Respiratory Syncytial Virus InfectionsPhase 2NCT03191383
A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the GlaxoSmithKline (GSK) Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine (GSK3003891A) in Healthy Pregnant Women and Infants Born to Vaccinated Mothers
A Phase 2 study testing RSV vaccine (GSK3003891A) formulation 1, RSV vaccine (GSK3003891A) formulation 2 and RSV vaccine (GSK3003891A) formulation 3 in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 12 sites in 3 countries.
Trial summary
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the investigational GSK RSV vaccine in pregnant women aged 18 to 40 years and infants born to the vaccinated women Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- RSV vaccine (GSK3003891A) formulation 1, RSV vaccine (GSK3003891A) formulation 2 and RSV vaccine (GSK3003891A) formulation 3
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 11 Jul 2017to 14 Jul 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed consent for study participation of the mother obtained from the mother or the mother and father, as applicable by local law, prior to performance of any study specific procedure.
- Written informed consent for study participation of the infant obtained from the infant's mother and/or father, as applicable by local law, or legally acceptable representative [LAR] prior to performance of any study specific procedure.
- Subjects between, and including, 18 and 40 years of age at the time of the first study visit.
- Pregnant females > 24 weeks of gestation at the time of screening and at 28 0/7 to 33 6/7 weeks of gestation at the time of vaccination, as established by ultrasound examination and last menstrual period date.
- Healthy pregnant females as established by medical history and clinical examination before entering into the study.
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- Pregnant females not at high risk for complications, as determined by the obstetrical risk assessment form.
- No significant foetal findings observed during a second or third trimester ultrasound.
- Subjects who are willing to provide cord blood.
- Subjects who do not plan to give their child for adoption or place the child in care.
- Re-signed written informed consent for study participation of the infant obtained from the infant's mother and/or father, as applicable by local law, or LAR.
Who cannot join
- Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before vaccination , or planned use during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before vaccination and ending at delivery with the exception of seasonal influenza vaccine and diphtheria, tetanus, pertussis/tetanus, diphtheria, pertussis [dTpa/Tdap] vaccine as part of standard of care which may be administered ≥ 15 days before or after study vaccination.
- Chronic administration of systemic immunosuppressants or other immune-modifying drugs, as well as administration of long-acting immune-modifying drugs during the period starting 6 months prior to study vaccination, or planned administration up to delivery. Topical steroids are allowed. Inhaled steroids are allowed up to the limit of ≤500 µg/day for beclomethasone or fluticasone, or ≤ 800 µg/day for budesonide.
- Administration of immunoglobulins (with the exception of prophylactic anti-Rh0D immune globulin) and/or any blood products during the period starting 3 months before study vaccination or planned administration during the study period.
- Previous experimental vaccination against RSV.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
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- Low lying placenta during the current pregnancy, unless there is documented sonographic evidence that the placenta has moved up prior to enrolment.
- Any abnormal finding observed in nuchal translucency scan, serum testing and any other prenatal tests, if conducted.
- Incompetent cervix or cerclage during the current pregnancy.
- Having received medical treatment for suspected preterm delivery during the current pregnancy.
- Prior preterm delivery or having ongoing intervention in current pregnancy to prevent preterm delivery.
- Prior stillbirth or neonatal death, or ≥ 2 spontaneous abortions.
- Personal history of major congenital anomalies or early onset of eclampsia/pre-eclampsia in previous pregnancy.
- 1st degree relatives family history of major congenital anomalies and/ or hereditary immunodeficiency.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Hemodynamically significant cardiac disorders.
- Gestational diabetes as determined by glucose challenge/tolerance test conducted after 20 weeks of gestation or as per local recommendations of the country, requiring intervention other than diet for control. In countries where glucose challenge/tolerance testing is not routinely performed in all pregnant women, should the screening urinalysis test show presence of glucose in urine, a glucose challenge/tolerance test should be performed and results should be available prior to enrolment, in order to exclude gestational diabetes prior to subject receiving the study vaccine.
- History of gestational diabetes in previous pregnancy(ies).
- Hypertension during the current pregnancy as defined below or if any antihypertensive medication is being provided, or history of hypertension requiring antihypertensive medication:
- Hypertension during current pregnancy is defined as:
- a blood pressure systolic > 140 and/or diastolic 90 mmHg, documented in at least 2 separate measurements .
- Current obstetric cholestasis or history of obstetric cholestasis.
- Asthma and/or chronic obstructive pulmonary disease [COPD] if the subject is receiving treatment with chronic systemic glucocorticoids at any dose or inhaled glucocorticoids > 500 µg/day of beclomethasone or fluticasone, or > 800 µg/day of budesonide.
- Significant neuro-psychiatric illness deemed likely to interfere with protocol compliance, safety reporting or receipt of pre-natal care, or requiring treatment with psychotropic drugs.
- Diagnosed with Zika virus infection or suspected to have or have had Zika virus infection during the current pregnancy.
- Known HIV infection, as assessed by local standard of care serologic tests conducted during the current pregnancy and prior to enrolment.
- Known or suspected Hepatitis B virus [HBV] or Hepatitis C virus [HCV] infection.
- Known infection during the current pregnancy with Toxoplasma, Parvovirus B19, Syphilis, Rubella, cytomegalovirus [CMV] or primary Herpes Simplex.
- Known foetal anomalies in the current pregnancy.
- Any clinically significant haematological and/or biochemical laboratory abnormality.
- Subjects with haematological/ biochemical values out of normal range which are expected to be temporary may be re-screened at a later date within the allowed time interval.
- Acute disease and/or fever within 3 days prior to enrolment .
- Fever is defined as temperature ≥ 37.5°C/99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- For subjects with acute disease and/ or fever at the time of enrolment, Visit 1 may be scheduled at a later date within the allowed time interval and gestational age.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Hypersensitivity to latex.
- Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
- History of drug or alcohol abuse within the past 2 years.
- Any condition which, in the investigator's opinion, would increase the risks of study participation to the unborn infant.
- Planned move to a location that will prohibit participating in the trial until study end.
- Any condition which, in the investigator's opinion, would increase the risks of study participation to the infant.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Spain7 sites
GSK Investigational Site
Aravaca, 28023
GSK Investigational Site
Burgos, 09006
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Majadahonda (Madrid), 28222
GSK Investigational Site
Santiago, 15705
GSK Investigational Site
Santiago de Compostela, 15706
GSK Investigational Site
Seville, 41014
United States3 sites
GSK Investigational Site
Ellensburg, Washington, 98926
GSK Investigational Site
Newton, Kansas, 67114
GSK Investigational Site
Syracuse, New York, 13210
Finland2 sites
GSK Investigational Site
Oulu, 90220
GSK Investigational Site
Seinäjoki, 60100
About this study
Official title: An Observer-blind Study to Assess the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Pregnant Women and Infants Born to Vaccinated Mothers
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the investigational GSK RSV vaccine in pregnant women aged 18 to 40 years and infants born to the vaccinated women
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- RSV vaccine (GSK3003891A) formulation 1, RSV vaccine (GSK3003891A) formulation 2, RSV vaccine (GSK3003891A) formulation 3, Placebo (Formulation buffer S9b)
- Keywords
- Maternal immunization, Immunogenicity, Vaccines, Safety, Reactogenicity, Respiratory Syncytial Virus
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSV vaccine (GSK3003891A) formulation 1Biological
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
RSV vaccine (GSK3003891A) formulation 2Biological
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
RSV vaccine (GSK3003891A) formulation 3Biological
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
Placebo (Formulation buffer S9b)Drug
Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
| Study group | Role | What they receive |
|---|---|---|
| GSK3003891A vaccine formulation 1 mother Group | Experimental | Subjects in this group will receive a single 30µg dose of the GSK3003891A investigational vaccine, by intramuscular injection into the deltoid region of the non-dominant arm. Receives: Biological: RSV vaccine (GSK3003891A) formulation 1 |
| GSK3003891A vaccine formulation 2 mother Group | Experimental | Subjects in this group will receive a single 60µg dose of the GSK3003891A investigational vaccine, by intramuscular injection into the deltoid region of the non-dominant arm. Receives: Biological: RSV vaccine (GSK3003891A) formulation 2 |
| GSK3003891A vaccine formulation 3 mother Group | Experimental | Subjects in this group will receive a single 120µg dose of the GSK3003891A investigational vaccine, by intramuscular injection into the deltoid region of the non-dominant arm. Receives: Biological: RSV vaccine (GSK3003891A) formulation 3 |
| Control group | Placebo comparator | Subjects in this group will receive a single placebo injection, intramuscularly into the deltoid region of the non-dominant arm. Receives: Drug: Placebo (Formulation buffer S9b) |
| GSK3003891A vaccine formulation 1 infant Group | No intervention | Infants born to mothers vaccinated with a single 30µg dose of the investigational GSK3003891A vaccine |
| GSK3003891A vaccine formulation 2 infant Group | No intervention | Infants born to mothers vaccinated with a single 60µg dose of the investigational GSK3003891A vaccine |
| GSK3003891A vaccine formulation 3 infant Group | No intervention | Infants born to mothers vaccinated with a single 120µg dose of the investigational GSK3003891A vaccine |
| Control infant Group | No intervention | Infants born to mothers who received a single placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with solicited local adverse events (AEs)
Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevents normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Measured: During a 7-day follow-up period after vaccination (i.e. the day of vaccination and 6 subsequent days)
Number of subjects with solicited general AEs
Assessed solicited general symptoms are fatigue, fever [defined as oral/axillary/tympanic route temperature equal to or above 37.5 degrees Celsius (°C) or ≥ 38 °C for rectal route], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain] and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevents normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination
Measured: During the 7-day follow-up period after vaccination (i.e. the day of vaccination and 6 subsequent days)
Number of subjects with unsolicited AEs
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevents normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Measured: During a 30-day follow-up period after vaccination (i.e. the day of vaccination and 29 subsequent days)
Number of subjects with haematological abnormalities
Haematological laboratory abnormalities include haemoglobin level, white blood cell count [WBC], lymphocyte, neutrophil, eosinophil, platelet count, red blood cell count and mean corpuscular volume.
Measured: At Day 0
Number of subjects with haematological abnormalities
Haematological laboratory abnormalities include haemoglobin level, white blood cell count [WBC], lymphocyte, neutrophil, eosinophil, platelet count, red blood cell count and mean corpuscular volume.
Measured: At Day 7
Number of subjects with biochemical abnormalities
Biochemical laboratory abnormalities include alanine amino-transferase [ALT], aspartate amino-transferase [AST], creatinine and blood urea nitrogen.
Measured: At Day 0
Number of subjects with biochemical abnormalities
Biochemical laboratory abnormalities include alanine amino-transferase [ALT], aspartate amino-transferase [AST], creatinine and blood urea nitrogen.
Measured: At Day 7
Number of subjects with any serious adverse events (SAEs)
SAEs are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From study start (Day 0) up to 6 months after delivery
Number of infant subjects with any SAEs
SAEs are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From birth up to 6 months after birth
Number of subjects with pregnancy outcomes
Pregnancy outcomes include live birth with no congenital anomalies, live birth with congenital anomalies, foetal death/still birth with no congenital anomalies, foetal death/still birth with congenital anomalies, elective/therapeutic termination with no congenital anomalies and elective/therapeutic termination with congenital anomalies.
Measured: From study start (Day 0) up to delivery
Number of subjects with pregnancy-related AEs of specific interest
Pregnancy-related adverse events of specific interest include: gestational diabetes, gestational liver disease (including obstetric cholestasis and acute fatty liver of pregnancy), chorioamnionitis, labour protraction and arrest disorders, maternal sepsis, pregnancy-related hypertension, preterm premature rupture of membranes, premature labour, intrauterine growth restriction/poor foetal growth, pre-eclampsia and eclampsia, vaginal or intrauterine haemorrhage, medical conditions necessitating early delivery (induced labour or urgent C-section) (placenta abruption, uterine infection, oligohydramnios, etc), maternal death.
Measured: From study start (Day 0) up to delivery
Number of infant subjects with AEs of specific interest
Infant-related AEs of specific interest include preterm birth, neonatal death, low birth weight and/or small for gestational age, neonatal sepsis, foetal/perinatal distress or asphyxia, failure to thrive/growth deficiency, congenital anomalies and neurodevelopmental delay.
Measured: From birth up to 6 months after birth
Secondary outcomes (13)
Number of infant subjects with SAEs
SAEs are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From birth and up to study end (Year 2)
Number of infant subjects with AEs potentially related to maternal vaccination
Related infant AEs = AEs occurring in the infant assessed by the investigator as potentially related to the vaccination of the mother.
Measured: From birth up to study end (Year 2)
Number of infant subjects with neuro-developmental delays
Infant subjects with Ages and Stages Questionnaires version 3 (ASQ-3) scores in the grey and black zones for any of the 5 developmental areas or domains (communication, gross motor skills, fine motor skills, problem solving and personal-social) :
Grey zone (i.e. Monitoring zone) score means that the child's score falls ≥ 1 but <2 standard deviations below the mean score in any developmental area.
Black zone (i.e. Referral zone) score means that the child's score falls below the cut-off (i.e. 2 standard deviations below the mean score) in any developmental area. Infant subjects scoring in the black zone in any of the 5 domains of the ASQ-3 will be referred for formal neurological evaluation
Measured: At Year 1 and Year 2
Number of infant subjects referred for formal neurological evaluation
Neuro-developmental formal evaluation will be performed, for infants with ASQ3 black zone scores, using the Bayley Scale for Infant Development, Version III (BSID-III) or an equivalent.
Measured: At Year 1 and Year 2
Number of infant subjects with confirmed developmental delay
Infants confirmed as having neuro-developmental delay following formal evaluation using the Bayley Scale for Infant Development, Version III (BSID-III) or an equivalent.
Measured: At Year 1 and Year 2
Neutralizing antibody titres against RSV-A, for all vaccinated mothers
Titres will be expressed as geometric mean titres (GMTs)
Measured: At pre-vaccination (Day 0), Day 30 and Day 60 post vaccination and at delivery
Neutralizing antibody titres against RSV-B, for all vaccinated mothers
Titres will be expressed as geometric mean titres (GMTs)
Measured: At pre-vaccination (Day 0), Day 30 and Day 60 post vaccination and at delivery
Palivizumab competing antibody (PCA) concentrations, for all vaccinated mothers.
Concentrations will be expressed as geometric mean concentrations (GMCs)
Measured: At pre-vaccination (Day 0), Day 30 and Day 60 post-vaccination and at delivery
Neutralizing antibody titres against RSV-A, for all infants born to vaccinated mothers
Titres will be expressed as geometric mean titres (GMTs). Infants will be allocated to one of the 2 defined sub-cohorts (Month 3 or Month 6) and have the blood sample for immunogenicity obtained at the corresponding sub-cohort timepoint.
Measured: At birth, at Month 3 and at Month 6
Neutralizing antibody titres against RSV-B, for all infants born to vaccinated mothers
Titres will be expressed as geometric mean titres (GMTs). Infants will be allocated to one of the 2 defined sub-cohorts (Month 3 or Month 6) and have the blood sample for immunogenicity obtained at the corresponding sub-cohort timepoint.
Measured: At birth, at Month 3 and at Month 6
PCA concentrations, for all infants born to vaccinated mothers
Concentrations will be expressed as geometric mean concentrations (GMCs). Infants will be allocated to one of the 2 defined sub-cohorts (Month 3 or Month 6) and have the blood sample for immunogenicity obtained at the corresponding sub-cohort timepoint.
Measured: At birth, at Month 3 and at Month 6
Number of infant subjects with lower respiratory tract infection (LRTI), severe LRTI and respiratory tract infection (RTI) with parental concern (according to the case definitions) associated with a respiratory syncytial virus (RSV) infection
Occurrence of RSV-LRTI, severe RSV-LRTI, RSV-RTI with parental concern
Measured: From birth up to study end (Year 2)
Number of subjects (vaccinated mothers) with medically-attended (MA) RTI associated with an RSV infection
Occurrence of RSV associated MA-RTI. A MA-RTI is defined as a visit of the mother to a health care professional for any respiratory symptom, including cough, sputum production and difficulty breathing
Measured: From Day 0 up to Month 6 post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start11 Jul 2017
- Primary completion14 Jul 2017
- Study completion14 Jul 2017
Why it stopped: Study was canceled due to instability of the PreF antigen during manufacturing. No safety concern has been identified in past or ongoing studies.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191383
- Sponsor's protocol ID
- 204810
- Other IDs
- 2016-002733-30, 2016
- Status last verified
- Oct 2018
- First submitted
- 15 Jun 2017
- Last updated
- 15 Oct 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through https://www.clinicalstudydatarequest.com/ following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observer-blind Study to Assess the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Investigational RSV Vaccine (GSK3003891A), in Healthy Pregnant Women and Infants Born to Vaccinated Mothers
- ClinicalTrials.gov ID
- NCT03191383
- Acronym / sponsor ID
- 204810
- Conditions
- Respiratory Syncytial Virus Infections
- Keywords
- Maternal immunization, Immunogenicity, Vaccines, Safety, Reactogenicity, Respiratory Syncytial Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was canceled due to instability of the PreF antigen during manufacturing. No safety concern has been identified in past or ongoing studies.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2017 (actual)
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 14 Jul 2017 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the investigational GSK RSV vaccine in pregnant women aged 18 to 40 years and infants born to the vaccinated women
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| GSK3003891A vaccine formulation 1 mother Group | Experimental | Biological: RSV vaccine (GSK3003891A) formulation 1Subjects in this group will receive a single 30µg dose of the GSK3003891A investigational vaccine, by intramuscular injection into the deltoid region of the non-dominant arm. |
| GSK3003891A vaccine formulation 2 mother Group | Experimental | Biological: RSV vaccine (GSK3003891A) formulation 2Subjects in this group will receive a single 60µg dose of the GSK3003891A investigational vaccine, by intramuscular injection into the deltoid region of the non-dominant arm. |
| GSK3003891A vaccine formulation 3 mother Group | Experimental | Biological: RSV vaccine (GSK3003891A) formulation 3Subjects in this group will receive a single 120µg dose of the GSK3003891A investigational vaccine, by intramuscular injection into the deltoid region of the non-dominant arm. |
| Control group | Placebo comparator | Drug: Placebo (Formulation buffer S9b)Subjects in this group will receive a single placebo injection, intramuscularly into the deltoid region of the non-dominant arm. |
| GSK3003891A vaccine formulation 1 infant Group | No intervention | –Infants born to mothers vaccinated with a single 30µg dose of the investigational GSK3003891A vaccine |
| GSK3003891A vaccine formulation 2 infant Group | No intervention | –Infants born to mothers vaccinated with a single 60µg dose of the investigational GSK3003891A vaccine |
| GSK3003891A vaccine formulation 3 infant Group | No intervention | –Infants born to mothers vaccinated with a single 120µg dose of the investigational GSK3003891A vaccine |
| Control infant Group | No intervention | –Infants born to mothers who received a single placebo injection |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- Written informed consent for study participation of the mother obtained from the mother or the mother and father, as applicable by local law, prior to performance of any study specific procedure.
- Written informed consent for study participation of the infant obtained from the infant's mother and/or father, as applicable by local law, or legally acceptable representative [LAR] prior to performance of any study specific procedure.
- Subjects between, and including, 18 and 40 years of age at the time of the first study visit.
- Pregnant females > 24 weeks of gestation at the time of screening and at 28 0/7 to 33 6/7 weeks of gestation at the time of vaccination, as established by ultrasound examination and last menstrual period date.
Key exclusion criteria (42 listed)
- Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before vaccination , or planned use during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before vaccination and ending at delivery with the exception of seasonal influenza vaccine and diphtheria, tetanus, pertussis/tetanus, diphtheria, pertussis [dTpa/Tdap] vaccine as part of standard of care which may be administered ≥ 15 days before or after study vaccination.
- Chronic administration of systemic immunosuppressants or other immune-modifying drugs, as well as administration of long-acting immune-modifying drugs during the period starting 6 months prior to study vaccination, or planned administration up to delivery. Topical steroids are allowed. Inhaled steroids are allowed up to the limit of ≤500 µg/day for beclomethasone or fluticasone, or ≤ 800 µg/day for budesonide.
- Administration of immunoglobulins (with the exception of prophylactic anti-Rh0D immune globulin) and/or any blood products during the period starting 3 months before study vaccination or planned administration during the study period.
- Previous experimental vaccination against RSV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSV vaccine (GSK3003891A) formulation 1Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm | Biological | GSK3003891A vaccine formulation 1 mother Group |
| RSV vaccine (GSK3003891A) formulation 2Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm | Biological | GSK3003891A vaccine formulation 2 mother Group |
| RSV vaccine (GSK3003891A) formulation 3Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm | Biological | GSK3003891A vaccine formulation 3 mother Group |
| Placebo (Formulation buffer S9b)Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm | Drug | Control group |
Primary outcome
Number of subjects with solicited local adverse events (AEs)
Time frame: During a 7-day follow-up period after vaccination (i.e. the day of vaccination and 6 subsequent days)
Assessed solicited local symptoms are pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevents normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Number of subjects with solicited general AEs
Time frame: During the 7-day follow-up period after vaccination (i.e. the day of vaccination and 6 subsequent days)
Assessed solicited general symptoms are fatigue, fever [defined as oral/axillary/tympanic route temperature equal to or above 37.5 degrees Celsius (°C) or ≥ 38 °C for rectal route], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain] and headache. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevents normal activity. Grade 3 fever = fever > 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination
Number of subjects with unsolicited AEs
Time frame: During a 30-day follow-up period after vaccination (i.e. the day of vaccination and 29 subsequent days)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevents normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Number of subjects with haematological abnormalities
Time frame: At Day 0
Haematological laboratory abnormalities include haemoglobin level, white blood cell count [WBC], lymphocyte, neutrophil, eosinophil, platelet count, red blood cell count and mean corpuscular volume.
Number of subjects with haematological abnormalities
Time frame: At Day 7
Haematological laboratory abnormalities include haemoglobin level, white blood cell count [WBC], lymphocyte, neutrophil, eosinophil, platelet count, red blood cell count and mean corpuscular volume.
Number of subjects with biochemical abnormalities
Time frame: At Day 0
Biochemical laboratory abnormalities include alanine amino-transferase [ALT], aspartate amino-transferase [AST], creatinine and blood urea nitrogen.
Number of subjects with biochemical abnormalities
Time frame: At Day 7
Biochemical laboratory abnormalities include alanine amino-transferase [ALT], aspartate amino-transferase [AST], creatinine and blood urea nitrogen.
Number of subjects with any serious adverse events (SAEs)
Time frame: From study start (Day 0) up to 6 months after delivery
SAEs are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of infant subjects with any SAEs
Time frame: From birth up to 6 months after birth
SAEs are defined as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Number of subjects with pregnancy outcomes
Time frame: From study start (Day 0) up to delivery
Pregnancy outcomes include live birth with no congenital anomalies, live birth with congenital anomalies, foetal death/still birth with no congenital anomalies, foetal death/still birth with congenital anomalies, elective/therapeutic termination with no congenital anomalies and elective/therapeutic termination with congenital anomalies.
Number of subjects with pregnancy-related AEs of specific interest
Time frame: From study start (Day 0) up to delivery
Pregnancy-related adverse events of specific interest include: gestational diabetes, gestational liver disease (including obstetric cholestasis and acute fatty liver of pregnancy), chorioamnionitis, labour protraction and arrest disorders, maternal sepsis, pregnancy-related hypertension, preterm premature rupture of membranes, premature labour, intrauterine growth restriction/poor foetal growth, pre-eclampsia and eclampsia, vaginal or intrauterine haemorrhage, medical conditions necessitating early delivery (induced labour or urgent C-section) (placenta abruption, uterine infection, oligohydramnios, etc), maternal death.
Number of infant subjects with AEs of specific interest
Time frame: From birth up to 6 months after birth
Infant-related AEs of specific interest include preterm birth, neonatal death, low birth weight and/or small for gestational age, neonatal sepsis, foetal/perinatal distress or asphyxia, failure to thrive/growth deficiency, congenital anomalies and neurodevelopmental delay.
13 secondary outcomes
Number of infant subjects with SAEs
Time frame: From birth and up to study end (Year 2)
Number of infant subjects with AEs potentially related to maternal vaccination
Time frame: From birth up to study end (Year 2)
Number of infant subjects with neuro-developmental delays
Time frame: At Year 1 and Year 2
Number of infant subjects referred for formal neurological evaluation
Time frame: At Year 1 and Year 2
Number of infant subjects with confirmed developmental delay
Time frame: At Year 1 and Year 2
Neutralizing antibody titres against RSV-A, for all vaccinated mothers
Time frame: At pre-vaccination (Day 0), Day 30 and Day 60 post vaccination and at delivery
Neutralizing antibody titres against RSV-B, for all vaccinated mothers
Time frame: At pre-vaccination (Day 0), Day 30 and Day 60 post vaccination and at delivery
Palivizumab competing antibody (PCA) concentrations, for all vaccinated mothers.
Time frame: At pre-vaccination (Day 0), Day 30 and Day 60 post-vaccination and at delivery
Neutralizing antibody titres against RSV-A, for all infants born to vaccinated mothers
Time frame: At birth, at Month 3 and at Month 6
Neutralizing antibody titres against RSV-B, for all infants born to vaccinated mothers
Time frame: At birth, at Month 3 and at Month 6
PCA concentrations, for all infants born to vaccinated mothers
Time frame: At birth, at Month 3 and at Month 6
Number of infant subjects with lower respiratory tract infection (LRTI), severe LRTI and respiratory tract infection (RTI) with parental concern (according to the case definitions) associated with a respiratory syncytial virus (RSV) infection
Time frame: From birth up to study end (Year 2)
Number of subjects (vaccinated mothers) with medically-attended (MA) RTI associated with an RSV infection
Time frame: From Day 0 up to Month 6 post delivery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through https://www.clinicalstudydatarequest.com/ following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RSV vaccine (GSK3003891A) formulation 1, RSV vaccine (GSK3003891A) formulation 2 and RSV vaccine (GSK3003891A) formulation 3 in people with Respiratory Syncytial Virus Infections, run by GlaxoSmithKline at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain, United States, Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with solicited local adverse events (AEs) (time frame: During a 7-day follow-up period after vaccination (i.e. the day of vaccination and 6 subsequent days)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.