NCT02927873

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

Completed Phase 1, PHASE2 Results posted Last updated 28 October 2021

What this trial tests

Phase 1, PHASE2 trial testing RSV (GSK3389245A) low dose formulation vaccine in Respiratory Syncytial Virus Infections in 107 participants. Completed in 26 November 2020.

Timeline

11 January 2017

Primary endpoint
19 February 2019

26 November 2020

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	107
Start date	11 January 2017
Primary completion	19 February 2019
Estimated completion	26 November 2020
Sites	24 locations across Italy, Panama, Taiwan, Poland, Mexico, Canada, United States, Spain

Drugs / interventions tested

• RSV (GSK3389245A) low dose formulation vaccine — full drug profile →
• RSV (GSK3389245A) middle dose formulation vaccine — full drug profile →
• RSV (GSK3389245A) high dose formulation vaccine — full drug profile →
• Placebo

Conditions studied

• Respiratory Syncytial Virus Infections — all drugs for Respiratory Syncytial Virus Infections →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 12 Months to 23 Months, any sex, with Respiratory Syncytial Virus Infections. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Any Solicited Local Adverse Events (AEs) Primary · 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.

DOSE 1, Any Pain

Group	Value	95% CI
RSV LD Group	1
RSV MD Group	2
RSV HD Group	0
Placebo LD Group	2
Placebo MD Group	0
Placebo HD Group	2

DOSE 1, Any Redness

Group	Value	95% CI
RSV LD Group	2
RSV MD Group	1
RSV HD Group	3
Placebo LD Group	3
Placebo MD Group	0
Placebo HD Group	3

DOSE 1, Any Swelling

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	1
Placebo LD Group	1
Placebo MD Group	1
Placebo HD Group	2

DOSE 2, Any Pain

Group	Value	95% CI
RSV LD Group	2
RSV MD Group	2
RSV HD Group	2
Placebo LD Group	1
Placebo MD Group	0
Placebo HD Group	3

DOSE 2, Any Redness

Group	Value	95% CI
RSV LD Group	2
RSV MD Group	1
RSV HD Group	2
Placebo LD Group	3
Placebo MD Group	0
Placebo HD Group	2

DOSE 2, Any Swelling

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	1
Placebo MD Group	0
Placebo HD Group	2

Number of Subjects With Any Solicited General AEs Primary · 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.

DOSE 1, Any Drowsiness

Group	Value	95% CI
RSV LD Group	4
RSV MD Group	2
RSV HD Group	4
Placebo LD Group	5
Placebo MD Group	3
Placebo HD Group	4

DOSE 1, Any Irritability / Fussiness

Group	Value	95% CI
RSV LD Group	3
RSV MD Group	3
RSV HD Group	4
Placebo LD Group	4
Placebo MD Group	2
Placebo HD Group	2

DOSE 1, Any Loss Of Appetite

Group	Value	95% CI
RSV LD Group	3
RSV MD Group	3
RSV HD Group	4
Placebo LD Group	2
Placebo MD Group	2
Placebo HD Group	3

DOSE 1, Any Fever

Group	Value	95% CI
RSV LD Group	3
RSV MD Group	3
RSV HD Group	10
Placebo LD Group	3
Placebo MD Group	2
Placebo HD Group	0

DOSE 2, Any Drowsiness

Group	Value	95% CI
RSV LD Group	2
RSV MD Group	1
RSV HD Group	5
Placebo LD Group	3
Placebo MD Group	2
Placebo HD Group	5

DOSE 2, Any Irritability / Fussiness

Group	Value	95% CI
RSV LD Group	3
RSV MD Group	1
RSV HD Group	5
Placebo LD Group	3
Placebo MD Group	1
Placebo HD Group	6

DOSE 2, Any Loss Of Appetite

Group	Value	95% CI
RSV LD Group	3
RSV MD Group	0
RSV HD Group	6
Placebo LD Group	3
Placebo MD Group	2
Placebo HD Group	5

DOSE 2, Any Fever

Group	Value	95% CI
RSV LD Group	2
RSV MD Group	2
RSV HD Group	5
Placebo LD Group	1
Placebo MD Group	2
Placebo HD Group	1

Number of Subjects With Any Unsolicited AEs Primary · 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.

Group	Value	95% CI
RSV LD Group	9
RSV MD Group	9
RSV HD Group	13
Placebo LD Group	7
Placebo MD Group	10
Placebo HD Group	13

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

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	1
Placebo LD Group	1
Placebo MD Group	0
Placebo HD Group	2

Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Specific Interest) Primary · 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.

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	0

Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2 Primary · 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. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 2\].

HgL, Below, Below

Group	Value	95% CI
RSV LD Group	3
RSV MD Group	2
RSV HD Group	1
Placebo LD Group	1
Placebo MD Group	0
Placebo HD Group	0

HgL, Within, Unknown

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	1
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	0

HgL, Within, Below

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	2
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	2
Placebo HD Group	2

HgL, Within, Within

Group	Value	95% CI
RSV LD Group	8
RSV MD Group	9
RSV HD Group	15
Placebo LD Group	10
Placebo MD Group	9
Placebo HD Group	13

HgL, Within, Above

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	1

HgL, Above, Within

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	1

HgL, Above, Above

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	1
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	0

WBC, Below, Below

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	1
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	0

Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8 Primary · 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. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 8\].

HgL, Below, Below

Group	Value	95% CI
RSV LD Group	2
RSV MD Group	1
RSV HD Group	0
Placebo LD Group	1
Placebo MD Group	0
Placebo HD Group	0

HgL, Within, Within

Group	Value	95% CI
RSV LD Group	7
RSV MD Group	2
RSV HD Group	2
Placebo LD Group	7
Placebo MD Group	5
Placebo HD Group	2

HgL, Above, Above

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	1

WBC, Within, Within

Group	Value	95% CI
RSV LD Group	8
RSV MD Group	2
RSV HD Group	2
Placebo LD Group	8
Placebo MD Group	2
Placebo HD Group	3

WBC, Within, Above

Group	Value	95% CI
RSV LD Group	1
RSV MD Group	1
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	0

WBC, Above, Within

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	3
Placebo HD Group	0

PLC, Within, Within

Group	Value	95% CI
RSV LD Group	7
RSV MD Group	3
RSV HD Group	1
Placebo LD Group	8
Placebo MD Group	0
Placebo HD Group	3

PLC, Within, Above

Group	Value	95% CI
RSV LD Group	1
RSV MD Group	0
RSV HD Group	1
Placebo LD Group	0
Placebo MD Group	3
Placebo HD Group	0

Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 Primary · 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. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 31\].

HgL, Below, Below

Group	Value	95% CI
RSV LD Group	3
RSV MD Group	1
RSV HD Group	1
Placebo LD Group	1
Placebo MD Group	0
Placebo HD Group	0

HgL, Below, Within

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	1
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	0

HgL, Within, Unknown

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	1
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	0

HgL, Within, Below

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	1
Placebo HD Group	2

HgL, Within, Within

Group	Value	95% CI
RSV LD Group	7
RSV MD Group	9
RSV HD Group	15
Placebo LD Group	9
Placebo MD Group	8
Placebo HD Group	14

HgL, Within, Above

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	1
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	0

HgL, Above, Within

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	1
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	1

WBC, Below, Within

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	1
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	1

Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32 Primary · 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. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 32\].

HgL, Below, Below

Group	Value	95% CI
RSV LD Group	2
RSV MD Group	2
RSV HD Group	1
Placebo LD Group	1
Placebo MD Group	0
Placebo HD Group	0

HgL, Below, Within

Group	Value	95% CI
RSV LD Group	1
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	0

HgL, Within, Unknown

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	1
Placebo MD Group	0
Placebo HD Group	0

HgL, Within, Below

Group	Value	95% CI
RSV LD Group	1
RSV MD Group	1
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	1
Placebo HD Group	2

HgL, Within, Within

Group	Value	95% CI
RSV LD Group	6
RSV MD Group	7
RSV HD Group	14
Placebo LD Group	9
Placebo MD Group	8
Placebo HD Group	14

HgL, Within, Above

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	1
Placebo LD Group	0
Placebo MD Group	1
Placebo HD Group	0

HgL, Above, Within

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	1

HgL, Above, Above

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	1
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	0

Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38 Primary · 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. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 38\].

HgL, Below, Below

Group	Value	95% CI
RSV LD Group	2
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	1
Placebo MD Group	0
Placebo HD Group	0

HgL, Within, Within

Group	Value	95% CI
RSV LD Group	6
RSV MD Group	1
RSV HD Group	0
Placebo LD Group	5
Placebo MD Group	2
Placebo HD Group	1

HgL, Above, Above

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	1

WBC, Within, Within

Group	Value	95% CI
RSV LD Group	8
RSV MD Group	1
RSV HD Group	0
Placebo LD Group	4
Placebo MD Group	1
Placebo HD Group	2

WBC, Within, Above

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	2
Placebo MD Group	0
Placebo HD Group	0

WBC, Above, Above

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	1
Placebo HD Group	0

PLC, Within, Within

Group	Value	95% CI
RSV LD Group	7
RSV MD Group	1
RSV HD Group	0
Placebo LD Group	5
Placebo MD Group	0
Placebo HD Group	1

PLC, Within, Above

Group	Value	95% CI
RSV LD Group	1
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	1
Placebo MD Group	1
Placebo HD Group	1

Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61 Primary · 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. \[e.g. HgL, Below, Below = HgL below normal ranges at baseline versus below normal ranges at Day 61\].

HgL, Below, Below

Group	Value	95% CI
RSV LD Group	2
RSV MD Group	1
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	0

HgL, Below, Within

Group	Value	95% CI
RSV LD Group	1
RSV MD Group	0
RSV HD Group	1
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	0

HgL, Within, Unknown

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	1
Placebo MD Group	0
Placebo HD Group	0

HgL, Within, Below

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	1
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	2

HgL, Within, Within

Group	Value	95% CI
RSV LD Group	7
RSV MD Group	10
RSV HD Group	16
Placebo LD Group	8
Placebo MD Group	11
Placebo HD Group	13

HgL, Above, Within

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	1

HgL, Above, Above

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	1
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	0

WBC, Below, Within

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	1
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	1

Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31 Primary · 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. \[e.g. ALT, Below, Below = ALT below normal ranges at baseline versus below normal ranges at Day 31\].

ALT, Below, Below

Group	Value	95% CI
RSV LD Group	1
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	0

ALT, Below, Within

Group	Value	95% CI
RSV LD Group	1
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	0

ALT, Below, Above

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	1

ALT, Within, Unknown

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	1
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	0

ALT, Within, Below

Group	Value	95% CI
RSV LD Group	1
RSV MD Group	0
RSV HD Group	0
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	0

ALT, Within, Within

Group	Value	95% CI
RSV LD Group	7
RSV MD Group	10
RSV HD Group	15
Placebo LD Group	11
Placebo MD Group	7
Placebo HD Group	13

ALT, Within, Above

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	0
RSV HD Group	1
Placebo LD Group	0
Placebo MD Group	2
Placebo HD Group	0

ALT, Above, Within

Group	Value	95% CI
RSV LD Group	0
RSV MD Group	1
RSV HD Group	1
Placebo LD Group	0
Placebo MD Group	0
Placebo HD Group	2

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

RSV LD Group

Serious: 1/11 (9%)

Deaths: 0/11

RSV MD Group

Serious: 1/14 (7%)

Deaths: 0/14

RSV HD Group

Serious: 2/18 (11%)

Deaths: 0/18

Placebo LD Group

Serious: 3/11 (27%)

Deaths: 0/11

Placebo MD Group

Serious: 1/11 (9%)

Deaths: 0/11

Placebo HD Group

Serious: 2/17 (12%)

Deaths: 0/17

Serious adverse events (14 terms)

Reaction	System	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
Respiratory syncytial virus infection	Infections and infestations	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—
Coronavirus infection	Infections and infestations	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—
Enterovirus infection	Infections and infestations	—	—	—	—	—	—
Escherichia urinary tract infection	Infections and infestations	—	—	—	—	—	—
Respiratory syncytial virus bronchiolitis	Infections and infestations	—	—	—	—	—	—
Rhinovirus infection	Infections and infestations	—	—	—	—	—	—
Tonsillitis	Infections and infestations	—	—	—	—	—	—
Herpangina	Infections and infestations	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—
Unresponsive to stimuli	Nervous system disorders	—	—	—	—	—	—
Febrile convulsion	Nervous system disorders	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—

Other adverse events (51 terms — click to expand)

Reaction	System	RSV LD Group	RSV MD Group	RSV HD Group	Placebo LD Group	Placebo MD Group	Placebo HD Group
Pyrexia	General disorders	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—
Injection site erythema	General disorders	—	—	—	—	—	—
Injection site pain	General disorders	—	—	—	—	—	—
Injection site swelling	General disorders	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—
Conjunctivitis	Infections and infestations	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—
Impetigo	Infections and infestations	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
Pharyngotonsillitis	Infections and infestations	—	—	—	—	—	—
Tonsillitis streptococcal	Infections and infestations	—	—	—	—	—	—
Otitis media	Infections and infestations	—	—	—	—	—	—
Varicella	Infections and infestations	—	—	—	—	—	—
Bronchiolitis	Infections and infestations	—	—	—	—	—	—
Croup infectious	Infections and infestations	—	—	—	—	—	—
Gastroenteritis viral	Infections and infestations	—	—	—	—	—	—
Hand-foot-and-mouth disease	Infections and infestations	—	—	—	—	—	—
Paronychia	Infections and infestations	—	—	—	—	—	—
Pharyngitis	Infections and infestations	—	—	—	—	—	—
Tonsillitis	Infections and infestations	—	—	—	—	—	—
Acarodermatitis	Infections and infestations	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—
Pharyngitis streptococcal	Infections and infestations	—	—	—	—	—	—
Teething	Gastrointestinal disorders	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Gastrointestinal inflammation	Gastrointestinal disorders	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Catarrh	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Dermatitis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Dermatitis diaper	Skin and subcutaneous tissue disorders	—	—	—	—	—	—

Most-reported serious reactions: Respiratory syncytial virus infection, Gastroenteritis, Coronavirus infection, Bronchitis, Enterovirus infection, Escherichia urinary tract infection, Respiratory syncytial virus bronchiolitis, Rhinovirus infection.

Data from ClinicalTrials.gov NCT02927873 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Past, Present and Future Approaches to the Prevention and Treatment of Respiratory Syncytial Virus Infection in Children.
   Simões EAF, Bont L, Manzoni P, Fauroux B, et al · · 2018 · cited 116× · PMID 29470837 · DOI 10.1007/s40121-018-0188-z
2. The Future of Respiratory Syncytial Virus Disease Prevention and Treatment.
   Domachowske JB, Anderson EJ, Goldstein M. · · 2021 · cited 90× · PMID 33656652 · DOI 10.1007/s40121-020-00383-6
3. Respiratory syncytial virus: from pathogenesis to potential therapeutic strategies.
   Shang Z, Tan S, Ma D. · · 2021 · cited 74× · PMID 34671221 · DOI 10.7150/ijbs.64762
4. Ongoing developments in RSV prophylaxis: a clinician's analysis.
   Rezaee F, Linfield DT, Harford TJ, Piedimonte G. · · 2017 · cited 52× · PMID 28500974 · DOI 10.1016/j.coviro.2017.03.015
5. First-in-Human Randomized Study to Assess the Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus (RSV) Vaccine Based on Chimpanzee-Adenovirus-155 Viral Vector-Expressing RSV Fusion, Nucleocapsid, and Antitermination Viral Proteins in Healthy Adults.
   Cicconi P, Jones C, Sarkar E, Silva-Reyes L, et al · · 2020 · cited 49× · PMID 31340042 · DOI 10.1093/cid/ciz653
6. Current State and Challenges in Developing Respiratory Syncytial Virus Vaccines.
   Biagi C, Dondi A, Scarpini S, Rocca A, et al · · 2020 · cited 45× · PMID 33187337 · DOI 10.3390/vaccines8040672
7. Promising approaches for the treatment and prevention of viral respiratory illnesses.
   Papadopoulos NG, Megremis S, Kitsioulis NA, Vangelatou O, et al · · 2017 · cited 40× · PMID 28739285 · DOI 10.1016/j.jaci.2017.07.001
8. Prevention of Pediatric Respiratory Syncytial Virus Lower Respiratory Tract Illness: Perspectives for the Next Decade.
   Aranda SS, Polack FP. · · 2019 · cited 37× · PMID 31134078 · DOI 10.3389/fimmu.2019.01006