Non Inferiority Trial of Locally Manufactured Meningococcal ACWY Vaccine 'Ingovax ACWY' in Bangladesh.
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|ClinicalTrials.gov Identifier: NCT03263403|
Recruitment Status : Completed
First Posted : August 28, 2017
Last Update Posted : March 22, 2018
|Condition or disease||Intervention/treatment||Phase|
|Meningococcal Vaccine||Biological: Ingovax ACWY Biological: Quadri Meningo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|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.|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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): NCT03263403
|Mohiul Islam Chowdhury|
|Dhaka, Bangladesh, 1212|
|Study Director:||Firdausi Qadri, PhD||International Centre for Diarrhoeal Disease Research, Bangladesh|