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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00667602
Other study ID # V59P22
Secondary ID 2007-004754-82
Status Completed
Phase Phase 3
First received April 24, 2008
Last updated September 3, 2013
Start date March 2008
Est. completion date October 2010

Study information

Verified date September 2013
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationGermany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial Summary

The primary immunogenicity objective is to assess and compare the immunogenicity of one dose of MenACWY to one dose of Menjugate given to healthy toddlers at 12 months of age as measured by the percentage of subjects with serum bactericidal titers directed against N. meningitidis serogroup C ≥ 1:8 obtained in the serum bactericidal assay using human complement (hSBA).


Recruitment information / eligibility

Status Completed
Enrollment 662
Est. completion date October 2010
Est. primary completion date July 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Months to 8 Months
Eligibility Inclusion Criteria:

- infants 6 to 8 months old inclusive, who were born after full term pregnancy and previously received three doses of both Prevenar and Infanrix-hexa vaccines at least 30 days before study entry

Exclusion Criteria:

- who previously received any meningococcal vaccine;

- who have had a previous confirmed or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis;

- 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;

- Subjects with any serious, acute or chronic progressive disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

Biological:
MenACWY-CRM197 (two doses)
Two 0.5mL doses of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.
MenC
One 0.5mL dose of MenC vaccine was administered by intramuscular injection.
PCV7
One 0.5mL dose of Pneumococcal 7-valent Conjugate Vaccine (PCV7) was administered by intramuscular injection.
DTPa-IPV-HepB-Hib
One 0.5mL dose of Combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-IPV-HepB-Hib) vaccine was administered by intramuscular injection.
MenACWY-CRM197 (one dose)
One 0.5mL dose of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.

Locations

Country Name City State
Germany Site 22 Bad Kreuznach
Germany Site 38 Bad Lobenstein
Germany Site 24 Balve
Germany Site 13 Berlin
Germany Site 20 Berlin
Germany Site 25 Berlin
Germany Site 26 Berlin
Germany Site 27 Berlin
Germany Site 3 Berlin
Germany Site 31 Berlin
Germany Site 15 Bönnigheim
Germany Site 39 Eschwege
Germany Site 32 Flensburg
Germany Site 16 Frankenthal
Germany Site 33 Glücksburg
Germany Site 35 Hamburg
Germany Site 2 Kehl
Germany Site 28 Mainz
Germany Site 44 Mainz
Germany Site 43 München-Ramersdorf
Germany Site 42 Neuhaus am Rennweg
Germany Site 21 Neumünster
Germany Site 9 Neumünster
Germany Site 10 Oberstenfeld
Germany Site 19 Stuttgart
Germany Site 4 Stuttgart
Germany Site 30 Weilheim i OB
Germany Site 6 Wiesloch

Sponsors (1)

Lead Sponsor Collaborator
Novartis Vaccines

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentages of Subjects With Serum Bactericidal Titer = 1:8 Against N.Meningitidis Serogroup C Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was measured using serum bactericidal assay with human complement (hSBA) titer = 1:8 against N.meningitidis serogroup C. 1 month postvaccination No
Secondary Percentages of Subjects With Human Serum Bactericidal Titer = 1:4 Against N.Meningitidis Serogroup C Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentage of subjects with serum bactericidal activity using human complement (hSBA) titers = 1:4 against N. meningitidis serogroup C. 1 month postvaccination No
Secondary Percentages of Subjects With Human Serum Bactericidal Titer = 1:8 and Titer = 1:4 Against N. Meningitidis Serogroups A, C, W, Y Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month postvaccination was assessed and compared as percentages of subjects with serum bactericidal titer with human complement (hSBA) = 1:8, = 1:4 against N.meningitidis Serogroup C.
Immunogenicity of two doses of MenACWY-CRM197 vaccine one month postvaccination was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) = 1:8, = 1:4 against N.meningitidis Serogroup A, W, Y.
1 month postvaccination. No
Secondary Percentages of Subjects With Human Serum Bactericidal Titer = 1:8 and Titer = 1:4 Against N. Meningitidis Serogroups A, W, Y Immunogenicity for one dose of MenACWY was assessed as percentages of subjects with serum bactericidal titer with human complement (hSBA) = 1:8 and titer = 1:4 by serogroups A, W, Y.
Serogroup C is not shown here as it is shown in other outcome measures.
1 month postvaccination. No
Secondary Human Serum Bactericidal Activity Geometric Mean Titers After One Dose of MenACWY-CRM197 and MenC Against N.Meningitidis Serogroup C Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed with geometric mean titer (GMT) of serum bactericidal assay with human complement (hSBA) against N. meningitidis serogroup C. 1 month postvaccination No
Secondary Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y Immunogenicity of one dose of MenACWY-CRM197 one month postvaccination was assessed with GMT of serum bactericidal assay with hSBA against Serogroups A, W, Y. 1 month postvaccination No
Secondary Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W, Y The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed and compared as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroup C.
The immunogenicity of two doses of MenACWY-CRM197, to a single dose of MenC was assessed as measured by human Serum Bactericidal Activity Geometric Mean Titers directed against N. meningitidis serogroups A, W, Y.
1 month postvaccination No
Secondary Percentages of Subjects With Seroresponse Rates After One Dose of DTPa-IPV-HepB-Hib (Concomitant Vaccine) The immunogenicity of one dose of MenC to one dose of DTPa-IPV-HepB-Hib concomitant vacccine was assessed.
For Pertussis antigens, Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN), the seroresponse in initially seronegative subjects (pre-vaccination antibody concentration < LLQ) is defined as post-vaccination antibody concentration >= LLQ; in initially seropositive subjects (pre-vaccination antibody concentration >=LLQ) seroresponse is defined as at least two fold increase of the pre-vaccination antibody concentration.
Diptheria and Tetanus: primary endpoint ELISA (Enzyme-linked immunosorbent assay) >=0.1 (international unit -IU) IU/mL and the secondary endpoint is ELISA>=1.0 IU/mL.
Polio type 1, 2 and 3: bNT (neutralization test) with >=1:8.
HepB (HBV): primary endpoint ELISA >=10mU/mL.
PRP-T: primary endpoint = 0.15 mcg/mL and = 1.00 mcg/mL.
1 month postvaccination No
Secondary Percentages of Subjects With Seroresponse Rates After One Dose of PCV7 (Concomitant Vaccine) To compare the immunogenicity of PCV7 (Pneumococcal 7-valent Conjugate)Vaccine when given concomitantly with one dose or two doses of MenACWY-CRM197 or with MenC to infants at 12 months of age.
Seroresponse for PCV7 (PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F, PnC 23F) is defined as: a subject with primary endpoint ELISA = 0.35 mcg/mL and secondary endpoint ELISA = 1.0 mcg/mL.
1 month postvaccination No
Secondary Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer = 1:8 and Titer = 1:4 Against N. Meningitidis Serogroup C Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titers = 1:8, and titers = 1:4 directed against N.meningitidis serogroup C (only for subjects enrolled in Australia). 1 month postvaccination and 6-18 months postvaccination. No
Secondary Persistence of Immune Response Measured as Percentages of Subjects With Human Serum Bactericidal Titer = 1:8 ,and Titer = 1:4 Against N. Meningitidis Serogroups A, W, Y Persistence of immune response to either one or two doses of MenACWY-CRM197 or one dose of MenC as measured by serum bactericidal assay with human complement (hSBA) titer = 1:8 and titer = 1:4 directed against N. meningitidis serogroups A, W and Y (only for subjects enrolled in Australia). 1 month postvaccination 6-18 months postvaccination No
Secondary Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C Persistence of immunogenicity of either one or two doses of MenACWY or one dose of MenC as measured by human serum bactericidal activity geometric mean titers directed against N.meningitidis serogroup C (only for subjects enrolled in Australia). 1 month postvaccination and 6-18 months postvaccination. No
Secondary Persistence of Human Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroups A, W, Y Immunogenicity of two doses of MenACWY to one dose of MenACWY as measured by hSBA GMTs directed against N.meningitidis serogroups A, W, Y (only for subjects enrolled in Australia). 6-18 months postvaccination. No
Secondary Percentages of Subjects With Rabbit Serum Bactericidal = 1:8, = 1:128 and Four Fold Rise Against N.Meningitidis Serogroup C Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) = 1:8, = 1:128, and four fold rise in titer against N.meningitidis Serogroup C.
Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) = 1:8, = 1:128, and four fold rise in titer against N.meningitidis Serogroup C.
1 month postvaccination. No
Secondary Percentages of Subjects With Rabbit Serum Bactericidal = 1:8, = 1:128, and Four Fold Rise Against N.Meningitidis Serogroup A, W, Y Immunogenicity of one dose of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) = 1:8, = 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y.
Immunogenicity of two doses of MenACWY-CRM197 vaccine to one dose of MenC vaccine one month post vaccination was assessed as percentages of subjects with serum bactericidal titer with rabbit complement (rSBA) = 1:8, = 1:128, and four fold rise in titer against N.meningitidis Serogroup A, W, Y.
1 month postvaccination. No
Secondary Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup C Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C.
Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup C.
1 month postvaccination. No
Secondary Rabbit Serum Bactericidal Activity Geometric Mean Titers Against N.Meningitidis Serogroup A, W, Y Immunogenicity of one dose of MenACWY-CRM197 to one dose of MenC vaccine at 12 months of age was assessed with GMT of SBA with rabbit complement (rSBA) against Serogroup A, W, Y.
Immunogenicity of two doses of MenACWY-CRM197 to one dose of MenC vaccine at 6 to 8 and 12 months of age was assessed with geometric mean titer (GMT) of serum bactericidal assay with rabbit complement (rSBA) against Serogroup A, W, Y.
1 month postvaccination. No
Secondary Number of Subjects Who Reported Solicited Local and Systemic Reactions (Day 1 to Day 7 Postvaccination), After Any Vaccination Safety was assessed as the number of subjects who reported solicited local reactions from day 1 to day 7 postvaccination for all the three vaccination groups.
safety was assessed as the number of subjects who reported solicited systemic reactions from day 1 to day 7 Following the Month 12 vaccination in all three vaccination groups
From day 1 to day 7 postvaccination Yes
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