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Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

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ClinicalTrials.gov Identifier: NCT00806195
Recruitment Status : Completed
First Posted : December 10, 2008
Results First Posted : July 9, 2013
Last Update Posted : July 9, 2013
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Meningitis
Meningococcal Infection
Interventions Biological: MenACWY-CRM197
Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
Biological: Hib (Haemophilus influenza b) Vaccine
Biological: IPV (Inactivated Polio Vaccine) Vaccine
Biological: Pneumococcal conjugate Vaccine
Biological: MMR (Measles, Mumps, and Rubella) Vaccine
Biological: Varicella Vaccine
Biological: Hepatitis A Virus
Enrollment 7744
Recruitment Details  
Pre-assignment Details All subjects enrolled were included in the trial.
Arm/Group Title MenACWY-CRM197 + Routine Vaccines (Non-detailed) Routine Vaccines (Non-detailed) MenACWY-CRM197 + Routine Vaccines (Detailed) Routine Vaccines (Detailed)
Hide Arm/Group Description

Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

Non-Detailed - subjects who only provided Serious Adverse Events (SAEs) and medically attended Adverse (AE).

Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

Non-Detailed - subjects who only provided SAEs and medically attended AEs.

Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.

Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

Detailed - subjects who provided Reactogenicity, all AEs for 7 days, SAEs and medically attended AEs.

Period Title: Overall Study
Started 4363 1483 1409 489
Completed 3849 1321 1139 383
Not Completed 514 162 270 106
Reason Not Completed
Death             6             0             1             0
Adverse Event             25             5             11             2
Withdrawal by Subject             119             31             76             35
Lost to Follow-up             217             66             90             34
Inappropriate Enrollment             0             1             0             0
Administrative Reason             113             35             66             26
Protocol Violation             34             24             26             9
Arm/Group Title MenACWY-CRM197 + Routine Vaccines (Non-Detailed) Routine Vaccines (Non-Detailed) MenACWY-CRM197 + Routine Vaccines (Detailed) Routine Vaccines (Detailed) Total
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Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

Non-Detailed - subjects who only provided SAEs and medically attended AEs.

Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

Non-Detailed - subjects who only provided SAEs and medically attended AEs.

Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.

Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.

Total of all reporting groups
Overall Number of Baseline Participants 4363 1483 1409 489 7744
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 4363 participants 1483 participants 1409 participants 489 participants 7744 participants
64.9  (7.4) 64.7  (7.1) 65.5  (6.5) 65.2  (6.3) 65.0  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4363 participants 1483 participants 1409 participants 489 participants 7744 participants
Female
2135
  48.9%
703
  47.4%
716
  50.8%
232
  47.4%
3786
  48.9%
Male
2228
  51.1%
780
  52.6%
693
  49.2%
257
  52.6%
3958
  51.1%
1.Primary Outcome
Title Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination
Hide Description

To compare the percentages of subjects who reported at least one severe systemic reaction after any vaccination of MenACWY-CRM197 (detailed) plus routine vaccines (detailed) group to that observed in the routine vaccines alone (detailed) group administered at 2, 4, 6, and 12 months of age.

Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.

Time Frame 15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on As Treated Safety Population - Subjects who received at least one study dose and provided postbaseline safety data, and that subjects would be included in the group for the vaccination actually received (i.e., analyzed as treated).
Arm/Group Title MenACWY-CRM197 + Routine Vaccines (Detailed) Routine Vaccines (Detailed)
Hide Arm/Group Description:

Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.

Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.

Overall Number of Participants Analyzed 1349 461
Measure Type: Number
Unit of Measure: Percentages of subjects
16 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MenACWY-CRM197 + Routine Vaccines (Detailed), Routine Vaccines (Detailed)
Comments MenACWY-CRM 197 administered concomitantly with routine vaccines was considered noninferior to routine vaccines alone with respect to severe systemic reactions if the upper limit of the 2-sided 95% CI of the difference (MenACWY-CRM197 vaccine plus routine vaccines group minus routine vaccines only group) in the proportion of subjects experiencing at least one severe systemic reaction during the first 7 days (days 1-7) after any vaccination was <6%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The null hypothesis associated with the safety objective was that the upper limit of the two-sided 95% CI for this difference in the proportion of subjects experiencing at least one severe systemic reaction during the first 7 days after any vaccination (PMenACWY+Routine Vaccines–PRoutine Vaccines) was ≥ 6%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.0
Confidence Interval (2-Sided) 95%
-0.8 to 6.4
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentages of Subjects With At Least One Serious Adverse Event During the Entire Study Period
Hide Description To compare the percentages of subjects presenting at least one serious adverse event (SAE) through 6 months post-final dose in subjects who received MenACWY-CRM197 vaccine concomitantly with routine vaccinations to the percentages of subjects who received routine vaccinations alone.
Time Frame Day 1 (2 months of age) to 18 months of age
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on as treated safety population.
Arm/Group Title MenACWY-CRM197 + Routine Vaccines (All) Routine Vaccines (All)
Hide Arm/Group Description:

Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs.

Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs.

Overall Number of Participants Analyzed 5760 1968
Measure Type: Number
Unit of Measure: Percentages of subjects
6 6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MenACWY-CRM197 + Routine Vaccines (All), Routine Vaccines (All)
Comments MenACWY-CRM 197 administered concomitantly with routine vaccines was considered non inferior to routine vaccines alone with respect to serious adverse events if the upper limit of the 2-sided 95% CI of the difference (MenACWY vaccine plus routine vaccines group minus routine vaccines only group) of the proportion of subjects experiencing at least one serious adverse event was <5%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The null hypothesis associated with the SAE safety objective was that the upper limit of the two-sided 95% confidence interval for the difference between the MenACWY and routine vaccine groups in the proportion of subjects experiencing at least one SAE (PMenACWY + Routine Vaccines – PRoutine Vaccines) was ≥5%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.9 to 1.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection MenACWY-CRM197 + Routine Vaccines (All), Routine Vaccines (All)
Comments MenACWY-CRM 197 administered concomitantly with routine vaccines was considered non inferior to routine vaccines alone with respect to serious adverse events if the upper limit of the 2-sided 95% CI of the difference (MenACWY vaccine plus routine vaccines group minus routine vaccines only group) of the proportion of subjects experiencing at least one serious adverse event was <5%.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The null hypothesis associated with the SAE safety objective was that the upper limit of the two-sided 95% confidence interval for the difference between the MenACWY and routine vaccine groups in the proportion of subjects experiencing at least one SAE (PMenACWY + Routine Vaccines – PRoutine Vaccines) was <5%.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Miettinen and Nurminen
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-0.8 to 1.3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination
Hide Description To compare the percentage of subjects who reported local and systemic solicited adverse events from day 1 to day 7 after each vaccination with MenACWY-CRM197 given concomitantly with routine vaccinations to the routine vaccinations alone group.
Time Frame 15 minutes to Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on as treated safety population.
Arm/Group Title MenACWY-CRM 197 + Routine Vaccines (Detailed) Routine Vaccines (Detailed)
Hide Arm/Group Description:

Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

Detailed - subjects who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.

Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

Detailed - subjects who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.

Overall Number of Participants Analyzed 1313 451
Measure Type: Number
Unit of Measure: percentages of subjects
Any Local (2 month vaccination) (N=1313, 451) 53 56
Injection Site Tenderness (N=1301, 446) 46 49
Injection Site Erythema (N=1297, 445) 17 21
Injection Site Induration (N=1297, 446) 8 16
Any Local (4 month vaccination) (N=1262, 420) 46 54
Injection Site Tenderness (N=1255, 418) 37 42
Injection Site Erythema (N=1257, 417) 19 29
Injection Site Induration (N=1257, 417) 9 17
Any Local (6 month vaccination) (N=1120, 374) 41 50
Injection Site Tenderness (N=1106, 372) 30 37
Injection Site Erythema (N=1104, 370) 22 29
Injection Site Induration (N=1107, 370) 9 19
Any Local (12 month vaccination) (N=1102, 355) 47 57
Injection Site Tenderness (N=1098, 353) 39 50
Injection Site Erythema (N=1095, 349) 21 30
Injection Site Induration (N=1095, 351) 10 23
Any Systemic (2 month vaccination) (N=1313, 451) 77 73
Rash (N=1296, 446) 3 3
Change in Eating Habits (N=1289, 446) 23 24
Sleepiness (N=1297, 447) 52 52
Persistent crying (N=1299,46) 42 40
Irritability (N=1300, 446) 59 59
Vomiting (N=1298, 446) 10 9
Diarrhea (N=1299, 446) 16 11
Fever ( ≥ 38°C) (N=1297, 446) 3 2
Analges.Antipyr.Meds (N=1302, 448) 66 60
Any Systemic (4 month vaccination) (N=1262, 420) 65 63
Rash (N=1253, 416) 3 4
Change in Eating Habits (N=1245, 414) 18 17
Sleepiness (N=1253, 416) 38 37
Persistent Crying (N=1254, 417) 31 28
Irritability (N=1254, 416) 50 48
Vomiting (N=1254, 416) 8 6
Diarrhea (N=1255, 416) 11 8
Fever ( ≥ 38°C) (N=1251, 416) 4 6
Analges.Antipyr.Meds (N=1254, 416) 58 55
Any Systemic (6 month vaccination) (N=1120, 374) 58 54
Rash (N=1101, 367) 3 3
Change in Eating Habits (N=1094, 367) 17 14
Sleepiness (N=1104, 367) 31 29
Persistent Crying (N=1103, 368) 26 20
Irritability (N=1104, 369) 46 41
Vomiting (N=1106, 369) 6 4
Diarrhea (N=1102, 369) 8 6
Fever ( ≥ 38°C) (N=1108, 368) 7 6
Analges.Antipyr.Meds (N=1103, 370) 53 49
Any Systemic (12 month vaccination) (N=1102, 355) 63 62
Rash (N=1093, 353) 4 5
Change in Eating Habits (N=1089, 348) 18 16
Sleepiness (N=1096, 353) 30 29
Persistent Crying (N=1094, 353) 28 24
Irritability (N=1094, 354) 50 49
Vomiting (N=1094, 353) 5 4
Diarrhea (N=1094, 353) 12 9
Fever ( ≥ 38°C) (N=1092, 353) 9 8
Analges.Antipyr.Meds (N=1095, 354) 49 50
4.Secondary Outcome
Title Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination
Hide Description Safety data with medically attended events were collected throughout the study in the non-detailed safety groups and from Day 8 onwards for the detailed safety groups.
Time Frame Day 1 (2 months of age) to 18 months of age
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was done on as treated safety population.
Arm/Group Title MenACWY-CRM197 + Routine Vaccines (All) Routine Vaccines (All)
Hide Arm/Group Description:

Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

All (Detailed and Non-Detailed subjects): Detailed - infants who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - infants who only provided SAEs and medically attended AEs.

Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

All (Detailed and Non-Detailed subjects): Detailed - infants who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - infants who only provided SAEs and medically attended AEs.

Overall Number of Participants Analyzed 5760 1968
Measure Type: Number
Unit of Measure: Subjects
Any AE 4848 1659
Any SAE-Total 354 114
Possibly or Probably Related AEs 520 2
AEs Leading to Premature Withdrawals 44 8
Deaths 7 1
Time Frame Throughout study period.
Adverse Event Reporting Description Post-injection solicited Adverse Events (AEs) were collected from Days 1-7 after each vaccination in detailed group. Medically attended AEs and Serious AEs were collected throughout the study period. Subjects who terminated early were followed for 6 months post final dose for safety.
 
Arm/Group Title MenACWY-CRM197 + Routine Vaccines (All) Routine Vaccines (All)
Hide Arm/Group Description

Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs.

Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs.

All-Cause Mortality
MenACWY-CRM197 + Routine Vaccines (All) Routine Vaccines (All)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MenACWY-CRM197 + Routine Vaccines (All) Routine Vaccines (All)
Affected / at Risk (%) Affected / at Risk (%)
Total   354/5760 (6.15%)   114/1968 (5.79%) 
Blood and lymphatic system disorders     
Anaemia * 1  2/5760 (0.03%)  0/1968 (0.00%) 
Idiopathic Thrombocytopenic Purpura * 1  0/5760 (0.00%)  1/1968 (0.05%) 
Iron Deficiency Anaemia * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Leukocytosis * 1  2/5760 (0.03%)  0/1968 (0.00%) 
Mesenteric Lymphadenopathy * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Thrombocytopenia * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Lymphadenitis * 1  4/5760 (0.07%)  0/1968 (0.00%) 
Lymphadenopathy * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Cardiac disorders     
Cardiac Arrest * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Cyanosis * 1  2/5760 (0.03%)  0/1968 (0.00%) 
Supraventricular Tachycardia * 1  1/5760 (0.02%)  1/1968 (0.05%) 
Ventricular Tachycardia * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Congenital, familial and genetic disorders     
Anomalous Pulmonary Venous Connection * 2  0/5760 (0.00%)  1/1968 (0.05%) 
Congenital Absence Of Bile Ducts * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Congenital Aplastic Anaemia * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Craniosynostosis * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Cryptorchism * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Hamartoma * 3  1/5760 (0.02%)  0/1968 (0.00%) 
Mitochondrial Enzyme Deficiency * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Osteognesis Imperfecta * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Patent Ductus Arteriosus * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Phimosis * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Pyloric Stenosis * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Vitello-Intestinal Duct Remnant * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Eye disorders     
Retinal Haemorrhage * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Gastrointestinal disorders     
Abdominal Pain * 1  2/5760 (0.03%)  0/1968 (0.00%) 
Constipation * 1  0/5760 (0.00%)  1/1968 (0.05%) 
Diarrhoea  1  5/5760 (0.09%)  3/1968 (0.15%) 
Enteritis * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Enterocolitis * 1  3/5760 (0.05%)  1/1968 (0.05%) 
Gastritis * 1  2/5760 (0.03%)  0/1968 (0.00%) 
Gastrooesophageal Reflux Disease * 1  3/5760 (0.05%)  0/1968 (0.00%) 
Ileus * 1  1/5760 (0.02%)  1/1968 (0.05%) 
Inguinal Hernia * 1  2/5760 (0.03%)  0/1968 (0.00%) 
Inguinal Hernia, Obstructive * 1  0/5760 (0.00%)  1/1968 (0.05%) 
Intussusception * 1  4/5760 (0.07%)  3/1968 (0.15%) 
Stomatitis * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Vomiting * 1  3/5760 (0.05%)  0/1968 (0.00%) 
General disorders     
Brain Death * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Hernia * 1  0/5760 (0.00%)  1/1968 (0.05%) 
Pyrexia * 1  7/5760 (0.12%)  3/1968 (0.15%) 
Hepatobiliary disorders     
Jaundice * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Infections and infestations     
Acute Tonsilitis * 1  1/5760 (0.02%)  1/1968 (0.05%) 
Adenovirus Infection * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Arthritis Bacterial * 1  0/5760 (0.00%)  1/1968 (0.05%) 
Ascariasis * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Bacteraemia * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Bacterial Diarrhoea * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Bacterial Tracheitis * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Bronchiolitis * 1  64/5760 (1.11%)  15/1968 (0.76%) 
Bronchitis * 1  1/5760 (0.02%)  3/1968 (0.15%) 
Bronchopneumonia * 1  19/5760 (0.33%)  5/1968 (0.25%) 
Cellulitis * 1  5/5760 (0.09%)  4/1968 (0.20%) 
Cellulitis Staphylococcal * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Cellulitis Streptococcal * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Chest Wall Abscess * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Croup Infectious * 1  10/5760 (0.17%)  5/1968 (0.25%) 
Diarrhoea Infectious * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Dysentery * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Enterovirus Infection * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Escherichia Urinary Tract Infection * 1  1/5760 (0.02%)  2/1968 (0.10%) 
Exanthema Subitam * 1  0/5760 (0.00%)  3/1968 (0.15%) 
Furuncle * 1  0/5760 (0.00%)  1/1968 (0.05%) 
Gastroenteritis * 1  20/5760 (0.35%)  7/1968 (0.36%) 
Gastroenteritis Rotavirus * 1  2/5760 (0.03%)  0/1968 (0.00%) 
Gastroenteritis Salmonella * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Gastroenteritis Viral * 1  7/5760 (0.12%)  3/1968 (0.15%) 
Genital Abscess * 1  2/5760 (0.03%)  0/1968 (0.00%) 
Groin Abscess * 1  2/5760 (0.03%)  0/1968 (0.00%) 
Haemophilus Bacteraemia * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Hand-Foot-And-Mouth Disease * 1  10/5760 (0.17%)  0/1968 (0.00%) 
Herpangina * 1  4/5760 (0.07%)  2/1968 (0.10%) 
Incision Site Cellulitis * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Infected Cyst * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Influenza * 1  4/5760 (0.07%)  0/1968 (0.00%) 
Klebsiella Bacteraemia * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Lobar Pneumonia * 1  1/5760 (0.02%)  1/1968 (0.05%) 
Lower Respiratory Tract Infection * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Lymph Node Abscess * 1  0/5760 (0.00%)  1/1968 (0.05%) 
Meningitis * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Meningitis Enteroviral * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Metapneumovirus Infection * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Otitis Media * 1  2/5760 (0.03%)  3/1968 (0.15%) 
Otitis Media Acute * 1  1/5760 (0.02%)  3/1968 (0.15%) 
Periorbital Cellulitis * 1  3/5760 (0.05%)  0/1968 (0.00%) 
Peritonsillar Abscess * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Pharyngitis * 1  2/5760 (0.03%)  0/1968 (0.00%) 
Pneumonia * 1  31/5760 (0.54%)  10/1968 (0.51%) 
Pharyngotonsillitis * 1  0/5760 (0.00%)  1/1968 (0.05%) 
Pneumococcal bacteraemia * 1  0/5760 (0.00%)  1/1968 (0.05%) 
Pneumonia Adenoviral * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Pneumonia Bacterial * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Pneumonia Influenzal * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Pneumonia Primary Atypical * 1  0/5760 (0.00%)  1/1968 (0.05%) 
Pneumonia Respiratory Syncytial Viral * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Pneumonia Viral * 1  3/5760 (0.05%)  1/1968 (0.05%) 
Pyelonephritis * 1  1/5760 (0.02%)  2/1968 (0.10%) 
Pyelonephritis Acute * 1  4/5760 (0.07%)  0/1968 (0.00%) 
Respiratory Syncytial Virus Bronchiolitis * 1  20/5760 (0.35%)  7/1968 (0.36%) 
Respiratory Synctial Virus Infection * 1  4/5760 (0.07%)  2/1968 (0.10%) 
Rotavirus Infection * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Sepsis * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Septic Shock * 1  3/5760 (0.05%)  0/1968 (0.00%) 
Sinusitis * 1  0/5760 (0.00%)  1/1968 (0.05%) 
Staphylococcal Abscess * 1  1/5760 (0.02%)  2/1968 (0.10%) 
Tonsilitis * 1  0/5760 (0.00%)  1/1968 (0.05%) 
Upper Respiratory Tract Infection * 1  4/5760 (0.07%)  1/1968 (0.05%) 
Urachal Abscess * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Urinary Tract Infection * 1  28/5760 (0.49%)  10/1968 (0.51%) 
Urinary Tract Infection Enterococcal * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Urosepsis * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Varicella * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Viral Diarrhoea * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Viral Infection * 1  4/5760 (0.07%)  0/1968 (0.00%) 
Wound Infection * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Meningitis Viral * 1  2/5760 (0.03%)  0/1968 (0.00%) 
Staphylococcal Infection * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Injury, poisoning and procedural complications     
Accidental Poisoning * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Contusion * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Craniocerebral Injury * 1  5/5760 (0.09%)  2/1968 (0.10%) 
Electrical Burn * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Fall * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Foreign Body * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Head Injury * 1  1/5760 (0.02%)  2/1968 (0.10%) 
Humerus Fracture * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Injury * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Post Procedural Complication * 1  0/5760 (0.00%)  1/1968 (0.05%) 
Skull Fracture * 1  1/5760 (0.02%)  1/1968 (0.05%) 
Subdural Haemorrhage * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Thermal Burn * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Tibia Fracture * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Upper Limb Fracture * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Subdural Hematoma * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Investigations     
Electrocardiogram Qt Prolonged * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Metabolism and nutrition disorders     
Dehydration * 1  18/5760 (0.31%)  9/1968 (0.46%) 
Failure To Thrive * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Feeding Disorder * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Hypoglycaemia * 1  2/5760 (0.03%)  0/1968 (0.00%) 
Metabolic Acidosis * 1  2/5760 (0.03%)  0/1968 (0.00%) 
Nervous system disorders     
Acute Disseminated Encephalomyelitis * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Convulsion * 1  5/5760 (0.09%)  3/1968 (0.15%) 
Encephalitis * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Epilepsy * 1  2/5760 (0.03%)  0/1968 (0.00%) 
Febrile Convulsion * 1  9/5760 (0.16%)  6/1968 (0.30%) 
Hydrocephalus * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Myoclonic Epilepsy * 1  0/5760 (0.00%)  1/1968 (0.05%) 
Presyncope * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Syncope * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Tremor * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Psychiatric disorders     
Breath Holding * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Drug Abuse * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Mental Status Changes * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Renal and urinary disorders     
Renal Failure Acute * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Renal Mass * 1  0/5760 (0.00%)  2/1968 (0.10%) 
Vesicoureteric Reflux * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Reproductive system and breast disorders     
Balanitis * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Scrotal mass * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Adenoidal Hypertrophy * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Apnoea * 1  0/5760 (0.00%)  1/1968 (0.05%) 
Asthma * 1  6/5760 (0.10%)  2/1968 (0.10%) 
Atelectasis * 1  2/5760 (0.03%)  0/1968 (0.00%) 
Bronchial Hyperreactivity * 1  6/5760 (0.10%)  6/1968 (0.30%) 
Bronchomalacia * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Bronchospasm * 1  2/5760 (0.03%)  1/1968 (0.05%) 
Cough * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Epistaxis * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Hypoxia * 1  3/5760 (0.05%)  0/1968 (0.00%) 
Pneumonia Aspiration * 1  0/5760 (0.00%)  1/1968 (0.05%) 
Pneumonitis * 1  0/5760 (0.00%)  1/1968 (0.05%) 
Pulmonary Oedema * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Respiratory Distress * 1  12/5760 (0.21%)  3/1968 (0.15%) 
Respiratory Failure * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Status Asthmaticus * 1  1/5760 (0.02%)  3/1968 (0.15%) 
Wheezing * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermal Cyst * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Dermatitis Atopic * 1  0/5760 (0.00%)  1/1968 (0.05%) 
Erythema Multiforme * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Urticaria * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Surgical and medical procedures     
Hernia Repair * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Inguinal Hernia Repair * 1  0/5760 (0.00%)  1/1968 (0.05%) 
Vascular disorders     
Angiopathy * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Kawasaki's Disease * 1  4/5760 (0.07%)  1/1968 (0.05%) 
Vasculitis * 1  1/5760 (0.02%)  0/1968 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
2
Term from vocabulary, cMedDRA
3
Term from vocabulary, MedDRAc
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MenACWY-CRM197 + Routine Vaccines (All) Routine Vaccines (All)
Affected / at Risk (%) Affected / at Risk (%)
Total   4701/5760 (81.61%)   1600/1968 (81.30%) 
Blood and lymphatic system disorders     
Anaemia * 1  276/5760 (4.79%)  94/1968 (4.78%) 
Eye disorders     
Conjunctivitis * 1  732/5760 (12.71%)  234/1968 (11.89%) 
Gastrointestinal disorders     
Constipation * 1  275/5760 (4.77%)  98/1968 (4.98%) 
Diarrhoea  1  1181/5760 (20.50%)  356/1968 (18.09%) 
Teething * 1  294/5760 (5.10%)  106/1968 (5.39%) 
Vomiting  1  500/5760 (8.68%)  155/1968 (7.88%) 
General disorders     
Injection Site Erythema  1  519/5760 (9.01%)  241/1968 (12.25%) 
Injection Site Induration  1  284/5760 (4.93%)  181/1968 (9.20%) 
Injection Site Pain  1  916/5760 (15.90%)  338/1968 (17.17%) 
Irritability  1  1146/5760 (19.90%)  405/1968 (20.58%) 
Pyrexia  1  1239/5760 (21.51%)  373/1968 (18.95%) 
Infections and infestations     
Bronchiolitis * 1  826/5760 (14.34%)  299/1968 (15.19%) 
Bronchitis * 1  446/5760 (7.74%)  153/1968 (7.77%) 
Croup Infectious * 1  284/5760 (4.93%)  98/1968 (4.98%) 
Gastroenteritis * 1  524/5760 (9.10%)  179/1968 (9.10%) 
Influenza * 1  415/5760 (7.20%)  124/1968 (6.30%) 
Nasopharyngitits * 1  751/5760 (13.04%)  239/1968 (12.14%) 
Otitis Media * 1  1579/5760 (27.41%)  551/1968 (28.00%) 
Otitis Media Acute * 1  412/5760 (7.15%)  154/1968 (7.83%) 
Pharyngitits * 1  609/5760 (10.57%)  208/1968 (10.57%) 
Sinusitis * 1  296/5760 (5.14%)  93/1968 (4.73%) 
Upper Respiratory Tract Infection * 1  2358/5760 (40.94%)  842/1968 (42.78%) 
Viral Infection * 1  591/5760 (10.26%)  175/1968 (8.89%) 
Nervous system disorders     
Crying  1  859/5760 (14.91%)  277/1968 (14.08%) 
Somnolence  1  927/5760 (16.09%)  307/1968 (15.60%) 
Psychiatric disorders     
Eating Disorder  1  593/5760 (10.30%)  187/1968 (9.50%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  504/5760 (8.75%)  171/1968 (8.69%) 
Skin and subcutaneous tissue disorders     
Dermatitis Diaper * 1  628/5760 (10.90%)  201/1968 (10.21%) 
Eczema * 1  399/5760 (6.93%)  145/1968 (7.37%) 
Rash  1  307/5760 (5.33%)  109/1968 (5.54%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
EMail: RegistryContactVaccinesUS@novartis.com
Layout table for additonal information
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00806195     History of Changes
Other Study ID Numbers: V59P23
First Submitted: December 9, 2008
First Posted: December 10, 2008
Results First Submitted: May 13, 2013
Results First Posted: July 9, 2013
Last Update Posted: July 9, 2013