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Phase 2 N=82 Randomized Quadruple-blind Prevention

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

Respiratory Syncytial Virus Infections

Enrolled (actual)
82
Serious AEs
12.2%
Results posted
Oct 2021
Primary outcome: Primary: Number of Subjects With Any Solicited Local Adverse Events (AEs) — 1; 2; 0; 2 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
RSV (GSK3389245A) low dose formulation vaccine (Biological); RSV (GSK3389245A) middle dose formulation vaccine (Biological); RSV (GSK3389245A) high dose formulation vaccine (Biological); Placebo (Drug)
Age
Pediatric · 0+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Feb 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects With Any Solicited Local Adverse Events (AEs)
1; 2; 0; 2; 0; 2
PRIMARY
Number of Subjects With Any Solicited General AEs
4; 2; 4; 5; 3; 4
PRIMARY
Number of Subjects With Any Unsolicited AEs
9; 9; 13; 7; 10; 13
PRIMARY
Number of Subjects With Any Serious Adverse Events (SAEs) From Day 1 up to Day 61
0; 0; 1; 1; 0; 2
PRIMARY
Number of Subjects With Episode of Spontaneous or Excessive Bleeding (AE of Specific Interest)
0; 0; 0; 0; 0; 0
PRIMARY
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 2
3; 2; 1; 1; 0; 0
PRIMARY
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 8
2; 1; 0; 1; 0; 0
PRIMARY
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
3; 1; 1; 1; 0; 0
PRIMARY
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 32
2; 2; 1; 1; 0; 0
PRIMARY
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 38
2; 0; 0; 1; 0; 0
PRIMARY
Number of Subjects With Hematological Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61
2; 1; 0; 0; 0; 0
PRIMARY
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 31
1; 0; 0; 0; 0; 0
PRIMARY
Number of Subjects With Biochemical Laboratory Results Change With Respect to Normal Laboratory Ranges and Versus Baseline, at Day 61
1; 0; 0; 0; 0; 0
SECONDARY
Number of Subjects With Any SAEs From Day 1 up to Day 366
1; 1; 1; 3; 1; 2
SECONDARY
Number of Subjects With Lower Respiratory Tract Infection Associated With RSV Infection (RSV-LRTI) (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Day 366
0; 1; 0; 3; 0; 0
SECONDARY
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
1; 3; 1; 4; 3; 3
SECONDARY
Number of Subjects With Any SAEs From Day 1 up to Study Conclusion at Day 731
1; 1; 2; 3; 1; 2
SECONDARY
Number of Subjects With RSV-LRTI (AE of Specific Interest) From Dose 1 Administration (Day 1) up to Study Conclusion at Day 731
0; 1; 0; 3; 0; 0
SECONDARY
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
2; 6; 2; 5; 4; 4
SECONDARY
Frequency of RSV-specific CD4+ T-cells Expressing at Least Two Markers Upon Stimulation With F, N and M2-1 Peptide Pools
169.5; 123; 1; 176; 1813; 291
SECONDARY
Anti-RSV-A Neutralizing Antibody Titers
127.4; 179.4; 495.7; 376.5; 214.6; 332
SECONDARY
Anti-RSV-F Antibody Concentrations
2082; 2061.6; 3686.4; 3933.2; 1216.3; 2988.6
SECONDARY
Palivizumab-competing Antibody Concentrations
5.2; 4.8; 6.6; 6.2; 4.8; 7.2

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.

Eligibility Criteria

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 pe
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02927873). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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