Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00308412
Status:
COMPLETED
Last Update Posted:
2010-07-16
First Post:
2006-03-28
Brief Title:
Safety of and Immune Response to a Human Parainfluenza Virus Vaccine rHPIV3cp45 in Healthy Infants
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Phase 1 Study to Determine the Safety Infectivity and Tolerability of Two Doses of Live Attenuated Recombinant Cold Passaged cp 45 Parainfluenza Type 3 Virus Vaccine rHPIV3cp45 Lot PIV3 102A Delivered as Nose Drops to Infants 6 to 12 Months of Age and to HPIV3 Seronegative Infants and Children 6 to 36 Months of Age
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Human parainfluenza viruses HPIVs are a major health concern in infants and young children under 5 years of age causing serious respiratory tract disease The purpose of this study is to test the safety of and immune response to a new HPIV vaccine in healthy infants and children
Detailed Description:
HPIV type 3 HPIV3 ranks second only to respiratory syncytial virus as the most important cause of bronchiolitis and pneumonia in infants less than 6 months of age HPIV3 can cause severe disease in the first 2 years of life and is responsible for 11 of hospitalizations for respiratory diseases in children This study will evaluate the safety and immunogenicity of a live recombinant attenuated intranasal HPIV3 vaccine rHPIV3cp45
This study will last for a maximum of 180 days Infants will be enrolled into one of two study groups Group 1 or Group 2 Depending on the study location groups will enroll either sequentially or concurrently Within each group infants will be randomly assigned to receive 2 immunizations of rHPIV3cp45 or placebo Immunizations will be given as nose drops Immunizations will be given at study entry and approximately 4 to 10 weeks after study entry
On the day of immunization a physical exam vital signs measurement blood collection and medical history will occur Infants will be observed for 15 minutes after immunization for any immediate adverse effects Parents or guardians will be given a thermometer to take with them and will be instructed on how to take their infants temperature They will be given the study schedule and will need to provide contact phone numbers so study personnel can contact them by phone during the days after immunization Parents and guardians will be contacted by telephone on days without study visits from Day 1 to Day 19 and on Day 180 after immunization and asked about any illnesses or adverse effects they have observed in their immunized infants
Parents or guardians will need to record their infants temperature daily for at least the 17 days immediately following immunization During this 17-day period there will be at least 6 study visits associated with each immunization visits will occur on the day of immunization and approximately 3 7 10 14 and 17 days after immunization At all study visits infants will undergo a physical exam and vital signs measurement Group 1 participants will also undergo a nasal wash for a viral culture There will be additional follow-up visits occurring sometime between 28 and 70 days after the first dose and 28 to 35 days after the second dose blood collection will occur at the follow-up visits Additional visits may be required on selected days during the month after immunization Infants who experience illness or side effects may be asked to return to the clinic for examination Parents or guardians will be made aware of whether their infant received the HPIV vaccine or placebo 18 days after the second immunization or in the event of a lower respiratory tract illness
This study will last for a maximum of 180 days Infants will be enrolled into one of two study groups Group 1 or Group 2 Depending on the study location groups will enroll either sequentially or concurrently Within each group infants will be randomly assigned to receive 2 immunizations of rHPIV3cp45 or placebo Immunizations will be given as nose drops Immunizations will be given at study entry and approximately 4 to 10 weeks after study entry
On the day of immunization a physical exam vital signs measurement blood collection and medical history will occur Infants will be observed for 15 minutes after immunization for any immediate adverse effects Parents or guardians will be given a thermometer to take with them and will be instructed on how to take their infants temperature They will be given the study schedule and will need to provide contact phone numbers so study personnel can contact them by phone during the days after immunization Parents and guardians will be contacted by telephone on days without study visits from Day 1 to Day 19 and on Day 180 after immunization and asked about any illnesses or adverse effects they have observed in their immunized infants
Parents or guardians will need to record their infants temperature daily for at least the 17 days immediately following immunization During this 17-day period there will be at least 6 study visits associated with each immunization visits will occur on the day of immunization and approximately 3 7 10 14 and 17 days after immunization At all study visits infants will undergo a physical exam and vital signs measurement Group 1 participants will also undergo a nasal wash for a viral culture There will be additional follow-up visits occurring sometime between 28 and 70 days after the first dose and 28 to 35 days after the second dose blood collection will occur at the follow-up visits Additional visits may be required on selected days during the month after immunization Infants who experience illness or side effects may be asked to return to the clinic for examination Parents or guardians will be made aware of whether their infant received the HPIV vaccine or placebo 18 days after the second immunization or in the event of a lower respiratory tract illness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIR H22050719A1 | None | None | None |