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Non Inferiority Trial of Locally Manufactured Meningococcal ACWY Vaccine 'Ingovax ACWY' in Bangladesh.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03263403
Recruitment Status : Completed
First Posted : August 28, 2017
Last Update Posted : March 22, 2018
Incepta Vaccine Limited
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary:
This study will be a randomized observer -blinded controlled non-inferiority study to evaluate and compare the immunogenicity of locally produced Ingovax ACWY with Quadri Meningo on a total of 88 healthy adult participants (18-45 years of age). 44 participants will receive locally produced Ingovax ACWY and 44 participants of comparator groups will receive Quadri Meningo which is produced by BiO-MeD Private Limited. Vaccination will be done in Day 0 following the screening and pre-immunization blood sample collection and post-immunization blood will be collected at Study Day 30. Follow- up by home visit will be carried out from Study day 1-6 and clinic follow-up is scheduled upto Study day 90. The hypothesis of this study is: locally produced subcutaneous Meningococcal vaccine Ingovax ACWY is non inferior and immunogenic among adults in Bangladesh as compared to Quadri Meningo.

Condition or disease Intervention/treatment Phase
Meningococcal Vaccine Biological: Ingovax ACWY Biological: Quadri Meningo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible participants will be assigned to receive the Ingovax ACWY Vaccine and Quadri Meningo Vaccine, in a 1:1 ratio across the target population according to the randomization schedule. 44 participants will receive locally produced Ingovax ACWY and 44 participants of comparator groups will receive Quadri Meningo which is produced by BiO-MeD Private Limited.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Since the test and comparator drugs used in this clinical study have different package of vial, a double blind design is not appropriate. Study investigators along with study staffs involved in safety evaluation and laboratory analysis will be blinded regarding the assigned treatment of the participant. The vaccine administration team will be unblinded to the treatment assignment list. The vaccine administrator team members will not be involved in the evaluation of vaccine safety and laboratory analysis.
Primary Purpose: Prevention
Official Title: A Randomized Observer-blinded Controlled Non-inferiority Trial to Evaluate the Immunogenicity of Locally Manufactured Meningococcal ACWY Vaccine 'Ingovax ACWY' in Bangladeshi Healthy Adults.
Actual Study Start Date : August 21, 2017
Actual Primary Completion Date : March 19, 2018
Actual Study Completion Date : March 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arm Intervention/treatment
Experimental: Test Group
44 participants will be randomly assigned to the test group for receiving the locally produced meningococcal vaccine "Ingovax ACWY" (Incepta).
Biological: Ingovax ACWY
The pharmaceutical company in Bangladesh is now currently marketing meningococcal vaccine of Yuxi Walvax Biotechnology Co. Ltd which is filled finish by Incepta Vaccines Ltd. This fill finish meningococcal vaccine is already registered and licensed in Bangladesh. However, at present, no locally produced meningococcal vaccine is available in Bangladesh. Once this clinical trial is completed, it will then proceed for registration and licensure in Bangladesh. Ingovax ACWY is a freeze-dried preparation of the group-specific polysaccharide antigens from Neisseria meningitidis Group A, Group C, Group Y and Group W135. When reconstituted, the vaccine is a clear, colorless sterile solution for subcutaneous use.

Active Comparator: Comparator Group
44 participants will be randomly assigned to the comparator group for receiving 'Quadri Meningo' (BiO-MeD Private Limited).
Biological: Quadri Meningo
Meningococcal polysaccharide vaccine Quadri Meningo vaccine manufactured by BiO-MeD Private Limited. Quadri Meningo [Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined] is a freeze-dried preparation of the Group-specific polysaccharide antigens from Neisseria meningitidis, Group A, Group C, Group Y, and Group W-135. After reconstitution with diluent, the vaccine is a clear colourless liquid.

Primary Outcome Measures :
  1. Assessment of proportion of participants showing seroconversion (defined as a ≥4-fold rise in SBA titers) vaccinated with either Ingovax ACWY Vaccine (Incepta) or Menomune ® -A/C/Y/W-135 vaccine (Sanofi Pasteur Inc.). The non-inferiority margin will be [ Time Frame: 30 days after administration of vaccine ]
    The test vaccine will induce similar seroconversion rates in compare to reference vaccine (defined as a ≥4-fold rise in SBA titers). This will be done by calculating the responder rate through comparing the pre and 30(±2) days post-vaccination serum bactericidal titres among Ingovax ACWY' or Menomune® - A/C/Y/W-135 vaccinated participants. The non-inferiority margin will be 10%. Serum bactericidal assay(SBA) titres and fold-rises will be logarithmically transformed prior to statistical analyses in order to better approximate normality.

Secondary Outcome Measures :
  1. To compare the GMTs between vaccines, and GMT ratios. [ Time Frame: 30 days after administration of vaccine ]
    Comparison of the geometric mean titre among the test and comparator group.

  2. Number of immediate reactions reported within 30 minutes after vaccination [ Time Frame: 30 minutes post vaccination ]
    After administration of study agents, participants will be requested to wait for at least 30 minutes at the vaccination sites to monitor for any solicited adverse events following vaccination.

  3. Number of solicited adverse events (prelisted in the participant's memory aid) occurring up to 6 days following vaccination. [ Time Frame: Post vaccination Day 1 to Day 6 ]
    Participants will be monitored specifically for local adverse reactions (redness, swelling, pain, tenderness, induration and ecchymosis) and systemic reactions (headache, seizure, rash, arthalgia, myalgia, fever, nausea, vomiting, diarrhea, shivering, fatigue and malaise). These adverse events will be monitored actively for the first 6 days in all participants following vaccination.

  4. Number of unsolicited AEs up to 28days after vaccination. [ Time Frame: 28 days following vaccination ]
    Adverse events will be monitored passively up to 28 days post dose of IP administration.

  5. Occurrence of serious adverse events (SAEs) throughout the trial [ Time Frame: upto 90 days post vaccination ]
    serious adverse events that occurs from the beginning of the study up to the end (90 days after vaccination) will be reported using the Serious Adverse Event forms.

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:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Apparently healthy adult of 18 to 45 years of age.
  2. Sex: Male, Female and Transgender
  3. Apparently healthy based on a medical history taken prior to vaccination. Any underlying chronic illness must be documented to be in stable condition.
  4. Women with child bearing potential must be non pregnant which will be confirmed by negative urine pregnancy test during screening and prior to vaccination on day 0 as well. Moreover, medical history will be taken thoroughly by study physician from the woman of childbearing age to completely exclude the probability of pregnancy.Women who are married and living with a partner must agree to use a reliable contraceptive method to prevent pregnancy until final follow-up following vaccination. However abstinence is also acceptable.

Exclusion Criteria:

  1. Prior history of Meningitis infection or vaccination with any Meningococcal vaccine.
  2. Prior history of taking any other polysaccharide vaccine (Pneumococcal Vaccine, Typhoid Vaccine) in last 6 months.
  3. Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine.
  4. Recent febrile illness (within last two weeks).
  5. Clinically significant abnormalities in screening hematology or serum chemistry, as determined by the Study Physician.
  6. Known or suspected hypersensitivity to any component of Meningococcal ACWY polysaccharide vaccine.
  7. Known or suspected impairment of immunologic function or recent use of immunomodulatory medications (e.g, systemic corticosteroids). Does not include topical and inhaled steroids.
  8. Pregnant women, nursing mothers, and women planning to become pregnant within the study period.
  9. Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

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 identifier (NCT number): NCT03263403

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Mohiul Islam Chowdhury
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Incepta Vaccine Limited
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Study Director: Firdausi Qadri, PhD International Centre for Diarrhoeal Disease Research, Bangladesh
Additional Information:
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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh Identifier: NCT03263403    
Other Study ID Numbers: PR-17068
First Posted: August 28, 2017    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 International Centre for Diarrhoeal Disease Research, Bangladesh:
Meningococcal Vaccine
Ingovax ACWY