Phase 2 N=524 Randomized Single-blind Prevention

Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents

Prevention of Meningococcal Disease

Bottom Line

View on ClinicalTrials.gov: NCT00262041 ↗

Enrolled (actual)

524

Serious AEs

2.5%

Results posted

Nov 2013

Primary outcome: Primary: Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine — 87; 84; 46; 93 Percentages Of Subjects — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: MenACWY-CRM conjugate vaccine, adjuvanted (Biological); MenACWY-CRM conjugate vaccine, unadjuvanted (Biological); MenACWY polysaccharide vaccine (Biological)
Age: Pediatric · 11+ yrs
Sex: All
Sponsor: Novartis Vaccines
Primary completion: Mar 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine	87; 84; 46; 93; 88; 71	<0.001 sig
SECONDARY hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine	34; 34; 6.97; 69; 58; 30	—
SECONDARY Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine	36; 44; 86; 69; 95; 72	—
SECONDARY hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine	4.24; 5.65; 28; 26; 40; 17	—
SECONDARY Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination	103; 102; 107; 24; 92; 95	—

Summary

The purpose of this study is to evaluate the safety and immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.

Eligibility Criteria

Inclusion Criteria

Healthy adolescents between and including 11-17 years of age, who provide written informed consent

Exclusion Criteria

Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00262041). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.