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A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months

Primary Purpose

Meningococcal Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

MenACWY-CRM

DTaP-IPV/Hib

HBV

PCV

MMR

About this trial

This is an interventional prevention trial for Meningococcal Disease focused on measuring MenACWY conjugate vaccine in infants, Meningococcal vaccine in infants, MenACWY

Eligibility Criteria

55 Days - 89 Days (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Two month-old infants, born after a full-term pregnancy with an estimated gestational age ≥37 weeks and a birth weight ≥2.5 kg.
Documented written informed consent provided by the parent/legal representative after the nature of the study had been explained.
Parent/legal representative was available for all visits scheduled in the study.
Subjects were in good health as determined by:
1. medical history
2. physical assessment
3. clinical judgment of the investigator

Exclusion Criteria:

Subjects who previously received any meningococcal vaccines or vaccines against diphtheria, tetanus, pertussis, polio (IPV or OPV), H. influenzae type b (Hib) or pneumococcus. Exceptions: prior doses HBV vaccination (one or two doses) are permitted.
Subjects who had 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).
Subjects who had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis, B. pertussis, Hib, C. diphtheriae, polio, or pneumococcal infection at any time since birth.
Subjects who had a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component.
Subjects who had experienced significant acute or chronic infection within the previous 7 days or have experienced fever (temperature ≥ 38.0°C [100.4°F]) within the previous 3 days.
Subjects who had any serious acute or chronic disease, neurological disease including seizures, congenital defects, or cytogenic disorders (e.g., Down syndrome).
Subjects who had a known or suspected autoimmune disease or persistent impairment/alteration of immune function.
Subjects who had a suspected or known HIV infection or were born to a mother known to be HIV positive.
Subjects who had ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin).
Subjects who had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Subjects who with their parents/legal representatives were planning to leave the area of the study site before the end of the study period.
Subjects who had any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.
Subjects who 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.
Subjects who were relatives of site research staff working on this study.

Sites / Locations

37 Alabama Clinical Therapeutics LLC 52 Medical Park East Drive Suite 203
15 Northwest Arkansas Pediatric Clinic 3383 N. Mana Court Suite 101
6 Children's Clinic of Jonesboro AR 800 South Church Street Suite 400 and 204
9 San Fernando Valley Research Associates 7111 Winnetka Avenue Suite 14
17 Edinger Medical Group Research Center 9900 Talbert Avenue Suite 204
28 Madera Family Medical Group 1111 West 4th Street
38 Center for Clinical Trials LLC 16660 Paramount Blvd Suite 301
8 Pharmax Research Clinic 7200 NW 7th Street Suite 350
48 Cotton O'Neil Clinical Research Center 4100 SW 15th Street
47 Cotton O'Neil Clinical Research Center 6725 SW 29th Street
29 Kentucky Pediatric/Adult Research 201 South 5th Street
4 Nassim McMonigle Mescia and Associates 5512 Bardstown Road Suite 2
40 Brownsboro Park Pediatrics 5512 Bardstown Road Suite 2
24 University Of Louisville 555 South Floyd Street
26 University Of Louisville 230 East Broadway
30 Kentucky Pediatric/Adult Research 102 West Depot Street
27 Ark-La-Tex Children's Clinic 1025 Highway 80 E
13 Willis Knighton Physician Network- Portico Pediatrics 7847 Youree Drive
35 Southwestern Medical Clinic P.C. 2002 S 11th Street
25 Center for Pharmaceutical Research 1010 Carondelet Drive Suite 426
31 Senders Pediatrics 2054 South Green Road
5 Dayton Clinical Research 1100 Salem Ave.
14 Ohio Pediatrics Research Association 7371 Brandt Pike Suite C
22 Ohio Pediatrics Research Association 1775 Delco Park Drive
45 Oklahoma State University Physicians 635 W 11th St
33 Primary Physicians Research Inc. 1580 McLaughlin Run Road
34 Primary Physicians Research Inc. 1580 McLaughlin Run Road
10 Holston Medical Group 105 W. Stone Drive Suite 3B
23 Focus Research Group 201 Signature Place
7 Amarillo Children's Clinical Research #17 Care Circle
46 Pediatric Healthcare of Northwest Houston P.A. 12015 Louetta Road Suite 100
12 Pediatric Healthcare of Northwest Houston P.A. 13406 Medical Complex Drive Suite 200
16 Westside Medical 1477 North 2000 West
42 Wee Care Pediatrics 934 S. Main Street Suite 8
43 Wee Care Pediatrics 1580 W. Antelope Drive Suite 100
19 Pediatric Care 1675 North Freedom Blvd Building 3
44 Wee Care Pediatrics 5991 S. 3500 W Suite 100 Rock Run Plaza
18 Copperview Medical Center 3556 West 9800 South
39 Dixie Pediatrics 1240 E 100 S Suite 14
41 Wee Care Pediatrics 1792 W. 1700 S. Suite 102
36 Dominion Medical Associates 304 East Leigh Street
21 CAMC Health Education and Research Institute 3100 McCorkle Ave. S.E. Suite 806
3 Sydney Children's Hospital Strasser Lab. Level 3 High Street
2 Royal Children's Hospital Herston Road
1 Murdoch Childrens Research Institute C/- School of Population Health The University of Melbourne
20 Medicor Research Inc 359 Riverside Suite 200

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

MenACWY-CRM + Routine Vaccines

Routine Vaccines

Arm Description

Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months of age. Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.

Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months. In addition subjects were offered a dose of MenACWY-CRM at 18 months as a benefit of participating in this study. However, blood was not drawn for immunogenicity analysis after this dose.

Outcomes

Primary Outcome Measures

Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM

Immunogenicity was measured as the percentage of subjects who achieved hSBA titer ≥1:8 against meningococcal serogroup A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age. The immune response was considered sufficient if the lower limit of the two-sided 95% confidence intervals (CIs) for the percentage of subjects with hSBA titer ≥1:8, at one month after toddler vaccination, was greater than 85% for the serogroup C, W, or Y and greater than 80% for the serogroup A.

Secondary Outcome Measures

hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM

Immunogenicity was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal serogroup A, C, W and Y, at baseline and one month after toddler dose of MenACWY-CRM administered at 12 months of age.

Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM

Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroup A, C, W and Y, before (baseline) and one month after 3 infant doses of MenACWY-CRM administered at 2, 4 and 6 months of age. Percentage of subjects who achieved at least four-fold rise in hSBA titers against serogroup A, C, W and Y was measured one month after 3 infant doses of MenACWY-CRM.

hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM

Immunogenicity was measured as the hSBA GMTs directed against meningococcal serogroups A, C, W and Y before (baseline) and one month after 3 infants doses of MenACWY-CRM administered at 2, 4 and 6 months of age.

Percentage of Subjects With Seroresponse to Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone

The immune seroresponse to routine concomitant vaccination was measured as the percentages of subjects with pre-specified cut-off limit of ≥0.1 IU/mL (Diphtheria and Tetanus); ≥0.15 μg/mL (Hib); ≥0.35 μg/mL (Pneumococcal antigens, PnC); and ≥10 mIU/mL (Hepatitis B), evaluated using enzyme-linked immunosorbent assay (ELISA) at one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age. The immune response to pertussis antigens (PT, FHA, Pertactin, FIM) was measured as percentage of subjects with seroresponse (in initially seronegative infants, ≥4 times the lower limit of quantification (LLQ); in initially seropositive infants, at least 4 times prevaccination concentration) by ELISA and percentage of subjects with titer ≥1:8 (Polio types 1, 2, and 3) by neutralization test (NT) one month after 3 doses of infant series vaccination administered at 2, 4 and 6 months of age.

Geometric Mean Concentrations Of Antibodies Against Routine Concomitant Vaccinations One Month After Infant Series, When Routine Vaccines Are Administered With MenACWY-CRM Compared With When Routine Vaccines Are Given Alone

The immune response was measured as the geometric mean concentrations (GMCs) of antibodies directed against diphtheria, tetanus, pertussis (PT, FHA, Pertactin, FIM), hepatitis B, Hib, polio (type 1, 2 and 3) and pneumococcal (PnC 4, 6B, 9V, 14, 18C, 19F and 23F) antigens when routine vaccines are administered concomitantly with MenACWY-CRM compared with when routine vaccines are given alone, one month after 3 doses of infant series vaccination at 2, 4 and 6 months of age.

Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone

Immunogenicity was measured as the GMCs of anti-pneumococcal antibodies against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age administered concomitantly with MenACWY-CRM compared with PCV given alone.

Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone

The immune seroresponse was measured as the percentage of subjects with anti-pneumococcal antigen antibodies ≥0.35 μg/mL against pneumococcal antigens PnC 4, 6B, 9V, 14, 18C, 19F and 23F, one month after toddler dose of PCV at 12 months of age when administered concomitantly with MenACWY-CRM compared with PCV given alone.

Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination

The antibody persistence was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.

Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination

The antibody persistence was measured as the hSBA GMTs directed against meningococcal serogroup A, C, W and Y, at baseline and six months after third infant dose of MenACWY-CRM administered at 6 months (12 months of age), before administration of the toddler dose of MenACWY-CRM.

Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM

The immune response was measured as the percentage of subjects who achieved four-fold increase in hSBA titers against meningococcal serogroup A, C, W and Y one month after toddler dose of MenACWY-CRM administered at 12 months of age as compared to hSBA titers before the toddler vaccination.

Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations

Safety of the study vaccines (MenACWY-CRM and other routine vaccines) was assessed in terms of the number of subjects who reported adverse events (AEs) and/or serious AEs per vaccine group at the following time points: entire study period, after infants vaccination (up to 7 months), between 2- and 4-months, between 4- and 6-months, between 6- and 12-months, between 7- and 12-months, 28 days after 12-month vaccination, and between 29 days after 12-month vaccination and study termination. Solicited reactions were not collected during this study. The safety analyses also included any AEs observed by study personnel within 15 minutes following vaccination. All AEs and SAEs were judged by the investigator as whether probably related, possibly related, or not related to vaccine.

Full Information

NCT ID

NCT01000311

First Posted

October 22, 2009

Last Updated

April 3, 2014

Sponsor

Novartis Vaccines

1. Study Identification

Unique Protocol Identification Number

NCT01000311

Brief Title

A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months

Official Title

A Phase 3, Randomized, Open Label, Controlled Multicenter Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Vaccines

4. Oversight

5. Study Description

Brief Summary

This Phase 3 study is designed to demonstrate the safety and immunogenicity of MenACWY and non-interference of concomitant routine vaccines by MenACWY in an infant age group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Meningococcal Disease

Keywords

MenACWY conjugate vaccine in infants, Meningococcal vaccine in infants, MenACWY

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

529 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MenACWY-CRM + Routine Vaccines

Arm Type

Experimental

Arm Description

Arm Title

Routine Vaccines

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

MenACWY-CRM

Intervention Description

One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2, 4, 6 and 12 months of age as IM injections in the anterolateral area of the thigh.

Intervention Type

Biological

Intervention Name(s)

DTaP-IPV/Hib

Other Intervention Name(s)

Combined diphtheria, tetanus toxoid, acellular pertussis and inactivated polio vaccine containing Haemophilus influenzae type B vaccine; Pentacel

Intervention Description

IM injections of 3 doses of 0.5 mL each of DTaP-IPV/Hib supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.

Intervention Type

Biological

Intervention Name(s)

HBV

Other Intervention Name(s)

Hepatitis B virus vaccine; Engerix-B

Intervention Description

IM injections of 3 doses of 0.5 mL each of HBV supplied in prefilled vial were administered at 2, 4 and 6 months of age in the anterolateral area of the thigh.

Intervention Type

Biological

Intervention Name(s)

PCV

Other Intervention Name(s)

Heptavalent Streptococcus pneumonia vaccine; Prevnar (PCV-7); Prevnar 13 (PCV-13)

Intervention Description

IM injections of 4 doses of 0.5 mL each of PCV supplied in prefilled vial were administered at 2, 4, 6 and 12 months of age in the anterolateral area of the thigh.

Intervention Type

Biological

Intervention Name(s)

MMR

Other Intervention Name(s)

Measles, mumps, and rubella vaccine; M-M-R II

Intervention Description

Subcutaneous (SC) injection of 1 dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 12 months of age in the anterolateral area of the thigh.

Primary Outcome Measure Information:

Title

Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM

Description

Time Frame

Baseline and one month after fourth-dose of MenACWY-CRM

Secondary Outcome Measure Information:

Title

hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM

Description

Time Frame

Baseline and one month after fourth-dose of MenACWY-CRM

Title

Percentage of Subjects With hSBA Titers ≥1:8, and Four-Fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM

Description

Time Frame

Baseline and one month after third infant dose of MenACWY-CRM

Title

hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Three Dose Infant Series Vaccination of MenACWY-CRM

Description

Time Frame

Baseline and one month after third infant dose of MenACWY-CRM

Title

Description

Time Frame

One month after third dose of routine infant series vaccination

Title

Description

Time Frame

One month after third dose of routine infant series vaccination

Title

Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone

Description

Time Frame

One month after PCV toddler vaccination

Title

Percentage of Subjects With Anti-pneumococcal Antigen Antibodies ≥0.35 μg/mL One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone

Description

Time Frame

One month after PCV toddler vaccination

Title

Antibody Persistence by Percentage of Subjects With hSBA Titers ≥1:8 Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination

Description

Time Frame

Baseline and Six months after third infant dose of MenACWY-CRM

Title

Persistence of hSBA Geometric Mean Titers Against Serogroup A, C, W and Y, Six Months After Third Infant Vaccination, Prior to MenACWY-CRM Toddler Vaccination

Description

Time Frame

Baseline and Six months after third infant dose of MenACWY-CRM

Title

Percentage of Subjects With Four-fold Increase in hSBA Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM

Description

Time Frame

One month after MenACWY-CRM toddler vaccination

Title

Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations

Description

Time Frame

From day 1 to 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Days

Maximum Age & Unit of Time

89 Days

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Two month-old infants, born after a full-term pregnancy with an estimated gestational age ≥37 weeks and a birth weight ≥2.5 kg. Documented written informed consent provided by the parent/legal representative after the nature of the study had been explained. Parent/legal representative was available for all visits scheduled in the study. Subjects were in good health as determined by: medical history physical assessment clinical judgment of the investigator Exclusion Criteria: Subjects who previously received any meningococcal vaccines or vaccines against diphtheria, tetanus, pertussis, polio (IPV or OPV), H. influenzae type b (Hib) or pneumococcus. Exceptions: prior doses HBV vaccination (one or two doses) are permitted. Subjects who had 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). Subjects who had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis, B. pertussis, Hib, C. diphtheriae, polio, or pneumococcal infection at any time since birth. Subjects who had a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component. Subjects who had experienced significant acute or chronic infection within the previous 7 days or have experienced fever (temperature ≥ 38.0°C [100.4°F]) within the previous 3 days. Subjects who had any serious acute or chronic disease, neurological disease including seizures, congenital defects, or cytogenic disorders (e.g., Down syndrome). Subjects who had a known or suspected autoimmune disease or persistent impairment/alteration of immune function. Subjects who had a suspected or known HIV infection or were born to a mother known to be HIV positive. Subjects who had ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation (including Hepatitis B immune globulin). Subjects who had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. Subjects who with their parents/legal representatives were planning to leave the area of the study site before the end of the study period. Subjects who had any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. Subjects who 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. Subjects who were relatives of site research staff working on this study.

Facility Information:

Facility Name

37 Alabama Clinical Therapeutics LLC 52 Medical Park East Drive Suite 203

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35235

Country

United States

Facility Name

15 Northwest Arkansas Pediatric Clinic 3383 N. Mana Court Suite 101

City

Fayetteville

State/Province

Arkansas

ZIP/Postal Code

72703

Country

United States

Facility Name

6 Children's Clinic of Jonesboro AR 800 South Church Street Suite 400 and 204

City

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72401

Country

United States

Facility Name

9 San Fernando Valley Research Associates 7111 Winnetka Avenue Suite 14

City

Canoga Park

State/Province

California

ZIP/Postal Code

91306

Country

United States

Facility Name

17 Edinger Medical Group Research Center 9900 Talbert Avenue Suite 204

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708-5153

Country

United States

Facility Name

28 Madera Family Medical Group 1111 West 4th Street

City

Madera

State/Province

California

ZIP/Postal Code

93637

Country

United States

Facility Name

38 Center for Clinical Trials LLC 16660 Paramount Blvd Suite 301

City

Paramount

State/Province

California

ZIP/Postal Code

90723

Country

United States

Facility Name

8 Pharmax Research Clinic 7200 NW 7th Street Suite 350

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Facility Name

48 Cotton O'Neil Clinical Research Center 4100 SW 15th Street

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66604

Country

United States

Facility Name

47 Cotton O'Neil Clinical Research Center 6725 SW 29th Street

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66614

Country

United States

Facility Name

29 Kentucky Pediatric/Adult Research 201 South 5th Street

City

Bardstown

State/Province

Kentucky

ZIP/Postal Code

40004

Country

United States

Facility Name

4 Nassim McMonigle Mescia and Associates 5512 Bardstown Road Suite 2

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40291

Country

United States

Facility Name

40 Brownsboro Park Pediatrics 5512 Bardstown Road Suite 2

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40291

Country

United States

Facility Name

24 University Of Louisville 555 South Floyd Street

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40402

Country

United States

Facility Name

26 University Of Louisville 230 East Broadway

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40402

Country

United States

Facility Name

30 Kentucky Pediatric/Adult Research 102 West Depot Street

City

Springfield

State/Province

Kentucky

ZIP/Postal Code

40069

Country

United States

Facility Name

27 Ark-La-Tex Children's Clinic 1025 Highway 80 E

City

Haughton

State/Province

Louisiana

ZIP/Postal Code

71037

Country

United States

Facility Name

13 Willis Knighton Physician Network- Portico Pediatrics 7847 Youree Drive

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71105

Country

United States

Facility Name

35 Southwestern Medical Clinic P.C. 2002 S 11th Street

City

Niles

State/Province

Michigan

ZIP/Postal Code

49120

Country

United States

Facility Name

25 Center for Pharmaceutical Research 1010 Carondelet Drive Suite 426

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64114

Country

United States

Facility Name

31 Senders Pediatrics 2054 South Green Road

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44121-4243

Country

United States

Facility Name

5 Dayton Clinical Research 1100 Salem Ave.

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45406

Country

United States

Facility Name

14 Ohio Pediatrics Research Association 7371 Brandt Pike Suite C

City

Huber Heights

State/Province

Ohio

ZIP/Postal Code

45424

Country

United States

Facility Name

22 Ohio Pediatrics Research Association 1775 Delco Park Drive

City

Kettering

State/Province

Ohio

ZIP/Postal Code

45420

Country

United States

Facility Name

45 Oklahoma State University Physicians 635 W 11th St

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74127

Country

United States

Facility Name

33 Primary Physicians Research Inc. 1580 McLaughlin Run Road

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

34 Primary Physicians Research Inc. 1580 McLaughlin Run Road

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

10 Holston Medical Group 105 W. Stone Drive Suite 3B

City

Kingsport

State/Province

Tennessee

ZIP/Postal Code

37660

Country

United States

Facility Name

23 Focus Research Group 201 Signature Place

City

Lebanon

State/Province

Tennessee

ZIP/Postal Code

37087

Country

United States

Facility Name

7 Amarillo Children's Clinical Research #17 Care Circle

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79124

Country

United States

Facility Name

46 Pediatric Healthcare of Northwest Houston P.A. 12015 Louetta Road Suite 100

City

Houston

State/Province

Texas

ZIP/Postal Code

77070

Country

United States

Facility Name

12 Pediatric Healthcare of Northwest Houston P.A. 13406 Medical Complex Drive Suite 200

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

Facility Name

16 Westside Medical 1477 North 2000 West

City

Clinton

State/Province

Utah

ZIP/Postal Code

84015

Country

United States

Facility Name

42 Wee Care Pediatrics 934 S. Main Street Suite 8

City

Layton

State/Province

Utah

ZIP/Postal Code

84041

Country

United States

Facility Name

43 Wee Care Pediatrics 1580 W. Antelope Drive Suite 100

City

Layton

State/Province

Utah

ZIP/Postal Code

84041

Country

United States

Facility Name

19 Pediatric Care 1675 North Freedom Blvd Building 3

City

Provo

State/Province

Utah

ZIP/Postal Code

84604

Country

United States

Facility Name

44 Wee Care Pediatrics 5991 S. 3500 W Suite 100 Rock Run Plaza

City

Roy

State/Province

Utah

ZIP/Postal Code

84067

Country

United States

Facility Name

18 Copperview Medical Center 3556 West 9800 South

City

South Jordan

State/Province

Utah

ZIP/Postal Code

84095

Country

United States

Facility Name

39 Dixie Pediatrics 1240 E 100 S Suite 14

City

St. George

State/Province

Utah

ZIP/Postal Code

84790

Country

United States

Facility Name

41 Wee Care Pediatrics 1792 W. 1700 S. Suite 102

City

Syracuse

State/Province

Utah

ZIP/Postal Code

84075

Country

United States

Facility Name

36 Dominion Medical Associates 304 East Leigh Street

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23219

Country

United States

Facility Name

21 CAMC Health Education and Research Institute 3100 McCorkle Ave. S.E. Suite 806

City

Charleston

State/Province

West Virginia

ZIP/Postal Code

25304

Country

United States

Facility Name

3 Sydney Children's Hospital Strasser Lab. Level 3 High Street

City

Randwick

State/Province

New South Wales

ZIP/Postal Code

2031

Country

Australia

Facility Name

2 Royal Children's Hospital Herston Road

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

1 Murdoch Childrens Research Institute C/- School of Population Health The University of Melbourne

City

Carlton

State/Province

Victoria

ZIP/Postal Code

3010

Country

Australia

Facility Name

20 Medicor Research Inc 359 Riverside Suite 200

City

Sudbury

State/Province

Ontario

ZIP/Postal Code

P3E 1H5

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months

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