NCT00767416: MEDI-559

A Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, and Viral Shedding of MEDI-559, a Live Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus in Healthy 1 to <24 Month-Old Children

Completed Phase 1/Phase 2 Last updated 18 July 2016

What this trial tests

Phase 1/Phase 2 trial testing MEDI-559 in Healthy in 116 participants. Completed in 1 December 2011.

Timeline

1 October 2008

Primary endpoint
1 December 2011

1 December 2011

Quick facts

Lead sponsor	MedImmune LLC
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	quadruple
Primary purpose	treatment
Enrollment	116
Start date	1 October 2008
Primary completion	1 December 2011
Estimated completion	1 December 2011
Sites	76 locations across United States, Puerto Rico

Drugs / interventions tested

• MEDI-559 — full drug profile →
• Placebo

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

MedImmune LLC — full company profile →

Who can join

Adults 1 Month to 23 Months, any sex, with Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Incidence of solicited symptoms after Dose 1
  Time frame: Through Day 28 after each dose
  Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms for this study include: fever \>100.4°F (\>38.0 °C) regardless of route, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/Fussiness, oropharyngeal irritation (laryngitis), e
• Incidence of solicited symptoms after Dose 2
  Time frame: Through Day 28 after each dose
  Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms for this study include: fever \>100.4°F (\>38.0 °C) regardless of route, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/Fussiness, oropharyngeal irritation (laryngitis), e
• Incidence of solicited symptoms after Dose 3
  Time frame: Through Day 28 after each dose
  Solicited symptoms are predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms for this study include: fever \>100.4°F (\>38.0 °C) regardless of route, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/Fussiness, oropharyngeal irritation (laryngitis), e
• Incidence of adverse events (AEs) after Dose 1
  Time frame: Through Day 28 after each dose
  As defined by the ICH Guideline for Good Clinical Practice, an AE is: Any untoward medical occurrence in a participant or clinical investigations subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), sy
• Incidence of AEs after Dose 2
  Time frame: Through Day 28 after each dose
  As defined by the ICH Guideline for Good Clinical Practice, an AE is: Any untoward medical occurrence in a participant or clinical investigations subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), sy
• Incidence of AEs after Dose 3
  Time frame: Through Day 28 after each dose
  As defined by the ICH Guideline for Good Clinical Practice, an AE is: Any untoward medical occurrence in a participant or clinical investigations subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), sy

Sponsor's own description

The primary objective of this study is to describe the 28-day post-final dose safety and tolerability of three doses of MEDI-559 at 10\^5 FFU when administered to healthy RSV seronegative children 1 to \<24 months of age.

Publications & conference data

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

1. Respiratory syncytial virus--a comprehensive review.
   Borchers AT, Chang C, Gershwin ME, Gershwin LJ. · · 2013 · cited 483× · PMID 23575961 · DOI 10.1007/s12016-013-8368-9
2. Live-attenuated respiratory syncytial virus vaccines.
   Karron RA, Buchholz UJ, Collins PL. · · 2013 · cited 118× · PMID 24362694 · DOI 10.1007/978-3-642-38919-1_13
3. Respiratory syncytial virus vaccine development.
   Hurwitz JL. · · 2011 · cited 86× · PMID 21988307 · DOI 10.1586/erv.11.120
4. Respiratory syncytial virus modified by deletions of the NS2 gene and amino acid S1313 of the L polymerase protein is a temperature-sensitive, live-attenuated vaccine candidate that is phenotypically stable at physiological temperature.
   Luongo C, Winter CC, Collins PL, Buchholz UJ. · · 2013 · cited 63× · PMID 23236065 · DOI 10.1128/jvi.02769-12
5. Safety and immunogenicity of a live attenuated RSV vaccine in healthy RSV-seronegative children 5 to 24 months of age.
   Malkin E, Yogev R, Abughali N, Sliman J, et al · · 2013 · cited 61× · PMID 24204744 · DOI 10.1371/journal.pone.0077104
6. 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
7. The immunogenicity and safety of respiratory syncytial virus vaccines in development: A systematic review.
   Shan J, Britton PN, King CL, Booy R. · · 2021 · cited 47× · PMID 33764693 · DOI 10.1111/irv.12850
8. Noninvasive vaccination against infectious diseases.
   Zheng Z, Diaz-Arévalo D, Guan H, Zeng M. · · 2018 · cited 46× · PMID 29624470 · DOI 10.1080/21645515.2018.1461296