Meningococcal Meningitis Respiratory
Conditions
Interventions
MenFive Vaccine
Normal Saline
Sponsors
PATH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Maternal Inclusion Criteria: 1. Written informed consent obtained at =18 years of age and willing to comply with study requirements. 2. Females =18 and =40 years of age at time of randomization 3. Registered for Antenatal Care 4. Healthy as defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history and clinical assessment 5. Pregnant between 14 weeks+0 days and 32 weeks+6 days weeks of gestation at time of randomization, • as established by Last menstrual period date corroborated by first or second trimester ultrasound examination i.e. at or before 28 weeks of gestation. • or 1st or 2nd trimester U/S only, if LMP is unknown/uncertain/inconsistent. 6. Uncomplicated, singleton pregnancy, with no risk factors for complications. 7. Negative for HIV, Syphilis and HBV at screening or based on any previous reports for these tests performed during current pregnancy. 8. At least one ultrasound assessing fetal anomalies performed prior to randomization with confirmation of no fetal anomalies identified. Note that U/S for fetal anomalies must occur after a minimum of 12 weeks gestation. 9. No fetal genetic abnormalities (based on genetic analysis if performed). 10. Who intend to give birth at a health facility where study procedures can be performed. 11. Who intend to breastfeed. 12. Who do not plan to give their infant for adoption. 13. Who plan to reside in the study area for at least 6 months after delivery. Infant Inclusion Criteria (0-3 days): 1. Live birth. 2. Parent(s)/legal guardian(s) consenting for infant participation in the study. 3. Parent(s)/legal guardian(s) ability to comply with study procedures in the investigator judgement
Exclusion criteria
Exclusion criteria: Maternal exclusion criteria Significant current pregnancy complications Significant uterus or cervix structural abnormalities Previous infant with known genetic disorder or major congenital anomaly Prior =34 weeks gestation preterm births =2 consecutive spontaneous abortions Complications in previous pregnancy at high-risk of recurring Known or suspected Toxoplasma, Parvovirus B19, Zika, Rubella, Varicella, CMV, HCV or primary genital Herpes Simplex infection in current pregnancy Second-degree cousin or closer consanguinity of maternal participant and partner Other pregnancy-related complications that would preclude trial participation or pose risk to the mother or fetus Acute medical illness Active tuberculosis infection (no testing required) Any known or suspected immunosuppressive condition Malignancy history in past 5 years History of GBS Chronic administration (=14 days) of immunosuppressive/immunomodulating drugs =6months History or suspicion of alcohol or substance abuse =1year Local condition that precludes study vaccination or local reactogenicity assessment Condition posing a health risk to the participant or her fetus, or could interfere with the vaccine evaluation Antenatal history posing a health risk to the participant or her fetus, or could interfere with the vaccine evaluation Anaphylaxis or serious allergic reactions to any vaccine or study vaccine components Receipt of IP =30days or planning to participate in another research involving investigation product during study Contraindication to parenteral injections or history of bleeding or coagulation disorder Planned/actual administration of blood products =6months or during the study, with the exception of anti-Rh0D-IG Receipt of meningococcal C, W, Y, or X serogroup containing vaccine Planned/actual vaccination =14 days before or after study vaccination Any site employees or their close relatives including unborn infant father Infant Exclusion Criteria Infant in care or adopted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a) Immediate adverse events (IAEs) within 30 minutes following study vaccination in pregnancy. b) Solicited local AEs within 7 days following study vaccination in pregnancy (pain and swelling/induration at the injection site). c) Solicited systemic AEs within 7 days following study vaccination in pregnancy (fever, headache, myalgia, arthralgia, fatigue, anorexia, vomiting and diarrhea). d) Unsolicited AEs within 28 days following study vaccination in pregnancy. e) Medically attended adverse events (MAAEs) within 180 days following study vaccination in pregnancy or until vaccination during breastfeeding whichever occurs first. f) Serious adverse events (SAEs) within 180 days following study vaccination in pregnancy or until vaccination during breastfeeding whichever occurs first;MAAEs and SAEs in infants ;In pregnant women, antibody titer against serogroups A, C, W, Y, and X at baseline and day 28 post vaccination measured by rabbit complement serum bactericidal antibody (rSBA) assay [Summary: Geometric mean titers (GMTs) and Seroresponse rate] | — |
Secondary
| Measure | Time frame |
|---|---|
| Pregnancy outcome (Live birth/Stillbirth/Miscarriage (spontaneous abortion)/Induced abortion) ;Gestation and weight at birth of infants;a) Immediate AEs within 30 minutes following study vaccination during breastfeeding. b) Solicited local AEs within 7 days following study vaccination during breastfeeding (pain and swelling/induration at the injection site). c) Solicited systemic AEs within 7 days following study vaccination during breastfeeding (fever, headache, myalgia, arthralgia, fatigue, anorexia, vomiting and diarrhea). d) Unsolicited AEs within 28 days following study vaccination during breastfeeding.;Adverse Events in Lactation and Breastfeeding reported as MAAEs and SAEs within 138 days following maternal dosing of MenFive during breastfeeding;In infants, weight, length at six weeks and at six months (180 days) of age;In pregnant women, antibody titer against serogroups A, C, W, Y, and X at baseline and day 28 post vaccination measured by rabbit complement serum bactericidal antibody (rSBA) assay [Summary:Percentage of pregnant women with rSBA titer of = 1:8 and = 1:128];In infants, antibody titer against serogroups A, C, W, Y, and X at birth measured by rSBA assay;In breastfeeding women, antibody titer against serogroups A, C, W, Y, and X at baseline and day 28 post vaccination measured by rSBA assay;In infants, antibody concentration against diphtheria toxoid, tetanus toxoid, Haemophilus influenzae type b capsular polysaccharide (PRP), and pneumococcal serotype-specific capsular polysaccharides measured 4 weeks post-dose 3 (28 days after completing the 3-dose immunization regimen with routine infant vaccines) | — |
Countries
Mali
Contacts
Public ContactLionel Martellet
Associate Director Clinical Operations
Outcome results
None listed