A Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to <24 Month-old Children and in 2 Month-old Infants

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

1,338

Participants

Timeline

Start Date

June 30, 2008

Primary Completion Date

August 31, 2012

Study Completion Date

August 31, 2012

Conditions
Healthy
Interventions
BIOLOGICAL

MEDI-534, Cohort 1

Participants aged 6 to less than (\<) 24 months will receive MEDI-534, 10\^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.

OTHER

Placebo, Cohort 1

Participants aged 6 to \<24 months will receive placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.

BIOLOGICAL

MEDI-534, Cohort 2

Participants aged 6 to \<24 months will receive MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.

OTHER

Placebo, Cohort 2

Participants aged 6 to \<24 months will receive placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.

BIOLOGICAL

MEDI-534, Cohort 3

Participants aged 2 months will receive MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.

OTHER

Placebo, Cohort 3

Participants aged 2 months will receive placebo matched to MEDI-534, 10\^4 TCID50 by intranasal route at Month 0, 2, and 4.

BIOLOGICAL

MEDI-534, Cohort 4

Participants aged 2 months will receive MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.

OTHER

Placebo, Cohort 4

Participants aged 2 months will receive placebo matched to MEDI-534, 10\^5 TCID50 by intranasal route at Month 0, 2, and 4.

BIOLOGICAL

MEDI-534, Cohort 5

Participants aged 2 months will receive MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.

OTHER

Placebo, Cohort 5

Participants aged 2 months will receive placebo matched to MEDI-534, 10\^6 TCID50 by intranasal route at Month 0, 2, and 4.

Trial Locations (100)

2013

Research Site, Johannesburg

2605

Research Site, Garran

4006

Research Site, Herston

5006

Research Site, North Adelaide

6008

Research Site, Subiaco

7530

Research Site, Belle Ville Cape Town

7824

Research Site, Cape Town

10365

Research Site, Berlin

11042

Research Site, Lake Success

11407

Research Site, Jerez de la Frontera

13210

Research Site, Syracuse

15706

Research Site, Santiago de Compostela

18960

Research Site, Sellersville

20014

Research Site, Donostia / San Sebastian

23113

Research Site, Midlothian

25701

Research Site, Huntington

28041

Research Site, Madrid

28046

Research Site, Madrid

28562

Research Site, New Bern

29011

Research Site, Málaga

30721

Research Site, Dalton

32607

Research Site, Gainesville

33100

Research Site, Tampere

33606

Research Site, Tampa

38305

Research Site, Jackson

40503

Research Site, Lexington

42003

Research Site, Paducah

45229

Research Site, Cincinnati

46010

Research Site, Valencia

46011

Research Site, Valencia

46017

Research Site, Valencia

46021

Research Site, Valencia

46022

Research Site, Valencia

46024

Research Site, Valencia

46183

Research Site, La Eliana, Valencia

46470

Research Site, Catarroja

55108

Research Site, Saint Paul

60614

Research Site, Chicago

63044

Research Site, Bridgeton

66604

Research Site, Topeka

68131

Research Site, Omaha

68134

Research Site, Omaha

72202

Research Site, Little Rock

72712

Research Site, Bentonville

77030

Research Site, Houston

77070

Research Site, Tomball

78229

Research Site, San Antonio

78258

Research Site, San Antonio

79106

Research Site, Freiburg im Breisgau

84041

Research Site, Layton

84058

Research Site, Orem

84790

Research Site, St. George

90201

Research Site, Bell Gardens

90241

Research Site, Downey

90712

Research Site, Lakewood

90723

Research Site, Paramount

91790

Research Site, West Covina

92103

Research Site, San Diego

92801

Research Site, Anaheim

97030

Research Site, Gresham

99010

Research Site, Passo Fundo-RS

Unknown

Research Site, Mobile

Research Site, Anaheim

Research Site, Long Beach

Research Site, Thornton

Research Site, Kansas City

Research Site, Shreveport

Research Site, Las Vegas

Research Site, Brooklyn

Research Site, Johnson City

Research Site, Pittsburgh

Research Site, Amarillo

Research Site, Dallas

Research Site, Poteet

Research Site, San Antonio

Research Site, Porto Alegre - RS

Research Site, Sao Paulo - SP

Research Site, Mainz

Research Site, Netanya

Research Site, Esplugues de Llobregat

11794-8111

Research Site, Stony Brook

05437-010

Research Site, São Paulo

90035-903

Research Site, Porto Alegre/RS

14048-990

Research Site, Ribeirao Preto - SP

01221-020

Research Site, São Paulo

L6W3E1

Research Site, Brampton

S7N 0W8

Research Site, Saskatoon

FI-00930

Research Site, Helsinki

04400

Research Site, Järvenpää

FI-67100

Research Site, Kokkola

FI-70211

Research Site, Kuopio

FI-15140

Research Site, Lahti

FI-90220

Research Site, Oulu

FI-28100

Research Site, Pori

FI-20520

Research Site, Turku

0001

Research Site, Pretoria

04007

Research Site, Almería

04009

Research Site, Almería

04120

Research Site, Almería

08003

Research Site, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MedImmune LLC

INDUSTRY

NCT00686075 - A Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to <24 Month-old Children and in 2 Month-old Infants | Biotech Hunter | Biotech Hunter