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Completed

NCT Number: NCT00474526

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

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.

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Key information

Conditions

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

Age range

2 month–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CEDEPAP Rio IV, Alvear 1439 PB Dpto, Rio IV, Cordoba, Córdoba Province, Argentina

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meningococcal ACWY conjugate vaccine

Biological

Other names: Menveo

DTaP-IPV-HBV

Biological

Other names: Pediarix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined

Hib

Biological

Other names: ActHIB® (Haemophilus influenzae type b Conjugate Vaccine)

Rotavirus

Biological

Other names: RotaTeq® Rotavirus Vaccine, Live, Oral, Pentavalent

Pneumococcal 7-valent Conjugate Vaccine

Biological

Other names: Prevnar®

HAV

Biological

Other names: Havrix® (Hepatitis A Vaccine, Inactivated)

MMR-V

Biological

Other names: ProQuad™ (Measles, Mumps, Rubella and Varicella vaccine)

DTaP

Biological

Other names: Infanrix® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

Primary outcomes

  1. Percentage of Subjects With hSBA Titer >=1:8 - US Subjects

    Time frame: 13 months of age (one month post-toddler vaccination)

    Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age

  2. Geometric Mean hSBA Titers - US Subjects

    Time frame: 13 months of age (one month post-toddler vaccination)

    Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.

Secondary outcomes

  1. Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series

    Time frame: 7 days after vaccination

    Solicited local and systemic reactions post first vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.

  2. Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series

    Time frame: 7 days after vaccination

    Solicited local and systemic reactions post second vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.

  3. Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series

    Time frame: 7 days after vaccination

    Solicited local and systemic reactions post third vaccination of infant series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.

  4. Number of Subjects With Solicited Local and Systemic Reactions After Vaccination at 12 Months of Age

    Time frame: 7 days after vaccination

    Solicited local and systemic reactions after receiving MenACWY-CRM vaccination at 12 months of age were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.

  5. Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Toddler Series

    Time frame: 7 days post vaccination

    Solicited local and systemic reactions post first vaccination of toddler series were compared in subjects receiving Infant Vaccines only and subjects receiving MenACWY-CRM concomitantly with Infant Vaccines.

  6. Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Toddler Series

    Time frame: 7 days post vaccination

    Solicited local and systemic reactions post second vaccination of toddler series at 15 months of age.

  7. Number of Subjects With Solicited Local and Systemic Reactions Post First Vaccination - Infant Series

    Time frame: 7 days post-vaccination

    Solicited local and systemic reactions reported post first vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.

  8. Number of Subjects With Solicited Local and Systemic Reactions Post Second Vaccination - Infant Series

    Time frame: 7 days post-vaccination

    Solicited local and systemic reactions reported post second vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.

  9. Number of Subjects With Solicited Local and Systemic Reactions Post Third Vaccination - Infant Series

    Time frame: 7 days post-vaccination

    Solicited local and systemic reactions reported post third vaccination was compared in subjects receiving MenACWY versus Hib Vaccines.

  10. Geometric Mean hSBA Titers Post-infant Series - US Subjects

    Time frame: 7 months of age (one month post-infant series)

    Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after three doses at 2, 4, and 6 months of age.

  11. Geometric Mean hSBA Titers Post-infant Series - LA Subjects

    Time frame: 7 months of age (one month post-infant series)

    Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 (LA3) months of age.

  12. Percentage of Subjects With hSBA Titer >=1:8 - US Subjects

    Time frame: 7 months of age (one month post-infant series)

    Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.

  13. Percentage of Subjects With hSBA Titer >=1:4 - US Subjects

    Time frame: 7 months of age (one month post-infant series)

    Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after three doses of MenACWY at 2, 4, and 6 months of age.

  14. Percentage of Subjects With hSBA Titer >=1:8 - LA Subjects

    Time frame: 7 months of age (one month post-infant series)

    Immunogenicity as measured by percentage of subjects with hSBA titer >=1:8 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .

  15. Percentage of Subjects With hSBA Titer >=1:4 - LA Subjects

    Time frame: 7 months of age (one month post-infant series)

    Immunogenicity as measured by percentage of subjects with hSBA titer >=1:4 directed against N. meningitidis serogroups A, C, W and Y; after two doses of MenACWY at 2 and 6 months (LA1) versus three doses at 2, 4, and 6 months of age (LA3) .

  16. Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects

    Time frame: 7 months of age (one month post-infant series)

    Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.

  17. Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - US Subjects

    Time frame: 7 months of age (one month post-infant series)

    Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.

  18. Geometric Mean Concentrations or Titers of DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects

    Time frame: 7 months of age (one month post-infant series)

    Immunogenicity as measured by antibody GMCs / GMTs directed against DTaP, HBV, Hib, pneumococcal and polio antigens.

  19. Seroresponse Rates to DTaP, HBV, Hib, Pneumococcal and Polio Antigens at 1 Month After Infant Series Vaccination - LA Subjects

    Time frame: 7 months of age (one month post-infant series)

    Immunogenicity as measured by percentage of subjects with predefined seroprotective antibody titers against DTaP, HBV, Hib, pneumococcal and polio antigens.

  20. Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 Months of Age- US Subject

    Time frame: 12 Months of Age (one month pre-toddler vaccination)

    Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.

  21. Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 Months of Age- US Subject

    Time frame: 12 Months of Age (one month pre-toddler vaccination)

    Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.

  22. Persistence Antibodies Geometric Mean Titers - US Subject

    Time frame: 12 Months of Age (one month pre-toddler vaccination)

    Geometric Mean hSBA Titers directed against N. meningitides serogroups A, C, W and Y was measured at 12 Months of Age.

  23. Percentage of Subjects With Persistence Antibodies hSBA ≥1:4 at 12 or 16 Months of Age- LA Subject

    Time frame: 12 or 16 Months of Age (one month pre-toddler vaccination)

    Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N.meningitidis serogroups A, C, W and Y.

  24. Percentage of Subjects With Persistence Antibodies hSBA ≥1:8 at 12 or 16 Months of Age- LA Subject

    Time frame: 12 or 16 Months of Age (one month pre-toddler vaccination)

    Persistence of Antibodies as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.

  25. Persistence Antibodies Geometric Mean Titers - LA Subjects

    Time frame: 12 or 16 Months of Age (one month pre-toddler vaccination)

    Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y was measured at 12 or 16 Months of Age.

  26. Percentage of Subjects (95% CI) With hSBA ≥ 1:4 at 1 Month After Toddler MenACWY Vaccination - US Subjects

    Time frame: 13 months of age (one month post-toddler vaccination)

    Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4 , directed against N.meningitidis serogroups A, C, W and Y.

  27. Percentage of Subjects (95% CI) With hSBA ≥ 1:8 at 1 Month After Toddler MenACWY Vaccination - US Subjects

    Time frame: 13 months of age (one month post-toddler vaccination)

    Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8 , directed against N.meningitidis serogroups A, C, W and Y.

  28. Percentage of Subjects (95% CI) With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - US Subjects

    Time frame: 13 months of age (one month post-toddler vaccination)

    Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16 , directed against N.meningitidis serogroups A, C, W and Y.

  29. Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - US Subjects

    Time frame: 13 months of age (one month post-toddler vaccination)

    Immunogenicity as measured by Geometric Mean hSBA Titers directed against N. meningitidis serogroups A, C, W and Y; comparison of four doses of MenACWY-CRM at 2, 4, and 6 and 12 months of age versus a single dose at 12 months of age.

  30. Percentage of Subjects (95% CI) With hSBA ≥1:4 at 1 Month After Toddler MenACWY Vaccination - LA Subjects

    Time frame: 13 or 17 Months of Age (one month post-toddler vaccination)

    Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:4, directed against N. meningitidis serogroups A, C, W and Y.

  31. Percentage of Subjects (95% CI) With hSBA ≥1:8 at 1 Month After Toddler MenACWY Vaccination - LA Subjects

    Time frame: 13 or 17 Months of Age (one month post-toddler vaccination)

    Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N. meningitidis serogroups A, C, W and Y.

  32. Percentage of Subjects With hSBA ≥ 1:16 at 1 Month After Toddler MenACWY Vaccination - LA Subjects

    Time frame: 13 or 17 Months of Age (one month post-toddler vaccination)

    Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:16, directed against N. meningitidis serogroups A, C, W and Y.

  33. Geometric Mean hSBA Titers at 1 Month After Toddler MenACWY Vaccination - LA Subjects

    Time frame: 13 or 17 Months of Age (one month post-toddler vaccination)

    Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.

  34. Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - US Subjects

    Time frame: 13 months of age (one month post-toddler vaccination)

    Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.

  35. Percentage of Subjects With Pneumococcal Antibody GMCs ≥1.0 μg/mL at 1 Month After Toddler Vaccination - US Subjects

    Time frame: 13 months of age (one month post-toddler vaccination)

    Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.

  36. Geometric Mean Concentrations of Pneumococcal Antibodies at 1 Month After Toddler Vaccination - LA Subjects

    Time frame: 13 months of age (one month post-toddler vaccination)

    Immunogenicity as measured by antibody GMTs, directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F.

  37. Percentage of Subjects With Pneumococcal Antibody Concentration ≥1.0 μg/mL at 1 Month After Toddler Vaccination - LA Subjects

    Time frame: 13 months of age (one month post-toddler vaccination)

    Immunogenicity as measured by Percentage of Subjects with Pneumococcal Antibody GMCs ≥1.0 μg/mL directed against pneumococcal antigens PnC 4, PnC 6B, PnC 9V, PnC 14, PnC 18C, PnC 19F and PnC 23F

  38. Geometric Mean Concentrations or Titers of DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects

    Time frame: 17 months of age (one month post-toddler vaccination)

    Immunogenicity as measured by antibody GMCs/GMTs, directed against DTaP and Hib Antigens

  39. Seroresponse Rates to DTaP and Hib Antigens at 1 Month After Toddler Vaccination - LA Subjects

    Time frame: 17 months of age (one month post-toddler vaccination)

    Immunogenicity as measured by Percentage of Subjects with predefined seroprotective antibody titers against DTaP and Hib Antigens

  40. Percentage of Subjects With hSBA ≥1:8 at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects

    Time frame: 12 or 15 months of age (one month post 1st or 2nd toddler vaccination)

    Immunogenicity as measured by the percentage of subjects with serum bactericidal activity using human complement (hSBA) ≥ 1:8, directed against N.meningitidis serogroups A, C, W and Y.

  41. Geometric Mean hSBA Titers at 1 Month After 1st (LA2) or 2nd (LA4) Toddler MenACWY Vaccination - LA Subjects

    Time frame: 12 or 15 months of age (one month post 1st or 2nd toddler vaccination)

    Immunogenicity as measured by Serum bactericidal activity using human complement (hSBA) GMTs, directed against N. meningitidis serogroups A, C, W and Y.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study title

A Phase 3, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
May 17, 2007
Registry last updated
Mar 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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