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Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life

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ClinicalTrials.gov Identifier: NCT01214837
Recruitment Status : Completed
First Posted : October 5, 2010
Results First Posted : October 2, 2014
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Brief Summary:
The purpose of this study was to assess immunogenicity of a 3-dose versus 4-dose infant vaccination schedule including kinetics of immune response in the early phases of the series.

Condition or disease Intervention/treatment Phase
Meningococcal Disease Meningococcal Meningitis Biological: MenACWY-CRM Biological: Routine Vaccines Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 751 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 3b, Randomized, Open-Label, Multi-Center Study to Evaluate the Safety and Immunogenicity of 2 or 3 Doses of MenACWY Conjugate Vaccine in Healthy Infants and the Effects of a Booster Dose of MenACWY Administered in the Second Year of Life.
Study Start Date : October 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : May 2012


Arm Intervention/treatment
Experimental: MenACWY3
Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
Biological: MenACWY-CRM
This group received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.

Biological: Routine Vaccines
Each 0.5 mL dose of the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) is formulated to contain approximately 2.2 μg of each of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.

Experimental: MenACWY4
All the subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
Biological: MenACWY-CRM
This group received a 3-dose primary series at 2, 4, and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.

Biological: Routine Vaccines
Each 0.5 mL dose of the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) is formulated to contain approximately 2.2 μg of each of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.

Placebo Comparator: Routine Vaccines
Subjects received routine vaccines only, including PCV-13, at 2, 4 and 6 months of age and a toddler dose at 12 months of age.
Biological: Routine Vaccines
Each 0.5 mL dose of the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) is formulated to contain approximately 2.2 μg of each of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.




Primary Outcome Measures :
  1. Percentage of Subjects With Serum Bactericidal Activity Using Human Complement (hSBA) ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following a 4-dose Schedule of Men ACWY Vaccination. [ Time Frame: 13 months of age ]
    The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4, 6 and 12 months of age.

  2. Percentage of Subjects With hSBA ≥ 1:8 Against N. Meningitidis Serogroups A, C, W and Y Following 4-Dose and 3-Dose Schedule of Men ACWY Vaccination. [ Time Frame: 13 months of age ]
    The immune response was assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y following 4 doses of Men ACWY vaccine given to infants at 2, 4,6 and 12 months of age and 3 doses of Men ACWY given to infants at 2, 4 and 12 months of age.


Secondary Outcome Measures :
  1. Percentage of Subjects With hSBA ≥1:8 Against N. Meningitidis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. [ Time Frame: Baseline (2 months of age), 3 months, 4 months , 5 months and 7 months of age ]
    Antibody levels were assessed in terms of percentage of subjects with hSBA ≥ 1:8 against N. meningitidis serogroups A, C, W and Y at baseline (2 months of age) and at 3, 4, 5 and 7 months of age.

  2. Geometric Mean hSBA Titers Against N Meningitis Serogroups A, C, W and Y at Baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age. [ Time Frame: Baseline(2 months of age), 3 months, 4 months , 5 months and 7 months of age. ]
    Antibody levels were assessed in terms of geometric mean titers (GMTs) against N. meningitidis serogroups A, C, W and Y at baseline (2 Months of Age) and at 3, 4, 5, and 7 Months of Age.

  3. Percentage of Subjects With hSBA ≥1:8 Following 2 and 3 Infant Doses of MenACWY. [ Time Frame: 12 months of age. ]
    Percentage of subjects with hSBA ≥1:8 against N meningitis serogroups A, C, W and Y was assessed following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.

  4. Geometric Mean hSBA Titers Following 2 and 3 Infant Doses of MenACWY. [ Time Frame: 12 months of age ]
    The immune response was assessed in terms of GMTs against N. meningitidis serogroups A, C, W and Y following 2 and 3 infant doses of MenACWY as measured prior to the toddler dose at 12 months of age.

  5. GMTs at 13 Months of Age After Completion of 3- and 4-Dose Series of MenACWY. [ Time Frame: 13 months of age ]
    Immune response was assessed in terms of GMTs against N meningitis serogroups A, C, W and Y at 1 month after completion of a 3- and 4- dose series of MenACWY.

  6. Percentage of Subjects With 4-fold Increase in hSBA Titers Against N Meningitis Serogroups A, C, W and Y Between 12 and 13 Months of Age. [ Time Frame: 13 months of age ]
    The immune response was assessed in terms of percentage of subjects with 4-fold increase in hSBA titers between post and pre toddler dose against N meningitis serogroups A, C, W and Y, 1 month after completing a 3- or 4-dose series of MenACWY.

  7. Effect of Concomitant Administration of 2 or 3 Doses of MenACWY on Immune Response to PCV-13 Antigens at 7 Months of Age. [ Time Frame: 7 months of age. ]
    Percentage of subjects with IgG concentration ≥ 0.35 μg/mL against pneumococcal conjugate vaccine (PCV-13) antigens at 7 Months of age following concomitant administration of 2 or 3 doses of MenACWY with PCV-13.

  8. Effect of Concomitant Administration of 3 or 4 Doses of MenACWY on Immune Response to PCV-13 Antigens at 13 Months of Age. [ Time Frame: 13 months of age. ]
    Geometric mean concentrations (GMCs) of antibodies against PCV-13 vaccine antigens at 13 months of age following concomitant administration of a 3- or 4-dose series of MenACWY with PCV-13.

  9. Percentage Of Subjects Reporting at Least One Severe Systemic Solicited Adverse Event. [ Time Frame: Within 7 days ]
    Safety was assessed as the percentages of subjects who reported severe solicited systemic adverse events within 30 minutes through day 7 of MenACWY administration with concomitant vaccines vs. concomitant vaccines alone.

  10. Number Of Subjects Reporting Solicited Local or Systemic Adverse Events. [ Time Frame: Day 1 through Day 7 ]
    Safety was assessed as the number of subjects who reported solicited local or systemic adverse events between 6 hours and day 7 after administration of MenACWY with concomitant vaccines vs. concomitant vaccines alone.

  11. Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. [ Time Frame: 13 months of age ]


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Ages Eligible for Study:   55 Days to 89 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants of both genders who are in generally good health will be eligible for this study. For infants to be enrolled, the parents/legal representatives need to provide written informed consent and to be available for all study visits.

Exclusion Criteria:

  • Serious, acute, or chronic illnesses are reasons for exclusion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214837


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Sponsors and Collaborators
Novartis Vaccines

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01214837     History of Changes
Other Study ID Numbers: V59_36
First Posted: October 5, 2010    Key Record Dates
Results First Posted: October 2, 2014
Last Update Posted: October 9, 2018
Last Verified: September 2018
Keywords provided by Novartis ( Novartis Vaccines ):
Meningococcal
ACWY
Conjugate Vaccine
Meningitis
Infants
Persistence
Additional relevant MeSH terms:
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Meningococcal Infections
Meningitis, Meningococcal
Meningitis
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs