CompletedNCT00329849Updated Oct 9, 2018Results posted

Safety and Immunogenicity of Meningococcal ACWY Conjugate Versus Polysaccharide Vaccine in Children 2 to 10 Years of Age

A Phase 3 interventional study of Meningococcal ACWY-CRM conjugate vaccine and Meningococcal ACWY-PS polysaccharide vaccine in Meningococcal Disease, sponsored by Novartis Vaccines. Completed at 3 sites in Argentina. Open to participants aged 2 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-09.

Sponsored by Novartis Vaccines · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 1,500
Allocation: Randomized
Ages: 2 Years to 10 Years
Sex: All

Study summary

Safety and immunogenicity of meningococcal ACWY conjugate versus polysaccharide vaccine in children 2 to 10 years of age

Conditions studied

Meningococcal Disease

Browse trials for

Meningococcal Infections 219

Keywords

Meningitis
children
vaccine
safety
efficacy

In context

Meningococcal Infections

219 studies on the registry are indexed under Meningococcal Infections; 6 are open to participants now.

This study's enrollment of 1,500 is above the median of 450 across 190 interventional studies indexed under Meningococcal Infections.

Browse Meningococcal Infections studies →

Lead sponsor

Novartis Vaccines is the lead sponsor of 161 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 2 Years to 10 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy children 2 to 10 years of age inclusive whose parents or legal guardians gave written informed consent at the time of enrollment;
Available for all visits and telephone calls (parents or legal guardians) scheduled for the study;
Good health as determined by the clinical judgment of the investigator.

Exclusion criteria

Exclusion Criteria:

Individuals not eligible to be enrolled into the study were those:

whose parent or legal guardian was unwilling or unable to give written informed consent to participate in the study;
whose parent or legal guardian were perceived as unreliable or unavailable for the duration of the study period;
who had a previous or suspected disease caused by N meningitidis;
who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment;
who had previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational);
who had received any investigational agents or vaccines within 90 days prior to enrollment or who expected to receive an investigational agent or vaccine prior to the completion of the study;
who had received any licensed vaccines within one month prior to enrollment or for whom receipt of a licensed vaccine was anticipated within one month after vaccination (Exception: influenza vaccine could be administered up to 15 days prior to study vaccination and no less than 15 days after study vaccination);
who had received a live viral vaccine within 60 days prior to enrollment;
who had experienced, within the 7 days prior to enrollment, significant acute or chronic infection (for example requiring systemic antibiotic treatment or antiviral therapy) or had experienced fever (defined as axillary temperature ≥38°C) within 3 days prior to enrollment;
who had any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, Human Immunodeficiency Virus (HIV) infection or Acquired Immune Deficiency Syndrome (AIDS), or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition). (Exception: subjects with mild asthma were eligible for enrollment; subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids were not eligible for enrollment);
who had epilepsy or any progressive neurological disease;
who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine component;
who had a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
receipt of immunosuppressive therapy within 30 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose >1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy);
receipt of immunostimulants;
receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study;
common childhood exanthematous diseases (varicella, mumps, measles, rubella) occurring 6 weeks prior to vaccination;
who were known to have a bleeding diathesis or any condition that could be associated with a prolonged bleeding time;
who had Down syndrome or other known cytogenic disorders;
whose families were planning to leave the area of the study site before the end of the study period;
who had any condition that, in the opinion of the investigator, could interfere with the evaluation of the study objectives.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 1,500 participants (actual)

Study arms

Experimental
MenACWY-CRM
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
Biological: Meningococcal ACWY-CRM conjugate vaccine
Active comparator
MenACWY-PS
Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide (PS) vaccine (MenACWY-PS)
Biological: Meningococcal ACWY-PS polysaccharide vaccine

Interventions

BiologicalMeningococcal ACWY-CRM conjugate vaccine
MenACWY-CRM vaccine was obtained by extemporaneous mixing of the lyophilized MenA component to be resuspended with the liquid MenCWY component. One dose (0.5 mL) was administered by IM injection in the deltoid area of the arm without a BCG scar.
BiologicalMeningococcal ACWY-PS polysaccharide vaccine
MenACWY-PS vaccine was supplied as a single dose (one vial of vaccine and one vial of diluent). One dose (0.5 mL) of MenACWY-PS vaccine was administered by SC injection in the deltoid area of the arm without a BCG scar.

What researchers measure

Primary outcomes

Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Immunogenicity was measured as the percentage of subjects with hSBA seroresponse, directed against each of meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), one month after vaccination (day 29)with MenACWY-CRM or MenACWY-PS vaccine. Seroresponse was defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8; 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.
Time frame: 1 month after vaccination (day 29)
Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination
Safety was assessed in terms of the number of subjects who reported at least one severe systemic reaction after vaccination with MenACWY-CRM or MenACWY-PS from day 1 to day 7 after vaccination.
Time frame: Day 1 to 7 postvaccination

Secondary outcomes

Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month (day 29)after one vaccination with MenACWY-CRM or MenACWY-PS.
Time frame: Day 1 and 29
The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
The immune response was measured as the hSBA geometric mean titers (GMTs) directed against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month(day 29) after one vaccination with MenACWY-CRM or MenACWY-PS.
Time frame: Day 1 and 29
Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
The persistence of immune response was measured as the percentage of subjects with hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at day 181 after vaccination with MenACWY-CRM or MenACWY-PS.
Time frame: Day 181
The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
The persistence of immune response was measured in terms of the hSBA GMTs persisting at day 181 against each of four meningococcal serogroups A, C, W and Y after vaccination with MenACWY-CRM or MenACWY-PS
Time frame: Day 181
Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
Safety was assessed as the number of subjects who reported local and systemic reactions and axillary temperature during day 1 to day 7 after vaccination with MenACWY-CRM or MenACWY-PS.
Time frame: Day 1 to 7 postvaccination

Results

Posted Nov 5, 2013

Participant flow

Subjects were enrolled at 3 study centers in Argentina.

Participant flow — Overall Study
Milestone	MenACWY-CRM	MenACWY-PS
Started	950	550
Completed	944	546
Not completed	6	4
Withdrew: Withdrawal by subject	6	4

Outcome measures

PrimaryPercentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS

Immunogenicity was measured as the percentage of subjects with hSBA seroresponse, directed against each of meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), one month after vaccination (day 29)with MenACWY-CRM or MenACWY-PS vaccine. Seroresponse was defined as: 1. for subjects with a prevaccination hSBA titer \<1:4, a postvaccination hSBA titer ≥1:8; 2. for subjects with a prevaccination hSBA titer ≥1:4, an increase in hSBA titer of at least four times the prevaccination titer.

Time frame:: 1 month after vaccination (day 29)
Reported as:: Number · Percentage of subjects

Percentage of Subjects With hSBA Seroresponse Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Percentage of subjects	MenACWY-CRM	MenACWY-PS
Serogroup A	93 (87 to 96)	55 (46 to 63)
Serogroup C (N=147,144)	82 (74 to 88)	52 (44 to 60)
Serogroup W (N=143,142)	74 (66 to 81)	46 (37 to 54)
Serogroup Y (N=146,146)	82 (74 to 87)	63 (55 to 71)

Statistical analysis

MenACWY-CRM vs MenACWY-PS · Chi-squared · Group difference: 38 · 95% CI 29 to 47
MenACWY-CRM vs MenACWY-PS · Chi-squared · Group difference: 30 · 95% CI 19 to 40
MenACWY-CRM vs MenACWY-PS · Chi-squared · Group difference: 28 · 95% CI 17 to 39
MenACWY-CRM vs MenACWY-PS · Chi-squared · Group difference: 18 · 95% CI 8 to 28

PrimaryNumber of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination

Safety was assessed in terms of the number of subjects who reported at least one severe systemic reaction after vaccination with MenACWY-CRM or MenACWY-PS from day 1 to day 7 after vaccination.

Time frame:: Day 1 to 7 postvaccination
Reported as:: Number · Number of subjects

Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination
Number of subjects	MenACWY-CRM	MenACWY-PS
Number of Subjects With At Least One Severe Systemic Reaction to MenACWY-CRM or MenACWY-PS Within 7 Days Postvaccination	11	1

Statistical analysis

MenACWY-CRM vs MenACWY-PS · Risk ratio(MenACWY-CRM/MenACWY-PS) · Group ratio: 6.37 · 95% CI 0.82 to 49.2

SecondaryPercentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS

Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month (day 29)after one vaccination with MenACWY-CRM or MenACWY-PS.

Time frame:: Day 1 and 29
Reported as:: Number · Percentage of subjects

Percentage of Subjects With hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Percentage of subjects	MenACWY-CRM	MenACWY-PS
Serogroup A (hSBA ≥1:4)- Day 1	5 (2 to 10)	3 (1 to 8)
Serogroup A (hSBA ≥1:4)- Day 29	95 (90 to 98)	55 (47 to 64)
Serogroup C (hSBA ≥1:4)- Day 1 (N=147,144)	26 (19 to 34)	31 (23 to 39)
Serogroup C (hSBA ≥1:4)- Day 29 (N=147,144)	91 (85 to 95)	80 (72 to 86)
Serogroup W (hSBA ≥1:4)- Day 1 (N=143,142)	40 (32 to 48)	37 (29 to 46)
Serogroup W (hSBA ≥1:4)- Day 29 (N=143,142)	99 (96 to 100)	78 (70 to 85)
Serogroup Y (hSBA ≥1:4)- Day 1 (N=146,146)	17 (11 to 24)	15 (10 to 22)
Serogroup Y (hSBA ≥1:4)- Day 29 (N=146,146)	90 (84 to 95)	77 (69 to 83)
Serogroup A (hSBA ≥1:8)- Day 1	4 (2 to 9)	2 (0 to 6)
Serogroup A (hSBA ≥1:8)- Day 29	95 (90 to 98)	55 (47 to 64)
Serogroup C (hSBA ≥1:8)- Day 1 (N=147,144)	16 (10 to 23)	20 (14 to 28)
Serogroup C (hSBA ≥1:8)- Day 29 (N=147,144)	88 (82 to 93)	70 (62 to 77)
Serogroup W (hSBA ≥1:8)- Day 1 (N=143,142)	38 (30 to 46)	35 (27 to 43)
Serogroup W (hSBA ≥1:8)- Day 29 (N=143,142)	99 (96 to 100)	73 (64 to 80)
Serogroup Y (hSBA ≥1:8)- Day 1 (N=146,146)	14 (9 to 21)	11 (6 to 17)
Serogroup Y (hSBA ≥1:8)- Day 29 (N=146,146)	89 (83 to 94)	66 (58 to 74)

SecondaryThe hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS

The immune response was measured as the hSBA geometric mean titers (GMTs) directed against each of four meningococcal serogroups A, C, W and Y at baseline (day 1) and one month(day 29) after one vaccination with MenACWY-CRM or MenACWY-PS.

Time frame:: Day 1 and 29
Reported as:: Geometric mean · Geometric Mean Titers

The hSBA Geometric Mean Titers Against Serogroups A, C, W and Y One Month After Vaccination With MenACWY-CRM or MenACWY-PS
Geometric Mean Titers	MenACWY-CRM	MenACWY-PS
Serogroup A - Day 1	2.25 (2.10 to 2.41)	2.09 (1.95 to 2.24)
Serogroup A - Day 29	65 (51 to 82)	11 (8.66 to 14)
Serogroup C (N=147,144) - Day 1	3.09 (2.69 to 3.53)	3.27 (2.85 to 3.75)
Serogroup C (N=147,144) - Day 29	42 (32 to 54)	20 (15 to 26)
Serogroup W (N=143,142) - Day 1	6.22 (4.90 to 7.90)	5.40 (4.25 to 6.87)
Serogroup W (N=143,142) - Day 29	72 (56 to 92)	20 (16 to 26)
Serogroup Y (N=146,146) - Day 1	2.81 (2.48 to 3.19)	2.64 (2.33 to 2.99)
Serogroup Y (N=146,146) - Day 29	47 (35 to 63)	25 (19 to 34)

SecondaryPercentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS

The persistence of immune response was measured as the percentage of subjects with hSBA titers ≥1:4 and ≥1:8 against each of four meningococcal serogroups A, C, W and Y at day 181 after vaccination with MenACWY-CRM or MenACWY-PS.

Time frame:: Day 181
Reported as:: Number · Percentage of subjects

Percentage of Subjects With Persisting hSBA Titers ≥1:4 and ≥1:8 Against Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Percentage of subjects	MenACWY-CRM	MenACWY-PS
Serogroup A(≥1:4)-Day 29 (1 month postvaccination)	96 (91 to 98)	54 (46 to 62)
Serogroup A(≥1:4)-Day 181(6 months postvaccination	39 (31 to 47)	41 (33 to 49)
Serogroup C (hSBA ≥1:4) - Day 29 (N=141,139)	91 (85 to 95)	79 (71 to 86)
Serogroup C (hSBA ≥1:4) - Day 181 (N=141,139)	87 (81 to 92)	71 (63 to 79)
Serogroup W (hSBA ≥1:4) - Day 29 (N=137,137)	99 (96 to 100)	78 (70 to 85)
Serogroup W (hSBA ≥1:4) - Day 181 (N=137,137)	97 (93 to 99)	69 (60 to 76)
Serogroup Y (hSBA ≥1:4) - Day 29 (N=140,141)	90 (84 to 94)	77 (69 to 83)
Serogroup Y (hSBA ≥1:4) - Day 181 (N=140,141)	94 (88 to 97)	65 (56 to 72)
Serogroup A (hSBA ≥1:8) - Day 29	95 (90 to 98)	54 (46 to 62)
Serogroup A (hSBA ≥1:8) - Day 181	35 (27 to 44)	38 (30 to 47)
Serogroup C (hSBA ≥1:8) - Day 29 (N=141,139)	88 (81 to 93)	70 (61 to 77)
Serogroup C (hSBA ≥1:8) - Day 181 (N=141,139)	81 (73 to 87)	55 (47 to 64)
Serogroup W (hSBA ≥1:8) - Day 29 (N=137,137)	99 (96 to 100)	72 (64 to 80)
Serogroup W (hSBA ≥1:8) - Day 181 (N=137,137)	96 (92 to 99)	66 (57 to 74)
Serogroup Y (hSBA ≥1:8) - Day 29 (N=140,141)	89 (82 to 93)	67 (59 to 75)
Serogroup Y (hSBA ≥1:8) - Day 181 (N=140,141)	89 (83 to 94)	59 (50 to 67)

SecondaryThe hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS

The persistence of immune response was measured in terms of the hSBA GMTs persisting at day 181 against each of four meningococcal serogroups A, C, W and Y after vaccination with MenACWY-CRM or MenACWY-PS

Time frame:: Day 181
Reported as:: Geometric mean · Geometric Mean Titers

The hSBA Geometric Mean Titers Persisting Against Meningococcal Serogroups A, C, W and Y at Day 181 After Vaccination With MenACWY-CRM or MenACWY-PS
Geometric Mean Titers	MenACWY-CRM	MenACWY-PS
Serogroup A - Day 29 (1 month post vaccination)	66 (52 to 83)	11 (8.33 to 13)
Serogroup A - Day 181 (6 months post vaccination)	5.06 (4.05 to 6.33)	5.85 (4.68 to 7.32)
Serogroup C (N=141,139) - Day 29	41 (31 to 54)	20 (15 to 27)
Serogroup C (N=141,139) - Day 181	22 (17 to 28)	11 (8.84 to 14)
Serogroup W (N=137,137) - Day 29	74 (58 to 95)	21 (16 to 27)
Serogroup W (N=137,137) - Day 181	69 (54 to 89)	16 (13 to 21)
Serogroup Y (N=140,141) - Day 29	47 (35 to 64)	26 (19 to 35)
Serogroup Y (N=140,141) - Day 181	39 (29 to 51)	14 (11 to 19)

SecondaryNumber of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS

Safety was assessed as the number of subjects who reported local and systemic reactions and axillary temperature during day 1 to day 7 after vaccination with MenACWY-CRM or MenACWY-PS.

Time frame:: Day 1 to 7 postvaccination
Reported as:: Number · participants

Number of Subjects Reporting Local and Systemic Reactions and Axillary Temperature During 7-Day Period After Vaccination With MenACWY-CRM or MenACWY-PS
participants	MenACWY-CRM_2 to 5 Years	MenACWY-PS_2 to 5 Years	MenACWY-CRM_6 to 10 Years	MenACWY-PS_6 to 10 Years
Any local reaction	138	99	189	125
Injection site pain	89	68	132	100
Injection site erythema	75	34	91	37
Injection site induration	59	23	84	38
Any systemic reaction	130	73	119	69
Change in Eating Habits	36	24	NA	NA
Sleepiness	29	13	NA	NA
Irritability	36	18	NA	NA
Vomiting	21	9	NA	NA
Diarrhea	31	20	NA	NA
Arthralgia	26	11	18	15
Headache	46	22	74	46
Chills	NA	NA	18	17
Nausea	NA	NA	16	11
Malaise	NA	NA	50	28
Myalgia	NA	NA	35	25
Any other AE	69	42	69	47
Axillary Temperature ≥38 °C	35	18	20	16
Analgesic/Antipyretic medicine used	69	42	69	47

Adverse events

Collected over Solicited adverse events (AEs) were collected from Day 1 through 7,Serious AEs were collected from day 1 to day 181 after vaccination.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
MenACWY-CRM	—	9/950 (0.9%)	409/950 (43.1%)
MenACWY-PS	—	1/550 (0.2%)	271/550 (49.3%)

Most frequent serious events

Most frequent serious events
Event	MenACWY-CRM	MenACWY-PS
PneumoniaInfections and infestations	3/950	0/550
AppendicitisInfections and infestations	2/950	0/550
Lobar PneumoniaInfections and infestations	0/950	1/550
InjuryInjury, poisoning and procedural complications	1/950	0/550
Febrile ConvulsionNervous system disorders	1/950	0/550
Tonic ConvulsionNervous system disorders	1/950	0/550
Asthmatic CrisisRespiratory, thoracic and mediastinal disorders	1/950	0/550

Most frequent other events

Most frequent other events
Event	MenACWY-CRM	MenACWY-PS
Injection site painGeneral disorders	221/950	168/550
Injection site erythemaGeneral disorders	166/950	71/550
Injection site indurationGeneral disorders	143/950	61/550
HeadacheNervous system disorders	125/950	72/550
PyrexiaGeneral disorders	75/950	49/550
MalaiseGeneral disorders	50/950	28/550

Baseline characteristics

Analysis was done on all enrolled subjects.

Age, Continuous
Age, Continuous(Years)	MenACWY-CRM	MenACWY-PS	Total
Mean	5.8 ± 2.5	5.7 ± 2.5	5.8 ± 2.5

Sex: Female, Male
Sex: Female, Male(Participants)	MenACWY-CRM	MenACWY-PS	Total
Female	482	288	770
Male	468	262	730

Study locations

3 sites

FUNCEI, French 3085
Buenos Aires, Argentina
Centro di Desarrollo de Proyectos Avanzados (CEDEPAP) Roma 1464
Cordoba, Argentina
Hospital de Pediatria "Sor Maria Ludovica", Calle 14 N1631,(1900)
La Plata, Argentina

References and documents

Publications

Black S, Klein NP, Shah J, Bedell L, Karsten A, Dull PM. Immunogenicity and tolerability of a quadrivalent meningococcal glycoconjugate vaccine in children 2-10 years of age. Vaccine. 2010 Jan 8;28(3):657-63. doi: 10.1016/j.vaccine.2009.10.104. Epub 2009 Nov 4. PubMed 19895922 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00329849
Lead sponsor: Novartis Vaccines
Responsible party: Sponsor
First posted: May 25, 2006
Start date: May 2006
Primary completion: Mar 2007
Completion: Mar 2007
Results posted: Nov 5, 2013
Last update: Oct 9, 2018

Study contacts

Novartis Vaccines & Diagnostics

study chair · Novartis Vaccines & Diagnostics

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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