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Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

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ClinicalTrials.gov Identifier: NCT00806195
Recruitment Status : Completed
First Posted : December 10, 2008
Results First Posted : July 9, 2013
Last Update Posted : July 9, 2013
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis

Tracking Information
First Submitted Date  ICMJE December 9, 2008
First Posted Date  ICMJE December 10, 2008
Results First Submitted Date  ICMJE May 13, 2013
Results First Posted Date  ICMJE July 9, 2013
Last Update Posted Date July 9, 2013
Study Start Date  ICMJE December 2008
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2013)
Percentages of Subjects With At Least One Severe Systemic Reaction After Any Vaccination [ Time Frame: 15 minutes to Day 7 after any vaccination administered at 2, 4, 6 and 12 months of age ]
To compare the percentages of subjects who reported at least one severe systemic reaction after any vaccination of MenACWY-CRM197 (detailed) plus routine vaccines (detailed) group to that observed in the routine vaccines alone (detailed) group administered at 2, 4, 6, and 12 months of age. Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs.
Original Primary Outcome Measures  ICMJE
 (submitted: December 9, 2008)
Safety will be assessed in terms of number of subjects with reported medically significant or serious adverse events and/or resulting in withdrawal from the study, per vaccination group. [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2013)
  • Percentages of Subjects With At Least One Serious Adverse Event During the Entire Study Period [ Time Frame: Day 1 (2 months of age) to 18 months of age ]
    To compare the percentages of subjects presenting at least one serious adverse event (SAE) through 6 months post-final dose in subjects who received MenACWY-CRM197 vaccine concomitantly with routine vaccinations to the percentages of subjects who received routine vaccinations alone.
  • Percentages of Subjects Reporting Solicited Adverse Events, After Each Vaccination [ Time Frame: 15 minutes to Day 7 ]
    To compare the percentage of subjects who reported local and systemic solicited adverse events from day 1 to day 7 after each vaccination with MenACWY-CRM197 given concomitantly with routine vaccinations to the routine vaccinations alone group.
  • Number of Subjects Who Reported Unsolicited Adverse Events After Any Vaccination [ Time Frame: Day 1 (2 months of age) to 18 months of age ]
    Safety data with medically attended events were collected throughout the study in the non-detailed safety groups and from Day 8 onwards for the detailed safety groups.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
Official Title  ICMJE A Phase 3b, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
Brief Summary The primary objective of this phase 3b study is to evaluate the safety and tolerability of Novartis MenACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Meningitis
  • Meningococcal Infection
Intervention  ICMJE
  • Biological: MenACWY-CRM197
    Four 0.5mL vaccinations of MenACWY-CRM197 conjugate vaccine was administered by intramuscular injection at 2, 4, 6 and 12 months of age.
  • Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
    Four vaccinations of DTaP (Diptheria, Tetanus, Pertussis) was administered at 2, 4, 6, and 15 months of age.
  • Biological: Hib (Haemophilus influenza b) Vaccine
    Four vaccinations of Hib (Haemophilus influenza b) vaccine was administered at 2, 4, 6 and 15 months of age.
  • Biological: IPV (Inactivated Polio Vaccine) Vaccine
    Three vaccinations of IPV (Inactivated Polio Vaccine) was administered at 2, 4, and 6 months of age.
  • Biological: Pneumococcal conjugate Vaccine
    Four vaccinations of Pneumococcal conjugate vaccine was administered at 2, 4, 6 and 12 months of age.
  • Biological: MMR (Measles, Mumps, and Rubella) Vaccine
    One vaccination of MMR (Measles, Mumps, and Rubella) was administered at 12 months of age.
  • Biological: Varicella Vaccine
    One vaccination of Varicella vaccine was administered at 12 months of age.
  • Biological: Hepatitis A Virus
    One vaccination of Hepatitis A Virus vaccine was administered at 12 months of age.
Study Arms  ICMJE
  • Experimental: MenACWY-CRM197 + Routine Vaccines (Non-Detailed)

    Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.

    Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

    Non-Detailed - infants who only provided SAEs (Serious Adverse Events) and medically attended AEs (Adverse Events).

    Interventions:
    • Biological: MenACWY-CRM197
    • Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
    • Biological: Hib (Haemophilus influenza b) Vaccine
    • Biological: IPV (Inactivated Polio Vaccine) Vaccine
    • Biological: Pneumococcal conjugate Vaccine
    • Biological: MMR (Measles, Mumps, and Rubella) Vaccine
  • Active Comparator: Routine Vaccines (Non-Detailed)

    Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.

    Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

    Non-Detailed - subjects who only provided SAEs and medically attended AEs.

    Interventions:
    • Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
    • Biological: Hib (Haemophilus influenza b) Vaccine
    • Biological: IPV (Inactivated Polio Vaccine) Vaccine
    • Biological: Pneumococcal conjugate Vaccine
    • Biological: MMR (Measles, Mumps, and Rubella) Vaccine
  • Experimental: MenACWY-CRM197 + Routine Vaccines (Detailed)

    Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

    Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

    Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.

    Interventions:
    • Biological: MenACWY-CRM197
    • Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
    • Biological: Hib (Haemophilus influenza b) Vaccine
    • Biological: IPV (Inactivated Polio Vaccine) Vaccine
    • Biological: Pneumococcal conjugate Vaccine
    • Biological: MMR (Measles, Mumps, and Rubella) Vaccine
    • Biological: Varicella Vaccine
    • Biological: Hepatitis A Virus
  • Active Comparator: Routine Vaccines (Detailed)

    Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

    Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

    Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs.

    Interventions:
    • Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
    • Biological: Hib (Haemophilus influenza b) Vaccine
    • Biological: IPV (Inactivated Polio Vaccine) Vaccine
    • Biological: Pneumococcal conjugate Vaccine
    • Biological: MMR (Measles, Mumps, and Rubella) Vaccine
    • Biological: Varicella Vaccine
    • Biological: Hepatitis A Virus
  • Experimental: MenACWY-CRM197 + Routine Vaccines (All)

    Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

    Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

    All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs.

    Interventions:
    • Biological: MenACWY-CRM197
    • Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
    • Biological: Hib (Haemophilus influenza b) Vaccine
    • Biological: IPV (Inactivated Polio Vaccine) Vaccine
    • Biological: Pneumococcal conjugate Vaccine
    • Biological: MMR (Measles, Mumps, and Rubella) Vaccine
    • Biological: Varicella Vaccine
    • Biological: Hepatitis A Virus
  • Active Comparator: Routine Vaccines (All)

    Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.

    Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.

    All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs.

    Interventions:
    • Biological: DTaP (Diptheria, Tetanus, Pertussis) Vaccine
    • Biological: Hib (Haemophilus influenza b) Vaccine
    • Biological: IPV (Inactivated Polio Vaccine) Vaccine
    • Biological: Pneumococcal conjugate Vaccine
    • Biological: MMR (Measles, Mumps, and Rubella) Vaccine
    • Biological: Varicella Vaccine
    • Biological: Hepatitis A Virus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2013)
7744
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2008)
4300
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy 2-month-old infants (aged 55 - 89 days); babies must have been born after a full-term pregnancy with an estimated gestation age ≥37 weeks and a birth weight ≥2.5 kg
  • for whom a parent/legal representative has given written informed consent after the nature of the study has been explained;
  • who are available for all visits scheduled in the study;
  • who are in good health as determined by medical history and physical assessment.

Exclusion Criteria:

  • who previously received any meningococcal vaccine or D, T, P, IPV or OPV, H influenzae type b (Hib) or Pneumococcus; prior doses of BCG (one) and/or HBV (two) are permitted
  • who have a previous confirmed or suspected disease caused by N meningitidis, C diphtheriae, C tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B pertussis (history of laboratory confirmed, or clinical condition of paroxysmal cough for a period of longer than or equal to 2 weeks associated with apnea or whooping);
  • who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N meningitidis (serogroups A, C, W135, or Y), B pertussis, Hib, C diphtheriae, Polio, or pneumococcal infection at any time since birth;
  • who have a history of anaphylactic shock, asthma, urticaria or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;
  • who have experienced significant acute or chronic infection within the previous 7 days or have experienced fever (axillary temperature ≥ 38.0°C [100.4°F]) within the previous 3 days;
  • who have any present or suspected serious acute (e.g. leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac disease, renal failure, severe malnutrition, or insulin dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's syndrome);
  • who have a known or suspected autoimmune disease or persistent impairment/alteration of immune function resulting from (for example):

    1. receipt of any immunosuppressive therapy at any time since birth
    2. receipt of immunostimulants at any time since birth
    3. receipt of any systemic corticosteroid since birth;
  • who have a suspected or known HIV infection or HIV related disease;
  • who have ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation;
  • who have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;
  • who have any history of seizure;
  • who with their parents/legal representatives are planning to leave the area of the study site before the end of the study period;
  • who have any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives;
  • who have received any investigational agents or vaccines since birth or who expect to receive an investigational agent or vaccine prior to the completion of the study.
  • who are relatives of site research staff working on this study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Days to 89 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   Costa Rica,   Guatemala,   Panama,   Peru,   United States
Removed Location Countries Puerto Rico,   Taiwan
 
Administrative Information
NCT Number  ICMJE NCT00806195
Other Study ID Numbers  ICMJE V59P23
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Novartis Vaccines
Investigators  ICMJE Not Provided
PRS Account Novartis
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP