CompletedNCT02927873Updated Oct 28, 2021Results posted

A Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' RSV Investigational Vaccine Based on Viral Proteins Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A) in RSV-seropositive Infants

A Phase 1/2 interventional study of RSV (GSK3389245A) low dose formulation vaccine and RSV (GSK3389245A) middle dose formulation vaccine in Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline. Completed at 24 sites in 8 countries. Open to participants aged 12 Months to 23 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-28.

Sponsored by GlaxoSmithKline · Phase 1/2, Interventional, and Prevention

Phase: Phase 1/2
Study type: Interventional
Enrollment: 107
Allocation: Randomized
Ages: 12 Months to 23 Months
Sex: All

Study summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of the respiratory syncytial virus (RSV) candidate vaccine when first administered via intramuscular (IM) injection according to a 0, 1-month schedule to RSV-seropositive infants aged 12 to 23 months.

Read the detailed description

The RSV PED-002 study, designed to evaluate the safety, reactogenicity and immunogenicity of the RSV candidate vaccine when administered in 3 sequential doses to seropositive infants aged 12 to 23 months, will be conducted in an observer-blind manner in Epoch 1 and single-blinded in Epoch 2.

Conditions studied

Respiratory Syncytial Virus Infections

Browse trials for

Respiratory Syncytial Virus Infections 293

Keywords

Safety
Respiratory syncytial virus (RSV)
Immunogenicity
Reactogenicity
Infants
Vaccine

In context

Respiratory Syncytial Virus Infections

293 studies on the registry are indexed under Respiratory Syncytial Virus Infections; 45 are open to participants now.

This study's enrollment of 107 is above the median of 90 across 213 interventional studies indexed under Respiratory Syncytial Virus Infections.

Browse Respiratory Syncytial Virus Infections studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Months to 23 Months
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Subjects' parent(s)/ Legally acceptable representative (LAR[s]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.
A male or female between, and including, 12 and 23 months at the time of the first vaccination.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Seropositive for RSV as determined by IBL International kit.
Born full-term (i.e. after a gestation period of 37 to less than 42 completed weeks) with a minimum birth weight of 2.5 kg. (Required for Spain)
Subjects' parent(s)/LAR(s) need to have access to a consistent mean of telephone contact or computer.

Exclusion criteria

Exclusion Criteria:

Child in care.
Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 0), or planned use during the study period.
Any medical condition that in the judgment of the investigator would make IM injection unsafe.
Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine. For corticosteroids, this will mean prednisone, or equivalent. Inhaled and topical steroids are allowed.
Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
Administration of immunoglobulins and/or any blood products during the period starting three months before the first dose of study vaccine or planned administration during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine administration, with the exception of scheduled routine pediatric vaccines which may be administered ≥ 14 days before a dose or ≥ 7 days after a dose.
Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
Serious chronic illness.
Major congenital defects.
History of any neurological disorders or seizures.
History of or current autoimmune disease.
History of recurrent wheezing.
History of chronic cough.
Previous hospitalization for respiratory illnesses.
History of thrombocytopenia.
History of anemia.
Previous, current or planned administration of Synagis.
Neurological complications following any prior vaccination.
Born to a mother known or suspected to be HIV-positive.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Family history of congenital or hereditary immunodeficiency.
Previous vaccination with a recombinant simian or human adenoviral vaccine.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Hypersensitivity to latex.
Current severe eczema.
Acute disease and/or fever at the time of 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. The preferred route for recording temperature in this study will be axillary.
- Clinically significant upper respiratory tract infection
- Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
Any clinically significant Grade 1 or any ≥ Grade 2 hematological or biochemical laboratory abnormality detected at the last screening blood sampling.
Any other conditions that the investigator judges may interfere with study procedures or findings.
Any conditions that could constitute a risk for the subjects while participating to this study.
Weight below the fifth percentile of the local weight-for-age curve.
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.
Planned move to a location that will prohibit participating in the trial until study end.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 107 participants (actual)

Study arms

Experimental
RSV LD Group
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV low dose (LD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
Biological: RSV (GSK3389245A) low dose formulation vaccine
Experimental
RSV MD Group
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of the RSV middle dose (MD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
Biological: RSV (GSK3389245A) middle dose formulation vaccine
Experimental
RSV HD Group
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of the RSV high dose (HD) vaccine, administered intramuscularly, one each at Day 1 and Day 31.
Biological: RSV (GSK3389245A) high dose formulation vaccine
Placebo comparator
Placebo LD group
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Drug: Placebo
Placebo comparator
Placebo MD group
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.15 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Drug: Placebo
Placebo comparator
Placebo HD group
RSV-seropositive infants, aged 12 to 23 months at the time of first vaccination, received 2 doses (0.5 mL each) of placebo, administered intramuscularly, one each at Day 1 and Day 31.
Drug: Placebo

Interventions

BiologicalRSV (GSK3389245A) low dose formulation vaccine
2 doses of 0.5 ml each of RSV (GSK3389245A) low dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
BiologicalRSV (GSK3389245A) middle dose formulation vaccine
2 doses of 0.15 ml each of RSV (GSK3389245A) middle dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
BiologicalRSV (GSK3389245A) high dose formulation vaccine
2 doses of 0.5 ml each of RSV (GSK3389245A) high dose formulation vaccine administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.
DrugPlacebo
2 doses (0.5 mL each for Placebo LD and Placebo HD groups and 0.15 mL each for Placebo MD group) of Placebo administered intramuscularly in the left anterolateral thigh or deltoid, at Day 1 and Day 31.

What researchers measure

Primary outcomes

Number of Subjects With Any Solicited Local Adverse Events (AEs)
Assessed solicited local symptoms are pain, redness and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade. Any redness and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.
Time frame: During a 7-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)
Number of Subjects With Any Solicited General AEs
Assessed solicited general symptoms are drowsiness, fever \[defined as temperature equal to or above (≥) 37.5 degrees Celsius (°C)/99.5 degrees Fahrenheit (°F) for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route, the preferred route for recording temperature in this study being axillary\], irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade or relation to study vaccination.
Time frame: During a 7-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)
Number of Subjects With Any 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. Unsolicited AEs are 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 study vaccination.
Time frame: During a 30-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)
Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61
Assessed SAEs include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.
Time frame: From Day 1 up to Day 61
Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Specific Interest)
Any episode of spontaneous or excessive bleeding if occurring after vaccination was to be fully investigated with a full range of hematological tests to identify the underlying cause and reported as an AE of specific interest.
Time frame: During a 30-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2
Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 2\].
Time frame: At Day 2
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 8\].
Time frame: At Day 8
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 31\].
Time frame: At Day 31
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32
Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 32\].
Time frame: At Day 32
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38
Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 38\].
Time frame: At Day 38
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61
Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 61\].
Time frame: At Day 61
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Assessed biochemical laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CREA\]. Biochemical abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. ALT, Below, Below = ALT below normal ranges at baseline versus below normal ranges at Day 31\].
Time frame: At Day 31
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61
Assessed biochemical laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CREA\]. Biochemical abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. \[e.g. ALT, Below, Below = ALT below normal ranges at baseline versus below normal ranges at Day 61\].
Time frame: At Day 61

Secondary outcomes

Number of Subjects With Any SAEs From Day 1 up to Day 366
Assessed SAEs include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.
Time frame: From Day 1 up to Day 366
Number of Subjects With Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI) (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Day 366
Subjects experiencing an LRTI associated with RSV infection were reported as AE of specific interest. To identify RSV-LRTI for the purpose of AE of specific interest, the diagnosis was based on the investigators' clinical judgment taking into account the clinical history, the examination, relevant medical investigations and locally-available diagnostic test for RSV.
Time frame: From Dose 1 administration (Day 1) up to Day 366
Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366
RSV-RTI refers to subject having runny nose OR blocked nose OR cough AND confirmed RSV infection \[RSV infection confirmed on nasal swab positive for RSV A or B by quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) performed at sponsor level\]. RSV-LRTI refers to subject with history of cough OR difficulty breathing \[based on history reported by parents/legally acceptable representatives (LARs) and includes difficulty breathing (e.g. showing signs of wheezing or stridor, tachypnoea, flaring of nostrils, chest in-drawing, apnoea) associated with nasal obstruction\] AND Blood Oxygen Saturation (SpO2) lower than (\<) 95 percent (%), OR respiratory rate (RR) increase \[defined as ≥ 40/minute (12 months of age or above)\] AND confirmed RSV infection. RSV-severe LRTI are cases meeting the case definition of RSV-LRTI AND SpO2 \< 93%, OR lower chest wall in-drawing.
Time frame: From Dose 1 administration (Day 1) up to Day 366
Number of Subjects With Any SAEs From Day 1 up to Study Conclusion at Day 731
Assessed SAEs include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.
Time frame: From Day 1 up to study conclusion at Day 731
Number of Subjects With RSV-LRTI (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731
Subjects experiencing an LRTI associated with RSV infection were reported as AE of specific interest. To identify RSV-LRTI for the purpose of AE of specific interest, the diagnosis was based on the investigators' clinical judgment taking into account the clinical history, the examination, relevant medical investigations and locally-available diagnostic test for RSV.
Time frame: From Dose 1 administration (Day 1) up to study conclusion at Day 731
Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731
RSV-RTI refers to subject having runny nose OR blocked nose OR cough AND confirmed RSV infection (RSV infection confirmed on nasal swab positive for RSV A or B by qRT-PCR performed at sponsor level). RSV-LRTI refers to subject with history of cough OR difficulty breathing \[based on history reported by parents/LARs and includes difficulty breathing (e.g. showing signs of wheezing or stridor, tachypnoea, flaring of nostrils, chest in-drawing, apnoea) associated with nasal obstruction\] AND Sp02 \< 95% OR respiratory rate (RR) increase \[defined as ≥ 40/minute (12 months of age or above)\] AND confirmed RSV infection. RSV-severe LRTI are cases meeting the case definition of RSV-LRTI AND SpO2 \< 93%, OR lower chest wall in-drawing.
Time frame: From Dose 1 administration (Day 1) up to study conclusion at Day 731
Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools
Magnitude of cell mediated immunity (CMI) response to the investigational RSV vaccine was measured in terms of frequency of RSV-specific CD4+ T-cells expressing at least two markers upon stimulation with F, N and M2-1 peptide pools and expressed in RSV-specific CD4+ T-cells/million cells. Assessed markers were CD40-L, IL-2, TNF-α and IFN-ɣ.
Time frame: At Pre-vaccination (Screening), Day 31, Day 61 and Day 366
Anti-RSV-A Neutralizing Antibody Titers
Humoral response to the investigational RSV vaccine was measured in terms of anti-RSV-A neutralizing antibody titers and expressed as geometric mean titers (GMTs) in Estimated Dilution 60 (ED60) titers.
Time frame: At Pre-vaccination (Screening), Day 31, Day 61 and Day 366
Anti-RSV-F Antibody Concentrations
Humoral response to the investigational RSV vaccine was measured as anti-RSV F antibody concentrations and expressed as geometric mean concentrations (GMCs) in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL).
Time frame: At Pre-vaccination (Screening), Day 31, Day 61 and Day 366
Palivizumab-competing Antibody Concentrations
Humoral response to the investigational RSV vaccine was measured as Palivizumab-competing antibody concentrations and expressed as geometric mean concentrations (GMCs) in microgram/milliliter (µg/mL).
Time frame: At Pre-vaccination (Screening), Day 31 and Day 61

Results

Posted Oct 28, 2021

Participant flow

The study was conducted at 32 centers in 8 countries (Canada, Italy, Mexico, Panama, Poland, Spain, Taiwan and United States).

Participant flow — Overall Study
Milestone	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
Started	11	14	18	11	11	17
Completed	9	11	18	11	11	16
Not completed	2	3	0	0	0	1
Withdrew: Lost to follow-up	0	1	0	0	0	0
Withdrew: Consent withdrawal not due to adv. event	0	1	0	0	0	0
Withdrew: Migrated / moved from the study area	0	0	0	0	0	1
Withdrew: Parents not able to come to site	0	1	0	0	0	0
Withdrew: Subject withdrawn at an interim timepoint, but accepted calls for safety surveillance	1	0	0	0	0	0
Withdrew: Parents refused safety follow-up	1	0	0	0	0	0

Outcome measures

PrimaryNumber of Subjects With Any Solicited Local Adverse Events (AEs)

Assessed solicited local symptoms are pain, redness and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade. Any redness and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters.

Time frame:: During a 7-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)
Reported as:: Count of participants · Participants

Number of Subjects With Any Solicited Local Adverse Events (AEs)
Participants	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
DOSE 1, Any Pain	1	2	0	2	0	2
DOSE 1, Any Redness	2	1	3	3	0	3
DOSE 1, Any Swelling	0	0	1	1	1	2
DOSE 2, Any Pain	2	2	2	1	0	3
DOSE 2, Any Redness	2	1	2	3	0	2
DOSE 2, Any Swelling	0	0	0	1	0	2

PrimaryNumber of Subjects With Any Solicited General AEs

Assessed solicited general symptoms are drowsiness, fever \[defined as temperature equal to or above (≥) 37.5 degrees Celsius (°C)/99.5 degrees Fahrenheit (°F) for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route, the preferred route for recording temperature in this study being axillary\], irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade or relation to study vaccination.

Time frame:: During a 7-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)
Reported as:: Count of participants · Participants

Number of Subjects With Any Solicited General AEs
Participants	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
DOSE 1, Any Drowsiness	4	2	4	5	3	4
DOSE 1, Any Irritability / Fussiness	3	3	4	4	2	2
DOSE 1, Any Loss Of Appetite	3	3	4	2	2	3
DOSE 1, Any Fever	3	3	10	3	2	0
DOSE 2, Any Drowsiness	2	1	5	3	2	5
DOSE 2, Any Irritability / Fussiness	3	1	5	3	1	6
DOSE 2, Any Loss Of Appetite	3	0	6	3	2	5
DOSE 2, Any Fever	2	2	5	1	2	1

PrimaryNumber of Subjects With Any 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. Unsolicited AEs are 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 study vaccination.

Time frame:: During a 30-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)
Reported as:: Count of participants · Participants

Number of Subjects With Any Unsolicited AEs
Participants	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
Number of Subjects With Any Unsolicited AEs	9	9	13	7	10	13

PrimaryNumber of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61

Assessed SAEs include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.

Time frame:: From Day 1 up to Day 61
Reported as:: Count of participants · Participants

Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61
Participants	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61	0	0	1	1	0	2

PrimaryNumber of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Specific Interest)

Any episode of spontaneous or excessive bleeding if occurring after vaccination was to be fully investigated with a full range of hematological tests to identify the underlying cause and reported as an AE of specific interest.

Time frame:: During a 30-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)
Reported as:: Count of participants · Participants

Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Specific Interest)
Participants	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Specific Interest)	0	0	0	0	0	0

PrimaryNumber of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2

Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 2\].

Time frame:: At Day 2
Reported as:: Count of participants · Participants

Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2
Participants	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
HgL, Below, Below	3	2	1	1	0	0
HgL, Within, Unknown	0	1	0	0	0	0
HgL, Within, Below	0	2	0	0	2	2
HgL, Within, Within	8	9	15	10	9	13
HgL, Within, Above	0	0	0	0	0	1
HgL, Above, Within	0	0	0	0	0	1
HgL, Above, Above	0	0	1	0	0	0
WBC, Below, Below	0	0	1	0	0	0
WBC, Below, Within	0	0	0	0	0	1
WBC, Within, Unknown	0	1	0	0	0	0
WBC, Within, Below	0	2	1	0	0	2
WBC, Within, Within	11	11	13	11	6	13
WBC, Within, Above	0	0	0	0	1	1
WBC, Above, Within	0	0	1	0	2	0
WBC, Above, Above	0	0	1	0	2	0
PLC, Within, Unknown	0	1	0	0	0	0
PLC, Within, Below	0	0	1	0	0	0
PLC, Within, Within	10	10	12	9	4	12
PLC, Within, Above	0	1	2	0	2	3
PLC, Above, Within	1	1	2	1	2	0
PLC, Above, Above	0	0	0	1	3	2

PrimaryNumber of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8

Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 8\].

Time frame:: At Day 8
Reported as:: Count of participants · Participants

Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Participants	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
HgL, Below, Below	2	1	0	1	0	0
HgL, Within, Within	7	2	2	7	5	2
HgL, Above, Above	0	0	0	0	0	1
WBC, Within, Within	8	2	2	8	2	3
WBC, Within, Above	1	1	0	0	0	0
WBC, Above, Within	0	0	0	0	3	0
PLC, Within, Within	7	3	1	8	0	3
PLC, Within, Above	1	0	1	0	3	0
PLC, Above, Within	1	0	0	0	1	0
PLC, Above, Above	0	0	0	0	1	0

PrimaryNumber of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31

Time frame:: At Day 31
Reported as:: Count of participants · Participants

Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Participants	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
HgL, Below, Below	3	1	1	1	0	0
HgL, Below, Within	0	1	0	0	0	0
HgL, Within, Unknown	0	1	0	0	0	0
HgL, Within, Below	0	0	0	0	1	2
HgL, Within, Within	7	9	15	9	8	14
HgL, Within, Above	0	0	1	0	0	0
HgL, Above, Within	0	0	1	0	0	1
WBC, Below, Within	0	0	1	0	0	1
WBC, Within, Unknown	0	1	0	0	0	0
WBC, Within, Below	0	0	0	0	0	1
WBC, Within, Within	10	9	13	10	4	15
WBC, Within, Above	0	2	2	0	1	0
WBC, Above, Within	0	0	1	0	3	0
WBC, Above, Above	0	0	1	0	1	0
PLC, Within, Unknown	0	1	0	0	0	0
PLC, Within, Within	9	8	15	8	4	13
PLC, Within, Above	1	2	1	0	1	2
PLC, Above, Within	0	1	2	2	2	1
PLC, Above, Above	0	0	0	0	2	1

PrimaryNumber of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32

Time frame:: At Day 32
Reported as:: Count of participants · Participants

Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32
Participants	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
HgL, Below, Below	2	2	1	1	0	0
HgL, Below, Within	1	0	0	0	0	0
HgL, Within, Unknown	0	0	0	1	0	0
HgL, Within, Below	1	1	0	0	1	2
HgL, Within, Within	6	7	14	9	8	14
HgL, Within, Above	0	0	1	0	1	0
HgL, Above, Within	0	0	0	0	0	1
HgL, Above, Above	0	0	1	0	0	0
WBC, Below, Within	0	0	1	0	0	1
WBC, Within, Unknown	0	0	0	1	0	0
WBC, Within, Below	1	2	3	0	1	2
WBC, Within, Within	9	7	11	10	5	14
WBC, Within, Above	0	1	0	0	1	0
WBC, Above, Within	0	0	1	0	2	0
WBC, Above, Above	0	0	1	0	1	0
PLC, Within, Unknown	0	0	0	1	0	0
PLC, Within, Below	0	1	0	0	0	0
PLC, Within, Within	10	7	15	7	4	14
PLC, Within, Above	0	1	0	1	1	1
PLC, Above, Within	0	1	2	2	4	1
PLC, Above, Above	0	0	0	0	1	1

PrimaryNumber of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38

Assessed hematological laboratory parameters include hemoglobin level \[HgL\] white blood cells \[WBC\] and platelet count \[PLC\]. Hematological abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 38\].

Time frame:: At Day 38
Reported as:: Count of participants · Participants

Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38
Participants	RSV LD Group	RSV MD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
HgL, Below, Below	2	0	1	0	0
HgL, Within, Within	6	1	5	2	1
HgL, Above, Above	0	0	0	0	1
WBC, Within, Within	8	1	4	1	2
WBC, Within, Above	0	0	2	0	0
WBC, Above, Above	0	0	0	1	0
PLC, Within, Within	7	1	5	0	1
PLC, Within, Above	1	0	1	1	1
PLC, Above, Above	0	0	0	1	0

PrimaryNumber of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61

Time frame:: At Day 61
Reported as:: Count of participants · Participants

Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61
Participants	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
HgL, Below, Below	2	1	0	0	0	0
HgL, Below, Within	1	0	1	0	0	0
HgL, Within, Unknown	0	0	0	1	0	0
HgL, Within, Below	0	1	0	0	0	2
HgL, Within, Within	7	10	16	8	11	13
HgL, Above, Within	0	0	0	0	0	1
HgL, Above, Above	0	0	1	0	0	0
WBC, Below, Within	0	0	1	0	0	1
WBC, Within, Unknown	0	0	0	1	0	0
WBC, Within, Below	1	0	0	0	0	3
WBC, Within, Within	9	11	14	8	6	10
WBC, Within, Above	0	1	1	0	1	2
WBC, Above, Within	0	0	1	0	4	0
WBC, Above, Above	0	0	1	0	0	0
PLC, Within, Unknown	0	0	0	1	0	0
PLC, Within, Below	0	0	0	0	0	1
PLC, Within, Within	9	8	15	4	5	8
PLC, Within, Above	1	3	1	1	1	5
PLC, Above, Within	0	1	2	2	4	1
PLC, Above, Above	0	0	0	0	1	1

PrimaryNumber of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31

Assessed biochemical laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CREA\]. Biochemical abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Unknown, Below, Within or Above. \[e.g. ALT, Below, Below = ALT below normal ranges at baseline versus below normal ranges at Day 31\].

Time frame:: At Day 31
Reported as:: Count of participants · Participants

Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Participants	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
ALT, Below, Below	1	0	0	0	0	0
ALT, Below, Within	1	0	0	0	0	0
ALT, Below, Above	0	0	0	0	0	1
ALT, Within, Unknown	0	1	0	0	0	0
ALT, Within, Below	1	0	0	0	0	0
ALT, Within, Within	7	10	15	11	7	13
ALT, Within, Above	0	0	1	0	2	0
ALT, Above, Within	0	1	1	0	0	2
ALT, Above, Above	0	0	1	0	0	1
AST, Within, Unknown	0	1	0	0	0	0
AST, Within, Within	9	7	13	9	7	14
AST, Within, Above	0	1	2	1	1	0
AST, Above, Below	0	0	0	0	0	1
AST, Above, Within	1	1	1	1	0	0
AST, Above, Above	0	2	2	0	1	2
CREA, Below, Unknown	0	1	0	0	0	0
CREA, Below, Below	4	3	1	7	1	0
CREA, Below, Within	3	0	3	1	0	0
CREA, Within, Below	3	1	4	0	0	4
CREA, Within, Within	0	7	10	3	7	12
CREA, Within, Above	0	0	0	0	0	1
CREA, Above, Within	0	0	0	0	1	0

PrimaryNumber of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61

Assessed biochemical laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\] and creatinine \[CREA\]. Biochemical abnormalities refer to range indicator at timing, categorized as Below, Within or Above normal ranges, and compared to baseline range indicator of the same parameter, at Screening (Day-29 to Day 1) i.e. Below, Within or Above. \[e.g. ALT, Below, Below = ALT below normal ranges at baseline versus below normal ranges at Day 61\].

Time frame:: At Day 61
Reported as:: Count of participants · Participants

Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61
Participants	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
ALT, Below, Below	1	0	0	0	0	0
ALT, Below, Within	1	0	0	0	0	1
ALT, Within, Within	8	10	15	10	9	12
ALT, Within, Above	0	1	1	1	1	0
ALT, Above, Within	0	1	2	0	1	1
ALT, Above, Above	0	0	0	0	0	1
AST, Within, Within	9	9	15	10	8	13
AST, Within, Above	0	1	0	0	1	0
AST, Above, Within	1	1	1	0	0	1
AST, Above, Above	0	1	2	1	2	2
CREA, Below, Below	4	2	2	7	1	0
CREA, Below, Within	3	1	2	1	1	0
CREA, Within, Below	3	1	3	0	0	1
CREA, Within, Within	0	8	10	3	8	15
CREA, Within, Above	0	0	1	0	0	0
CREA, Above, Within	0	0	0	0	1	0

SecondaryNumber of Subjects With Any SAEs From Day 1 up to Day 366

Time frame:: From Day 1 up to Day 366
Reported as:: Count of participants · Participants

Number of Subjects With Any SAEs From Day 1 up to Day 366
Participants	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
Number of Subjects With Any SAEs From Day 1 up to Day 366	1	1	1	3	1	2

SecondaryNumber of Subjects With Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI) (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Day 366

Subjects experiencing an LRTI associated with RSV infection were reported as AE of specific interest. To identify RSV-LRTI for the purpose of AE of specific interest, the diagnosis was based on the investigators' clinical judgment taking into account the clinical history, the examination, relevant medical investigations and locally-available diagnostic test for RSV.

Time frame:: From Dose 1 administration (Day 1) up to Day 366
Reported as:: Count of participants · Participants

Number of Subjects With Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI) (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Day 366
Participants	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
Number of Subjects With Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI) (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Day 366	0	1	0	3	0	0

SecondaryNumber of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366

RSV-RTI refers to subject having runny nose OR blocked nose OR cough AND confirmed RSV infection \[RSV infection confirmed on nasal swab positive for RSV A or B by quantitative Reverse Transcription Polymerase Chain Reaction (qRT-PCR) performed at sponsor level\]. RSV-LRTI refers to subject with history of cough OR difficulty breathing \[based on history reported by parents/legally acceptable representatives (LARs) and includes difficulty breathing (e.g. showing signs of wheezing or stridor, tachypnoea, flaring of nostrils, chest in-drawing, apnoea) associated with nasal obstruction\] AND Blood Oxygen Saturation (SpO2) lower than (\<) 95 percent (%), OR respiratory rate (RR) increase \[defined as ≥ 40/minute (12 months of age or above)\] AND confirmed RSV infection. RSV-severe LRTI are cases meeting the case definition of RSV-LRTI AND SpO2 \< 93%, OR lower chest wall in-drawing.

Time frame:: From Dose 1 administration (Day 1) up to Day 366
Reported as:: Count of participants · Participants

Number of Subjects With Respiratory Tract Infection Associated With RSV Infection (RSV-RTI), RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Day 366
Participants	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
RSV-RTI	1	3	1	4	3	3
RSV-LRTI	0	0	0	1	0	0
RSV-severe LRTI	0	0	0	1	0	0

SecondaryNumber of Subjects With Any SAEs From Day 1 up to Study Conclusion at Day 731

Time frame:: From Day 1 up to study conclusion at Day 731
Reported as:: Count of participants · Participants

Number of Subjects With Any SAEs From Day 1 up to Study Conclusion at Day 731
Participants	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
Number of Subjects With Any SAEs From Day 1 up to Study Conclusion at Day 731	1	1	2	3	1	2

SecondaryNumber of Subjects With RSV-LRTI (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731

Time frame:: From Dose 1 administration (Day 1) up to study conclusion at Day 731
Reported as:: Count of participants · Participants

Number of Subjects With RSV-LRTI (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731
Participants	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
Number of Subjects With RSV-LRTI (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731	0	1	0	3	0	0

SecondaryNumber of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731

RSV-RTI refers to subject having runny nose OR blocked nose OR cough AND confirmed RSV infection (RSV infection confirmed on nasal swab positive for RSV A or B by qRT-PCR performed at sponsor level). RSV-LRTI refers to subject with history of cough OR difficulty breathing \[based on history reported by parents/LARs and includes difficulty breathing (e.g. showing signs of wheezing or stridor, tachypnoea, flaring of nostrils, chest in-drawing, apnoea) associated with nasal obstruction\] AND Sp02 \< 95% OR respiratory rate (RR) increase \[defined as ≥ 40/minute (12 months of age or above)\] AND confirmed RSV infection. RSV-severe LRTI are cases meeting the case definition of RSV-LRTI AND SpO2 \< 93%, OR lower chest wall in-drawing.

Time frame:: From Dose 1 administration (Day 1) up to study conclusion at Day 731
Reported as:: Count of participants · Participants

Number of Subjects With RSV-RTI, RSV-LRTI, Severe RSV-LRTI (According to Standardized Case Definitions) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731
Participants	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
RSV-RTI	2	6	2	5	4	4
RSV-LRTI	0	0	0	1	0	0
RSV-severe LRTI	0	0	0	1	0	0

SecondaryFrequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools

Magnitude of cell mediated immunity (CMI) response to the investigational RSV vaccine was measured in terms of frequency of RSV-specific CD4+ T-cells expressing at least two markers upon stimulation with F, N and M2-1 peptide pools and expressed in RSV-specific CD4+ T-cells/million cells. Assessed markers were CD40-L, IL-2, TNF-α and IFN-ɣ.

Time frame:: At Pre-vaccination (Screening), Day 31, Day 61 and Day 366
Reported as:: Median · RSV-specific CD4+ T-cells/million cells

Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools
RSV-specific CD4+ T-cells/million cells	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
RSV F pool 15/11 Ag, Screening	169.5 (85 to 218)	123 (32 to 268)	1 (1 to 1)	176 (120 to 336)	1813 (1813 to 1813)	—
RSV F pool 15/11 Ag, Day 31	291 (231 to 469)	546 (484 to 608)	1086 (1086 to 1086)	234 (48 to 350)	1129.5 (379 to 1880)	—
RSV F pool 15/11 Ag, Day 61	214 (74.5 to 331.5)	451 (93 to 495)	394 (394 to 394)	105.5 (1 to 193)	759 (218 to 1300)	—
RSV F pool 15/11 Ag, Day 366	206 (71 to 288.5)	108.5 (1 to 216)	1164 (1164 to 1164)	252.5 (169.5 to 495)	664.5 (252 to 1077)	229 (229 to 229)
RSV N pool 15/11 Ag, Screening	51 (1 to 121)	54 (1 to 369)	140 (140 to 140)	104 (27 to 174)	253 (253 to 253)	—
RSV N pool 15/11 Ag, Day 31	129.5 (23.5 to 226.5)	229 (1 to 457)	289 (289 to 289)	58 (1 to 102)	193 (180 to 206)	—
RSV N pool 15/11 Ag, Day 61	70 (1 to 165)	144 (34 to 426)	1 (1 to 1)	71 (50 to 117)	64.5 (52 to 77)	—
RSV N pool 15/11 Ag, Day 366	56 (1 to 269)	41.5 (1 to 82)	82 (82 to 82)	89 (42 to 113)	78 (27 to 129)	91 (91 to 91)
RSV M2-1 pool 15/11 Ag, Screening	1 (1 to 9)	1 (1 to 10)	56 (56 to 56)	1 (1 to 1)	214 (214 to 214)	—
RSV M2-1 pool 15/11 Ag, Day 31	1 (1 to 34)	21.5 (1 to 42)	229 (229 to 229)	1 (1 to 13)	145.5 (100 to 191)	—
RSV M2-1 pool 15/11 Ag, Day 61	8 (1 to 57)	2 (1 to 55)	46 (46 to 46)	30 (1 to 33)	1 (1 to 1)	—
RSV M2-1 pool 15/11 Ag, Day 366	7 (1 to 81)	2.5 (1 to 4)	13 (13 to 13)	23 (6 to 27)	48 (1 to 95)	56 (56 to 56)

SecondaryAnti-RSV-A Neutralizing Antibody Titers

Humoral response to the investigational RSV vaccine was measured in terms of anti-RSV-A neutralizing antibody titers and expressed as geometric mean titers (GMTs) in Estimated Dilution 60 (ED60) titers.

Time frame:: At Pre-vaccination (Screening), Day 31, Day 61 and Day 366
Reported as:: Geometric mean · Titers

Anti-RSV-A Neutralizing Antibody Titers
Titers	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
Screening	127.4 (44 to 368.5)	179.4 (99.2 to 324.5)	495.7 (242.5 to 1013.1)	376.5 (89.3 to 1587.5)	214.6 (80.8 to 569.9)	332 (158.5 to 695.4)
Day 31	711.7 (229.7 to 2204.9)	1646 (815.8 to 3321)	2203.9 (1383.7 to 3510.3)	645.9 (266.3 to 1566.5)	703.9 (244.3 to 2028.4)	295 (149.6 to 581.8)
Day 61	1081.3 (648.3 to 1803.3)	1809 (1022.6 to 3200.2)	1974.9 (1356.9 to 2874.3)	421.5 (178.9 to 993.1)	316.4 (169 to 592.3)	307.1 (148.5 to 634.9)
Day 366	236.9 (105.7 to 531)	837 (546.6 to 1281.6)	1038 (629.3 to 1712.3)	398.5 (163.5 to 971.7)	545.4 (269.4 to 1104.3)	493.8 (216 to 1129.1)

SecondaryAnti-RSV-F Antibody Concentrations

Humoral response to the investigational RSV vaccine was measured as anti-RSV F antibody concentrations and expressed as geometric mean concentrations (GMCs) in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EU/mL).

Time frame:: At Pre-vaccination (Screening), Day 31, Day 61 and Day 366
Reported as:: Geometric mean · EU/mL

Anti-RSV-F Antibody Concentrations
EU/mL	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
Screening	2082 (864.3 to 5015.5)	2061.6 (1343.6 to 3163.4)	3686.4 (1964.5 to 6917.5)	3933.2 (1789.1 to 8646.7)	1216.3 (472.9 to 3128.7)	2988.6 (1420.9 to 6286)
Day 31	4807.2 (1738.5 to 13292.8)	10810.9 (4062.2 to 28771.1)	17419 (11639.6 to 26068.2)	6134.2 (2752 to 13673)	7911.6 (3187.7 to 19636)	2350.6 (1235.9 to 4470.7)
Day 61	6167.5 (3701.3 to 10277.1)	15577.4 (8012.9 to 30283.2)	15083.8 (10555 to 21555.7)	2983.3 (1612.8 to 5518.3)	3182 (1737.1 to 5828.8)	2101.3 (1038.3 to 4252.6)
Day 366	3988.5 (1789.4 to 8890.1)	6521.1 (3702.5 to 11485.4)	6490.7 (4509.7 to 9341.8)	3591.3 (1472.8 to 8756.9)	3047.5 (1577.7 to 5886.6)	4487.9 (1936.8 to 10398.8)

SecondaryPalivizumab-competing Antibody Concentrations

Humoral response to the investigational RSV vaccine was measured as Palivizumab-competing antibody concentrations and expressed as geometric mean concentrations (GMCs) in microgram/milliliter (µg/mL).

Time frame:: At Pre-vaccination (Screening), Day 31 and Day 61
Reported as:: Geometric mean · µg/mL

Palivizumab-competing Antibody Concentrations
µg/mL	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
Screening	5.2 (4.3 to 6.3)	4.8 (4.8 to 4.8)	6.6 (5 to 8.6)	6.2 (4.2 to 9.2)	4.8 (4.8 to 4.8)	7.2 (4.8 to 10.9)
Day 31	7.9 (5.3 to 11.7)	11.1 (6.2 to 19.8)	17.5 (13 to 23.6)	8 (4.4 to 14.5)	12.5 (6.2 to 25.5)	6.8 (4.8 to 9.6)
Day 61	6.3 (4.6 to 8.6)	15.2 (9.2 to 25.1)	14 (10.1 to 19.4)	6.1 (4.3 to 8.6)	7 (4.5 to 10.8)	6.6 (4.8 to 9)

Adverse events

Collected over Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period after any vaccination. Serious adverse events were collected from Day 1 up to Day 731.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
RSV LD Group	0/11 (0%)	1/11 (9.1%)	10/11 (90.9%)
RSV MD Group	0/14 (0%)	1/14 (7.1%)	11/14 (78.6%)
RSV HD Group	0/18 (0%)	2/18 (11.1%)	17/18 (94.4%)
Placebo LD Group	0/11 (0%)	3/11 (27.3%)	11/11 (100%)
Placebo MD Group	0/11 (0%)	1/11 (9.1%)	10/11 (90.9%)
Placebo HD Group	0/17 (0%)	2/17 (11.8%)	14/17 (82.4%)

Most frequent serious events

Showing 10 of 14

Most frequent serious events
Event	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
Respiratory syncytial virus infectionInfections and infestations	0/11	1/14	0/18	2/11	0/11	0/17
GastroenteritisInfections and infestations	0/11	0/14	2/18	0/11	0/11	0/17
Coronavirus infectionInfections and infestations	0/11	0/14	0/18	1/11	1/11	0/17
BronchitisInfections and infestations	0/11	0/14	0/18	1/11	0/11	0/17
Enterovirus infectionInfections and infestations	0/11	0/14	0/18	0/11	1/11	0/17
Escherichia urinary tract infectionInfections and infestations	1/11	0/14	0/18	0/11	0/11	0/17
Respiratory syncytial virus bronchiolitisInfections and infestations	0/11	0/14	0/18	1/11	0/11	0/17
Rhinovirus infectionInfections and infestations	0/11	0/14	0/18	0/11	1/11	0/17
TonsillitisInfections and infestations	0/11	0/14	0/18	1/11	0/11	0/17
Unresponsive to stimuliNervous system disorders	0/11	0/14	0/18	0/11	1/11	0/17

Most frequent other events

Showing 10 of 51

Most frequent other events
Event	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
PyrexiaGeneral disorders	5/11	5/14	11/18	5/11	4/11	2/17
NasopharyngitisInfections and infestations	2/11	6/14	7/18	0/11	4/11	5/17
Injection site erythemaGeneral disorders	2/11	2/14	4/18	3/11	0/11	4/17
Injection site painGeneral disorders	3/11	3/14	2/18	2/11	0/11	4/17
GastroenteritisInfections and infestations	0/11	1/14	3/18	0/11	3/11	1/17
ConjunctivitisInfections and infestations	3/11	0/14	0/18	0/11	0/11	0/17
DiarrhoeaGastrointestinal disorders	2/11	2/14	0/18	2/11	2/11	3/17
CoughRespiratory, thoracic and mediastinal disorders	0/11	0/14	2/18	0/11	2/11	1/17
Injection site swellingGeneral disorders	0/11	0/14	1/18	1/11	1/11	3/17
Decreased appetiteMetabolism and nutrition disorders	1/11	0/14	2/18	0/11	0/11	3/17

Baseline characteristics

Age, Continuous
Age, Continuous(MONTHS)	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group	Total
Mean	15.4 ± 1.6	15.6 ± 3.3	16.3 ± 4.0	15.0 ± 1.9	16.2 ± 2.7	17.4 ± 3.8	16.1 ± 3.2

Sex: Female, Male
Sex: Female, Male(Participants)	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group	Total
Female	4	7	10	5	3	12	41
Male	7	7	8	6	8	5	41

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group	Total
AFRICAN HERITAGE / AFRICAN AMERICAN	0	0	0	0	1	0	1
ASIAN - EAST ASIAN HERITAGE	0	0	3	0	1	3	7
ASIAN - SOUTH EAST ASIAN HERITAGE	0	0	1	0	1	0	2
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER	0	1	0	0	0	0	1
OTHER, NOT SPECIFIED	0	7	12	2	4	9	34
WHITE - CAUCASIAN / EUROPEAN HERITAGE	11	6	2	9	4	5	37

Study locations

24 sites

GSK Investigational Site
Anaheim, California 92804, United States
GSK Investigational Site
Aurora, Colorado 80045, United States
GSK Investigational Site
Topeka, Kansas 66604, United States
GSK Investigational Site
Frederick, Maryland 21702, United States
GSK Investigational Site
Syracuse, New York 13210, United States
GSK Investigational Site
Sioux Falls, South Dakota 57105, United States
GSK Investigational Site
Halifax, Nova Scotia B3K 6R8, Canada
GSK Investigational Site
Milano, Lombardia 20122, Italy
GSK Investigational Site
Perugia, Umbria 06132, Italy
GSK Investigational Site
Mexico, 04530, Mexico
GSK Investigational Site
David, Chiriquí 0401, Panama
GSK Investigational Site
Panama, 0801, Panama
GSK Investigational Site
Debica, 39-200, Poland
GSK Investigational Site
Burgos, 09006, Spain
GSK Investigational Site
Madrid, 28040, Spain
GSK Investigational Site
Madrid, 28041, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Majadahonda (Madrid), 28222, Spain
GSK Investigational Site
Santiago de Compostela, 15706, Spain
GSK Investigational Site
Valencia, 46020, Spain
GSK Investigational Site
Hsinchu, 300, Taiwan
GSK Investigational Site
Taipei, 100, Taiwan
GSK Investigational Site
Taipei, 104, Taiwan
GSK Investigational Site
Taoyuan, 333, Taiwan

References and documents

Study documents

Study protocol · Dec 10, 2017
Statistical analysis plan · Mar 28, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.

Supporting information: Study protocol, Sap, Icf, Csr

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02927873
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Oct 7, 2016
Start date: Jan 11, 2017
Primary completion: Feb 19, 2019
Completion: Nov 26, 2020
Results posted: Oct 28, 2021
Last update: Oct 28, 2021

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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