Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.

NCT00310817 | Completed Phase 2 Results

• 2 other identifiers: V59P7EUDRACT NUMBER: 2004-001896-21
• Study Type: interventional
• Target: 623
• Locations: 2 countries
• Sites: 2

Brief Summary

To compare the functional immune response 28 days after administration of one dose of Men ACWY-CRM conjugate vaccine without adjuvant (MenACWY-CRM(Ad-)) with that of a Men ACWY polysaccharide (PS) vaccine

Conditions

Meningococcal Meningitis

Keywords

meningitis; children; vaccine

Outcome Measures

Primary Outcomes (1)

• Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers ≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age

  Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 28 days after administration to subjects aged 36 to 59 months, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers ≥ 1:4 against N. meningitidis serogroups A, C, W, and Y.

  28 days after first vaccination.

Secondary Outcomes (25)

• Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age

  28 days after first vaccination

• hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age

  28 days after first vaccination

• hSBA GMTs After One Dose of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age

  6 months after first vaccination and 12 months after first vaccination

• Percentage of Subjects With hSBA Titers ≥ 1:4 After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age

  6 months after first vaccination and 12 months after first vaccination

• Percentages of Subjects With hSBA Titers ≥ 1:8 After One Dose Of Either MenACWY -CRM(Ad-) or MenACWY-PS Vaccine In Subjects 36-59 Months Of Age

  6 months after first vaccination and 12 months after first vaccination

Study Arms (4)

MenACWY-CRM(Ad+) 12 to 35 Months

EXPERIMENTAL

Subjects received one dose of MenACWY-CRM conjugate vaccine with adjuvant (Ad+) on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.

Biological: MenACWY-CRM conjugate vaccine, adjuvanted

MenACWY-CRM(Ad-) 12 to 35 Months

EXPERIMENTAL

Subjects received one dose of MenACWY-CRM conjugate vaccine without adjuvant (Ad-) on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.

Biological: MenACWY-CRM conjugate vaccine, unadjuvanted

MenACWY-CRM(Ad-) 36 to 59 Months

EXPERIMENTAL

Subjects received one dose of MenACWY-CRM conjugate vaccine without adjuvant on day 1 and second dose on day 169 or day 337.

Biological: MenACWY-CRM conjugate vaccine, unadjuvanted

MenACWY-PS (36 to 59 Months)

ACTIVE COMPARATOR

Subjects received one dose of MenACWY polysaccharide (PS) vaccine on day 1 and second dose of MenACWY-CRM conjugate vaccine without adjuvant on day 169 or day 337.

Biological: MenACWY polysaccharide vaccine

Interventions

MenACWY-CRM conjugate vaccine, adjuvanted BIOLOGICAL

MenACWY-CRM(Ad+) 12 to 35 Months

MenACWY polysaccharide vaccine BIOLOGICAL

MenACWY-PS (36 to 59 Months)

MenACWY-CRM conjugate vaccine, unadjuvanted BIOLOGICAL

MenACWY-CRM(Ad-) 12 to 35 Months; MenACWY-CRM(Ad-) 36 to 59 Months

Eligibility Criteria

• Age: 12 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• healthy 12-\<60 month old children;

You may not qualify if:

• subjects who have previously received any meningococcal vaccine
• subjects with any serious acute or chronic progressive disease

Sponsors & Collaborators

• Novartis Vaccines: lead
• Novartis: collaborator

Study Sites (2)

University of Tampere Medical School

Tampere, Finland

Location

Oddz. Neuroinfekcji, Szpital Jana Pawla II, Krakow

Samodzielny ZOZ, Lubartów, Poland

Location

MeSH Terms

Conditions

Meningitis, Meningococcal; Meningitis

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Results Point of Contact

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

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines - Drug Information Services

  Novartis

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2006
• First Posted: April 5, 2006
• Study Start: March 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: November 6, 2015
• Results First Posted: November 6, 2015

Record last verified: 2015-10

Locations

PL (1); FI (1)