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

NCT01000311 | Completed Phase 3 Results

• 1 other identifier: V59_33
• Study Type: interventional
• Target: 529
• Locations: 3 countries
• Sites: 46

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.

Conditions

Meningococcal Disease

Keywords

MenACWY conjugate vaccine in infants; Meningococcal vaccine in infants; MenACWY

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (11)

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

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

• 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

  Baseline and one month after third infant dose 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

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

• 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

  One month after third dose of routine infant series vaccination

• 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

  One month after third dose of routine infant series vaccination

Study Arms (2)

MenACWY-CRM + Routine Vaccines

EXPERIMENTAL

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.

Biological: MenACWY-CRM; Biological: DTaP-IPV/Hib; Biological: HBV; Biological: PCV; Biological: MMR

Routine Vaccines

EXPERIMENTAL

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.

Biological: DTaP-IPV/Hib; Biological: HBV; Biological: PCV; Biological: MMR

Interventions

MenACWY-CRM BIOLOGICAL

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.

MenACWY-CRM + Routine Vaccines

DTaP-IPV/Hib BIOLOGICAL

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.

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

MenACWY-CRM + Routine Vaccines; Routine Vaccines

HBV BIOLOGICAL

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.

Also known as: Hepatitis B virus vaccine; Engerix-B

MenACWY-CRM + Routine Vaccines; Routine Vaccines

PCV BIOLOGICAL

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.

Also known as: Heptavalent Streptococcus pneumonia vaccine; Prevnar (PCV-7); Prevnar 13 (PCV-13)

MenACWY-CRM + Routine Vaccines; Routine Vaccines

MMR BIOLOGICAL

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.

Also known as: Measles, mumps, and rubella vaccine; M-M-R II

MenACWY-CRM + Routine Vaccines; Routine Vaccines

Eligibility Criteria

• Age: 55 Days - 89 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (46)

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

Birmingham, Alabama, 35235, United States

Location

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

Fayetteville, Arkansas, 72703, United States

Location

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

Jonesboro, Arkansas, 72401, United States

Location

9 San Fernando Valley Research Associates 7111 Winnetka Avenue Suite 14

Canoga Park, California, 91306, United States

Location

17 Edinger Medical Group Research Center 9900 Talbert Avenue Suite 204

Fountain Valley, California, 92708-5153, United States

Location

28 Madera Family Medical Group 1111 West 4th Street

Madera, California, 93637, United States

Location

38 Center for Clinical Trials LLC 16660 Paramount Blvd Suite 301

Paramount, California, 90723, United States

Location

8 Pharmax Research Clinic 7200 NW 7th Street Suite 350

Miami, Florida, 33126, United States

Location

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

Topeka, Kansas, 66604, United States

Location

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

Topeka, Kansas, 66614, United States

Location

29 Kentucky Pediatric/Adult Research 201 South 5th Street

Bardstown, Kentucky, 40004, United States

Location

4 Nassim McMonigle Mescia and Associates 5512 Bardstown Road Suite 2

Louisville, Kentucky, 40291, United States

Location

40 Brownsboro Park Pediatrics 5512 Bardstown Road Suite 2

Louisville, Kentucky, 40291, United States

Location

24 University Of Louisville 555 South Floyd Street

Louisville, Kentucky, 40402, United States

Location

26 University Of Louisville 230 East Broadway

Louisville, Kentucky, 40402, United States

Location

30 Kentucky Pediatric/Adult Research 102 West Depot Street

Springfield, Kentucky, 40069, United States

Location

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

Haughton, Louisiana, 71037, United States

Location

13 Willis Knighton Physician Network- Portico Pediatrics 7847 Youree Drive

Shreveport, Louisiana, 71105, United States

Location

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

Niles, Michigan, 49120, United States

Location

25 Center for Pharmaceutical Research 1010 Carondelet Drive Suite 426

Kansas City, Missouri, 64114, United States

Location

31 Senders Pediatrics 2054 South Green Road

Cleveland, Ohio, 44121-4243, United States

Location

5 Dayton Clinical Research 1100 Salem Ave.

Dayton, Ohio, 45406, United States

Location

14 Ohio Pediatrics Research Association 7371 Brandt Pike Suite C

Huber Heights, Ohio, 45424, United States

Location

22 Ohio Pediatrics Research Association 1775 Delco Park Drive

Kettering, Ohio, 45420, United States

Location

45 Oklahoma State University Physicians 635 W 11th St

Tulsa, Oklahoma, 74127, United States

Location

33 Primary Physicians Research Inc. 1580 McLaughlin Run Road

Pittsburgh, Pennsylvania, 15241, United States

Location

34 Primary Physicians Research Inc. 1580 McLaughlin Run Road

Pittsburgh, Pennsylvania, 15241, United States

Location

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

Kingsport, Tennessee, 37660, United States

Location

23 Focus Research Group 201 Signature Place

Lebanon, Tennessee, 37087, United States

Location

7 Amarillo Children's Clinical Research #17 Care Circle

Amarillo, Texas, 79124, United States

Location

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

Houston, Texas, 77070, United States

Location

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

Tomball, Texas, 77375, United States

Location

16 Westside Medical 1477 North 2000 West

Clinton, Utah, 84015, United States

Location

42 Wee Care Pediatrics 934 S. Main Street Suite 8

Layton, Utah, 84041, United States

Location

43 Wee Care Pediatrics 1580 W. Antelope Drive Suite 100

Layton, Utah, 84041, United States

Location

19 Pediatric Care 1675 North Freedom Blvd Building 3

Provo, Utah, 84604, United States

Location

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

Roy, Utah, 84067, United States

Location

18 Copperview Medical Center 3556 West 9800 South

South Jordan, Utah, 84095, United States

Location

39 Dixie Pediatrics 1240 E 100 S Suite 14

St. George, Utah, 84790, United States

Location

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

Syracuse, Utah, 84075, United States

Location

36 Dominion Medical Associates 304 East Leigh Street

Richmond, Virginia, 23219, United States

Location

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

Charleston, West Virginia, 25304, United States

Location

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

Randwick, New South Wales, 2031, Australia

Location

2 Royal Children's Hospital Herston Road

Herston, Queensland, 4029, Australia

Location

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

Carlton, Victoria, 3010, Australia

Location

20 Medicor Research Inc 359 Riverside Suite 200

Greater Sudbury, Ontario, P3E 1H5, Canada

Location

MeSH Terms

Conditions

Meningococcal Infections

Interventions

MenACWY-CRM vaccine; diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine; Tetanus Toxoid; pentacel; Hepatitis B Vaccines; Engerix-B; Heptavalent Pneumococcal Conjugate Vaccine; 13-valent pneumococcal vaccine; Rubella Vaccine; Measles-Mumps-Rubella Vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures; Viral Hepatitis Vaccines; Viral Vaccines; Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines, Combined; Measles Vaccine; Mumps Vaccine

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 23, 2009
• Study Start: November 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 21, 2014
• Results First Posted: March 26, 2014

Record last verified: 2014-04

Locations

US (42); CA (1); AU (3)