccine<br> <br> * Other names: Menveo;Biological: DTaP-IPV-HBV<br> <br> * Other names: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined;Biological: Hib<br> <br> * Other names: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine);Biological: Rotavirus<br> <br> * Other names: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent;Biological: Pneumococcal 7-valent Conjugate Vaccine<br> <br> * Other names: Prevnar®;Biological: HAV<br> <br> * Other names: Havrix® (Hepatitis A Vaccine, Inactivated);Biological: MMR-V<br> <br> * Other names: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine);|
| Experimental: US2 (Infant Vaccines Only)<br>Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months | Biological: Meningococcal ACWY Conjugate Vaccine<br> <br> * Other names: Menveo;Biological: DTaP-IPV-HBV<br> <br> * Other names: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined;Biological: Hib<br> <br> * Other names: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine);Biological: Rotavirus<br> <br> * Other names: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent;Biological: Pneumococcal 7-valent Conjugate Vaccine<br> <br> * Other names: Prevnar®;Biological: HAV<br> <br> * Other names: Havrix® (Hepatitis A Vaccine, Inactivated);Biological: MMR-V<br> <br> * Other names: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine);|
| Experimental: US3 (MenACWY-CRM + Infant Vaccines)<br>Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months | Biological: Meningococcal ACWY Conjugate Vaccine<br> <br> * Other names: Menveo;Biological: DTaP-IPV-HBV<br> <br> * Other names: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined;Biological: Hib<br> <br> * Other names: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine);Biological: Rotavirus<br> <br> * Other names: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent;Biological: Pneumococcal 7-valent Conjugate Vaccine<br> <br> * Other names: Prevnar®;Biological: HAV<br> <br> * Other names: Havrix® (Hepatitis A Vaccine, Inactivated);Biological: MMR-V<br> <br> * Other names: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine);|
| Experimental: US4A (Infant Vaccines Only)<br>Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months | Biological: Meningococcal ACWY Conjugate Vaccine<br> <br> * Other names: Menveo;Biological: DTaP-IPV-HBV<br> <br> * Other names: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined;Biological: Hib<br> <br> * Other names: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine);Biological: Rotavirus<br> <br> * Other names: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent;Biological: HAV<br> <br> * Other names: Havrix® (Hepatitis A Vaccine, Inactivated);Biological: MMR-V<br> <br> * Other names: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine);|
| Experimental: US4B (Infant Vaccines Only)<br>Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months | Biological: Meningococcal ACWY Conjugate Vaccine<br> <br> * Other names: Menveo;Biological: DTaP-IPV-HBV<br> <br> * Other names: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined;Biological: Hib<br> <br> * Other names: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine);Biological: Rotavirus<br> <br> * Other names: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent;Biological: Pneumococcal 7-valent Conjugate Vaccine<br> <br> * Other names: Prevnar®;Biological: HAV<br> <br> * Other names: Havrix® (Hepatitis A Vaccine, Inactivated);Biological: MMR-V<br> <br> * Other names: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine);|
| Experimental: US4C (Infant Vaccines Only)<br>Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months | Biological: Meningococcal ACWY Conjugate Vaccine<br> <br> * Other names: Menveo;Biological: DTaP-IPV-HBV<br> <br> * Other names: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined;Biological: Hib<br> <br> * Other names: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine);Biological: Rotavirus<br> <br> * Other names: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent;Biological: Pneumococcal 7-valent Conjugate Vaccine<br> <br> * Other names: Prevnar®;Biological: HAV<br> <br> * Other names: Havrix® (Hepatitis A Vaccine, Inactivated);Biological: MMR-V<br> <br> * Other names: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine);|
| Experimental: LA1A (MenACWY-CRM + Infant Vaccines)<br>Received vaccines: MenACWY: 2, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months | Biological: Meningococcal ACWY Conjugate Vaccine<br> <br> * Other names: Menveo;Biological: DTaP-IPV-HBV<br> <br> * Other names: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined;Biological: Hib<br> <br> * Other names: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine);Biological: Rotavirus<br> <br> * Other names: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent;Biological: Pneumococcal 7-valent Conjugate Vaccine<br> <br> * Other names: Prevnar®;Biological: HAV<br> <br> * Other names: Havrix® (Hepatitis A Vaccine, Inactivated);Biological: MMR-V<br> <br> * Other names: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine);|
| Experimental: LA1B (MenACWY-CRM + Infant Vaccines)<br>Received vaccines: MenACWY: 2, 6, and 13 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months | Biological: Meningococcal ACWY Conjugate Vaccine<br> <br> * Other names: Menveo;Biological: DTaP-IPV-HBV<br> <br> * Other names: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined;Biological: Hib<br> <br> * Other names: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine);Biological: Rotavirus<br> <br> * Other names: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent;Biological: Pneumococcal 7-valent Conjugate Vaccine<br> <br> * Other names: Prevnar®;Biological: HAV<br> <br> * Other names: Havrix® (Hepatitis A Vaccine, Inactivated);Biological: MMR-V<br> <br> * Other names: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine);|
| Experimental: LA2 (Infant Vaccines Only)<br>Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months | Biological: Meningococcal ACWY Conjugate Vaccine<br> <br> * Other names: Menveo;Biological: DTaP-IPV-HBV<br> <br> * Other names: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined;Biological: Hib<br> <br> * Other names: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine);Biological: Rotavirus<br> <br> * Other names: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent;Biological: Pneumococcal 7-valent Conjugate Vaccine<br> <br> * Other names: Prevnar®;Biological: HAV<br> <br> * Other names: Havrix® (Hepatitis A Vaccine, Inactivated);Biological: MMR-V<br> <br> * Other names: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine);|
| Experimental: LA3A (MenACWY-CRM + Infant Vaccines)<br>Received vaccines: MenACWY: 2, 4, 6, and 16 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months | Biological: Meningococcal ACWY Conjugate Vaccine<br> <br> * Other names: Menveo;Biological: DTaP-IPV-HBV<br> <br> * Other names: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined;Biological: Hib<br> <br> * Other names: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine);Biological: Rotavirus<br> <br> * Other names: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent;Biological: Pneumococcal 7-valent Conjugate Vaccine<br> <br> * Other names: Prevnar®;Biological: HAV<br> <br> * Other names: Havrix® (Hepatitis A Vaccine, Inactivated);Biological: MMR-V<br> <br> * Other names: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine);Biological: DTaP<br> <br> * Other names: Infanrix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed);|
| Experimental: LA3B (MenACWY-CRM + Infant Vaccines)<br>Received vaccines: MenACWY: 2, 4, 6, and 17 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 16 months Pneumococcal, HAV, and MMR-V: 12 months | Biological: Meningococcal ACWY Conjugate Vaccine<br> <br> * Other names: Menveo;Biological: DTaP-IPV-HBV<br> <br> * Other names: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined;Biological: Hib<br> <br> * Other names: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine);Biological: Rotavirus<br> <br> * Other names: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent;Biological: Pneumococcal 7-valent Conjugate Vaccine<br> <br> * Other names: Prevnar®;Biological: HAV<br> <br> * Other names: Havrix® (Hepatitis A Vaccine, Inactivated);Biological: MMR-V<br> <br> * Other names: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine);Biological: DTaP<br> <br> * Other names: Infanrix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed);|
| Experimental: LA4 (Infant Vaccines Only)<br>Received vaccines: MenACWY: 12 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months DTaP, Hib: 15 months Pneumococcal, HAV, and MMR-V: 12 months | Biological: Meningococcal ACWY Conjugate Vaccine<br> <br> * Other names: Menveo;Biological: DTaP-IPV-HBV<br> <br> * Other names: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined;Biological: Hib<br> <br> * Other names: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine);Biological: Rotavirus<br> <br> * Other names: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent;Biological: Pneumococcal 7-valent Conjugate Vaccine<br> <br> * Other names: Prevnar®;Biological: HAV<br> <br> * Other names: Havrix® (Hepatitis A Vaccine, Inactivated);Biological: MMR-V<br> <br> * Other names: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine);Biological: DTaP<br> <br> * Other names: Infanrix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed);|
| Experimental: LA5 (MenACWY-CRM + Infant Vaccines)<br>Received vaccines: MenACWY: 2, 4, 6, and 12 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months | Biological: Meningococcal ACWY Conjugate Vaccine<br> <br> * Other names: Menveo;Biological: DTaP-IPV-HBV<br> <br> * Other names: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined;Biological: Hib<br> <br> * Other names: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine);Biological: Rotavirus<br> <br> * Other names: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent;Biological: Pneumococcal 7-valent Conjugate Vaccine<br> <br> * Other names: Prevnar®;Biological: HAV<br> <br> * Other names: Havrix® (Hepatitis A Vaccine, Inactivated);Biological: MMR-V<br> <br> * Other names: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine);|
| Experimental: LA6A (Infant Vaccines Only)<br>Received vaccines: MenACWY: 12, and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months | Biological: Meningococcal ACWY Conjugate Vaccine<br> <br> * Other names: Menveo;Biological: DTaP-IPV-HBV<br> <br> * Other names: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined;Biological: Hib<br> <br> * Other names: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine);Biological: Rotavirus<br> <br> * Other names: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent;Biological: Pneumococcal 7-valent Conjugate Vaccine<br> <br> * Other names: Prevnar®;Biological: HAV<br> <br> * Other names: Havrix® (Hepatitis A Vaccine, Inactivated);Biological: MMR-V<br> <br> * Other names: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine);|
| Experimental: LA6B (Infant Vaccines Only)<br>Received vaccines: MenACWY: 13 and 15 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months | Biological: Meningococcal ACWY Conjugate Vaccine<br> <br> * Other names: Menveo;Biological: DTaP-IPV-HBV<br> <br> * Other names: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined;Biological: Hib<br> <br> * Other names: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine);Biological: Rotavirus<br> <br> * Other names: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent;Biological: Pneumococcal 7-valent Conjugate Vaccine<br> <br> * Other names: Prevnar®;Biological: HAV<br> <br> * Other names: Havrix® (Hepatitis A Vaccine, Inactivated);Biological: MMR-V<br> <br> * Other names: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine);|
| Experimental: LA6C (Infant Vaccines Only)<br>Received vaccines: MenACWY: 18 months DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines: 2, 4, and 6 months Pneumococcal, HAV, and MMR-V: 12 months | Biological: Meningococcal ACWY Conjugate Vaccine<br> <br> * Other names: Menveo;Biological: DTaP-IPV-HBV<br> <br> * Other names: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined;Biological: Hib<br> <br> * Other names: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine);Biological: Rotavirus<br> <br> * Other names: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent;Biological: Pneumococcal 7-valent Conjugate Vaccine<br> <br> * Other names: Prevnar®;Biological: HAV<br> <br> * Other names: Havrix® (Hepatitis A Vaccine, Inactivated);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With hSBA Titer >=1:8 - US Subjects | Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age | 13 months of age (one month post-toddler vaccination) | 
| Geometric Mean hSBA Titers - US Subjects | Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age. | 13 months of age (one month post-toddler vaccination) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series | Solicited local and systemic reactions post first vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines. | 7 days after vaccination | 
| Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series | Solicited local and systemic reactions post second vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines. | 7 days after vaccination | 
| Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series | Solicited local and systemic reactions post third vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines. | 7 days after vaccination | 
| Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age | Solicited local and systemic reactions after receiving MenACWY-CRM vaccination at 12 months of age were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines. | 7 days after vaccination | 
| Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series | Solicited local and systemic reactions post first vaccination of toddler series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines. | 7 days post vaccination | 
| Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series | Solicited local and systemic reactions post second vaccination of toddler series at 15 months of age. | 7 days post vaccination | 
| Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series | Solicited local and systemic reactions reported post first vaccination was compared in subjects receiving MenACWY versus Hib Vaccines. | 7 days post-vaccination | 
| Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series | Solicited local and systemic reactions reported post second vaccination was compared in subjects receiving MenACWY versus Hib Vaccines. | 7 days post-vaccination | 
| Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series | Solicited local and systemic reactions reported post third vaccination was compared in subjects receiving MenACWY versus Hib Vaccines. | 7 days post-vaccination | 
| Geometric Mean hSBA Titers Post-infant Series - US Subjects | Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after three doses at 2, 4, and 6 months of age. | 7 months of age (one month post-infant series) | 
| Geometric Mean hSBA Titers Post-infant Series - LA Subjects | Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 (LA3) months of age. | 7 months of age (one month post-infant series) | 
| Percentage of Subjects With hSBA Titer >=1:8 - US Subjects | Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age. | 7 months of age (one month post-infant series) | 
| Percentage of Subjects With hSBA Titer >=1:4 - US Subjects | Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age. | 7 months of age (one month post-infant series) | 
| Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects | Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) . | 7 months of age (one month post-infant series) | 
| Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects | Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) . | 7 months of age (one month post-infant series) | 
| Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects | Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens. | 7 months of age (one month post-infant series) | 
| Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects | Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens. | 7 months of age (one month post-infant series) | 
| Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects | Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens. | 7 months of age (one month post-infant series) | 
| Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects | Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens. | 7 months of age (one month post-infant series) | 
| Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject | Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y. | 12 Months of Age (one month pre-toddler vaccination) | 
| Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject | Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y. | 12 Months of Age (one month pre-toddler vaccination) | 
| Persistence Antibodies Geometric Mean Titers - US Subject | Geometric Mean hSBA Titers directed against N. meningitides serogroups A, C, W and Y was measured at 12 Months of Age. | 12 Months of Age (one month pre-toddler vaccination) | 
| Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject | Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y. | 12 or 16 Months of Age (one month pre-toddler vaccination) | 
| Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject | Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y. | 12 or 16 Months of Age (one month pre-toddler vaccination) | 
| Persistence Antibodies Geometric Mean Titers - LA Subjects | Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured at 12 or 16 Months of Age. | 12 or 16 Months of Age (one month pre-toddler vaccination) | 
| Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4 , directed against N.meningitidis serogroups A, C, W and Y. | 13 months of age (one month post-toddler vaccination) | 
| Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8 , directed against N.meningitidis serogroups A, C, W and Y. | 13 months of age (one month post-toddler vaccination) | 
| Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16 , directed against N.meningitidis serogroups A, C, W and Y. | 13 months of age (one month post-toddler vaccination) | 
| Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects | Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age. | 13 months of age (one month post-toddler vaccination) | 
| Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N. meningitidis serogroups A, C, W and Y. | 13 or 17 Months of Age (one month post-toddler vaccination) | 
| Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N. meningitidis serogroups A, C, W and Y. | 13 or 17 Months of Age (one month post-toddler vaccination) | 
| Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16, directed against N. meningitidis serogroups A, C, W and Y. | 13 or 17 Months of Age (one month post-toddler vaccination) | 
| Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects | Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y. | 13 or 17 Months of Age (one month post-toddler vaccination) | 
| Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects | Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F. | 13 months of age (one month post-toddler vaccination) | 
| Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects | Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F. | 13 months of age (one month post-toddler vaccination) | 
| Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects | Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F. | 13 months of age (one month post-toddler vaccination) | 
| Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects | Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F | 13 months of age (one month post-toddler vaccination) | 
| Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects | Immunogenicity as measured by antibody GMCs/GMTs, directed against DTaP and Hib Antigens | 17 months of age (one month post-toddler vaccination) | 
| Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects | Immunogenicity as measured by Percentage of Subjects with predefined seroprotective antibody titers against DTaP and Hib Antigens | 17 months of age (one month post-toddler vaccination) | 
| Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects | Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y. | 12 or 15 months of age (one month post 1st or 2nd toddler vaccination) | 
| Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects | Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y. | 12 or 15 months of age (one month post 1st or 2nd toddler vaccination) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaccine, Meningococcal, meningitis, infants, Meningococcal meningitis, Meningococcal disease