A study on the safety and immune response to anunadjuvanted RSV Maternal vaccine, in high riskpregnant women aged 15 to 49 years and infantsborn to the vaccinated mothers.
- Conditions
- Health Condition 1: O09- Supervision of high risk pregnancy
- Registration Number
- CTRI/2021/10/037383
- Lead Sponsor
- GlaxoSmithKline Biologicals SA GSK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Maternal participants
Maternal participants must satisfy ALL the following criteria at study entry:
1.Participants who, in the opinion of the investigator, can and will comply with the
requirements of the protocol (e.g. completion of diaries, return for follow-up visits).
2.Participants and legally acceptable representatives (LARs) who give written or
witnessed/thumb printed informed consent after the study has been explained according to local regulatory requirements, and before any study specific procedures are performed. The informed consent given at screening should (consistent with local regulations / guidelines) either:
â?? include consent for both the maternal participantâ??s participation and
participation of the infant after the infantâ??s birth, or
â?? include consent for the maternal participantâ??s participation and expressed
willingness to consider permitting the infant to take part after the infantâ??s birth
(if local regulations/guidelines require parent(s) to provide an additional informed consent after the infantâ??s birth).
Written informed consent obtained from parents/LARs and written informed assent
obtained from the maternal participant if she is less than legal age, or written
informed consent obtained from the participant if the participant has achieved legal
age. The legal age is determined according to local regulations in each participating
country.
In case the legal age is achieved during the conduct of the study, an additional
written informed consent from the maternal participant should be obtained at the
time of the legal age.
â?? both mother and father should consent if local regulations / guidelines require it.
3.Pre-pregnancy Body Mass Index (BMI) (based on participantâ??s report) 18.5 to 39.9
kg/m2, inclusive.
4. Healthy (as established by medical history and clinical examination) adolescent
pregnant women, 15 to 17 YOA, inclusive, at the time of study intervention
administration.
OR
5. Pregnant women, 18 to 49 YOA, inclusive, at the time of study intervention administration with:
- HIV infection (as confirmed by local standard of care serologic tests)
AND/OR
â?? Obstetric complications or risk factors during the current pregnancy, where the expectant management of the pregnancy is possible and without evidence of non-reassuring fetal status (only cases for which fetal heart rate can be
ascertained) as follows:
â?? Gestational diabetes, well-controlled on medications (with or without diet or
exercise): i.e. when normoglycemia is maintained (fasting or preprandial
blood glucose values <95 mg/dL [5.3 mmol/L], and/or postprandial blood
glucose concentration <140 mg/dL [7.8 mmol/L] at 1 hour and/or
postprandial blood glucose concentration: <120 mg/dL [6.7 mmol/L] at 2
hours).
- Gestational hypertension, well-controlled on diet or medications below 160/110 mmHg
- Pre-eclampsia without severe features (i.e. eclampsia, severe hypertension [ >160/110 mmHg], organ dysfunction, unstable or complicated by
Hemolysis, Elevated Liver enzymes, and Low Platelets [HELLP] syndrome).
- Fetal Growth Restriction in singleton pregnancies, with normal umbilical artery (UA) Doppler and estimated fetal weight 3 to 10th percentile for ge
Maternal participants
1.Medical conditions
-History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
-Hypersensitivity to latex.
-Any pre-existing medical conditions or obstetric complications in the current pregnancy that, based on the investigators clinical judgment, are poorly controlled and or with clinical evidence of a non-reassuring fetal status and or are likely to result in delivery within 7 days after study intervention administration and or when the timing of planned delivery is within 7 days after study intervention administration and or acute conditions requiring immediate medical attention for maternal stabilization and or treatment.
-A multiple pregnancy with 3 or more fetuses.
-Complicated twin gestation (e.g twin to twin transfusion syndrome or fetal growth
restriction).
-Placenta Accreta Spectrum, including placenta increta, percreta, and accreta.
-Fetal structural defects or genetic abnormalities that affect (or are likely to affect) fetal health or survival during the first year of life.
-Known or suspected impairment of the immune system or immunodeficiency syndrome other than HIV.
-Lymphoproliferative disorder or malignancy within 5 years before study dose administration (excluding effectively treated non-melanoma skin cancer).
-Any illness of the mother or conditions of the fetus that, in the investigators judgment, may substantially interfere with the maternal participants ability to comply with study procedures, or could increase the risks to the mother or the fetus, or could preclude the evaluation of the participants data.
-Any other clinical condition that, in the opinion of the investigator, might pose
additional risk to the participant due to participation in the study, as determined by
medical history, physical examination or laboratory screening tests.
-Women with any diagnosis, condition, treatment, or other factor that, in the opinion of the investigator, has the potential to affect or confound assessments of immunogenicity or safety
-Any conditions which, in the investigators opinion, would increase the risks of study participation to the unborn infant.
2. Prior/Concomitant therapy
- Prior receipt of an RSV maternal vaccine.
- Use of any investigational or non-registered product (drug, vaccine or medical
device) other than the study intervention(s) during the period beginning-
â?? For a drug, vaccine or medical device - 29 days before the dose of study intervention(s) (Day -28 to Day 1), or their planned use during the study period.
â?? For immunoglobulins - 90 days before the dose of study intervention(s), or their
planned use during the study period.
The exception to this is investigational products (drugs or vaccines or immunoglobulins) administered in the setting of a pandemic. Administration in this case should respect the same period outlined above prior to study intervention administration, but may be allowed following delivery.
-Planned administration or administration of a vaccine not foreseen by the study
protocol in the period starting 29 days before the study Day 1 and ending at delivery,
with the exception of seasonal influenza vaccines, tetanus vaccines, dTpa or Tdap â?? alone vaccines, dTpa or Tdap vaccines that also contain other antigens
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety - Maternal <br/ ><br>Number and percentage of maternal participants reporting: <br/ ><br>1. Solicited administration site, systemic events during a 7-day follow-up period after dosing. <br/ ><br> <br/ ><br>Timepoint: Safety - Maternal <br/ ><br>1. Day 1 to Day 7 included <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method