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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

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT02927873
Collaborator
(none)
107
Enrollment
24
Locations
6
Arms
46.5
Actual Duration (Months)
4.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: RSV (GSK3389245A) low dose formulation vaccine
  • Biological: RSV (GSK3389245A) middle dose formulation vaccine
  • Biological: RSV (GSK3389245A) high dose formulation vaccine
  • Drug: Placebo
 Phase 1/Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
107 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Observer blind
Primary Purpose:
Prevention
Official Title:
A Phase 1/2, Randomized, Observer-blind, Controlled, Multi-center, Dose-escalation Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine Based on the RSV Viral Proteins F, N and M2-1 Encoded by Chimpanzee-derived Adenovector (ChAd155-RSV) (GSK3389245A), When Administered Intramuscularly According to a 0, 1-month Schedule to RSV-seropositive Infants Aged 12 to 23 Months
Actual Study Start Date :
Jan 11, 2017
Actual Primary Completion Date :
Feb 19, 2019
Actual Study Completion Date :
Nov 26, 2020

Arms and Interventions

Arm Intervention/Treatment
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.

Outcome Measures

Primary Outcome Measures

  1. Number of Subjects With Any Solicited Local Adverse Events (AEs) [During a 7-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)]

    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.

  2. Number of Subjects With Any Solicited General AEs [During a 7-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)]

    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.

  3. Number of Subjects With Any Unsolicited AEs [During a 30-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)]

    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.

  4. Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61 [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.

  5. Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Specific Interest) [During a 30-day follow-up period after each vaccination (vaccine/placebo administered at Day 1 and Day 31)]

    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.

  6. Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 [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].

  7. Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 [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].

  8. Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 [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].

  9. Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 [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].

  10. Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 [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].

  11. Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 [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].

  12. Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 [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].

  13. Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 [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].

Secondary Outcome Measures

  1. Number of Subjects With Any SAEs From Day 1 up to Day 366 [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.

  2. 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 [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.

  3. 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 [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.

  4. Number of Subjects With Any SAEs From Day 1 up to Study Conclusion at Day 731 [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.

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

  6. 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 [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.

  7. Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools [At Pre-vaccination (Screening), Day 31, Day 61 and Day 366]

    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.

  8. Anti-RSV-A Neutralizing Antibody Titers [At Pre-vaccination (Screening), Day 31, Day 61 and Day 366]

    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.

  9. Anti-RSV-F Antibody Concentrations [At Pre-vaccination (Screening), Day 31, Day 61 and Day 366]

    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).

  10. Palivizumab-competing Antibody Concentrations [At Pre-vaccination (Screening), Day 31 and Day 61]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Months to 23 Months
Sexes Eligible for Study:
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:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 GSK Investigational Site Anaheim California United States 92804
2 GSK Investigational Site Aurora Colorado United States 80045
3 GSK Investigational Site Topeka Kansas United States 66604
4 GSK Investigational Site Frederick Maryland United States 21702
5 GSK Investigational Site Syracuse New York United States 13210
6 GSK Investigational Site Sioux Falls South Dakota United States 57105
7 GSK Investigational Site Halifax Nova Scotia Canada B3K 6R8
8 GSK Investigational Site Milano Lombardia Italy 20122
9 GSK Investigational Site Perugia Umbria Italy 06132
10 GSK Investigational Site Mexico Mexico 04530
11 GSK Investigational Site David Chiriquí Panama 0401
12 GSK Investigational Site Panama Panama 0801
13 GSK Investigational Site Debica Poland 39-200
14 GSK Investigational Site Burgos Spain 09006
15 GSK Investigational Site Madrid Spain 28040
16 GSK Investigational Site Madrid Spain 28041
17 GSK Investigational Site Madrid Spain 28046
18 GSK Investigational Site Majadahonda (Madrid) Spain 28222
19 GSK Investigational Site Santiago de Compostela Spain 15706
20 GSK Investigational Site Valencia Spain 46020
21 GSK Investigational Site Hsinchu Taiwan 300
22 GSK Investigational Site Taipei Taiwan 100
23 GSK Investigational Site Taipei Taiwan 104
24 GSK Investigational Site Taoyuan Taiwan 333

Sponsors and Collaborators

  • GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02927873
Other Study ID Numbers:
  • 204838
  • 2016-000117-76
First Posted:
Oct 7, 2016
Last Update Posted:
Oct 28, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by GlaxoSmithKline
Safety
Respiratory syncytial virus (RSV)
Immunogenicity
Reactogenicity
Infants
Vaccine
Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections
Vaccines

Study Results

Participant Flow

Recruitment Details The study was conducted at 32 centers in 8 countries (Canada, Italy, Mexico, Panama, Poland, Spain, Taiwan and United States).
Pre-assignment Detail Out of 107 participants enrolled in the study, 21 participants were not assigned to any study group and 4 participants did not receive any study treatment. 82 subjects were vaccinated and included in the Exposed Set.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Period Title: Overall Study
STARTED 11 14 18 11 11 17
COMPLETED 9 11 18 11 11 16
NOT COMPLETED 2 3 0 0 0 1

Baseline Characteristics

Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group Total
Arm/Group Description 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. 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. 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. 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. 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. 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. Total of all reporting groups
Overall Participants 11 14 18 11 11 17 82
Age (MONTHS) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [MONTHS]
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 (Count of Participants)
Female
4
36.4%
7
50%
10
55.6%
5
45.5%
3
27.3%
12
70.6%
41
50%
Male
7
63.6%
7
50%
8
44.4%
6
54.5%
8
72.7%
5
29.4%
41
50%
Race/Ethnicity, Customized (Count of Participants)
AFRICAN HERITAGE / AFRICAN AMERICAN
0
0%
0
0%
0
0%
0
0%
1
9.1%
0
0%
1
1.2%
ASIAN - EAST ASIAN HERITAGE
0
0%
0
0%
3
16.7%
0
0%
1
9.1%
3
17.6%
7
8.5%
ASIAN - SOUTH EAST ASIAN HERITAGE
0
0%
0
0%
1
5.6%
0
0%
1
9.1%
0
0%
2
2.4%
NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER
0
0%
1
7.1%
0
0%
0
0%
0
0%
0
0%
1
1.2%
OTHER, NOT SPECIFIED
0
0%
7
50%
12
66.7%
2
18.2%
4
36.4%
9
52.9%
34
41.5%
WHITE - CAUCASIAN / EUROPEAN HERITAGE
11
100%
6
42.9%
2
11.1%
9
81.8%
4
36.4%
5
29.4%
37
45.1%

Outcome Measures

1. Primary Outcome
Title Number of Subjects With Any Solicited Local Adverse Events (AEs)
Description 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)

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with the diary card completed after each vaccination.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 11 13 18 11 11 17
DOSE 1, Any Pain
1
9.1%
2
14.3%
0
0%
2
18.2%
0
0%
2
11.8%
DOSE 1, Any Redness
2
18.2%
1
7.1%
3
16.7%
3
27.3%
0
0%
3
17.6%
DOSE 1, Any Swelling
0
0%
0
0%
1
5.6%
1
9.1%
1
9.1%
2
11.8%
DOSE 2, Any Pain
2
18.2%
2
14.3%
2
11.1%
1
9.1%
0
0%
3
17.6%
DOSE 2, Any Redness
2
18.2%
1
7.1%
2
11.1%
3
27.3%
0
0%
2
11.8%
DOSE 2, Any Swelling
0
0%
0
0%
0
0%
1
9.1%
0
0%
2
11.8%
2. Primary Outcome
Title Number of Subjects With Any Solicited General AEs
Description 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)

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with the diary card completed after each vaccination.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 11 13 18 11 11 17
DOSE 1, Any Drowsiness
4
36.4%
2
14.3%
4
22.2%
5
45.5%
3
27.3%
4
23.5%
DOSE 1, Any Irritability / Fussiness
3
27.3%
3
21.4%
4
22.2%
4
36.4%
2
18.2%
2
11.8%
DOSE 1, Any Loss Of Appetite
3
27.3%
3
21.4%
4
22.2%
2
18.2%
2
18.2%
3
17.6%
DOSE 1, Any Fever
3
27.3%
3
21.4%
10
55.6%
3
27.3%
2
18.2%
0
0%
DOSE 2, Any Drowsiness
2
18.2%
1
7.1%
5
27.8%
3
27.3%
2
18.2%
5
29.4%
DOSE 2, Any Irritability / Fussiness
3
27.3%
1
7.1%
5
27.8%
3
27.3%
1
9.1%
6
35.3%
DOSE 2, Any Loss Of Appetite
3
27.3%
0
0%
6
33.3%
3
27.3%
2
18.2%
5
29.4%
DOSE 2, Any Fever
2
18.2%
2
14.3%
5
27.8%
1
9.1%
2
18.2%
1
5.9%
3. Primary Outcome
Title Number of Subjects With Any Unsolicited AEs
Description 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)

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 11 14 18 11 11 17
Count of Participants [Participants]
9
81.8%
9
64.3%
13
72.2%
7
63.6%
10
90.9%
13
76.5%
4. Primary Outcome
Title Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61
Description 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

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 11 14 18 11 11 17
Count of Participants [Participants]
0
0%
0
0%
1
5.6%
1
9.1%
0
0%
2
11.8%
5. Primary Outcome
Title Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Specific Interest)
Description 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)

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 11 14 18 11 11 17
Count of Participants [Participants]
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
6. Primary Outcome
Title Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2
Description 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

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with available results for the specified parameter and time point.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 11 14 15 11 11 16
HgL, Below, Below
3
27.3%
2
14.3%
1
5.6%
1
9.1%
0
0%
0
0%
HgL, Within, Unknown
0
0%
1
7.1%
0
0%
0
0%
0
0%
0
0%
HgL, Within, Below
0
0%
2
14.3%
0
0%
0
0%
2
18.2%
2
11.8%
HgL, Within, Within
8
72.7%
9
64.3%
15
83.3%
10
90.9%
9
81.8%
13
76.5%
HgL, Within, Above
0
0%
0
0%
0
0%
0
0%
0
0%
1
5.9%
HgL, Above, Within
0
0%
0
0%
0
0%
0
0%
0
0%
1
5.9%
HgL, Above, Above
0
0%
0
0%
1
5.6%
0
0%
0
0%
0
0%
WBC, Below, Below
0
0%
0
0%
1
5.6%
0
0%
0
0%
0
0%
WBC, Below, Within
0
0%
0
0%
0
0%
0
0%
0
0%
1
5.9%
WBC, Within, Unknown
0
0%
1
7.1%
0
0%
0
0%
0
0%
0
0%
WBC, Within, Below
0
0%
2
14.3%
1
5.6%
0
0%
0
0%
2
11.8%
WBC, Within, Within
11
100%
11
78.6%
13
72.2%
11
100%
6
54.5%
13
76.5%
WBC, Within, Above
0
0%
0
0%
0
0%
0
0%
1
9.1%
1
5.9%
WBC, Above, Within
0
0%
0
0%
1
5.6%
0
0%
2
18.2%
0
0%
WBC, Above, Above
0
0%
0
0%
1
5.6%
0
0%
2
18.2%
0
0%
PLC, Within, Unknown
0
0%
1
7.1%
0
0%
0
0%
0
0%
0
0%
PLC, Within, Below
0
0%
0
0%
1
5.6%
0
0%
0
0%
0
0%
PLC, Within, Within
10
90.9%
10
71.4%
12
66.7%
9
81.8%
4
36.4%
12
70.6%
PLC, Within, Above
0
0%
1
7.1%
2
11.1%
0
0%
2
18.2%
3
17.6%
PLC, Above, Within
1
9.1%
1
7.1%
2
11.1%
1
9.1%
2
18.2%
0
0%
PLC, Above, Above
0
0%
0
0%
0
0%
1
9.1%
3
27.3%
2
11.8%
7. Primary Outcome
Title Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
Description 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

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with available results for the specified parameter and time point.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 9 3 2 8 5 3
HgL, Below, Below
2
18.2%
1
7.1%
0
0%
1
9.1%
0
0%
0
0%
HgL, Within, Within
7
63.6%
2
14.3%
2
11.1%
7
63.6%
5
45.5%
2
11.8%
HgL, Above, Above
0
0%
0
0%
0
0%
0
0%
0
0%
1
5.9%
WBC, Within, Within
8
72.7%
2
14.3%
2
11.1%
8
72.7%
2
18.2%
3
17.6%
WBC, Within, Above
1
9.1%
1
7.1%
0
0%
0
0%
0
0%
0
0%
WBC, Above, Within
0
0%
0
0%
0
0%
0
0%
3
27.3%
0
0%
PLC, Within, Within
7
63.6%
3
21.4%
1
5.6%
8
72.7%
0
0%
3
17.6%
PLC, Within, Above
1
9.1%
0
0%
1
5.6%
0
0%
3
27.3%
0
0%
PLC, Above, Within
1
9.1%
0
0%
0
0%
0
0%
1
9.1%
0
0%
PLC, Above, Above
0
0%
0
0%
0
0%
0
0%
1
9.1%
0
0%
8. Primary Outcome
Title Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Description 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

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with available results for the specified parameter and time point.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 10 12 16 10 9 16
HgL, Below, Below
3
27.3%
1
7.1%
1
5.6%
1
9.1%
0
0%
0
0%
HgL, Below, Within
0
0%
1
7.1%
0
0%
0
0%
0
0%
0
0%
HgL, Within, Unknown
0
0%
1
7.1%
0
0%
0
0%
0
0%
0
0%
HgL, Within, Below
0
0%
0
0%
0
0%
0
0%
1
9.1%
2
11.8%
HgL, Within, Within
7
63.6%
9
64.3%
15
83.3%
9
81.8%
8
72.7%
14
82.4%
HgL, Within, Above
0
0%
0
0%
1
5.6%
0
0%
0
0%
0
0%
HgL, Above, Within
0
0%
0
0%
1
5.6%
0
0%
0
0%
1
5.9%
WBC, Below, Within
0
0%
0
0%
1
5.6%
0
0%
0
0%
1
5.9%
WBC, Within, Unknown
0
0%
1
7.1%
0
0%
0
0%
0
0%
0
0%
WBC, Within, Below
0
0%
0
0%
0
0%
0
0%
0
0%
1
5.9%
WBC, Within, Within
10
90.9%
9
64.3%
13
72.2%
10
90.9%
4
36.4%
15
88.2%
WBC, Within, Above
0
0%
2
14.3%
2
11.1%
0
0%
1
9.1%
0
0%
WBC, Above, Within
0
0%
0
0%
1
5.6%
0
0%
3
27.3%
0
0%
WBC, Above, Above
0
0%
0
0%
1
5.6%
0
0%
1
9.1%
0
0%
PLC, Within, Unknown
0
0%
1
7.1%
0
0%
0
0%
0
0%
0
0%
PLC, Within, Within
9
81.8%
8
57.1%
15
83.3%
8
72.7%
4
36.4%
13
76.5%
PLC, Within, Above
1
9.1%
2
14.3%
1
5.6%
0
0%
1
9.1%
2
11.8%
PLC, Above, Within
0
0%
1
7.1%
2
11.1%
2
18.2%
2
18.2%
1
5.9%
PLC, Above, Above
0
0%
0
0%
0
0%
0
0%
2
18.2%
1
5.9%
9. Primary Outcome
Title Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32
Description 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

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with available results for the specified parameter and time point.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 10 10 15 11 10 16
HgL, Below, Below
2
18.2%
2
14.3%
1
5.6%
1
9.1%
0
0%
0
0%
HgL, Below, Within
1
9.1%
0
0%
0
0%
0
0%
0
0%
0
0%
HgL, Within, Unknown
0
0%
0
0%
0
0%
1
9.1%
0
0%
0
0%
HgL, Within, Below
1
9.1%
1
7.1%
0
0%
0
0%
1
9.1%
2
11.8%
HgL, Within, Within
6
54.5%
7
50%
14
77.8%
9
81.8%
8
72.7%
14
82.4%
HgL, Within, Above
0
0%
0
0%
1
5.6%
0
0%
1
9.1%
0
0%
HgL, Above, Within
0
0%
0
0%
0
0%
0
0%
0
0%
1
5.9%
HgL, Above, Above
0
0%
0
0%
1
5.6%
0
0%
0
0%
0
0%
WBC, Below, Within
0
0%
0
0%
1
5.6%
0
0%
0
0%
1
5.9%
WBC, Within, Unknown
0
0%
0
0%
0
0%
1
9.1%
0
0%
0
0%
WBC, Within, Below
1
9.1%
2
14.3%
3
16.7%
0
0%
1
9.1%
2
11.8%
WBC, Within, Within
9
81.8%
7
50%
11
61.1%
10
90.9%
5
45.5%
14
82.4%
WBC, Within, Above
0
0%
1
7.1%
0
0%
0
0%
1
9.1%
0
0%
WBC, Above, Within
0
0%
0
0%
1
5.6%
0
0%
2
18.2%
0
0%
WBC, Above, Above
0
0%
0
0%
1
5.6%
0
0%
1
9.1%
0
0%
PLC, Within, Unknown
0
0%
0
0%
0
0%
1
9.1%
0
0%
0
0%
PLC, Within, Below
0
0%
1
7.1%
0
0%
0
0%
0
0%
0
0%
PLC, Within, Within
10
90.9%
7
50%
15
83.3%
7
63.6%
4
36.4%
14
82.4%
PLC, Within, Above
0
0%
1
7.1%
0
0%
1
9.1%
1
9.1%
1
5.9%
PLC, Above, Within
0
0%
1
7.1%
2
11.1%
2
18.2%
4
36.4%
1
5.9%
PLC, Above, Above
0
0%
0
0%
0
0%
0
0%
1
9.1%
1
5.9%
10. Primary Outcome
Title Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38
Description 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

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with available results for the specified parameter and time point. As per Protocol, hematology testing for RSV HD group on Day 38 was not performed since no platelet decrease (i.e. less than 150000 cells/cubic millimeter) was detected on Day 32.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 8 1 0 6 2 2
HgL, Below, Below
2
18.2%
0
0%
0
0%
1
9.1%
0
0%
0
0%
HgL, Within, Within
6
54.5%
1
7.1%
0
0%
5
45.5%
2
18.2%
1
5.9%
HgL, Above, Above
0
0%
0
0%
0
0%
0
0%
0
0%
1
5.9%
WBC, Within, Within
8
72.7%
1
7.1%
0
0%
4
36.4%
1
9.1%
2
11.8%
WBC, Within, Above
0
0%
0
0%
0
0%
2
18.2%
0
0%
0
0%
WBC, Above, Above
0
0%
0
0%
0
0%
0
0%
1
9.1%
0
0%
PLC, Within, Within
7
63.6%
1
7.1%
0
0%
5
45.5%
0
0%
1
5.9%
PLC, Within, Above
1
9.1%
0
0%
0
0%
1
9.1%
1
9.1%
1
5.9%
PLC, Above, Above
0
0%
0
0%
0
0%
0
0%
1
9.1%
0
0%
11. Primary Outcome
Title Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61
Description 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

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with available results for the specified parameter and time point.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 10 12 16 9 11 15
HgL, Below, Below
2
18.2%
1
7.1%
0
0%
0
0%
0
0%
0
0%
HgL, Below, Within
1
9.1%
0
0%
1
5.6%
0
0%
0
0%
0
0%
HgL, Within, Unknown
0
0%
0
0%
0
0%
1
9.1%
0
0%
0
0%
HgL, Within, Below
0
0%
1
7.1%
0
0%
0
0%
0
0%
2
11.8%
HgL, Within, Within
7
63.6%
10
71.4%
16
88.9%
8
72.7%
11
100%
13
76.5%
HgL, Above, Within
0
0%
0
0%
0
0%
0
0%
0
0%
1
5.9%
HgL, Above, Above
0
0%
0
0%
1
5.6%
0
0%
0
0%
0
0%
WBC, Below, Within
0
0%
0
0%
1
5.6%
0
0%
0
0%
1
5.9%
WBC, Within, Unknown
0
0%
0
0%
0
0%
1
9.1%
0
0%
0
0%
WBC, Within, Below
1
9.1%
0
0%
0
0%
0
0%
0
0%
3
17.6%
WBC, Within, Within
9
81.8%
11
78.6%
14
77.8%
8
72.7%
6
54.5%
10
58.8%
WBC, Within, Above
0
0%
1
7.1%
1
5.6%
0
0%
1
9.1%
2
11.8%
WBC, Above, Within
0
0%
0
0%
1
5.6%
0
0%
4
36.4%
0
0%
WBC, Above, Above
0
0%
0
0%
1
5.6%
0
0%
0
0%
0
0%
PLC, Within, Unknown
0
0%
0
0%
0
0%
1
9.1%
0
0%
0
0%
PLC, Within, Below
0
0%
0
0%
0
0%
0
0%
0
0%
1
5.9%
PLC, Within, Within
9
81.8%
8
57.1%
15
83.3%
4
36.4%
5
45.5%
8
47.1%
PLC, Within, Above
1
9.1%
3
21.4%
1
5.6%
1
9.1%
1
9.1%
5
29.4%
PLC, Above, Within
0
0%
1
7.1%
2
11.1%
2
18.2%
4
36.4%
1
5.9%
PLC, Above, Above
0
0%
0
0%
0
0%
0
0%
1
9.1%
1
5.9%
12. Primary Outcome
Title Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
Description 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

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with available results for the specified parameter and time point.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 9 11 16 11 9 17
ALT, Below, Below
1
9.1%
0
0%
0
0%
0
0%
0
0%
0
0%
ALT, Below, Within
1
9.1%
0
0%
0
0%
0
0%
0
0%
0
0%
ALT, Below, Above
0
0%
0
0%
0
0%
0
0%
0
0%
1
5.9%
ALT, Within, Unknown
0
0%
1
7.1%
0
0%
0
0%
0
0%
0
0%
ALT, Within, Below
1
9.1%
0
0%
0
0%
0
0%
0
0%
0
0%
ALT, Within, Within
7
63.6%
10
71.4%
15
83.3%
11
100%
7
63.6%
13
76.5%
ALT, Within, Above
0
0%
0
0%
1
5.6%
0
0%
2
18.2%
0
0%
ALT, Above, Within
0
0%
1
7.1%
1
5.6%
0
0%
0
0%
2
11.8%
ALT, Above, Above
0
0%
0
0%
1
5.6%
0
0%
0
0%
1
5.9%
AST, Within, Unknown
0
0%
1
7.1%
0
0%
0
0%
0
0%
0
0%
AST, Within, Within
9
81.8%
7
50%
13
72.2%
9
81.8%
7
63.6%
14
82.4%
AST, Within, Above
0
0%
1
7.1%
2
11.1%
1
9.1%
1
9.1%
0
0%
AST, Above, Below
0
0%
0
0%
0
0%
0
0%
0
0%
1
5.9%
AST, Above, Within
1
9.1%
1
7.1%
1
5.6%
1
9.1%
0
0%
0
0%
AST, Above, Above
0
0%
2
14.3%
2
11.1%
0
0%
1
9.1%
2
11.8%
CREA, Below, Unknown
0
0%
1
7.1%
0
0%
0
0%
0
0%
0
0%
CREA, Below, Below
4
36.4%
3
21.4%
1
5.6%
7
63.6%
1
9.1%
0
0%
CREA, Below, Within
3
27.3%
0
0%
3
16.7%
1
9.1%
0
0%
0
0%
CREA, Within, Below
3
27.3%
1
7.1%
4
22.2%
0
0%
0
0%
4
23.5%
CREA, Within, Within
0
0%
7
50%
10
55.6%
3
27.3%
7
63.6%
12
70.6%
CREA, Within, Above
0
0%
0
0%
0
0%
0
0%
0
0%
1
5.9%
CREA, Above, Within
0
0%
0
0%
0
0%
0
0%
1
9.1%
0
0%
13. Primary Outcome
Title Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61
Description 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

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented and with available results for the specified parameter and time point.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 9 11 16 11 10 16
ALT, Below, Below
1
9.1%
0
0%
0
0%
0
0%
0
0%
0
0%
ALT, Below, Within
1
9.1%
0
0%
0
0%
0
0%
0
0%
1
5.9%
ALT, Within, Within
8
72.7%
10
71.4%
15
83.3%
10
90.9%
9
81.8%
12
70.6%
ALT, Within, Above
0
0%
1
7.1%
1
5.6%
1
9.1%
1
9.1%
0
0%
ALT, Above, Within
0
0%
1
7.1%
2
11.1%
0
0%
1
9.1%
1
5.9%
ALT, Above, Above
0
0%
0
0%
0
0%
0
0%
0
0%
1
5.9%
AST, Within, Within
9
81.8%
9
64.3%
15
83.3%
10
90.9%
8
72.7%
13
76.5%
AST, Within, Above
0
0%
1
7.1%
0
0%
0
0%
1
9.1%
0
0%
AST, Above, Within
1
9.1%
1
7.1%
1
5.6%
0
0%
0
0%
1
5.9%
AST, Above, Above
0
0%
1
7.1%
2
11.1%
1
9.1%
2
18.2%
2
11.8%
CREA, Below, Below
4
36.4%
2
14.3%
2
11.1%
7
63.6%
1
9.1%
0
0%
CREA, Below, Within
3
27.3%
1
7.1%
2
11.1%
1
9.1%
1
9.1%
0
0%
CREA, Within, Below
3
27.3%
1
7.1%
3
16.7%
0
0%
0
0%
1
5.9%
CREA, Within, Within
0
0%
8
57.1%
10
55.6%
3
27.3%
8
72.7%
15
88.2%
CREA, Within, Above
0
0%
0
0%
1
5.6%
0
0%
0
0%
0
0%
CREA, Above, Within
0
0%
0
0%
0
0%
0
0%
1
9.1%
0
0%
14. Secondary Outcome
Title Number of Subjects With Any SAEs From Day 1 up to Day 366
Description 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

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 11 14 18 11 11 17
Count of Participants [Participants]
1
9.1%
1
7.1%
1
5.6%
3
27.3%
1
9.1%
2
11.8%
15. Secondary Outcome
Title 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
Description 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

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 11 14 18 11 11 17
Count of Participants [Participants]
0
0%
1
7.1%
0
0%
3
27.3%
0
0%
0
0%
16. Secondary Outcome
Title 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
Description 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

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 11 14 18 11 11 17
RSV-RTI
1
9.1%
3
21.4%
1
5.6%
4
36.4%
3
27.3%
3
17.6%
RSV-LRTI
0
0%
0
0%
0
0%
1
9.1%
0
0%
0
0%
RSV-severe LRTI
0
0%
0
0%
0
0%
1
9.1%
0
0%
0
0%
17. Secondary Outcome
Title Number of Subjects With Any SAEs From Day 1 up to Study Conclusion at Day 731
Description 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

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 11 14 18 11 11 17
Count of Participants [Participants]
1
9.1%
1
7.1%
2
11.1%
3
27.3%
1
9.1%
2
11.8%
18. Secondary Outcome
Title Number of Subjects With RSV-LRTI (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731
Description 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

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 11 14 18 11 11 17
Count of Participants [Participants]
0
0%
1
7.1%
0
0%
3
27.3%
0
0%
0
0%
19. Secondary Outcome
Title 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
Description 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

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Exposed Set, which included all subjects with at least one study vaccine administration documented.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 11 14 18 11 11 17
RSV-RTI
2
18.2%
6
42.9%
2
11.1%
5
45.5%
4
36.4%
4
23.5%
RSV-LRTI
0
0%
0
0%
0
0%
1
9.1%
0
0%
0
0%
RSV-severe LRTI
0
0%
0
0%
0
0%
1
9.1%
0
0%
0
0%
20. Secondary Outcome
Title Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools
Description 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

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Per-protocol set (PPS), which included all vaccinated subjects, meeting all protocol requirements and with available CMI results at the specified time point.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 9 3 1 10 2 1
RSV F pool 15/11 Ag, Screening
169.5
123
1
176
1813
RSV F pool 15/11 Ag, Day 31
291
546
1086
234
1129.5
RSV F pool 15/11 Ag, Day 61
214
451
394
105.5
759
RSV F pool 15/11 Ag, Day 366
206
108.5
1164
252.5
664.5
229
RSV N pool 15/11 Ag, Screening
51
54
140
104
253
RSV N pool 15/11 Ag, Day 31
129.5
229
289
58
193
RSV N pool 15/11 Ag, Day 61
70
144
1
71
64.5
RSV N pool 15/11 Ag, Day 366
56
41.5
82
89
78
91
RSV M2-1 pool 15/11 Ag, Screening
1
1
56
1
214
RSV M2-1 pool 15/11 Ag, Day 31
1
21.5
229
1
145.5
RSV M2-1 pool 15/11 Ag, Day 61
8
2
46
30
1
RSV M2-1 pool 15/11 Ag, Day 366
7
2.5
13
23
48
56
21. Secondary Outcome
Title Anti-RSV-A Neutralizing Antibody Titers
Description 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

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Per-protocol set (PPS), which included all vaccinated subjects, meeting all protocol requirements and with available immunogenicity results for the specified assay and time point.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 10 13 18 11 11 17
Screening
127.4
179.4
495.7
376.5
214.6
332
Day 31
711.7
1646
2203.9
645.9
703.9
295
Day 61
1081.3
1809
1974.9
421.5
316.4
307.1
Day 366
236.9
837
1038
398.5
545.4
493.8
22. Secondary Outcome
Title Anti-RSV-F Antibody Concentrations
Description 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

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Per-protocol set (PPS), which included all vaccinated subjects, meeting all protocol requirements and with available immunogenicity results for the specified assay and time point.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 10 13 17 11 11 17
Screening
2082
2061.6
3686.4
3933.2
1216.3
2988.6
Day 31
4807.2
10810.9
17419
6134.2
7911.6
2350.6
Day 61
6167.5
15577.4
15083.8
2983.3
3182
2101.3
Day 366
3988.5
6521.1
6490.7
3591.3
3047.5
4487.9
23. Secondary Outcome
Title Palivizumab-competing Antibody Concentrations
Description 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

Outcome Measure Data

Analysis Population Description
This analysis was performed on the Per-protocol set (PPS), which included all vaccinated subjects, meeting all protocol requirements and with available immunogenicity results for the specified assay and time point.
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
Measure Participants 10 13 17 11 11 17
Screening
5.2
4.8
6.6
6.2
4.8
7.2
Day 31
7.9
11.1
17.5
8
12.5
6.8
Day 61
6.3
15.2
14
6.1
7
6.6

Adverse Events

Time Frame 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.
Adverse Event Reporting Description
Arm/Group Title RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Arm/Group Description 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. 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. 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. 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. 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. 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.
All Cause Mortality
RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/11 (0%) 0/14 (0%) 0/18 (0%) 0/11 (0%) 0/11 (0%) 0/17 (0%)
Serious Adverse Events
RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/11 (9.1%) 1/14 (7.1%) 2/18 (11.1%) 3/11 (27.3%) 1/11 (9.1%) 2/17 (11.8%)
General disorders
Pyrexia 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/17 (0%) 0
Infections and infestations
Respiratory syncytial virus infection 0/11 (0%) 0 1/14 (7.1%) 1 0/18 (0%) 0 2/11 (18.2%) 2 0/11 (0%) 0 0/17 (0%) 0
Coronavirus infection 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 1/11 (9.1%) 1 1/11 (9.1%) 1 0/17 (0%) 0
Gastroenteritis 0/11 (0%) 0 0/14 (0%) 0 2/18 (11.1%) 2 0/11 (0%) 0 0/11 (0%) 0 0/17 (0%) 0
Bronchitis 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/17 (0%) 0
Enterovirus infection 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/17 (0%) 0
Escherichia urinary tract infection 1/11 (9.1%) 2 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 0/17 (0%) 0
Respiratory syncytial virus bronchiolitis 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/17 (0%) 0
Rhinovirus infection 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/17 (0%) 0
Tonsillitis 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/17 (0%) 0
Herpangina 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 1/17 (5.9%) 1
Pneumonia 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 1/17 (5.9%) 1
Nervous system disorders
Unresponsive to stimuli 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/17 (0%) 0
Febrile convulsion 0/11 (0%) 0 0/14 (0%) 0 1/18 (5.6%) 1 0/11 (0%) 0 0/11 (0%) 0 0/17 (0%) 0
Other (Not Including Serious) Adverse Events
RSV LD Group RSV MD Group RSV HD Group Placebo LD Group Placebo MD Group Placebo HD Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 10/11 (90.9%) 11/14 (78.6%) 17/18 (94.4%) 11/11 (100%) 10/11 (90.9%) 14/17 (82.4%)
Blood and lymphatic system disorders
Anaemia 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 1/17 (5.9%) 1
Ear and labyrinth disorders
Tympanic membrane perforation 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/17 (0%) 0
Gastrointestinal disorders
Diarrhoea 2/11 (18.2%) 2 2/14 (14.3%) 3 0/18 (0%) 0 2/11 (18.2%) 3 2/11 (18.2%) 3 3/17 (17.6%) 3
Teething 1/11 (9.1%) 1 0/14 (0%) 0 0/18 (0%) 0 1/11 (9.1%) 1 1/11 (9.1%) 1 1/17 (5.9%) 1
Vomiting 1/11 (9.1%) 1 0/14 (0%) 0 2/18 (11.1%) 2 1/11 (9.1%) 1 0/11 (0%) 0 0/17 (0%) 0
Constipation 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/17 (0%) 0
Gastrointestinal inflammation 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/17 (0%) 0
Stomatitis 0/11 (0%) 0 1/14 (7.1%) 1 0/18 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 0/17 (0%) 0
General disorders
Pyrexia 5/11 (45.5%) 7 5/14 (35.7%) 5 11/18 (61.1%) 15 5/11 (45.5%) 5 4/11 (36.4%) 6 2/17 (11.8%) 2
Injection site erythema 2/11 (18.2%) 4 2/14 (14.3%) 2 4/18 (22.2%) 5 3/11 (27.3%) 6 0/11 (0%) 0 4/17 (23.5%) 5
Injection site pain 3/11 (27.3%) 3 3/14 (21.4%) 4 2/18 (11.1%) 2 2/11 (18.2%) 3 0/11 (0%) 0 4/17 (23.5%) 5
Injection site swelling 0/11 (0%) 0 0/14 (0%) 0 1/18 (5.6%) 1 1/11 (9.1%) 2 1/11 (9.1%) 1 3/17 (17.6%) 4
Immune system disorders
Seasonal allergy 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/17 (0%) 0
Infections and infestations
Nasopharyngitis 2/11 (18.2%) 2 6/14 (42.9%) 10 7/18 (38.9%) 8 0/11 (0%) 0 4/11 (36.4%) 5 5/17 (29.4%) 7
Gastroenteritis 0/11 (0%) 0 1/14 (7.1%) 1 3/18 (16.7%) 3 0/11 (0%) 0 3/11 (27.3%) 3 1/17 (5.9%) 1
Conjunctivitis 3/11 (27.3%) 3 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 0/17 (0%) 0
Upper respiratory tract infection 1/11 (9.1%) 1 1/14 (7.1%) 2 0/18 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/17 (0%) 0
Pharyngotonsillitis 1/11 (9.1%) 1 0/14 (0%) 0 1/18 (5.6%) 1 0/11 (0%) 0 0/11 (0%) 0 1/17 (5.9%) 1
Influenza 0/11 (0%) 0 0/14 (0%) 0 2/18 (11.1%) 2 0/11 (0%) 0 1/11 (9.1%) 1 0/17 (0%) 0
Tonsillitis streptococcal 1/11 (9.1%) 1 0/14 (0%) 0 0/18 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/17 (0%) 0
Otitis media 0/11 (0%) 0 0/14 (0%) 0 1/18 (5.6%) 1 1/11 (9.1%) 1 0/11 (0%) 0 0/17 (0%) 0
Varicella 0/11 (0%) 0 1/14 (7.1%) 1 0/18 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 1/17 (5.9%) 1
Impetigo 0/11 (0%) 0 0/14 (0%) 0 2/18 (11.1%) 2 0/11 (0%) 0 0/11 (0%) 0 0/17 (0%) 0
Bronchiolitis 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/17 (0%) 0
Croup infectious 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/17 (0%) 0
Gastroenteritis viral 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/17 (0%) 0
Hand-foot-and-mouth disease 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/17 (0%) 0
Paronychia 1/11 (9.1%) 1 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 0/17 (0%) 0
Pharyngitis 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/17 (0%) 0
Tonsillitis 1/11 (9.1%) 1 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 0/17 (0%) 0
Acarodermatitis 0/11 (0%) 0 0/14 (0%) 0 1/18 (5.6%) 1 0/11 (0%) 0 0/11 (0%) 0 0/17 (0%) 0
Bronchitis 0/11 (0%) 0 0/14 (0%) 0 1/18 (5.6%) 2 0/11 (0%) 0 0/11 (0%) 0 0/17 (0%) 0
Pharyngitis streptococcal 0/11 (0%) 0 0/14 (0%) 0 1/18 (5.6%) 1 0/11 (0%) 0 0/11 (0%) 0 0/17 (0%) 0
Injury, poisoning and procedural complications
Face injury 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/17 (0%) 0
Head injury 1/11 (9.1%) 1 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 0/17 (0%) 0
Procedural pain 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/17 (0%) 0
Arthropod bite 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 1/17 (5.9%) 1
Metabolism and nutrition disorders
Decreased appetite 1/11 (9.1%) 1 0/14 (0%) 0 2/18 (11.1%) 2 0/11 (0%) 0 0/11 (0%) 0 3/17 (17.6%) 3
Psychiatric disorders
Irritability 1/11 (9.1%) 1 1/14 (7.1%) 1 0/18 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 1/17 (5.9%) 1
Respiratory, thoracic and mediastinal disorders
Cough 0/11 (0%) 0 0/14 (0%) 0 2/18 (11.1%) 2 0/11 (0%) 0 2/11 (18.2%) 2 1/17 (5.9%) 1
Rhinorrhoea 0/11 (0%) 0 1/14 (7.1%) 1 1/18 (5.6%) 2 0/11 (0%) 0 1/11 (9.1%) 1 1/17 (5.9%) 1
Catarrh 0/11 (0%) 0 1/14 (7.1%) 1 0/18 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/17 (0%) 0
Rhinitis allergic 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 1/17 (5.9%) 1
Nasal congestion 0/11 (0%) 0 0/14 (0%) 0 1/18 (5.6%) 1 0/11 (0%) 0 0/11 (0%) 0 0/17 (0%) 0
Skin and subcutaneous tissue disorders
Rash 1/11 (9.1%) 2 0/14 (0%) 0 0/18 (0%) 0 1/11 (9.1%) 1 1/11 (9.1%) 1 1/17 (5.9%) 1
Eczema 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 1/17 (5.9%) 1
Dermatitis 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/17 (0%) 0
Dermatitis diaper 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 1/11 (9.1%) 1 0/17 (0%) 0
Miliaria 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 1/11 (9.1%) 1 0/11 (0%) 0 0/17 (0%) 0
Rash macular 0/11 (0%) 0 0/14 (0%) 0 0/18 (0%) 0 0/11 (0%) 0 0/11 (0%) 0 1/17 (5.9%) 1
Erythema 0/11 (0%) 0 0/14 (0%) 0 1/18 (5.6%) 1 0/11 (0%) 0 0/11 (0%) 0 0/17 (0%) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.

Results Point of Contact

Name/Title GSK Response Center
Organization GlaxoSmithKline
Phone 866-435-7343
Email GSKClinicalSupportHD@gsk.com
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02927873
Other Study ID Numbers:
  • 204838
  • 2016-000117-76
First Posted:
Oct 7, 2016
Last Update Posted:
Oct 28, 2021
Last Verified:
Sep 1, 2021