Phase 3 N=4,545 Randomized Prevention

A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants

Meningitis, Meningococcal

Bottom Line

View on ClinicalTrials.gov: NCT00474526 ↗

Enrolled (actual)

4,545

Serious AEs

7.9%

Results posted

Mar 2014

Primary outcome: Primary: Percentage of Subjects With hSBA Titer >=1:8 - US Subjects — 94; 72; 98; 90 Percentages of subjects

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Meningococcal ACWY Conjugate Vaccine (Biological); DTaP-IPV-HBV (Biological); Hib (Biological); Rotavirus (Biological); Pneumococcal 7-valent Conjugate Vaccine (Biological); HAV (Biological); MMR-V (Biological); DTaP (Biological)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Novartis Vaccines
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	2; 3; 67; 1; 7; 5	—
PRIMARY Geometric Mean hSBA Titers - US Subjects	2.51; 2.14; 77; 17; 7.72; 2.26	—
SECONDARY Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	93; 77; 628; 338; 0; 6	—
SECONDARY Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	108; 95; 675; 356; 0; 2	—
SECONDARY Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	126; 95; 549; 311; 0; 2	—
SECONDARY Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age	11; 16; 81; 18; 70; 49	—
SECONDARY Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series	7; 81; 18; 9; 28; 36	—
SECONDARY Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series	14; 6; 143; 28; 0; 1	—
SECONDARY Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series	93; 77; 628; 338; 0; 6	—
SECONDARY Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series	108; 95; 675; 356; 0; 2	—
SECONDARY Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series	126; 95; 549; 311; 0; 2	—
SECONDARY Geometric Mean hSBA Titers Post-infant Series - US Subjects	2.11; 2.1; 13; 2.03; 2.48; 2.17	—
SECONDARY Geometric Mean hSBA Titers Post-infant Series - LA Subjects	2.09; 2.03; 31; 43; 2.32; 2.34	—
SECONDARY Percentage of Subjects With hSBA Titer >=1:8 - US Subjects	2; 3; 67; 1; 7; 5	—
SECONDARY Percentage of Subjects With hSBA Titer >=1:4 - US Subjects	2; 3; 71; 1; 10; 5	—
SECONDARY Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects	1; 0; 74; 89; 4; 4	—
SECONDARY Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects	2; 1; 78; 91; 10; 10	—
SECONDARY Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects	2.52; 2.88; 2.5; 2.31; 54; 54	—
SECONDARY Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects	100; 100; 100; 100; 87; 86	—
SECONDARY Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects	1.8; 1.54; 1.45; 1.77; 2.41; 2.19	—
SECONDARY Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects	99; 98; 99; 99; 100; 100	—
SECONDARY Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject	12; 3; 53; 8; 80; 4	—
SECONDARY Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject	10; 1; 50; 7; 71; 4	—
SECONDARY Persistence Antibodies Geometric Mean Titers - US Subject	2.51; 2.14; 7.72; 2.26; 14; 2.21	—
SECONDARY Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject	29; 1; 18; 1; 62; 4	—
SECONDARY Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject	25; 0; 15; 0; 57; 4	—
SECONDARY Persistence Antibodies Geometric Mean Titers - LA Subjects	4.26; 2.02; 2.96; 2.02; 12; 2.18	—
SECONDARY Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects	12; 3; 94; 78; 53; 8	—
SECONDARY Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects	10; 1; 94; 72; 50; 7	—
SECONDARY Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects	5; 1; 90; 55; 35; 0	—
SECONDARY Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects	2.51; 2.14; 77; 17; 7.72; 2.26	—
SECONDARY Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	28; 18; 94; 95; 61; 30	—
SECONDARY Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	23; 13; 94; 95; 57; 22	—
SECONDARY Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects	16; 9; 93; 94; 47; 18	—
SECONDARY Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects	3.83; 2.95; 112; 146; 11; 3.83	—
SECONDARY Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects	2.9; 3.24; 6.82; 8.58; 2.8; 3.13	—
SECONDARY Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects	91; 90; 84; 100; 96; 99	—
SECONDARY Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects	3.16; 4.02; 4.52; 5.61; 2.79; 3.77	—
SECONDARY Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects	93; 95; 86; 89; 92; 95	—
SECONDARY Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects	5.4; 5.16; 6.17; 6.58; 68; 62	—
SECONDARY Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects	98; 98; 98; 98; 89; 84	—
SECONDARY Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects	0; 0; 74; 97; 4; 1	—
SECONDARY Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects	2.02; 2.02; 25; 128; 2.18; 2.05	—

Summary

This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants.

Eligibility Criteria

Inclusion Criteria

Healthy term 2-month-old infants for whom a parent/legal representative has given written informed consent.

Exclusion Criteria

Subjects with a previous or suspected disease caused by Neisseria meningitidis, Corynebacterium diphtheriae, Clostridium tetani, Poliovirus, Hepatitis B, Haemophilus influenzae type b (Hib), Pneumococcus or Bordetella pertussis; previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) or prior vaccination with Diptheria, Tetanus, Pertussis (acellular or whole cell), inactivated polio vaccineIPV or oral polio vaccineOPV, H. influenzae type b (Hib) or Pneumococcus; who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W-135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth; Any serious acute, chronic or progressive disease

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Data sourced from ClinicalTrials.gov (NCT00474526). 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.