Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00806195
Collaborator
Novartis Vaccines (Industry)
7,744
153
6
35
50.6
1.4
Study Details
Study Description
Brief Summary
The primary objective of this phase 3b study is to evaluate the safety and tolerability of Novartis MenACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
7744 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Phase 3b, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
Study Start Date
:
Dec 1, 2008
Actual Primary Completion Date
:
Mar 1, 2011
Actual Study Completion Date
:
Nov 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MenACWY-CRM197 + Routine Vaccines (Non-Detailed) 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 - infants who only provided SAEs (Serious Adverse Events) and medically attended AEs (Adverse Events). |
Biological: MenACWY-CRM197
Four 0.5mL vaccinations of MenACWY-CRM197 conjugate vaccine was administered by intramuscular injection at 2, 4, 6 and 12 months of age.
Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.
Biological: Hib (Haemophilus influenza b) Vaccine
Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.
Biological: IPV (Inactivated Polio Vaccine) Vaccine
Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.
Biological: Pneumococcal conjugate Vaccine
Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.
Biological: MMR (Measles, Mumps, and Rubella) Vaccine
One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.
|
| Active Comparator: Routine Vaccines (Non-Detailed) 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. |
Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.
Biological: Hib (Haemophilus influenza b) Vaccine
Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.
Biological: IPV (Inactivated Polio Vaccine) Vaccine
Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.
Biological: Pneumococcal conjugate Vaccine
Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.
Biological: MMR (Measles, Mumps, and Rubella) Vaccine
One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.
|
| Experimental: MenACWY-CRM197 + Routine Vaccines (Detailed) 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. |
Biological: MenACWY-CRM197
Four 0.5mL vaccinations of MenACWY-CRM197 conjugate vaccine was administered by intramuscular injection at 2, 4, 6 and 12 months of age.
Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.
Biological: Hib (Haemophilus influenza b) Vaccine
Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.
Biological: IPV (Inactivated Polio Vaccine) Vaccine
Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.
Biological: Pneumococcal conjugate Vaccine
Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.
Biological: MMR (Measles, Mumps, and Rubella) Vaccine
One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.
Biological: Varicella Vaccine
One vaccination of Varicella vaccine was administered at 12 months of age.
Biological: Hepatitis A Virus
One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age.
|
| Active Comparator: Routine Vaccines (Detailed) 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. |
Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.
Biological: Hib (Haemophilus influenza b) Vaccine
Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.
Biological: IPV (Inactivated Polio Vaccine) Vaccine
Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.
Biological: Pneumococcal conjugate Vaccine
Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.
Biological: MMR (Measles, Mumps, and Rubella) Vaccine
One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.
Biological: Varicella Vaccine
One vaccination of Varicella vaccine was administered at 12 months of age.
Biological: Hepatitis A Virus
One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age.
|
| Experimental: MenACWY-CRM197 + Routine Vaccines (All) 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. |
Biological: MenACWY-CRM197
Four 0.5mL vaccinations of MenACWY-CRM197 conjugate vaccine was administered by intramuscular injection at 2, 4, 6 and 12 months of age.
Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.
Biological: Hib (Haemophilus influenza b) Vaccine
Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.
Biological: IPV (Inactivated Polio Vaccine) Vaccine
Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.
Biological: Pneumococcal conjugate Vaccine
Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.
Biological: MMR (Measles, Mumps, and Rubella) Vaccine
One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.
Biological: Varicella Vaccine
One vaccination of Varicella vaccine was administered at 12 months of age.
Biological: Hepatitis A Virus
One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age.
|
| Active Comparator: Routine Vaccines (All) 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. |
Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.
Biological: Hib (Haemophilus influenza b) Vaccine
Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.
Biological: IPV (Inactivated Polio Vaccine) Vaccine
Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.
Biological: Pneumococcal conjugate Vaccine
Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.
Biological: MMR (Measles, Mumps, and Rubella) Vaccine
One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.
Biological: Varicella Vaccine
One vaccination of Varicella vaccine was administered at 12 months of age.
Biological: Hepatitis A Virus
One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age.
|
Outcome Measures
Primary Outcome Measures
- Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination [15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age]
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.
Secondary Outcome Measures
- Percentages of Subjects With At Least One Serious Adverse Event During the Entire Study Period [Day 1 (2 months of age) to 18 months of age]
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.
- Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination [15 minutes to Day 7]
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.
- Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination [Day 1 (2 months of age) to 18 months of age]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
55 Days
to 89 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
healthy 2-month-old infants (aged 55 - 89 days); babies must have been born after a full-term pregnancy with an estimated gestation age ≥37 weeks and a birth weight ≥2.5 kg
-
for whom a parent/legal representative has given written informed consent after the nature of the study has been explained;
-
who are available for all visits scheduled in the study;
-
who are in good health as determined by medical history and physical assessment.
Exclusion Criteria:
-
who previously received any meningococcal vaccine or D, T, P, IPV or OPV, H influenzae type b (Hib) or Pneumococcus; prior doses of BCG (one) and/or HBV (two) are permitted
-
who have a previous confirmed 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 paroxysmal cough for a period of longer than or equal to 2 weeks associated with apnea or whooping);
-
who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N meningitidis (serogroups A, C, W135, or Y), B pertussis, Hib, C diphtheriae, Polio, or pneumococcal infection at any time since birth;
-
who have a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
-
who have experienced significant acute or chronic infection within the previous 7 days or have experienced fever (axillary temperature ≥ 38.0°C [100.4°F]) within the previous 3 days;
-
who have any present or suspected serious acute (e.g. leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac disease, renal failure, severe malnutrition, or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's syndrome);
-
who have a known or suspected autoimmune disease or persistent impairment/alteration of immune function resulting from (for example):
-
receipt of any immunosuppressive therapy at any time since birth
-
receipt of immunostimulants at any time since birth
-
receipt of any systemic corticosteroid since birth;
-
who have a suspected or known HIV infection or HIV related disease;
-
who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation;
-
who have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
-
who have any history of seizure;
-
who with their parents/legal representatives are planning to leave the area of the study site before the end of the study period;
-
who have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
-
who have received any investigational agents or vaccines since birth or who expect to receive an investigational agent or vaccine prior to the completion of the study.
-
who are relatives of site research staff working on this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 6 Alabama Clinical Therapeutics 806 St. Vincent's Drive, Ste 615 | Birmingham | Alabama | United States | 35205 |
| 2 | 43 Alabama Clinical Therapeutics, LLC 364 Honeysuckle Rd | Dothan | Alabama | United States | 36305 |
| 3 | 81 Cholla Pediatrics 2167 West Orange Grove Road | Tuscon | Arizona | United States | 85741 |
| 4 | 55 Central Arkansas Pediatric Clinic Pediatric 2301 Springhill Road Suite 200 | Benton | Arkansas | United States | 72019 |
| 5 | 21 Northwest Arkansas Pediatric Clinic 3383 N. MANA Court Suite 101 | Fayetteville | Arkansas | United States | 72703 |
| 6 | 30 Sparks Pediatric Clinic 1501 S. Waldron Road Suite 100 | Fort Smith | Arkansas | United States | 72903 |
| 7 | 14 The Children's Clinic of Jonesboro 800 S. Church Suite 400 | Jonesboro | Arkansas | United States | 72401 |
| 8 | 170 Little Rock Children's Clinic P.A. 9600 Lile Dr., Ste 360 | Little Rock | Arkansas | United States | 72205 |
| 9 | 3 Arkansas Pediatric Clinic 500 S. University Suite 200 | Little Rock | Arkansas | United States | 72205 |
| 10 | 179 Associated Pharmaceutical Research Center, Inc 8615 Knott Avenue Suite 5 | Buena Park | California | United States | 90620 |
| 11 | 160 San Fernando Valley Research Associates, Inc. 7111 Winnetka Ave. #14 | Canoga Park | California | United States | 91306 |
| 12 | 157 Universal Biopharma Research Institute Inc./Alta Family Health Clinic 888 N. Alta Ave. | Dinuba | California | United States | 93618 |
| 13 | 1 Premier Health Research Center, LLC 11525 Brookshire Ave Suite 400 | Downey | California | United States | 90241-4982 |
| 14 | 68 Sierra Medical Research 5150 N. Sixth, Suite 156 | Fresno | California | United States | 93710 |
| 15 | 129 Citrus Vally Family Practice 1400 Hacienda Blvd | La Puente | California | United States | 91744 |
| 16 | 114 Loma Linda University Health 11175 Campus Street Coleman Pavillion A-1120 | Loma Linda | California | United States | 92354 |
| 17 | 59 Loma Linda University Health 11175 Campus Street Coleman Pavillion A-1120 | Loma Linda | California | United States | 92354 |
| 18 | 153 Health Care Partners Medical Group Health Care Partners Medical Group 4401 Atlantic Ave. | Long Beach | California | United States | 90807 |
| 19 | 94 Health Care Partners Medical Group 1025 W. Olympic Blvd. | Los Angeles | California | United States | 90015 |
| 20 | 67 Madera Family Medical Group 1111 West 4th Street | Madera | California | United States | 93637 |
| 21 | 121 Kaiser Permanente (Oakland) 3505 Broadway 6th floor | Oakland | California | United States | 94611 |
| 22 | 63 Kaiser Permanente Vaccine Study Center One Kaiser Plaza 16th Floor | Oakland | California | United States | 94611 |
| 23 | 42 Children's Hospital of Orange County 455 S. Main Street | Orange | California | United States | 92868 |
| 24 | 12 Center For Clinical Trials, LLC. 16660 Paramount Blvd Suite 301 | Paramount | California | United States | 90723 |
| 25 | 122 Kaiser Permanente (Pleasanton) 7601 Stoneridge Drive, MOB North 2nd Floor | Pleasanton | California | United States | 94588 |
| 26 | 57 UC Davis Medical Center 2516 Stockton Blvd Ticon II | Sacramento | California | United States | 95817 |
| 27 | 123 Kaiser Permanente (San Francisco) 2200 O'Farrell Street 6th floor room 636 | San Francisco | California | United States | 94115 |
| 28 | 166 Buena Salud Pediatrics 2880 Story Road | San Jose | California | United States | 95127 |
| 29 | 20 White Memorial Pediatric Medical Group UCLA Center for Vaccine Research 1124 West Carson Street Liu Research Building (Room 132) | Torrance | California | United States | 90502 |
| 30 | 152 Health Care Partners Medical Group 3565 Del Amo Blvd Research Dept. | Torrance | California | United States | 90503 |
| 31 | 40 Center for Clinical Trials of San Gabriel 1300 S Sunset Avenue Suite 101 | West Covina | California | United States | 91790 |
| 32 | 54 1st International Research Centers 10370 Steeke Street | Thornton | Colorado | United States | 80229 |
| 33 | 29 Norwich Pediatric Group 92 New London Turnpike | Norwich | Connecticut | United States | 06360 |
| 34 | 99 Altamonte Pediatric Associates 101 N Country Club Rd. | Lake Mary | Florida | United States | 32746 |
| 35 | 60 Orlando Health Pediatric Faculty Practice 32 West Sturtevant St, MP-141 | Orlando | Florida | United States | 32806 |
| 36 | 34 Pediatric Partners Pediatrics 3401 PGA Blvd Ste 300 | Palm Beach Gardens | Florida | United States | 33410 |
| 37 | 88 Physician Care Clinical Research 1918 Robinhood Street | Sarasota | Florida | United States | 34231 |
| 38 | 162 North Georgia Clinical Research Center 1575 Chattanooga Avenue Suite 1 | Dalton | Georgia | United States | 30721 |
| 39 | 11 Pediatrics and Adolescent Medicine, PA 2155 Post Oak Tritt Road Suite 100 | Marietta | Georgia | United States | 30062 |
| 40 | 101 Pediatrics and Adolescent Medicine, PA 120 Stonebridge Parkway, Suite 410 | Woodstock | Georgia | United States | 30189 |
| 41 | 132 Kaiser Permanente Pediatric - Mapunapuna 2828 Paa Street, 2nd Floor | Honolulu | Hawaii | United States | 96819 |
| 42 | 131 Kaiser Permanente Waipio 1st Floor 94-1480 Moaniani Street | Waipahu | Hawaii | United States | 96797 |
| 43 | Northern Illinois Research Associates 625 E. Bethany Ste. 3 | Dekalb | Illinois | United States | 60115 |
| 44 | 95 Heartland Research Associates 510 West Radio Lane | Arkansas City | Kansas | United States | 67005 |
| 45 | 92 Heartland Research Associates LLC 700 Medical Center Dr. Suite 210 | Newton | Kansas | United States | 67114 |
| 46 | 178 Pediatric Care 6725 Southwest Twenty-Ninth Street | Topeka | Kansas | United States | 66614 |
| 47 | 51 Kentucky Pediatric/Adult Research 201 S. 5th Street | Bardstown | Kentucky | United States | 40004 |
| 48 | 84 Michael W. Simon M.D. 185 Pasadena Drive Suite 220 | Lexington | Kentucky | United States | 40503 |
| 49 | 106 University Child Health Specialists 230 East Broadway | Louisville | Kentucky | United States | 40202 |
| 50 | 24 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite 2 | Louisville | Kentucky | United States | 40291 |
| 51 | 76 Bluegrass Clinical Research, Inc 5512 Bardstown Road Suite2 | Louisville | Kentucky | United States | 40291 |
| 52 | 15 University of Louisville 571 South Floyd Suite 321 L | Ouisville | Kentucky | United States | 40202 |
| 53 | 108 Physicians to Children and Adolescents 102 West Depot Street | Springfield | Kentucky | United States | 40069 |
| 54 | 86 Willis-Knighton Physician Network 7847 Youree Drive | Shreveport | Louisiana | United States | 71105 |
| 55 | 22 Roslindale Pediatric Assoc, P.C 1153 Centre St Suite 31 | Boston | Massachusetts | United States | 02130 |
| 56 | 23 Pediatric Associates of Fall River 829 South Main Street | Fall River | Massachusetts | United States | 02724 |
| 57 | 126 North Andover Pediatrics Associates 800 Turnpike Street | North Andover | Massachusetts | United States | 01845 |
| 58 | 9 Woburn Pediatric Associates 7 Alfred Street Baldwin Park II | Woburn | Massachusetts | United States | 01801 |
| 59 | 168 Southwestern Medical Clinic 2002 South 11th Street | Niles | Michigan | United States | 49120 |
| 60 | 26 Southwestern Medical Clinic 5515 Cleveland Avenue Suite 1 | Stevensville | Michigan | United States | 49127 |
| 61 | 89 Aspen Medical Group 1020 Bandana Blvd West Ste 214 | St. Paul | Minnesota | United States | 55108 |
| 62 | 80 Craig A. Spiegel, M.D 12255 DePaul Drive Sutie 380 | Bridgeton | Missouri | United States | 63044 |
| 63 | 69 Clinical Research Center of Nevada 1012 East Sahara Avenue | Las Vegas | Nevada | United States | 89104 |
| 64 | 173 Maimonides Medical Center 948 48th Street 1st Floor | Brooklyn | New York | United States | 11219 |
| 65 | 70 Summer Pediatrics 4811 Buckley Road | Liverpool | New York | United States | 13088 |
| 66 | 16 Winthrop University Hospital Department of Pediatrics 120 Mineola Blvd Suite 210 | Mineola | New York | United States | 11501 |
| 67 | 77 SUNY Upstate Medical University 750 East Adams Street Suite 5400 | Syracuse | New York | United States | 13210 |
| 68 | 56 Cary Pediatrics 1001 Crescent Green Dr. | Cary | North Carolina | United States | 27511 |
| 69 | 103 Durham Pediatrics 2609 North Duke Street, Suite 1000 | Durham | North Carolina | United States | 27704 |
| 70 | 104 Regional Pediatrics 4022 Freedom Lake Drive | Durham | North Carolina | United States | 27704 |
| 71 | 13 Duke Health Center 4020 N. Roxboro Road | Durham | North Carolina | United States | 27704 |
| 72 | 48 Capitol Pediatrics and Adolescent Center 3801 Computer Drive Suite 200 | Raleigh | North Carolina | United States | 27609 |
| 73 | 91 Triangle Medical Research 5816 Creedmoor Rd. Suite 104 | Raleigh | North Carolina | United States | 27612 |
| 74 | 73 Piedmont Medical Research Assoc 1901 S Hawthorne Rd Ste 306 | Winston-Salem | North Carolina | United States | 27103 |
| 75 | 87 Innovis Health 1702 South University Drive Suite 1 | Fargo | North Dakota | United States | 58103 |
| 76 | 97 Children's Hospital Medical Center of Akron One Perkins Square | Akron | Ohio | United States | 44308 |
| 77 | 120 Akron Children's Hospital Pediatrics 62 Conservatory Drive, #A | Barberton | Ohio | United States | 44203 |
| 78 | 36 Dr. Senders and Associates, Pediatrics 2054 South Green Road | Cleveland | Ohio | United States | 44121 |
| 79 | 79 Dayton Clinical Research 1100 Salem Ave | Dayton | Ohio | United States | 45406 |
| 80 | 37 Pediatric Associates of Fairfield, Inc. 5900 Boymel Drive | Fairfield | Ohio | United States | 45014 |
| 81 | 4 Ohio Pediatrics, INC 7371 Brandt Pike Suite C | Huber Heights | Ohio | United States | 45424-3200 |
| 82 | 102 Ohio Pediatrics, INC 1775 Delco Park Drive | Kettering | Ohio | United States | 45420 |
| 83 | 28 Pediatric Associates of Youngstown 4308 Belmont Avenue | Youngstown | Ohio | United States | 44505 |
| 84 | 100 Pediatric Associates of Youngstown 727 East Western Reserve Road | Youngstown | Ohio | United States | 44514 |
| 85 | 25 Oklahoma State University-CHS C/O Pediatrics 635 West 11th Street | Tulsa | Oklahoma | United States | 74127 |
| 86 | 83 The Portland Clinic LLP 15950 SW Millikan Lane Research Dept. | Beaverton | Oregon | United States | 97006 |
| 87 | 7 Cyn3rgy Research 24850 SE Stark Street Suite 180 | Gresham | Oregon | United States | 97030 |
| 88 | 113 Children's Health Care-West 4671 West Lake Road | Erie | Pennsylvania | United States | 16505 |
| 89 | 109 UPMC/Community Medicine Inc. 90 Shenango Street | Greenville | Pennsylvania | United States | 16125 |
| 90 | 107 Pennridge Pediatric Associates 270 Main Street | Harleysville, | Pennsylvania | United States | 19438 |
| 91 | 110 Pediatric Alliance Southwestern - Squirrel Hill 4070 Beechwood Blvd | Pittsburgh | Pennsylvania | United States | 15217 |
| 92 | 112 Pediatric Alliance, Southwestern 850 Clairton Blvd | Pittsburgh | Pennsylvania | United States | 15236 |
| 93 | 118 Pediatric Alliance, PC Arcadia Division 9000 Perry Highway Suite 120 | Pittsburgh | Pennsylvania | United States | 15237 |
| 94 | 5 Primary Physicians Research, Inc 1580 McLaughlin Run Road | Pittsburgh | Pennsylvania | United States | 15241 |
| 95 | 49 Pennridge Pediatric Associates 711 Lawn Avenue | Sellersville | Pennsylvania | United States | 18960 |
| 96 | 41 Palmetto Pediatrics, PA Pediatrics 2781 Tricom Street | Charleston | South Carolina | United States | 29406 |
| 97 | 71 Holston Medical Group 105 W. Stone Dr. Suite 2A | Kingsport | Tennessee | United States | 37660 |
| 98 | 72 Holston Medical Group 2033 Meadowview Lane | Kingsport | Tennessee | United States | 37660 |
| 99 | 165 Focus Research Group 201 Signature Place Suite C | Lebanon | Tennessee | United States | 37087 |
| 100 | 52 Heritage Medical Associates 2325 Crestmoor Road | Nashville | Tennessee | United States | 37215 |
| 101 | 90 Premier Medical Group Alpha Clinical Research 279 Clear Sky Court | Ste C Clarksville | Tennessee | United States | 37043 |
| 102 | 64 Amarillo Childrens Clinical Research #17 Care Circle | Amarillo | Texas | United States | 79124 |
| 103 | 19 University of North Texas Health Science Center 3500 Camp Bowie Blvd | Fort Worth | Texas | United States | 76107 |
| 104 | 175 Sealy Center for Vaccine Development, Clinical Trials 301 University Blvd. Children's Hospital Room 3.270F L#20412 | Galveston | Texas | United States | 77555-0351 |
| 105 | 96 West Houston Clinical Research Service 2026 Wirt Road | Houston | Texas | United States | 77055 |
| 106 | 50 San Antonio Metropolitan Health District 332 West Commerce Room 307 | San Antonio | Texas | United States | 78205 |
| 107 | 31 Southwest Children's Research Associates, P. A. 5282 Medical Drive Suite 311 | San Antonio | Texas | United States | 78229 |
| 108 | 47 Dynamed Clinical Research 13406 Medical Complex Dr Suite 200 | Tomball | Texas | United States | 77375 |
| 109 | 75 Pediatric Care 1596 S. 500 W., 1st Floor | Bountiful | Utah | United States | 84010 |
| 110 | 82 Dixie Pediatrics 1240 E 100 S STE 14 St. | George | Utah | United States | 84790 |
| 111 | 115 Wee Care(Layton) 1580 West Antelope Drive | Layton | Utah | United States | 84041 |
| 112 | 116 Wee Care(Kaysville) 934 South Main Street, Suite 8 | Layton | Utah | United States | 84041 |
| 113 | 181 Jean Brown Research 164 East 5900 South Suite A-112 | Murray | Utah | United States | 84107 |
| 114 | 74 Utah Valley Pediatrics North University 7407 North Cedar St. | Provo | Utah | United States | 84604 |
| 115 | 117 Wee Care(Roy) 5991 South 3500 West, Suite 100 | Roy | Utah | United States | 84067 |
| 116 | 66 J. Lewis Research Inc. 2295 Foothill Drive | Salt Lake City | Utah | United States | 84109 |
| 117 | 61 Foothill Family Clinic South 6360 South 300 East Suite 100 | Salt Lake City | Utah | United States | 84121 |
| 118 | 151 Family First Pediatrics c/o Pharmaceutical Research Organization 1268 W. South Jordan Parkway Suite 201 | South Jordan | Utah | United States | 84095 |
| 119 | 44 Wee Care Pediatrics (Syracuse) 1792 West 1700 South Suite 102 | Syracuse | Utah | United States | 84075 |
| 120 | Jordan Ridge Kids & Teens 8822 S. Redwood Road Suite S103 | West Jordan | Utah | United States | 84088 |
| 121 | 85 Pediatric Research of Charlottesville, LLC 1011 East Jefferson St. Suite 3 | Charlottesville | Virginia | United States | 22902 |
| 122 | 158 Huguenot Pediatrics, PC 1407 Huguenot Rd. | Midlothian | Virginia | United States | 23113 |
| 123 | 46 Virginia Commonwealth University 1001 East Marshall Street P008 | Richmond | Virginia | United States | 23219 |
| 124 | 93 Advanced Pediatrics 100 East Street SE Suite 301 | Vienna | Virginia | United States | 22180 |
| 125 | 2 Rockwood Clinical Research Center 400 East Fifth Avenue | Spokane | Washington | United States | 99202 |
| 126 | 38 Rockwood Clinic, P.S. 9001 N. Country Homes Blvd. | Spokane | Washington | United States | 99218 |
| 127 | 124 The Vancouver Clinic/NE 87th Avenue 700 NE 87th Avenue | Vancouver | Washington | United States | 98664 |
| 128 | 125 The Vancouver Clinic/Columbia Tech Center 501 SE 172th Avenue | Vancouver | Washington | United States | 98684 |
| 129 | 167 The Vancouver Clinic/Salmon Creek 2525 NE 139th Street | Vancouver | Washington | United States | 98686 |
| 130 | 163 Wenatchee Valley Medical Center Clinical Research Department 820 North Chelan Avenue | Wenatchee | Washington | United States | 98801 |
| 131 | 304 Department of Pediatrics, Chang Gung Children's Hospital 12F, L Building, #5, Fu-Shin St. | Kweishan, Taoyuan 333 | Taiwan | China | |
| 132 | 301 Department of Pediatrics, National Taiwan University Hospital, 15F,Children's Hospital, No. 8 Chung Shan S. Rd, | Taipei | Taiwan | China | 100 |
| 133 | 302 Department of Pediatrics, Mackay Memorial Hospital No. 92, Sec. 2, ChangShan Road, | Taipei | Taiwan | China | 104 |
| 134 | 303 Department of Pediatrics, Taiwan Adventist Hospital 424, Sec 2, Pa-Te Road, | Taipei | Taiwan | China | |
| 135 | 401 Clínica Pediátrica Calle 20 Ave 0 y 2 Costado Oeste del Hospital Nacional de Niños - segundo piso, | San José | Costa Rica | ||
| 136 | 402 Centro Integral Medico 25 m Oeste e la Junta de Protección Social, | San José | Costa Rica | ||
| 137 | 404 Instituto de Atención Pediátrica (IAP) Del Restaurante La Bastilla, 50m Sur, Paseo Colón | San José | Costa Rica | ||
| 138 | 403 Centro Médico San Vicente 125m Este de la entrada Principal de Emergencia del Hospital | San Vicente de Paul, Heredia | Costa Rica | ||
| 139 | 507 Clínica Médica Privada Edificio Multimédica, 2 calle 25-19 Zona 15 | Vista Hermosa I | Guatemala CP 01015 | Guatemala | |
| 140 | 508 Unidad de Crecimiento y Desarrollo, Clínica del Niño Sano, Hospital Roosevelt 6ª Avenida 3-10 Zona 11, Ingreso Principal Hospital Roosevelt | Guatemala City | Guatemala CP. 01011 | Guatemala | |
| 141 | 502 Clínica Privada 6a Avenida 3-22 Zona 10, Centro Médico II, Ofic. 601 | Guatemala City, | Guatemala CP01010 | Guatemala | |
| 142 | 503 Clínica para Niños 6a Avenida 6-63 Zona 10, Edificio Sixtino, Oficina 305, Tercer Nivel, | Guatemala City | Guatemala CP01010 | Guatemala | |
| 143 | 506 Health Center 4ª Avenida 16-72 Zona 10, | Guatemala City | Guatemala CP01010 | Guatemala | |
| 144 | 504 Clínica Periférica El Amparo II, 38 Calle 31-89, Zona 7 Colonia El Amparo II, | Guatemala City | Guatemala. CP 01007 | Guatemala | |
| 145 | 501 Hospital Infantil de Infectología y Rehabilitación 9ª. Avenida 7-01 Zona 11 Colonia Roosevelt, | Guatemala City, | Guatemala | CP 01011 | |
| 146 | 601 Hospital Materno Infantil José Domingo De Obaldía, Centro para la Investigación y Desarrollo de Estudios Clínicos Vía Panamericana, San Pablo viejo, David, | Chiriquí | Panama | ||
| 147 | 602 Centro Pediátrico América, Consultorio América Segundo Piso Consultorio No. 223, Vía España, Carrasquilla, Frente al Hospital de Especialidades Pediátricas | Ciudad de Panamá | Panama | ||
| 148 | 603 Policentro Luis H. Moreno, Parque Lefevre | Via Cincuentenario | Panama | ||
| 149 | 704 Hospital Nacional Docente Madre Niño San Bartolomé Av. Alfonso Ugarte 825, | Cercado de Lima | Lima 01 | Peru | |
| 150 | 701 Instituto de Investigación Nutricional - Anexo Huáscar, SJL Manzana 122, Lote 21, Grupo 15 | Huascar, San Juan de Lurigancho | Lima 36 | Peru | |
| 151 | 703 Hospital María Auxiliadora Av. Miguel Iglesias 968, San Juan de Miraflores, | Lima 29 | Peru | ||
| 152 | 705 Hospital Nacional Cayetano Heredia Av. Honorio Delgado No. 262, Urbanización Ingeniería, San Martín de Porres | Lima 31 | Peru | ||
| 153 | 708 Hospital Nacional Guillermo Almenara Irigoyen Av. Grau No. 800, La Victoria, Lima 13 | Lima | Peru |
Sponsors and Collaborators
- Novartis
- Novartis Vaccines
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis
ClinicalTrials.gov Identifier:
NCT00806195
Other Study ID Numbers:
- V59P23
First Posted:
Dec 10, 2008
Last Update Posted:
Jul 9, 2013
Last Verified:
May 1, 2013
Keywords provided by Novartis
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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) |
|---|---|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | MenACWY-CRM197 + Routine Vaccines (Non-Detailed) | Routine Vaccines (Non-Detailed) | MenACWY-CRM197 + Routine Vaccines (Detailed) | Routine Vaccines (Detailed) | Total |
|---|---|---|---|---|---|
| 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 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 Participants | 4363 | 1483 | 1409 | 489 | 7744 |
| Age (Days) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Days] |
64.9
(7.4)
|
64.7
(7.1)
|
65.5
(6.5)
|
65.2
(6.3)
|
65.0
(7.1)
|
| Sex: Female, Male (Count of 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%
|
Outcome Measures
| Title | Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination |
|---|---|
| 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 |
Outcome Measure Data
| 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) |
|---|---|---|
| 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. |
| Measure Participants | 1349 | 461 |
| Number [Percentages of subjects] |
16
|
13
|
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 | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 3.0 | |
| Confidence Interval |
(2-Sided) 95% -0.8 to 6.4 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentages of Subjects With At Least One Serious Adverse Event During the Entire Study Period |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on as treated safety population. |
| Arm/Group Title | MenACWY-CRM197 + Routine Vaccines (All) | Routine Vaccines (All) |
|---|---|---|
| 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. |
| Measure Participants | 5760 | 1968 |
| Number [Percentages of subjects] |
6
|
6
|
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 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 | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.4 | |
| Confidence Interval |
(2-Sided) 95% -0.9 to 1.5 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| 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 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 | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | 0.3 | |
| Confidence Interval |
(2-Sided) 95% -0.8 to 1.3 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on as treated safety population. |
| Arm/Group Title | MenACWY-CRM 197 + Routine Vaccines (Detailed) | Routine Vaccines (Detailed) |
|---|---|---|
| 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. |
| Measure Participants | 1313 | 451 |
| 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
|
| Title | Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination |
|---|---|
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis was done on as treated safety population. |
| Arm/Group Title | MenACWY-CRM197 + Routine Vaccines (All) | Routine Vaccines (All) |
|---|---|---|
| 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. |
| Measure Participants | 5760 | 1968 |
| 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
|
Adverse Events
| 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) | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| MenACWY-CRM197 + Routine Vaccines (All) | Routine Vaccines (All) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 354/5760 (6.1%) | 114/1968 (5.8%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 2/5760 (0%) | 0/1968 (0%) | ||
| Idiopathic Thrombocytopenic Purpura | 0/5760 (0%) | 1/1968 (0.1%) | ||
| Iron Deficiency Anaemia | 1/5760 (0%) | 0/1968 (0%) | ||
| Leukocytosis | 2/5760 (0%) | 0/1968 (0%) | ||
| Mesenteric Lymphadenopathy | 1/5760 (0%) | 0/1968 (0%) | ||
| Thrombocytopenia | 1/5760 (0%) | 0/1968 (0%) | ||
| Lymphadenitis | 4/5760 (0.1%) | 0/1968 (0%) | ||
| Lymphadenopathy | 1/5760 (0%) | 0/1968 (0%) | ||
| Cardiac disorders | ||||
| Cardiac Arrest | 1/5760 (0%) | 0/1968 (0%) | ||
| Cyanosis | 2/5760 (0%) | 0/1968 (0%) | ||
| Supraventricular Tachycardia | 1/5760 (0%) | 1/1968 (0.1%) | ||
| Ventricular Tachycardia | 1/5760 (0%) | 0/1968 (0%) | ||
| Congenital, familial and genetic disorders | ||||
| Anomalous Pulmonary Venous Connection | 0/5760 (0%) | 1/1968 (0.1%) | ||
| Congenital Absence Of Bile Ducts | 1/5760 (0%) | 0/1968 (0%) | ||
| Congenital Aplastic Anaemia | 1/5760 (0%) | 0/1968 (0%) | ||
| Craniosynostosis | 1/5760 (0%) | 0/1968 (0%) | ||
| Cryptorchism | 1/5760 (0%) | 0/1968 (0%) | ||
| Hamartoma | 1/5760 (0%) | 0/1968 (0%) | ||
| Mitochondrial Enzyme Deficiency | 1/5760 (0%) | 0/1968 (0%) | ||
| Osteognesis Imperfecta | 1/5760 (0%) | 0/1968 (0%) | ||
| Patent Ductus Arteriosus | 1/5760 (0%) | 0/1968 (0%) | ||
| Phimosis | 1/5760 (0%) | 0/1968 (0%) | ||
| Pyloric Stenosis | 1/5760 (0%) | 0/1968 (0%) | ||
| Vitello-Intestinal Duct Remnant | 1/5760 (0%) | 0/1968 (0%) | ||
| Eye disorders | ||||
| Retinal Haemorrhage | 1/5760 (0%) | 0/1968 (0%) | ||
| Gastrointestinal disorders | ||||
| Abdominal Pain | 2/5760 (0%) | 0/1968 (0%) | ||
| Constipation | 0/5760 (0%) | 1/1968 (0.1%) | ||
| Diarrhoea | 5/5760 (0.1%) | 3/1968 (0.2%) | ||
| Enteritis | 1/5760 (0%) | 0/1968 (0%) | ||
| Enterocolitis | 3/5760 (0.1%) | 1/1968 (0.1%) | ||
| Gastritis | 2/5760 (0%) | 0/1968 (0%) | ||
| Gastrooesophageal Reflux Disease | 3/5760 (0.1%) | 0/1968 (0%) | ||
| Ileus | 1/5760 (0%) | 1/1968 (0.1%) | ||
| Inguinal Hernia | 2/5760 (0%) | 0/1968 (0%) | ||
| Inguinal Hernia, Obstructive | 0/5760 (0%) | 1/1968 (0.1%) | ||
| Intussusception | 4/5760 (0.1%) | 3/1968 (0.2%) | ||
| Stomatitis | 1/5760 (0%) | 0/1968 (0%) | ||
| Vomiting | 3/5760 (0.1%) | 0/1968 (0%) | ||
| General disorders | ||||
| Brain Death | 1/5760 (0%) | 0/1968 (0%) | ||
| Hernia | 0/5760 (0%) | 1/1968 (0.1%) | ||
| Pyrexia | 7/5760 (0.1%) | 3/1968 (0.2%) | ||
| Hepatobiliary disorders | ||||
| Jaundice | 1/5760 (0%) | 0/1968 (0%) | ||
| Infections and infestations | ||||
| Acute Tonsilitis | 1/5760 (0%) | 1/1968 (0.1%) | ||
| Adenovirus Infection | 1/5760 (0%) | 0/1968 (0%) | ||
| Arthritis Bacterial | 0/5760 (0%) | 1/1968 (0.1%) | ||
| Ascariasis | 1/5760 (0%) | 0/1968 (0%) | ||
| Bacteraemia | 1/5760 (0%) | 0/1968 (0%) | ||
| Bacterial Diarrhoea | 1/5760 (0%) | 0/1968 (0%) | ||
| Bacterial Tracheitis | 1/5760 (0%) | 0/1968 (0%) | ||
| Bronchiolitis | 64/5760 (1.1%) | 15/1968 (0.8%) | ||
| Bronchitis | 1/5760 (0%) | 3/1968 (0.2%) | ||
| Bronchopneumonia | 19/5760 (0.3%) | 5/1968 (0.3%) | ||
| Cellulitis | 5/5760 (0.1%) | 4/1968 (0.2%) | ||
| Cellulitis Staphylococcal | 1/5760 (0%) | 0/1968 (0%) | ||
| Cellulitis Streptococcal | 1/5760 (0%) | 0/1968 (0%) | ||
| Chest Wall Abscess | 1/5760 (0%) | 0/1968 (0%) | ||
| Croup Infectious | 10/5760 (0.2%) | 5/1968 (0.3%) | ||
| Diarrhoea Infectious | 1/5760 (0%) | 0/1968 (0%) | ||
| Dysentery | 1/5760 (0%) | 0/1968 (0%) | ||
| Enterovirus Infection | 1/5760 (0%) | 0/1968 (0%) | ||
| Escherichia Urinary Tract Infection | 1/5760 (0%) | 2/1968 (0.1%) | ||
| Exanthema Subitam | 0/5760 (0%) | 3/1968 (0.2%) | ||
| Furuncle | 0/5760 (0%) | 1/1968 (0.1%) | ||
| Gastroenteritis | 20/5760 (0.3%) | 7/1968 (0.4%) | ||
| Gastroenteritis Rotavirus | 2/5760 (0%) | 0/1968 (0%) | ||
| Gastroenteritis Salmonella | 1/5760 (0%) | 0/1968 (0%) | ||
| Gastroenteritis Viral | 7/5760 (0.1%) | 3/1968 (0.2%) | ||
| Genital Abscess | 2/5760 (0%) | 0/1968 (0%) | ||
| Groin Abscess | 2/5760 (0%) | 0/1968 (0%) | ||
| Haemophilus Bacteraemia | 1/5760 (0%) | 0/1968 (0%) | ||
| Hand-Foot-And-Mouth Disease | 10/5760 (0.2%) | 0/1968 (0%) | ||
| Herpangina | 4/5760 (0.1%) | 2/1968 (0.1%) | ||
| Incision Site Cellulitis | 1/5760 (0%) | 0/1968 (0%) | ||
| Infected Cyst | 1/5760 (0%) | 0/1968 (0%) | ||
| Influenza | 4/5760 (0.1%) | 0/1968 (0%) | ||
| Klebsiella Bacteraemia | 1/5760 (0%) | 0/1968 (0%) | ||
| Lobar Pneumonia | 1/5760 (0%) | 1/1968 (0.1%) | ||
| Lower Respiratory Tract Infection | 1/5760 (0%) | 0/1968 (0%) | ||
| Lymph Node Abscess | 0/5760 (0%) | 1/1968 (0.1%) | ||
| Meningitis | 1/5760 (0%) | 0/1968 (0%) | ||
| Meningitis Enteroviral | 1/5760 (0%) | 0/1968 (0%) | ||
| Metapneumovirus Infection | 1/5760 (0%) | 0/1968 (0%) | ||
| Otitis Media | 2/5760 (0%) | 3/1968 (0.2%) | ||
| Otitis Media Acute | 1/5760 (0%) | 3/1968 (0.2%) | ||
| Periorbital Cellulitis | 3/5760 (0.1%) | 0/1968 (0%) | ||
| Peritonsillar Abscess | 1/5760 (0%) | 0/1968 (0%) | ||
| Pharyngitis | 2/5760 (0%) | 0/1968 (0%) | ||
| Pneumonia | 31/5760 (0.5%) | 10/1968 (0.5%) | ||
| Pharyngotonsillitis | 0/5760 (0%) | 1/1968 (0.1%) | ||
| Pneumococcal bacteraemia | 0/5760 (0%) | 1/1968 (0.1%) | ||
| Pneumonia Adenoviral | 1/5760 (0%) | 0/1968 (0%) | ||
| Pneumonia Bacterial | 1/5760 (0%) | 0/1968 (0%) | ||
| Pneumonia Influenzal | 1/5760 (0%) | 0/1968 (0%) | ||
| Pneumonia Primary Atypical | 0/5760 (0%) | 1/1968 (0.1%) | ||
| Pneumonia Respiratory Syncytial Viral | 1/5760 (0%) | 0/1968 (0%) | ||
| Pneumonia Viral | 3/5760 (0.1%) | 1/1968 (0.1%) | ||
| Pyelonephritis | 1/5760 (0%) | 2/1968 (0.1%) | ||
| Pyelonephritis Acute | 4/5760 (0.1%) | 0/1968 (0%) | ||
| Respiratory Syncytial Virus Bronchiolitis | 20/5760 (0.3%) | 7/1968 (0.4%) | ||
| Respiratory Synctial Virus Infection | 4/5760 (0.1%) | 2/1968 (0.1%) | ||
| Rotavirus Infection | 1/5760 (0%) | 0/1968 (0%) | ||
| Sepsis | 1/5760 (0%) | 0/1968 (0%) | ||
| Septic Shock | 3/5760 (0.1%) | 0/1968 (0%) | ||
| Sinusitis | 0/5760 (0%) | 1/1968 (0.1%) | ||
| Staphylococcal Abscess | 1/5760 (0%) | 2/1968 (0.1%) | ||
| Tonsilitis | 0/5760 (0%) | 1/1968 (0.1%) | ||
| Upper Respiratory Tract Infection | 4/5760 (0.1%) | 1/1968 (0.1%) | ||
| Urachal Abscess | 1/5760 (0%) | 0/1968 (0%) | ||
| Urinary Tract Infection | 28/5760 (0.5%) | 10/1968 (0.5%) | ||
| Urinary Tract Infection Enterococcal | 1/5760 (0%) | 0/1968 (0%) | ||
| Urosepsis | 1/5760 (0%) | 0/1968 (0%) | ||
| Varicella | 1/5760 (0%) | 0/1968 (0%) | ||
| Viral Diarrhoea | 1/5760 (0%) | 0/1968 (0%) | ||
| Viral Infection | 4/5760 (0.1%) | 0/1968 (0%) | ||
| Wound Infection | 1/5760 (0%) | 0/1968 (0%) | ||
| Meningitis Viral | 2/5760 (0%) | 0/1968 (0%) | ||
| Staphylococcal Infection | 1/5760 (0%) | 0/1968 (0%) | ||
| Injury, poisoning and procedural complications | ||||
| Accidental Poisoning | 1/5760 (0%) | 0/1968 (0%) | ||
| Contusion | 1/5760 (0%) | 0/1968 (0%) | ||
| Craniocerebral Injury | 5/5760 (0.1%) | 2/1968 (0.1%) | ||
| Electrical Burn | 1/5760 (0%) | 0/1968 (0%) | ||
| Fall | 1/5760 (0%) | 0/1968 (0%) | ||
| Foreign Body | 1/5760 (0%) | 0/1968 (0%) | ||
| Head Injury | 1/5760 (0%) | 2/1968 (0.1%) | ||
| Humerus Fracture | 1/5760 (0%) | 0/1968 (0%) | ||
| Injury | 1/5760 (0%) | 0/1968 (0%) | ||
| Post Procedural Complication | 0/5760 (0%) | 1/1968 (0.1%) | ||
| Skull Fracture | 1/5760 (0%) | 1/1968 (0.1%) | ||
| Subdural Haemorrhage | 1/5760 (0%) | 0/1968 (0%) | ||
| Thermal Burn | 1/5760 (0%) | 0/1968 (0%) | ||
| Tibia Fracture | 1/5760 (0%) | 0/1968 (0%) | ||
| Upper Limb Fracture | 1/5760 (0%) | 0/1968 (0%) | ||
| Subdural Hematoma | 1/5760 (0%) | 0/1968 (0%) | ||
| Investigations | ||||
| Electrocardiogram Qt Prolonged | 1/5760 (0%) | 0/1968 (0%) | ||
| Metabolism and nutrition disorders | ||||
| Dehydration | 18/5760 (0.3%) | 9/1968 (0.5%) | ||
| Failure To Thrive | 1/5760 (0%) | 0/1968 (0%) | ||
| Feeding Disorder | 1/5760 (0%) | 0/1968 (0%) | ||
| Hypoglycaemia | 2/5760 (0%) | 0/1968 (0%) | ||
| Metabolic Acidosis | 2/5760 (0%) | 0/1968 (0%) | ||
| Nervous system disorders | ||||
| Acute Disseminated Encephalomyelitis | 1/5760 (0%) | 0/1968 (0%) | ||
| Convulsion | 5/5760 (0.1%) | 3/1968 (0.2%) | ||
| Encephalitis | 1/5760 (0%) | 0/1968 (0%) | ||
| Epilepsy | 2/5760 (0%) | 0/1968 (0%) | ||
| Febrile Convulsion | 9/5760 (0.2%) | 6/1968 (0.3%) | ||
| Hydrocephalus | 1/5760 (0%) | 0/1968 (0%) | ||
| Myoclonic Epilepsy | 0/5760 (0%) | 1/1968 (0.1%) | ||
| Presyncope | 1/5760 (0%) | 0/1968 (0%) | ||
| Syncope | 1/5760 (0%) | 0/1968 (0%) | ||
| Tremor | 1/5760 (0%) | 0/1968 (0%) | ||
| Psychiatric disorders | ||||
| Breath Holding | 1/5760 (0%) | 0/1968 (0%) | ||
| Drug Abuse | 1/5760 (0%) | 0/1968 (0%) | ||
| Mental Status Changes | 1/5760 (0%) | 0/1968 (0%) | ||
| Renal and urinary disorders | ||||
| Renal Failure Acute | 1/5760 (0%) | 0/1968 (0%) | ||
| Renal Mass | 0/5760 (0%) | 2/1968 (0.1%) | ||
| Vesicoureteric Reflux | 1/5760 (0%) | 0/1968 (0%) | ||
| Reproductive system and breast disorders | ||||
| Balanitis | 1/5760 (0%) | 0/1968 (0%) | ||
| Scrotal mass | 1/5760 (0%) | 0/1968 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Adenoidal Hypertrophy | 1/5760 (0%) | 0/1968 (0%) | ||
| Apnoea | 0/5760 (0%) | 1/1968 (0.1%) | ||
| Asthma | 6/5760 (0.1%) | 2/1968 (0.1%) | ||
| Atelectasis | 2/5760 (0%) | 0/1968 (0%) | ||
| Bronchial Hyperreactivity | 6/5760 (0.1%) | 6/1968 (0.3%) | ||
| Bronchomalacia | 1/5760 (0%) | 0/1968 (0%) | ||
| Bronchospasm | 2/5760 (0%) | 1/1968 (0.1%) | ||
| Cough | 1/5760 (0%) | 0/1968 (0%) | ||
| Epistaxis | 1/5760 (0%) | 0/1968 (0%) | ||
| Hypoxia | 3/5760 (0.1%) | 0/1968 (0%) | ||
| Pneumonia Aspiration | 0/5760 (0%) | 1/1968 (0.1%) | ||
| Pneumonitis | 0/5760 (0%) | 1/1968 (0.1%) | ||
| Pulmonary Oedema | 1/5760 (0%) | 0/1968 (0%) | ||
| Respiratory Distress | 12/5760 (0.2%) | 3/1968 (0.2%) | ||
| Respiratory Failure | 1/5760 (0%) | 0/1968 (0%) | ||
| Status Asthmaticus | 1/5760 (0%) | 3/1968 (0.2%) | ||
| Wheezing | 1/5760 (0%) | 0/1968 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Dermal Cyst | 1/5760 (0%) | 0/1968 (0%) | ||
| Dermatitis Atopic | 0/5760 (0%) | 1/1968 (0.1%) | ||
| Erythema Multiforme | 1/5760 (0%) | 0/1968 (0%) | ||
| Urticaria | 1/5760 (0%) | 0/1968 (0%) | ||
| Surgical and medical procedures | ||||
| Hernia Repair | 1/5760 (0%) | 0/1968 (0%) | ||
| Inguinal Hernia Repair | 0/5760 (0%) | 1/1968 (0.1%) | ||
| Vascular disorders | ||||
| Angiopathy | 1/5760 (0%) | 0/1968 (0%) | ||
| Kawasaki's Disease | 4/5760 (0.1%) | 1/1968 (0.1%) | ||
| Vasculitis | 1/5760 (0%) | 0/1968 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| MenACWY-CRM197 + Routine Vaccines (All) | Routine Vaccines (All) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4701/5760 (81.6%) | 1600/1968 (81.3%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 276/5760 (4.8%) | 94/1968 (4.8%) | ||
| Eye disorders | ||||
| Conjunctivitis | 732/5760 (12.7%) | 234/1968 (11.9%) | ||
| Gastrointestinal disorders | ||||
| Constipation | 275/5760 (4.8%) | 98/1968 (5%) | ||
| Diarrhoea | 1181/5760 (20.5%) | 356/1968 (18.1%) | ||
| Teething | 294/5760 (5.1%) | 106/1968 (5.4%) | ||
| Vomiting | 500/5760 (8.7%) | 155/1968 (7.9%) | ||
| General disorders | ||||
| Injection Site Erythema | 519/5760 (9%) | 241/1968 (12.2%) | ||
| Injection Site Induration | 284/5760 (4.9%) | 181/1968 (9.2%) | ||
| Injection Site Pain | 916/5760 (15.9%) | 338/1968 (17.2%) | ||
| Irritability | 1146/5760 (19.9%) | 405/1968 (20.6%) | ||
| Pyrexia | 1239/5760 (21.5%) | 373/1968 (19%) | ||
| Infections and infestations | ||||
| Bronchiolitis | 826/5760 (14.3%) | 299/1968 (15.2%) | ||
| Bronchitis | 446/5760 (7.7%) | 153/1968 (7.8%) | ||
| Croup Infectious | 284/5760 (4.9%) | 98/1968 (5%) | ||
| Gastroenteritis | 524/5760 (9.1%) | 179/1968 (9.1%) | ||
| Influenza | 415/5760 (7.2%) | 124/1968 (6.3%) | ||
| Nasopharyngitits | 751/5760 (13%) | 239/1968 (12.1%) | ||
| Otitis Media | 1579/5760 (27.4%) | 551/1968 (28%) | ||
| Otitis Media Acute | 412/5760 (7.2%) | 154/1968 (7.8%) | ||
| Pharyngitits | 609/5760 (10.6%) | 208/1968 (10.6%) | ||
| Sinusitis | 296/5760 (5.1%) | 93/1968 (4.7%) | ||
| Upper Respiratory Tract Infection | 2358/5760 (40.9%) | 842/1968 (42.8%) | ||
| Viral Infection | 591/5760 (10.3%) | 175/1968 (8.9%) | ||
| Nervous system disorders | ||||
| Crying | 859/5760 (14.9%) | 277/1968 (14.1%) | ||
| Somnolence | 927/5760 (16.1%) | 307/1968 (15.6%) | ||
| Psychiatric disorders | ||||
| Eating Disorder | 593/5760 (10.3%) | 187/1968 (9.5%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 504/5760 (8.8%) | 171/1968 (8.7%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Dermatitis Diaper | 628/5760 (10.9%) | 201/1968 (10.2%) | ||
| Eczema | 399/5760 (6.9%) | 145/1968 (7.4%) | ||
| Rash | 307/5760 (5.3%) | 109/1968 (5.5%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Posting Director |
|---|---|
| Organization | Novartis Vaccines and Diagnostics |
| Phone | |
| RegistryContactVaccinesUS@novartis.com |
Responsible Party:
Novartis
ClinicalTrials.gov Identifier:
NCT00806195
Other Study ID Numbers:
- V59P23
First Posted:
Dec 10, 2008
Last Update Posted:
Jul 9, 2013
Last Verified:
May 1, 2013