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Completed Phase 3 Interventional Accepts healthy volunteers Results available

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

ClinicalTrials.gov ID: NCT01000311

Public ClinicalTrials.gov record NCT01000311. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 7:55 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01000311
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Novartis Vaccines
Industry
Enrollment
529 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
55 Days to 89 Days
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 31, 2009
Primary completion
Oct 31, 2011
Completion
Oct 31, 2011
Last update posted
Apr 20, 2014

2009 – 2011

United States locations

U.S. sites
42
U.S. states
17
U.S. cities
36
Facility City State ZIP Site status
37 Alabama Clinical Therapeutics LLC 52 Medical Park East Drive Suite 203 Birmingham Alabama 35235
15 Northwest Arkansas Pediatric Clinic 3383 N. Mana Court Suite 101 Fayetteville Arkansas 72703
6 Children's Clinic of Jonesboro AR 800 South Church Street Suite 400 and 204 Jonesboro Arkansas 72401
9 San Fernando Valley Research Associates 7111 Winnetka Avenue Suite 14 Canoga Park California 91306
17 Edinger Medical Group Research Center 9900 Talbert Avenue Suite 204 Fountain Valley California 92708-5153
28 Madera Family Medical Group 1111 West 4th Street Madera California 93637
38 Center for Clinical Trials LLC 16660 Paramount Blvd Suite 301 Paramount California 90723
8 Pharmax Research Clinic 7200 NW 7th Street Suite 350 Miami Florida 33126
48 Cotton O'Neil Clinical Research Center 4100 SW 15th Street Topeka Kansas 66604
47 Cotton O'Neil Clinical Research Center 6725 SW 29th Street Topeka Kansas 66614
29 Kentucky Pediatric/Adult Research 201 South 5th Street Bardstown Kentucky 40004
4 Nassim McMonigle Mescia and Associates 5512 Bardstown Road Suite 2 Louisville Kentucky 40291
40 Brownsboro Park Pediatrics 5512 Bardstown Road Suite 2 Louisville Kentucky 40291
24 University Of Louisville 555 South Floyd Street Louisville Kentucky 40402
26 University Of Louisville 230 East Broadway Louisville Kentucky 40402
30 Kentucky Pediatric/Adult Research 102 West Depot Street Springfield Kentucky 40069
27 Ark-La-Tex Children's Clinic 1025 Highway 80 E Haughton Louisiana 71037
13 Willis Knighton Physician Network- Portico Pediatrics 7847 Youree Drive Shreveport Louisiana 71105
35 Southwestern Medical Clinic P.C. 2002 S 11th Street Niles Michigan 49120
25 Center for Pharmaceutical Research 1010 Carondelet Drive Suite 426 Kansas City Missouri 64114
31 Senders Pediatrics 2054 South Green Road Cleveland Ohio 44121-4243
5 Dayton Clinical Research 1100 Salem Ave. Dayton Ohio 45406
14 Ohio Pediatrics Research Association 7371 Brandt Pike Suite C Huber Heights Ohio 45424
22 Ohio Pediatrics Research Association 1775 Delco Park Drive Kettering Ohio 45420
45 Oklahoma State University Physicians 635 W 11th St Tulsa Oklahoma 74127
33 Primary Physicians Research Inc. 1580 McLaughlin Run Road Pittsburgh Pennsylvania 15241
34 Primary Physicians Research Inc. 1580 McLaughlin Run Road Pittsburgh Pennsylvania 15241
10 Holston Medical Group 105 W. Stone Drive Suite 3B Kingsport Tennessee 37660
23 Focus Research Group 201 Signature Place Lebanon Tennessee 37087
7 Amarillo Children's Clinical Research #17 Care Circle Amarillo Texas 79124
46 Pediatric Healthcare of Northwest Houston P.A. 12015 Louetta Road Suite 100 Houston Texas 77070
12 Pediatric Healthcare of Northwest Houston P.A. 13406 Medical Complex Drive Suite 200 Tomball Texas 77375
16 Westside Medical 1477 North 2000 West Clinton Utah 84015
42 Wee Care Pediatrics 934 S. Main Street Suite 8 Layton Utah 84041
43 Wee Care Pediatrics 1580 W. Antelope Drive Suite 100 Layton Utah 84041
19 Pediatric Care 1675 North Freedom Blvd Building 3 Provo Utah 84604
44 Wee Care Pediatrics 5991 S. 3500 W Suite 100 Rock Run Plaza Roy Utah 84067
18 Copperview Medical Center 3556 West 9800 South South Jordan Utah 84095
39 Dixie Pediatrics 1240 E 100 S Suite 14 St. George Utah 84790
41 Wee Care Pediatrics 1792 W. 1700 S. Suite 102 Syracuse Utah 84075
36 Dominion Medical Associates 304 East Leigh Street Richmond Virginia 23219
21 CAMC Health Education and Research Institute 3100 McCorkle Ave. S.E. Suite 806 Charleston West Virginia 25304

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01000311, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 20, 2014 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01000311 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →