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Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT (GSK134612) in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Prevenar 13™Vaccine

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ClinicalTrials.gov Identifier: NCT01939158
Recruitment Status : Active, not recruiting
First Posted : September 11, 2013
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
The purpose of this study is to compare the immediate and long term (up to 5 years) immunogenicity and safety of GSK Biologicals' MenACWY-TT vaccine when given as a single dose or as 2 doses to toddlers aged 12 to 14 months. Also, this study will also assess if co-administration of GSK Biologicals' MenACWY-TT with the booster dose of Pfizer's Prevenar 13 adversely impacts the immunogenicity of either of the vaccines.

Condition or disease Intervention/treatment Phase
Infections, Meningococcal Biological: Meningococcal vaccine GSK134612 Biological: Prevenar 13™ Phase 3

Detailed Description:
The Medicines Control Council (MCC) authorities requested that subjects be screened for HIV testing prior to study enrolment in South Africa to ensure that only HIV negative participants are enrolled. As such, HIV rapid test was added at Visit 1 only for subjects in South Africa. Subjects previously screened HIV positive will be excluded.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 877 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A PHASE III, RANDOMISED, OPEN, CONTROLLED, MULTICENTRE, PRIMARY VACCINATION STUDY TO EVALUATE THE IMMUNOGENICITY AND PERSISTENCE OF 1 AND 2 DOSES OF MENINGOCOCCAL CONJUGATE VACCINE MENACWY-TT IN TODDLERS (AFTER 1 MONTH AND UP TO 5 YEARS) AND TO DEMONSTRATE NON-INFERIORITY OF CO-ADMINISTRATION OF MENACWY-TT AND 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE PREVENAR 13(REGISTERED) VERSUS SEPARATE ADMINISTRATION OF THE 2 VACCINES
Actual Study Start Date : October 2, 2013
Estimated Primary Completion Date : February 12, 2020
Estimated Study Completion Date : February 12, 2020


Arm Intervention/treatment
Experimental: ACWY1d group
Subjects will receive 1 dose of the MenACWY-TT vaccine
Biological: Meningococcal vaccine GSK134612
1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region

Experimental: ACWY2d group
Subjects will receive 2 doses of the MenACWY-TT vaccine 2 months apart
Biological: Meningococcal vaccine GSK134612
1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region

Experimental: Co-ad group
Subjects will receive 1 dose of the MenACWY-TT vaccine co-administered with Prevenar 13™
Biological: Meningococcal vaccine GSK134612
1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region

Biological: Prevenar 13™
1 dose administered intramuscularly in the right anterolateral thigh or deltoid region

Active Comparator: PCV-13 group
Subjects will receive 1 dose of Prevenar 13™ and 1 dose of the MenACWY-TT vaccine 2 months later
Biological: Meningococcal vaccine GSK134612
1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region

Biological: Prevenar 13™
1 dose administered intramuscularly in the right anterolateral thigh or deltoid region




Primary Outcome Measures :
  1. Immunogenicity with respect to components of the study vaccines in terms of rSBA titres [ Time Frame: 1 month after administration of 1 dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad groups (Month 1) ]
    Percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:8

  2. Immunogenicity with respect to components of the study vaccines in terms of rSBA titres [ Time Frame: At Year 1 ]
    Percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:8, ≥ 1:128 and titres in the ACWY1d and ACWY2d groups

  3. Immunogenicity with respect to components of the study vaccines in terms of rSBA titres [ Time Frame: At Year 3 ]
    Percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:8, ≥ 1:128 and titres in the ACWY1d and ACWY2d groups

  4. Immunogenicity with respect to components of the study vaccines in terms of rSBA titres [ Time Frame: At Year 5 ]
    Percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:8, ≥ 1:128 and titres in the ACWY1d and ACWY2d groups

  5. Immunogenicity with respect to components of the study vaccines in terms of antibody concentration [ Time Frame: 1 month after administration of Prevenar 13 (Month 1) ]
    Anti-pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F antibody concentrations in the Co-ad and PCV-13 groups

  6. Immunogenicity with respect to components of the study vaccines in terms of rSBA titres [ Time Frame: 1 month after administration of 2 doses of MenACWY-TT in the ACWY2d group (Month 3) ]
    Percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:8


Secondary Outcome Measures :
  1. Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of hSBA titres [ Time Frame: 1 month after administration of 1 dose of MenACWY-TT in a subset of subjects in the ACWY1d and ACWY2d groups (Month 1) and 2 doses in the ACWY2d group (Month 3) ]
    Percentage of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres ≥ 1:4, ≥ 1:8 and titres

  2. Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of rSBA titres [ Time Frame: 1 month after administration of 1 dose of MenACWY-TT (Month 1) ]
    Percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:8, ≥ 1:128 and titres in the PCV-13 group

  3. Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of rSBA titres [ Time Frame: 1 month after administration of 1 dose of MenACWY-TT (Month 1) ]
    Percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:128 and titres in the ACWY1d, ACWY2d and Co-ad groups

  4. Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of hSBA titres [ Time Frame: At Years 1, 3 and 5 ]
    Percentage of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY titres ≥ 1:4, ≥1:8 and titres in a subset of subjects in the ACWY1d and ACWY2d groups.

  5. Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of rSBA titres [ Time Frame: At Years 1, 3 and 5 ]
    Percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥ 1:8, ≥1:128 and titres in the Co-ad and PCV-13 groups

  6. Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of antibody concentration [ Time Frame: One month after administration of Prevenar 13 (Month 1) ]
    Percentage of subjects with anti-pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F antibody concentrations ≥ 0.15 µg/ml, ≥ 0.26 µg/ml and ≥ 0.35 µg/ml in the Co-ad and PCV-13 groups

  7. Immunogenicity with respect to components of the study vaccines (on secondary readouts) in terms of OPA titres [ Time Frame: One month after administration of Prevenar 13 (Month 1) ]
    Percentage of subjects with anti-pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F OPA titres ≥ 1:8 and titres in the Co-ad and PCV-13 groups

  8. Occurrence of solicited local and general symptoms [ Time Frame: Within 4 days (Day 0 - Day 3) after each study vaccination ]
    Occurrence of each solicited local and general symptom

  9. Occurrence of unsolicited adverse events [ Time Frame: Within 31 days (Day 0 - Day 30) after any study vaccination ]
    Occurrence of unsolicited AEs according to the Medical Dictionary for Regulatory Activities (MedDRA) classification

  10. Occurrence of serious adverse events (SAEs) [ Time Frame: From Month 0 to Month 9 ]
    Occurrence of SAEs

  11. Occurrence of SAEs related to study vaccine administration [ Time Frame: From the first receipt of study vaccine until study end (Year 5) ]
    Occurrence of SAEs related to study vaccine administration and any event related to lack of vaccine efficacy (i.e. meningococcal disease)

  12. Occurrence of New Onset Chronic Illnesses (NOCIs) [ Time Frame: From Month 0 to Month 9 ]
    E.g. asthma, autoimmune disorders, type 1 diabetes, allergies



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Months to 14 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • A male or female between, and including, 12 and 14 months of age at the time of the first vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Vaccination records showing the completion of the full primary vaccination schedule with Prevenar 13 and Diphtheria, Tetanus and Pertussis (DTP) containing vaccine according to local recommendations at least 5 months before the study entry.

Exclusion Criteria:

  • Child in care.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine or planned use during the study period.
  • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the dose of vaccines, with the exception of a licensed inactivated influenza vaccine. Measles, Mumps Rubella (MMR) vaccine or Measles Mumps Rubella and Varicella (MMRV) vaccine can be co-administered with MenACWY-TT and/or Prevenar 13. A DTPa containing vaccine can be administered after the last blood sampling (at Visit 2 or 4 depending on the group).
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
  • Previous vaccination against Neisseria meningitidis.
  • Previous booster vaccination against Streptococcus pneumoniae.
  • Previous booster vaccination against Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis.
  • History of meningococcal disease.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required)*

    • Note: With the exception of HIV rapid testing which will be done for subjects in South Africa.
  • Family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity, including to diphtheria toxoid, likely to be exacerbated by any component of the vaccines.
  • Major congenital defects or serious chronic illness.
  • History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
  • Acute disease and/or fever at the time of enrollment.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

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): NCT01939158


  Show 50 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01939158     History of Changes
Other Study ID Numbers: MENACWY-TT-104
C0921003 ( Other Identifier: Alias Study Number )
2013-001083-28 ( EudraCT Number )
116892 ( Other Identifier: Alias Study Number )
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Co-administration
Safety
Persistence
Immunogenicity
Prevenar 13
Meningococcal vaccine
Toddlers
5 years
Additional relevant MeSH terms:
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Meningococcal Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs