Meningococcal DiseasePhase 3NCT01000311
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
A Phase 3 study testing MenACWY-CRM, DTaP-IPV/Hib and HBV in people with Meningococcal Disease, run by Novartis Vaccines at 46 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 89 daysHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Disease
- What is being tested?
- MenACWY-CRM, DTaP-IPV/Hib and HBV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 529 participants
- Where
- 46 sitesin 3 countries
- Study dates
- Nov 2009to Nov 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 89 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
Trial locations and contacts
46 sites in 3 countries.
46 sites in 3 countries
United States42 sites
7 Amarillo Children's Clinical Research #17 Care Circle
Amarillo, Texas, 79124
29 Kentucky Pediatric/Adult Research 201 South 5th Street
Bardstown, Kentucky, 40004
37 Alabama Clinical Therapeutics LLC 52 Medical Park East Drive Suite 203
Birmingham, Alabama, 35235
9 San Fernando Valley Research Associates 7111 Winnetka Avenue Suite 14
Canoga Park, California, 91306
21 CAMC Health Education and Research Institute 3100 McCorkle Ave. S.E. Suite 806
Charleston, West Virginia, 25304
31 Senders Pediatrics 2054 South Green Road
Cleveland, Ohio, 44121-4243
16 Westside Medical 1477 North 2000 West
Clinton, Utah, 84015
5 Dayton Clinical Research 1100 Salem Ave.
Dayton, Ohio, 45406
15 Northwest Arkansas Pediatric Clinic 3383 N. Mana Court Suite 101
Fayetteville, Arkansas, 72703
17 Edinger Medical Group Research Center 9900 Talbert Avenue Suite 204
Fountain Valley, California, 92708-5153
27 Ark-La-Tex Children's Clinic 1025 Highway 80 E
Haughton, Louisiana, 71037
46 Pediatric Healthcare of Northwest Houston P.A. 12015 Louetta Road Suite 100
Houston, Texas, 77070
14 Ohio Pediatrics Research Association 7371 Brandt Pike Suite C
Huber Heights, Ohio, 45424
6 Children's Clinic of Jonesboro AR 800 South Church Street Suite 400 and 204
Jonesboro, Arkansas, 72401
25 Center for Pharmaceutical Research 1010 Carondelet Drive Suite 426
Kansas City, Missouri, 64114
22 Ohio Pediatrics Research Association 1775 Delco Park Drive
Kettering, Ohio, 45420
10 Holston Medical Group 105 W. Stone Drive Suite 3B
Kingsport, Tennessee, 37660
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
23 Focus Research Group 201 Signature Place
Lebanon, Tennessee, 37087
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
28 Madera Family Medical Group 1111 West 4th Street
Madera, California, 93637
8 Pharmax Research Clinic 7200 NW 7th Street Suite 350
Miami, Florida, 33126
35 Southwestern Medical Clinic P.C. 2002 S 11th Street
Niles, Michigan, 49120
38 Center for Clinical Trials LLC 16660 Paramount Blvd Suite 301
Paramount, California, 90723
33 Primary Physicians Research Inc. 1580 McLaughlin Run Road
Pittsburgh, Pennsylvania, 15241
34 Primary Physicians Research Inc. 1580 McLaughlin Run Road
Pittsburgh, Pennsylvania, 15241
19 Pediatric Care 1675 North Freedom Blvd Building 3
Provo, Utah, 84604
36 Dominion Medical Associates 304 East Leigh Street
Richmond, Virginia, 23219
44 Wee Care Pediatrics 5991 S. 3500 W Suite 100 Rock Run Plaza
Roy, Utah, 84067
13 Willis Knighton Physician Network- Portico Pediatrics 7847 Youree Drive
Shreveport, Louisiana, 71105
18 Copperview Medical Center 3556 West 9800 South
South Jordan, Utah, 84095
30 Kentucky Pediatric/Adult Research 102 West Depot Street
Springfield, Kentucky, 40069
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
12 Pediatric Healthcare of Northwest Houston P.A. 13406 Medical Complex Drive Suite 200
Tomball, Texas, 77375
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
45 Oklahoma State University Physicians 635 W 11th St
Tulsa, Oklahoma, 74127
Australia3 sites
1 Murdoch Childrens Research Institute C/- School of Population Health The University of Melbourne
Carlton, Victoria, 3010
2 Royal Children's Hospital Herston Road
Herston, Queensland, 4029
3 Sydney Children's Hospital Strasser Lab. Level 3 High Street
Randwick, New South Wales, 2031
Canada1 site
20 Medicor Research Inc 359 Riverside Suite 200
Greater Sudbury, Ontario, P3E 1H5
About this study
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
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
- Being tested
- MenACWY-CRM, DTaP-IPV/Hib, HBV, PCV, MMR
- Keywords
- MenACWY conjugate vaccine in infants, Meningococcal vaccine in infants, MenACWY
- Medical subject headings
- Meningococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenACWY-CRMBiological
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.
DTaP-IPV/HibBiological
Also called Combined diphtheria, tetanus toxoid, acellular pertussis and inactivated polio vaccine containing Haemophilus influenzae type B vaccine; Pentacel
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.
HBVBiological
Also called Hepatitis B virus vaccine; Engerix-B
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.
PCVBiological
Also called Heptavalent Streptococcus pneumonia vaccine; Prevnar (PCV-7); Prevnar 13 (PCV-13)
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.
MMRBiological
Also called Measles, mumps, and rubella vaccine; M-M-R II
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: DTaP-IPV/Hib; Biological: HBV; Biological: PCV; Biological: MMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: One month after third dose of routine infant series vaccination
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.
Measured: One month after PCV toddler vaccination
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.
Measured: One month after PCV toddler vaccination
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.
Measured: Baseline and Six months after third infant 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.
Measured: Baseline and Six months after third infant 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.
Measured: One month after MenACWY-CRM 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.
Measured: From day 1 to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Meningococcal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 529 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000311
- Sponsor's protocol ID
- V59_33
- Status last verified
- Apr 2014
- First submitted
- 22 Oct 2009
- Last updated
- 21 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01000311
- Acronym / sponsor ID
- V59_33
- Conditions
- Meningococcal Disease
- Keywords
- MenACWY conjugate vaccine in infants, Meningococcal vaccine in infants, MenACWY
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 529 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 23 Oct 2009 (estimated)
- Results
- Posted 26 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MenACWY-CRM + Routine Vaccines | Experimental | Biological: MenACWY-CRM, Biological: DTaP-IPV/Hib, Biological: HBV, Biological: PCV, Biological: MMRInfants 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. |
| Routine Vaccines | Experimental | Biological: DTaP-IPV/Hib, Biological: HBV, Biological: PCV, Biological: MMRInfants 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. |
Who may qualify
- Ages
- 55 to 89 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MenACWY-CRMOne 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. | Biological | MenACWY-CRM + Routine Vaccines |
| DTaP-IPV/HibAlso: Combined diphtheria, tetanus toxoid, acellular pertussis and inactivated polio vaccine containing Haemophilus influenzae type B vaccine; PentacelIM 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. | Biological | MenACWY-CRM + Routine Vaccines, Routine Vaccines |
| HBVAlso: Hepatitis B virus vaccine; Engerix-BIM 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. | Biological | MenACWY-CRM + Routine Vaccines, Routine Vaccines |
| PCVAlso: Heptavalent Streptococcus pneumonia vaccine; Prevnar (PCV-7); Prevnar 13 (PCV-13)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. | Biological | MenACWY-CRM + Routine Vaccines, Routine Vaccines |
| MMRAlso: Measles, mumps, and rubella vaccine; M-M-R IISubcutaneous (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. | Biological | MenACWY-CRM + Routine Vaccines, Routine Vaccines |
Primary outcome
Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Time frame: Baseline and one month after fourth-dose 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.
11 secondary outcomes
hSBA Geometric Mean Titers Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: One month after third dose of routine infant series vaccination
Geometric Mean Concentrations Of Antibodies Against Pneumococcal Antigens One Month After Toddler Vaccination With PCV Administered With MenACWY-CRM Compared With PCV Given Alone
Time frame: One month after PCV toddler vaccination
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
Time frame: One month after PCV toddler vaccination
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
Time frame: Baseline and Six months after third infant 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
Time frame: Baseline and Six months after third infant 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
Time frame: One month after MenACWY-CRM toddler vaccination
Safety of MenACWY-CRM Vaccinations When Administered Concomitantly With Routine Vaccinations
Time frame: From day 1 to 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
46 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MenACWY-CRM, DTaP-IPV/Hib and HBV in people with Meningococcal Disease, run by Novartis Vaccines at 46 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With hSBA Titer ≥1:8 Against Serogroup A, C, W and Y One Month After Toddler Vaccination of MenACWY-CRM (time frame: Baseline and one month after fourth-dose of MenACWY-CRM). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.