A clinical study to evaluate immunogenicity and safety of a MenACYW conjugate vaccine with routine pediatirc vaccines in healthy infants and toddlers in India and South Africa.
- Registration Number
- CTRI/2023/05/052247
- Lead Sponsor
- Sanofi Pasteur Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
I01 Cohort I: 6 months of age (180 to 209 days of age) on the day of the first study visit
Cohort II: 6-8 weeks of age (42 to 62 days of age) on the day of the first study visit
I02 Healthy infants as determined by medical history, physical examination, and judgment of the Investigator.
I03 Cohort I: Z-score =-2 SD on the Weight-for-age table of the WHO Child Growth standards.
I04 Cohort II: Born at full term of pregnancy (= 37 weeks) and with a birth weight = 2.5 kg.
I05 Informed consent form (ICF) has been signed and dated by the parent(s) or other legally acceptable representative (LAR) (and by an independent witness if required by local regulations).
I06: Participant and parent/LAR are able to attend all scheduled visits and to comply with all study procedures.
E01 Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
E02 Receipt of any vaccine in the 4 weeks preceding the first study vaccination (except for Bacille Calmette–Guerin [BCG], birth dose OPV and birth dose of HepB vaccine) or planned receipt of any vaccine in the 4 weeks following each study vaccination except for the following vaccinations, which may be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines, multivalent influenza vaccines, any COVID-19 vaccines, and administration of OPV on National Immunization Day in India.
E03 Previous vaccination against meningococcal disease with either the study vaccine or another vaccine (ie, mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup containing vaccine).
E04 For Cohort II - Previous vaccination against diphtheria, tetanus, pertussis,
poliomyelitis (other than birth dose of OPV), Hepatitis A, measles, mumps, rubella, varicella; and of Hib, Streptococcus pneumoniae, and/or RV infection or disease.
E05 For Cohort II – Previous vaccination with more than 1 dose of HepB vaccine.
E06 Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
E07 Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
Note: Participants with a history of HIV but without evident severe
immunosuppression can be included.
E08 Family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
E09 Individuals with active tuberculosis.
E10 History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
E11 At high risk for meningococcal infection during the study (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants travelling to countries with high endemic or epidemic disease).
E12 History of intussusception.
E13 History of any neurologic disorders, including any seizures and progressive neurologic disorders.
E14 History of Guillain-Barre syndrome (GBS).
E15 Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the study or to a vaccine containing any of the same substances, including neomycin, gelatin, and yeast.
E16 Verbal report of thrombocytopenia, as reported by the parent/LAR, contraindicating IM vaccination in the Investigator’s opinion.
E17 Bleeding disorder, or receipt of anticoagulants in the 3
weeks preceding inclusion, contraindicating IM vaccination in the Investigator’s opinion.
E18 Chronic illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1- To demonstrate the non-inferiority of immunogenicity of 2 doses of MenACYW conjugate vaccine <br/ ><br>compared to 2 doses of Menactra vaccine in infants and toddlers 6 months to 16 months of age in terms <br/ ><br>of serum bactericidal assay using human complement hSBA seroprotection titers more than equal to 1 ratio 8 in India and the Republic of South Africa. <br/ ><br>Note: Please refer the study protocol for further primary and secondary outcomes/ Endpoints.Timepoint: •30 days(plus 14 days) after the second vaccination in infants and toddlers 6 months to 16 months of age in India and the RSA <br/ ><br> <br/ ><br>•30 days (plus 14 days) after the booster vaccination in infants and toddlers 6 weeks to 15 months of age in India and the RSA <br/ ><br>
- Secondary Outcome Measures
Name Time Method To describe the antibody titers to the meningococcal serogroups A, C, Y, and W before and 30 days post primary series of MenACYW conjugate vaccine and before and 30 days post booster dose of MenACYW conjugate vaccine in infants and toddlers 6 weeks to 15 months of age in India and the RSA when administered concomitantly with other age recommended vaccines <br/ ><br>Note: Please refer the study protocol for further primary and secondary outcomes/ Endpoints.Timepoint: •30 days(plus 14 days) after the second vaccination in infants and toddlers 6 months to 16 months of age in India and the RSA <br/ ><br> <br/ ><br>•30 days (plus 14 days) after the booster vaccination in infants and toddlers 6 weeks to 15 months of age in India and the RSA <br/ ><br>